Trial Outcomes & Findings for Ixazomib Citrate and Rituximab in Treating Patients With Indolent B-cell Non-Hodgkin Lymphoma (NCT NCT02339922)

Last Updated: 2026-03-05

Results Overview

ORR will be calculated for all treated patients for each disease cohort. The corresponding 95% two-sided confidence interval will be derived.

Recruitment status

ACTIVE_NOT_RECRUITING

Study phase

PHASE2

Target enrollment

33 participants

Primary outcome timeframe

Up to 5 years

Results posted on

2026-03-05

Participant Flow

Participant milestones

Participant milestones
Measure	Treatment (Ixazomib Citrate, Rituximab) Patients receive ixazomib citrate orally (PO) on days 1, 8 ,15, and 22. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Upon completion of 6 cycles of ixazomib citrate therapy, patients also receive rituximab intravenously (IV) once weekly for 4 doses total, followed by ixazomib citrate alone, until disease progression or unacceptable toxicity. Ixazomib Citrate: Given PO Laboratory Biomarker Analysis: Correlative studies Rituximab: Given IV
Overall Study STARTED	33
Overall Study Chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL)	2
Overall Study Follicular lymphoma (FL)	21
Overall Study Marginal zone lymphoma (MZL)	6
Overall Study Mantle cell lymphoma (MCL)	4
Overall Study Waldenstrom macroglobulinemia/lymphoplasmacytic lymphoma (WM/LPL)	0
Overall Study COMPLETED	5
Overall Study NOT COMPLETED	28

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Ixazomib Citrate and Rituximab in Treating Patients With Indolent B-cell Non-Hodgkin Lymphoma

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Treatment (Ixazomib Citrate, Rituximab) n=33 Participants Patients receive ixazomib citrate orally (PO) on days 1, 8 ,15, and 22. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Upon completion of 6 cycles of ixazomib citrate therapy, patients also receive rituximab intravenously (IV) once weekly for 4 doses total, followed by ixazomib citrate alone, until disease progression or unacceptable toxicity. Ixazomib Citrate: Given PO Laboratory Biomarker Analysis: Correlative studies Rituximab: Given IV
Race (NIH/OMB) Black or African American	0 Participants n=41 Participants
Age, Categorical <=18 years	0 Participants n=41 Participants
Age, Categorical Between 18 and 65 years	18 Participants n=41 Participants
Age, Categorical >=65 years	15 Participants n=41 Participants
Age, Continuous	62 years n=41 Participants
Sex: Female, Male Female	11 Participants n=41 Participants
Sex: Female, Male Male	22 Participants n=41 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants n=41 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	31 Participants n=41 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	1 Participants n=41 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=41 Participants
Race (NIH/OMB) Asian	5 Participants n=41 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=41 Participants
Race (NIH/OMB) White	27 Participants n=41 Participants
Race (NIH/OMB) More than one race	1 Participants n=41 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=41 Participants
Region of Enrollment United States	33 participants n=41 Participants

PRIMARY outcome

Timeframe: Up to 5 years

ORR will be calculated for all treated patients for each disease cohort. The corresponding 95% two-sided confidence interval will be derived.

Outcome measures

Outcome measures
Measure	Treatment (Ixazomib Citrate, Rituximab) for CLL/SLL n=2 Participants Patients receive ixazomib citrate orally (PO) on days 1, 8 ,15, and 22. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Upon completion of 6 cycles of ixazomib citrate therapy, patients also receive rituximab intravenously (IV) once weekly for 4 doses total, followed by ixazomib citrate alone, until disease progression or unacceptable toxicity. Ixazomib Citrate: Given PO Laboratory Biomarker Analysis: Correlative studies Rituximab: Given IV	Treatment (Ixazomib Citrate, Rituximab) for FL n=21 Participants Patients receive ixazomib citrate orally (PO) on days 1, 8 ,15, and 22. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Upon completion of 6 cycles of ixazomib citrate therapy, patients also receive rituximab intravenously (IV) once weekly for 4 doses total, followed by ixazomib citrate alone, until disease progression or unacceptable toxicity. Ixazomib Citrate: Given PO Laboratory Biomarker Analysis: Correlative studies Rituximab: Given IV	Treatment (Ixazomib Citrate, Rituximab) for MZL n=6 Participants Patients receive ixazomib citrate orally (PO) on days 1, 8 ,15, and 22. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Upon completion of 6 cycles of ixazomib citrate therapy, patients also receive rituximab intravenously (IV) once weekly for 4 doses total, followed by ixazomib citrate alone, until disease progression or unacceptable toxicity. Ixazomib Citrate: Given PO Laboratory Biomarker Analysis: Correlative studies Rituximab: Given IV	Treatment (Ixazomib Citrate, Rituximab) for MCL n=4 Participants Patients receive ixazomib citrate orally (PO) on days 1, 8 ,15, and 22. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Upon completion of 6 cycles of ixazomib citrate therapy, patients also receive rituximab intravenously (IV) once weekly for 4 doses total, followed by ixazomib citrate alone, until disease progression or unacceptable toxicity. Ixazomib Citrate: Given PO Laboratory Biomarker Analysis: Correlative studies Rituximab: Given IV	Treatment (Ixazomib Citrate, Rituximab) for WM/LPL Patients receive ixazomib citrate orally (PO) on days 1, 8 ,15, and 22. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Upon completion of 6 cycles of ixazomib citrate therapy, patients also receive rituximab intravenously (IV) once weekly for 4 doses total, followed by ixazomib citrate alone, until disease progression or unacceptable toxicity. Ixazomib Citrate: Given PO Laboratory Biomarker Analysis: Correlative studies Rituximab: Given IV
Overall Response Rate (ORR) (Complete Response [CR] + Partial Response [PR]) in Patients With Chronic Lymphocytic Leukemia (CLL)/ Small Lymphocytic Lymphoma (SLL), Follicular Lymphoma (FL), Marginal Zone Lymphoma (MZL), and Mantle Cell Lymphoma (MCL)	0 Participants	13 Participants	2 Participants	2 Participants	—

PRIMARY outcome

Timeframe: Up to 5 years

Population: No patients with Waldenstrom macroglobulinemia (WM)/lymphoplasmacytic lymphoma (LPL) were enrolled.

ORR will be calculated for all treated patients for each disease cohort. The corresponding 95% two-sided confidence interval will be derived.

Outcome measures

Outcome measures
Measure	Treatment (Ixazomib Citrate, Rituximab) for CLL/SLL Patients receive ixazomib citrate orally (PO) on days 1, 8 ,15, and 22. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Upon completion of 6 cycles of ixazomib citrate therapy, patients also receive rituximab intravenously (IV) once weekly for 4 doses total, followed by ixazomib citrate alone, until disease progression or unacceptable toxicity. Ixazomib Citrate: Given PO Laboratory Biomarker Analysis: Correlative studies Rituximab: Given IV	Treatment (Ixazomib Citrate, Rituximab) for FL Patients receive ixazomib citrate orally (PO) on days 1, 8 ,15, and 22. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Upon completion of 6 cycles of ixazomib citrate therapy, patients also receive rituximab intravenously (IV) once weekly for 4 doses total, followed by ixazomib citrate alone, until disease progression or unacceptable toxicity. Ixazomib Citrate: Given PO Laboratory Biomarker Analysis: Correlative studies Rituximab: Given IV	Treatment (Ixazomib Citrate, Rituximab) for MZL Patients receive ixazomib citrate orally (PO) on days 1, 8 ,15, and 22. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Upon completion of 6 cycles of ixazomib citrate therapy, patients also receive rituximab intravenously (IV) once weekly for 4 doses total, followed by ixazomib citrate alone, until disease progression or unacceptable toxicity. Ixazomib Citrate: Given PO Laboratory Biomarker Analysis: Correlative studies Rituximab: Given IV	Treatment (Ixazomib Citrate, Rituximab) for MCL Patients receive ixazomib citrate orally (PO) on days 1, 8 ,15, and 22. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Upon completion of 6 cycles of ixazomib citrate therapy, patients also receive rituximab intravenously (IV) once weekly for 4 doses total, followed by ixazomib citrate alone, until disease progression or unacceptable toxicity. Ixazomib Citrate: Given PO Laboratory Biomarker Analysis: Correlative studies Rituximab: Given IV	Treatment (Ixazomib Citrate, Rituximab) for WM/LPL Patients receive ixazomib citrate orally (PO) on days 1, 8 ,15, and 22. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Upon completion of 6 cycles of ixazomib citrate therapy, patients also receive rituximab intravenously (IV) once weekly for 4 doses total, followed by ixazomib citrate alone, until disease progression or unacceptable toxicity. Ixazomib Citrate: Given PO Laboratory Biomarker Analysis: Correlative studies Rituximab: Given IV
ORR (CR + Very Good PR + PR + Minor Response) in Patients With Waldenstrom Macroglobulinemia (WM)/ Lymphoplasmacytic Lymphoma (LPL)	0 Participants	—	—	—	—

SECONDARY outcome

Timeframe: From the time by which the measurement criteria are met for CR or PR, whichever is recorded first, until death or the first date by which recurrent or progressive disease is objectively documented, assessed up to 5 years

Population: No patients with CLL/SLL or WM/LPL met criteria to be included in DOR.

DOR will be calculated to determine durability. Non-responders will be excluded from the analysis of DOR. Kaplan Meier methodology will be used to estimate event-free curves.

Outcome measures

Outcome measures
Measure	Treatment (Ixazomib Citrate, Rituximab) for CLL/SLL Patients receive ixazomib citrate orally (PO) on days 1, 8 ,15, and 22. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Upon completion of 6 cycles of ixazomib citrate therapy, patients also receive rituximab intravenously (IV) once weekly for 4 doses total, followed by ixazomib citrate alone, until disease progression or unacceptable toxicity. Ixazomib Citrate: Given PO Laboratory Biomarker Analysis: Correlative studies Rituximab: Given IV	Treatment (Ixazomib Citrate, Rituximab) for FL n=13 Participants Patients receive ixazomib citrate orally (PO) on days 1, 8 ,15, and 22. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Upon completion of 6 cycles of ixazomib citrate therapy, patients also receive rituximab intravenously (IV) once weekly for 4 doses total, followed by ixazomib citrate alone, until disease progression or unacceptable toxicity. Ixazomib Citrate: Given PO Laboratory Biomarker Analysis: Correlative studies Rituximab: Given IV	Treatment (Ixazomib Citrate, Rituximab) for MZL n=2 Participants Patients receive ixazomib citrate orally (PO) on days 1, 8 ,15, and 22. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Upon completion of 6 cycles of ixazomib citrate therapy, patients also receive rituximab intravenously (IV) once weekly for 4 doses total, followed by ixazomib citrate alone, until disease progression or unacceptable toxicity. Ixazomib Citrate: Given PO Laboratory Biomarker Analysis: Correlative studies Rituximab: Given IV	Treatment (Ixazomib Citrate, Rituximab) for MCL n=2 Participants Patients receive ixazomib citrate orally (PO) on days 1, 8 ,15, and 22. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Upon completion of 6 cycles of ixazomib citrate therapy, patients also receive rituximab intravenously (IV) once weekly for 4 doses total, followed by ixazomib citrate alone, until disease progression or unacceptable toxicity. Ixazomib Citrate: Given PO Laboratory Biomarker Analysis: Correlative studies Rituximab: Given IV	Treatment (Ixazomib Citrate, Rituximab) for WM/LPL Patients receive ixazomib citrate orally (PO) on days 1, 8 ,15, and 22. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Upon completion of 6 cycles of ixazomib citrate therapy, patients also receive rituximab intravenously (IV) once weekly for 4 doses total, followed by ixazomib citrate alone, until disease progression or unacceptable toxicity. Ixazomib Citrate: Given PO Laboratory Biomarker Analysis: Correlative studies Rituximab: Given IV
Duration of Response (DOR)	—	42 months Interval 1.0 to 60.0	35 months Interval 10.0 to 60.0	60 months Interval 60.0 to 60.0	—

SECONDARY outcome

Timeframe: Time from the first study drug administration to the first occurrence of lymphoma progression or death from any cause, assessed up to 5 years

Population: No patients with Waldenstrom macroglobulinemia (WM)/lymphoplasmacytic lymphoma (LPL) were enrolled.

Data for subjects without disease progression or death will be censored at the date of the last tumor assessment. Kaplan-Meier methodology will be used to estimate the event-free curves.

Outcome measures

Outcome measures
Measure	Treatment (Ixazomib Citrate, Rituximab) for CLL/SLL n=2 Participants Patients receive ixazomib citrate orally (PO) on days 1, 8 ,15, and 22. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Upon completion of 6 cycles of ixazomib citrate therapy, patients also receive rituximab intravenously (IV) once weekly for 4 doses total, followed by ixazomib citrate alone, until disease progression or unacceptable toxicity. Ixazomib Citrate: Given PO Laboratory Biomarker Analysis: Correlative studies Rituximab: Given IV	Treatment (Ixazomib Citrate, Rituximab) for FL n=21 Participants Patients receive ixazomib citrate orally (PO) on days 1, 8 ,15, and 22. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Upon completion of 6 cycles of ixazomib citrate therapy, patients also receive rituximab intravenously (IV) once weekly for 4 doses total, followed by ixazomib citrate alone, until disease progression or unacceptable toxicity. Ixazomib Citrate: Given PO Laboratory Biomarker Analysis: Correlative studies Rituximab: Given IV	Treatment (Ixazomib Citrate, Rituximab) for MZL n=6 Participants Patients receive ixazomib citrate orally (PO) on days 1, 8 ,15, and 22. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Upon completion of 6 cycles of ixazomib citrate therapy, patients also receive rituximab intravenously (IV) once weekly for 4 doses total, followed by ixazomib citrate alone, until disease progression or unacceptable toxicity. Ixazomib Citrate: Given PO Laboratory Biomarker Analysis: Correlative studies Rituximab: Given IV	Treatment (Ixazomib Citrate, Rituximab) for MCL n=4 Participants Patients receive ixazomib citrate orally (PO) on days 1, 8 ,15, and 22. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Upon completion of 6 cycles of ixazomib citrate therapy, patients also receive rituximab intravenously (IV) once weekly for 4 doses total, followed by ixazomib citrate alone, until disease progression or unacceptable toxicity. Ixazomib Citrate: Given PO Laboratory Biomarker Analysis: Correlative studies Rituximab: Given IV	Treatment (Ixazomib Citrate, Rituximab) for WM/LPL Patients receive ixazomib citrate orally (PO) on days 1, 8 ,15, and 22. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Upon completion of 6 cycles of ixazomib citrate therapy, patients also receive rituximab intravenously (IV) once weekly for 4 doses total, followed by ixazomib citrate alone, until disease progression or unacceptable toxicity. Ixazomib Citrate: Given PO Laboratory Biomarker Analysis: Correlative studies Rituximab: Given IV
Progression-free Survival (PFS)	1 Participants	9 Participants	1 Participants	2 Participants	0 Participants

SECONDARY outcome

Timeframe: Up to 5 years

Population: No patients with Waldenstrom macroglobulinemia (WM)/lymphoplasmacytic lymphoma (LPL) were enrolled.

Outcome measures

Outcome measures
Measure	Treatment (Ixazomib Citrate, Rituximab) for CLL/SLL n=2 Participants Patients receive ixazomib citrate orally (PO) on days 1, 8 ,15, and 22. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Upon completion of 6 cycles of ixazomib citrate therapy, patients also receive rituximab intravenously (IV) once weekly for 4 doses total, followed by ixazomib citrate alone, until disease progression or unacceptable toxicity. Ixazomib Citrate: Given PO Laboratory Biomarker Analysis: Correlative studies Rituximab: Given IV	Treatment (Ixazomib Citrate, Rituximab) for FL n=21 Participants Patients receive ixazomib citrate orally (PO) on days 1, 8 ,15, and 22. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Upon completion of 6 cycles of ixazomib citrate therapy, patients also receive rituximab intravenously (IV) once weekly for 4 doses total, followed by ixazomib citrate alone, until disease progression or unacceptable toxicity. Ixazomib Citrate: Given PO Laboratory Biomarker Analysis: Correlative studies Rituximab: Given IV	Treatment (Ixazomib Citrate, Rituximab) for MZL n=6 Participants Patients receive ixazomib citrate orally (PO) on days 1, 8 ,15, and 22. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Upon completion of 6 cycles of ixazomib citrate therapy, patients also receive rituximab intravenously (IV) once weekly for 4 doses total, followed by ixazomib citrate alone, until disease progression or unacceptable toxicity. Ixazomib Citrate: Given PO Laboratory Biomarker Analysis: Correlative studies Rituximab: Given IV	Treatment (Ixazomib Citrate, Rituximab) for MCL n=4 Participants Patients receive ixazomib citrate orally (PO) on days 1, 8 ,15, and 22. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Upon completion of 6 cycles of ixazomib citrate therapy, patients also receive rituximab intravenously (IV) once weekly for 4 doses total, followed by ixazomib citrate alone, until disease progression or unacceptable toxicity. Ixazomib Citrate: Given PO Laboratory Biomarker Analysis: Correlative studies Rituximab: Given IV	Treatment (Ixazomib Citrate, Rituximab) for WM/LPL Patients receive ixazomib citrate orally (PO) on days 1, 8 ,15, and 22. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Upon completion of 6 cycles of ixazomib citrate therapy, patients also receive rituximab intravenously (IV) once weekly for 4 doses total, followed by ixazomib citrate alone, until disease progression or unacceptable toxicity. Ixazomib Citrate: Given PO Laboratory Biomarker Analysis: Correlative studies Rituximab: Given IV
Overall Survival	2 Participants	21 Participants	3 Participants	2 Participants	0 Participants

SECONDARY outcome

Timeframe: Up to 5 years

Population: No patients with Waldenstrom macroglobulinemia (WM)/lymphoplasmacytic lymphoma (LPL) were enrolled.

Outcome measures

Outcome measures
Measure	Treatment (Ixazomib Citrate, Rituximab) for CLL/SLL n=2 Participants Patients receive ixazomib citrate orally (PO) on days 1, 8 ,15, and 22. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Upon completion of 6 cycles of ixazomib citrate therapy, patients also receive rituximab intravenously (IV) once weekly for 4 doses total, followed by ixazomib citrate alone, until disease progression or unacceptable toxicity. Ixazomib Citrate: Given PO Laboratory Biomarker Analysis: Correlative studies Rituximab: Given IV	Treatment (Ixazomib Citrate, Rituximab) for FL n=21 Participants Patients receive ixazomib citrate orally (PO) on days 1, 8 ,15, and 22. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Upon completion of 6 cycles of ixazomib citrate therapy, patients also receive rituximab intravenously (IV) once weekly for 4 doses total, followed by ixazomib citrate alone, until disease progression or unacceptable toxicity. Ixazomib Citrate: Given PO Laboratory Biomarker Analysis: Correlative studies Rituximab: Given IV	Treatment (Ixazomib Citrate, Rituximab) for MZL n=6 Participants Patients receive ixazomib citrate orally (PO) on days 1, 8 ,15, and 22. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Upon completion of 6 cycles of ixazomib citrate therapy, patients also receive rituximab intravenously (IV) once weekly for 4 doses total, followed by ixazomib citrate alone, until disease progression or unacceptable toxicity. Ixazomib Citrate: Given PO Laboratory Biomarker Analysis: Correlative studies Rituximab: Given IV	Treatment (Ixazomib Citrate, Rituximab) for MCL n=4 Participants Patients receive ixazomib citrate orally (PO) on days 1, 8 ,15, and 22. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Upon completion of 6 cycles of ixazomib citrate therapy, patients also receive rituximab intravenously (IV) once weekly for 4 doses total, followed by ixazomib citrate alone, until disease progression or unacceptable toxicity. Ixazomib Citrate: Given PO Laboratory Biomarker Analysis: Correlative studies Rituximab: Given IV	Treatment (Ixazomib Citrate, Rituximab) for WM/LPL Patients receive ixazomib citrate orally (PO) on days 1, 8 ,15, and 22. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Upon completion of 6 cycles of ixazomib citrate therapy, patients also receive rituximab intravenously (IV) once weekly for 4 doses total, followed by ixazomib citrate alone, until disease progression or unacceptable toxicity. Ixazomib Citrate: Given PO Laboratory Biomarker Analysis: Correlative studies Rituximab: Given IV
CR Rate	0 Participants	8 Participants	1 Participants	1 Participants	0 Participants

SECONDARY outcome

Timeframe: From the time of first study drug administration until the date of subsequent the first subsequent therapy given to treat the B-NHL, assessed up to 5 years

Population: No patients with Waldenstrom macroglobulinemia (WM)/lymphoplasmacytic lymphoma (LPL) were enrolled.

Data for subjects that have not received additional anti-neoplastic therapy will be censored at the date of last known contact.

Outcome measures

Outcome measures
Measure	Treatment (Ixazomib Citrate, Rituximab) for CLL/SLL n=2 Participants Patients receive ixazomib citrate orally (PO) on days 1, 8 ,15, and 22. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Upon completion of 6 cycles of ixazomib citrate therapy, patients also receive rituximab intravenously (IV) once weekly for 4 doses total, followed by ixazomib citrate alone, until disease progression or unacceptable toxicity. Ixazomib Citrate: Given PO Laboratory Biomarker Analysis: Correlative studies Rituximab: Given IV	Treatment (Ixazomib Citrate, Rituximab) for FL n=21 Participants Patients receive ixazomib citrate orally (PO) on days 1, 8 ,15, and 22. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Upon completion of 6 cycles of ixazomib citrate therapy, patients also receive rituximab intravenously (IV) once weekly for 4 doses total, followed by ixazomib citrate alone, until disease progression or unacceptable toxicity. Ixazomib Citrate: Given PO Laboratory Biomarker Analysis: Correlative studies Rituximab: Given IV	Treatment (Ixazomib Citrate, Rituximab) for MZL n=6 Participants Patients receive ixazomib citrate orally (PO) on days 1, 8 ,15, and 22. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Upon completion of 6 cycles of ixazomib citrate therapy, patients also receive rituximab intravenously (IV) once weekly for 4 doses total, followed by ixazomib citrate alone, until disease progression or unacceptable toxicity. Ixazomib Citrate: Given PO Laboratory Biomarker Analysis: Correlative studies Rituximab: Given IV	Treatment (Ixazomib Citrate, Rituximab) for MCL n=4 Participants Patients receive ixazomib citrate orally (PO) on days 1, 8 ,15, and 22. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Upon completion of 6 cycles of ixazomib citrate therapy, patients also receive rituximab intravenously (IV) once weekly for 4 doses total, followed by ixazomib citrate alone, until disease progression or unacceptable toxicity. Ixazomib Citrate: Given PO Laboratory Biomarker Analysis: Correlative studies Rituximab: Given IV	Treatment (Ixazomib Citrate, Rituximab) for WM/LPL Patients receive ixazomib citrate orally (PO) on days 1, 8 ,15, and 22. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Upon completion of 6 cycles of ixazomib citrate therapy, patients also receive rituximab intravenously (IV) once weekly for 4 doses total, followed by ixazomib citrate alone, until disease progression or unacceptable toxicity. Ixazomib Citrate: Given PO Laboratory Biomarker Analysis: Correlative studies Rituximab: Given IV
Time to Next Therapy (TNT)	49 months Interval 38.0 to 60.0	30.3 months Interval 1.0 to 60.0	30.8 months Interval 0.0 to 60.0	23.5 months Interval 0.0 to 60.0	—

SECONDARY outcome

Timeframe: Up to 30 days after administration of the last dose of ixazomib citrate (Up to 6 years and 7 months).

Population: AE data was intended to be assessed and reported as a single combined group for this study.

Will be graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0. Safety summaries will include tabulations in the form of tables. The frequency of treatment-emergent AE's will be summarized. Additional AE summaries will include AE frequency by AE severity and relationship to the study drug. AE's requiring discontinuation of the study drug will be summarized separately, both overall and by AE severity and by relationship to the study drug. Clinically significant abnormal laboratory values will be summarized over study visits.

Outcome measures

Outcome measures
Measure	Treatment (Ixazomib Citrate, Rituximab) for CLL/SLL n=33 Participants Patients receive ixazomib citrate orally (PO) on days 1, 8 ,15, and 22. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Upon completion of 6 cycles of ixazomib citrate therapy, patients also receive rituximab intravenously (IV) once weekly for 4 doses total, followed by ixazomib citrate alone, until disease progression or unacceptable toxicity. Ixazomib Citrate: Given PO Laboratory Biomarker Analysis: Correlative studies Rituximab: Given IV	Treatment (Ixazomib Citrate, Rituximab) for FL Patients receive ixazomib citrate orally (PO) on days 1, 8 ,15, and 22. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Upon completion of 6 cycles of ixazomib citrate therapy, patients also receive rituximab intravenously (IV) once weekly for 4 doses total, followed by ixazomib citrate alone, until disease progression or unacceptable toxicity. Ixazomib Citrate: Given PO Laboratory Biomarker Analysis: Correlative studies Rituximab: Given IV	Treatment (Ixazomib Citrate, Rituximab) for MZL Patients receive ixazomib citrate orally (PO) on days 1, 8 ,15, and 22. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Upon completion of 6 cycles of ixazomib citrate therapy, patients also receive rituximab intravenously (IV) once weekly for 4 doses total, followed by ixazomib citrate alone, until disease progression or unacceptable toxicity. Ixazomib Citrate: Given PO Laboratory Biomarker Analysis: Correlative studies Rituximab: Given IV	Treatment (Ixazomib Citrate, Rituximab) for MCL Patients receive ixazomib citrate orally (PO) on days 1, 8 ,15, and 22. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Upon completion of 6 cycles of ixazomib citrate therapy, patients also receive rituximab intravenously (IV) once weekly for 4 doses total, followed by ixazomib citrate alone, until disease progression or unacceptable toxicity. Ixazomib Citrate: Given PO Laboratory Biomarker Analysis: Correlative studies Rituximab: Given IV	Treatment (Ixazomib Citrate, Rituximab) for WM/LPL Patients receive ixazomib citrate orally (PO) on days 1, 8 ,15, and 22. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Upon completion of 6 cycles of ixazomib citrate therapy, patients also receive rituximab intravenously (IV) once weekly for 4 doses total, followed by ixazomib citrate alone, until disease progression or unacceptable toxicity. Ixazomib Citrate: Given PO Laboratory Biomarker Analysis: Correlative studies Rituximab: Given IV
Incidence of Adverse Events (AEs)	31 Participants	—	—	—	—

Serious adverse events
Measure	Treatment (Ixazomib Citrate, Rituximab) n=33 participants at risk Patients receive ixazomib citrate orally (PO) on days 1, 8 ,15, and 22. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Upon completion of 6 cycles of ixazomib citrate therapy, patients also receive rituximab intravenously (IV) once weekly for 4 doses total, followed by ixazomib citrate alone, until disease progression or unacceptable toxicity. Ixazomib Citrate: Given PO Laboratory Biomarker Analysis: Correlative studies Rituximab: Given IV
Surgical and medical procedures Surgical and medical procedures - Other, specify	3.0% 1/33 • Number of events 1 • Up to 30 days after administration of the last dose of ixazomib citrate (Up to 6 years and 7 months). Adverse events are collected by spontaneous identification by the patient and/or in response to an open question from study personnel or revealed by observation, physical examination, or other diagnostic procedures. AE data was intended to be assessed and reported as a single combined group for this study.
Metabolism and nutrition disorders Hyponatremia	3.0% 1/33 • Number of events 1 • Up to 30 days after administration of the last dose of ixazomib citrate (Up to 6 years and 7 months). Adverse events are collected by spontaneous identification by the patient and/or in response to an open question from study personnel or revealed by observation, physical examination, or other diagnostic procedures. AE data was intended to be assessed and reported as a single combined group for this study.
Gastrointestinal disorders Nausea	3.0% 1/33 • Number of events 1 • Up to 30 days after administration of the last dose of ixazomib citrate (Up to 6 years and 7 months). Adverse events are collected by spontaneous identification by the patient and/or in response to an open question from study personnel or revealed by observation, physical examination, or other diagnostic procedures. AE data was intended to be assessed and reported as a single combined group for this study.
Gastrointestinal disorders Vomiting	3.0% 1/33 • Number of events 1 • Up to 30 days after administration of the last dose of ixazomib citrate (Up to 6 years and 7 months). Adverse events are collected by spontaneous identification by the patient and/or in response to an open question from study personnel or revealed by observation, physical examination, or other diagnostic procedures. AE data was intended to be assessed and reported as a single combined group for this study.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other, specify	3.0% 1/33 • Number of events 1 • Up to 30 days after administration of the last dose of ixazomib citrate (Up to 6 years and 7 months). Adverse events are collected by spontaneous identification by the patient and/or in response to an open question from study personnel or revealed by observation, physical examination, or other diagnostic procedures. AE data was intended to be assessed and reported as a single combined group for this study.
Infections and infestations Infections and infestations - Other, specify	3.0% 1/33 • Number of events 1 • Up to 30 days after administration of the last dose of ixazomib citrate (Up to 6 years and 7 months). Adverse events are collected by spontaneous identification by the patient and/or in response to an open question from study personnel or revealed by observation, physical examination, or other diagnostic procedures. AE data was intended to be assessed and reported as a single combined group for this study.
Respiratory, thoracic and mediastinal disorders Pleural effusion	3.0% 1/33 • Number of events 1 • Up to 30 days after administration of the last dose of ixazomib citrate (Up to 6 years and 7 months). Adverse events are collected by spontaneous identification by the patient and/or in response to an open question from study personnel or revealed by observation, physical examination, or other diagnostic procedures. AE data was intended to be assessed and reported as a single combined group for this study.
Nervous system disorders Syncope	3.0% 1/33 • Number of events 1 • Up to 30 days after administration of the last dose of ixazomib citrate (Up to 6 years and 7 months). Adverse events are collected by spontaneous identification by the patient and/or in response to an open question from study personnel or revealed by observation, physical examination, or other diagnostic procedures. AE data was intended to be assessed and reported as a single combined group for this study.

Other adverse events

Other adverse events
Measure	Treatment (Ixazomib Citrate, Rituximab) n=33 participants at risk Patients receive ixazomib citrate orally (PO) on days 1, 8 ,15, and 22. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Upon completion of 6 cycles of ixazomib citrate therapy, patients also receive rituximab intravenously (IV) once weekly for 4 doses total, followed by ixazomib citrate alone, until disease progression or unacceptable toxicity. Ixazomib Citrate: Given PO Laboratory Biomarker Analysis: Correlative studies Rituximab: Given IV
Gastrointestinal disorders Abdominal pain	15.2% 5/33 • Number of events 9 • Up to 30 days after administration of the last dose of ixazomib citrate (Up to 6 years and 7 months). Adverse events are collected by spontaneous identification by the patient and/or in response to an open question from study personnel or revealed by observation, physical examination, or other diagnostic procedures. AE data was intended to be assessed and reported as a single combined group for this study.
Investigations Alanine aminotransferase increased	15.2% 5/33 • Number of events 13 • Up to 30 days after administration of the last dose of ixazomib citrate (Up to 6 years and 7 months). Adverse events are collected by spontaneous identification by the patient and/or in response to an open question from study personnel or revealed by observation, physical examination, or other diagnostic procedures. AE data was intended to be assessed and reported as a single combined group for this study.
Investigations Alkaline phosphatase increased	3.0% 1/33 • Number of events 1 • Up to 30 days after administration of the last dose of ixazomib citrate (Up to 6 years and 7 months). Adverse events are collected by spontaneous identification by the patient and/or in response to an open question from study personnel or revealed by observation, physical examination, or other diagnostic procedures. AE data was intended to be assessed and reported as a single combined group for this study.
Immune system disorders Allergic reaction	3.0% 1/33 • Number of events 2 • Up to 30 days after administration of the last dose of ixazomib citrate (Up to 6 years and 7 months). Adverse events are collected by spontaneous identification by the patient and/or in response to an open question from study personnel or revealed by observation, physical examination, or other diagnostic procedures. AE data was intended to be assessed and reported as a single combined group for this study.
Skin and subcutaneous tissue disorders Alopecia	9.1% 3/33 • Number of events 3 • Up to 30 days after administration of the last dose of ixazomib citrate (Up to 6 years and 7 months). Adverse events are collected by spontaneous identification by the patient and/or in response to an open question from study personnel or revealed by observation, physical examination, or other diagnostic procedures. AE data was intended to be assessed and reported as a single combined group for this study.
Blood and lymphatic system disorders Anemia	12.1% 4/33 • Number of events 7 • Up to 30 days after administration of the last dose of ixazomib citrate (Up to 6 years and 7 months). Adverse events are collected by spontaneous identification by the patient and/or in response to an open question from study personnel or revealed by observation, physical examination, or other diagnostic procedures. AE data was intended to be assessed and reported as a single combined group for this study.
Metabolism and nutrition disorders Anorexia	24.2% 8/33 • Number of events 8 • Up to 30 days after administration of the last dose of ixazomib citrate (Up to 6 years and 7 months). Adverse events are collected by spontaneous identification by the patient and/or in response to an open question from study personnel or revealed by observation, physical examination, or other diagnostic procedures. AE data was intended to be assessed and reported as a single combined group for this study.
Psychiatric disorders Anxiety	3.0% 1/33 • Number of events 1 • Up to 30 days after administration of the last dose of ixazomib citrate (Up to 6 years and 7 months). Adverse events are collected by spontaneous identification by the patient and/or in response to an open question from study personnel or revealed by observation, physical examination, or other diagnostic procedures. AE data was intended to be assessed and reported as a single combined group for this study.
Musculoskeletal and connective tissue disorders Arthralgia	18.2% 6/33 • Number of events 6 • Up to 30 days after administration of the last dose of ixazomib citrate (Up to 6 years and 7 months). Adverse events are collected by spontaneous identification by the patient and/or in response to an open question from study personnel or revealed by observation, physical examination, or other diagnostic procedures. AE data was intended to be assessed and reported as a single combined group for this study.
Musculoskeletal and connective tissue disorders Arthritis	3.0% 1/33 • Number of events 2 • Up to 30 days after administration of the last dose of ixazomib citrate (Up to 6 years and 7 months). Adverse events are collected by spontaneous identification by the patient and/or in response to an open question from study personnel or revealed by observation, physical examination, or other diagnostic procedures. AE data was intended to be assessed and reported as a single combined group for this study.
Investigations Aspartate aminotransferase increased	15.2% 5/33 • Number of events 8 • Up to 30 days after administration of the last dose of ixazomib citrate (Up to 6 years and 7 months). Adverse events are collected by spontaneous identification by the patient and/or in response to an open question from study personnel or revealed by observation, physical examination, or other diagnostic procedures. AE data was intended to be assessed and reported as a single combined group for this study.
Musculoskeletal and connective tissue disorders Back pain	6.1% 2/33 • Number of events 3 • Up to 30 days after administration of the last dose of ixazomib citrate (Up to 6 years and 7 months). Adverse events are collected by spontaneous identification by the patient and/or in response to an open question from study personnel or revealed by observation, physical examination, or other diagnostic procedures. AE data was intended to be assessed and reported as a single combined group for this study.
Blood and lymphatic system disorders Blood and lymphatic system disorders - Other, specify	3.0% 1/33 • Number of events 1 • Up to 30 days after administration of the last dose of ixazomib citrate (Up to 6 years and 7 months). Adverse events are collected by spontaneous identification by the patient and/or in response to an open question from study personnel or revealed by observation, physical examination, or other diagnostic procedures. AE data was intended to be assessed and reported as a single combined group for this study.
Investigations Blood bilirubin increased	3.0% 1/33 • Number of events 1 • Up to 30 days after administration of the last dose of ixazomib citrate (Up to 6 years and 7 months). Adverse events are collected by spontaneous identification by the patient and/or in response to an open question from study personnel or revealed by observation, physical examination, or other diagnostic procedures. AE data was intended to be assessed and reported as a single combined group for this study.
Musculoskeletal and connective tissue disorders Bone pain	3.0% 1/33 • Number of events 1 • Up to 30 days after administration of the last dose of ixazomib citrate (Up to 6 years and 7 months). Adverse events are collected by spontaneous identification by the patient and/or in response to an open question from study personnel or revealed by observation, physical examination, or other diagnostic procedures. AE data was intended to be assessed and reported as a single combined group for this study.
Respiratory, thoracic and mediastinal disorders Bronchial infection	3.0% 1/33 • Number of events 1 • Up to 30 days after administration of the last dose of ixazomib citrate (Up to 6 years and 7 months). Adverse events are collected by spontaneous identification by the patient and/or in response to an open question from study personnel or revealed by observation, physical examination, or other diagnostic procedures. AE data was intended to be assessed and reported as a single combined group for this study.
Metabolism and nutrition disorders Bruising	6.1% 2/33 • Number of events 2 • Up to 30 days after administration of the last dose of ixazomib citrate (Up to 6 years and 7 months). Adverse events are collected by spontaneous identification by the patient and/or in response to an open question from study personnel or revealed by observation, physical examination, or other diagnostic procedures. AE data was intended to be assessed and reported as a single combined group for this study.
Cardiac disorders Cardiac disorders - Other, specify	3.0% 1/33 • Number of events 1 • Up to 30 days after administration of the last dose of ixazomib citrate (Up to 6 years and 7 months). Adverse events are collected by spontaneous identification by the patient and/or in response to an open question from study personnel or revealed by observation, physical examination, or other diagnostic procedures. AE data was intended to be assessed and reported as a single combined group for this study.
General disorders Chills	18.2% 6/33 • Number of events 6 • Up to 30 days after administration of the last dose of ixazomib citrate (Up to 6 years and 7 months). Adverse events are collected by spontaneous identification by the patient and/or in response to an open question from study personnel or revealed by observation, physical examination, or other diagnostic procedures. AE data was intended to be assessed and reported as a single combined group for this study.
Psychiatric disorders Confusion	3.0% 1/33 • Number of events 1 • Up to 30 days after administration of the last dose of ixazomib citrate (Up to 6 years and 7 months). Adverse events are collected by spontaneous identification by the patient and/or in response to an open question from study personnel or revealed by observation, physical examination, or other diagnostic procedures. AE data was intended to be assessed and reported as a single combined group for this study.
Eye disorders Conjunctivitis	6.1% 2/33 • Number of events 3 • Up to 30 days after administration of the last dose of ixazomib citrate (Up to 6 years and 7 months). Adverse events are collected by spontaneous identification by the patient and/or in response to an open question from study personnel or revealed by observation, physical examination, or other diagnostic procedures. AE data was intended to be assessed and reported as a single combined group for this study.
Gastrointestinal disorders Constipation	24.2% 8/33 • Number of events 10 • Up to 30 days after administration of the last dose of ixazomib citrate (Up to 6 years and 7 months). Adverse events are collected by spontaneous identification by the patient and/or in response to an open question from study personnel or revealed by observation, physical examination, or other diagnostic procedures. AE data was intended to be assessed and reported as a single combined group for this study.
Respiratory, thoracic and mediastinal disorders Cough	27.3% 9/33 • Number of events 12 • Up to 30 days after administration of the last dose of ixazomib citrate (Up to 6 years and 7 months). Adverse events are collected by spontaneous identification by the patient and/or in response to an open question from study personnel or revealed by observation, physical examination, or other diagnostic procedures. AE data was intended to be assessed and reported as a single combined group for this study.
Investigations Creatinine increased	6.1% 2/33 • Number of events 2 • Up to 30 days after administration of the last dose of ixazomib citrate (Up to 6 years and 7 months). Adverse events are collected by spontaneous identification by the patient and/or in response to an open question from study personnel or revealed by observation, physical examination, or other diagnostic procedures. AE data was intended to be assessed and reported as a single combined group for this study.
Psychiatric disorders Depression	6.1% 2/33 • Number of events 2 • Up to 30 days after administration of the last dose of ixazomib citrate (Up to 6 years and 7 months). Adverse events are collected by spontaneous identification by the patient and/or in response to an open question from study personnel or revealed by observation, physical examination, or other diagnostic procedures. AE data was intended to be assessed and reported as a single combined group for this study.
Gastrointestinal disorders Diarrhea	48.5% 16/33 • Number of events 29 • Up to 30 days after administration of the last dose of ixazomib citrate (Up to 6 years and 7 months). Adverse events are collected by spontaneous identification by the patient and/or in response to an open question from study personnel or revealed by observation, physical examination, or other diagnostic procedures. AE data was intended to be assessed and reported as a single combined group for this study.
Nervous system disorders Dizziness	33.3% 11/33 • Number of events 13 • Up to 30 days after administration of the last dose of ixazomib citrate (Up to 6 years and 7 months). Adverse events are collected by spontaneous identification by the patient and/or in response to an open question from study personnel or revealed by observation, physical examination, or other diagnostic procedures. AE data was intended to be assessed and reported as a single combined group for this study.
Eye disorders Dry eye	9.1% 3/33 • Number of events 3 • Up to 30 days after administration of the last dose of ixazomib citrate (Up to 6 years and 7 months). Adverse events are collected by spontaneous identification by the patient and/or in response to an open question from study personnel or revealed by observation, physical examination, or other diagnostic procedures. AE data was intended to be assessed and reported as a single combined group for this study.
Gastrointestinal disorders Dry mouth	3.0% 1/33 • Number of events 1 • Up to 30 days after administration of the last dose of ixazomib citrate (Up to 6 years and 7 months). Adverse events are collected by spontaneous identification by the patient and/or in response to an open question from study personnel or revealed by observation, physical examination, or other diagnostic procedures. AE data was intended to be assessed and reported as a single combined group for this study.
Skin and subcutaneous tissue disorders Dry skin	3.0% 1/33 • Number of events 2 • Up to 30 days after administration of the last dose of ixazomib citrate (Up to 6 years and 7 months). Adverse events are collected by spontaneous identification by the patient and/or in response to an open question from study personnel or revealed by observation, physical examination, or other diagnostic procedures. AE data was intended to be assessed and reported as a single combined group for this study.
Nervous system disorders Dysarthria	3.0% 1/33 • Number of events 1 • Up to 30 days after administration of the last dose of ixazomib citrate (Up to 6 years and 7 months). Adverse events are collected by spontaneous identification by the patient and/or in response to an open question from study personnel or revealed by observation, physical examination, or other diagnostic procedures. AE data was intended to be assessed and reported as a single combined group for this study.
Nervous system disorders Dysgeusia	9.1% 3/33 • Number of events 3 • Up to 30 days after administration of the last dose of ixazomib citrate (Up to 6 years and 7 months). Adverse events are collected by spontaneous identification by the patient and/or in response to an open question from study personnel or revealed by observation, physical examination, or other diagnostic procedures. AE data was intended to be assessed and reported as a single combined group for this study.
Gastrointestinal disorders Dyspepsia	3.0% 1/33 • Number of events 1 • Up to 30 days after administration of the last dose of ixazomib citrate (Up to 6 years and 7 months). Adverse events are collected by spontaneous identification by the patient and/or in response to an open question from study personnel or revealed by observation, physical examination, or other diagnostic procedures. AE data was intended to be assessed and reported as a single combined group for this study.
Respiratory, thoracic and mediastinal disorders Dyspnea	9.1% 3/33 • Number of events 3 • Up to 30 days after administration of the last dose of ixazomib citrate (Up to 6 years and 7 months). Adverse events are collected by spontaneous identification by the patient and/or in response to an open question from study personnel or revealed by observation, physical examination, or other diagnostic procedures. AE data was intended to be assessed and reported as a single combined group for this study.
Ear and labyrinth disorders Ear and labyrinth disorders - Other, specify	3.0% 1/33 • Number of events 3 • Up to 30 days after administration of the last dose of ixazomib citrate (Up to 6 years and 7 months). Adverse events are collected by spontaneous identification by the patient and/or in response to an open question from study personnel or revealed by observation, physical examination, or other diagnostic procedures. AE data was intended to be assessed and reported as a single combined group for this study.
Ear and labyrinth disorders Ear pain	3.0% 1/33 • Number of events 1 • Up to 30 days after administration of the last dose of ixazomib citrate (Up to 6 years and 7 months). Adverse events are collected by spontaneous identification by the patient and/or in response to an open question from study personnel or revealed by observation, physical examination, or other diagnostic procedures. AE data was intended to be assessed and reported as a single combined group for this study.
General disorders Edema face	3.0% 1/33 • Number of events 1 • Up to 30 days after administration of the last dose of ixazomib citrate (Up to 6 years and 7 months). Adverse events are collected by spontaneous identification by the patient and/or in response to an open question from study personnel or revealed by observation, physical examination, or other diagnostic procedures. AE data was intended to be assessed and reported as a single combined group for this study.
General disorders Edema limbs	15.2% 5/33 • Number of events 5 • Up to 30 days after administration of the last dose of ixazomib citrate (Up to 6 years and 7 months). Adverse events are collected by spontaneous identification by the patient and/or in response to an open question from study personnel or revealed by observation, physical examination, or other diagnostic procedures. AE data was intended to be assessed and reported as a single combined group for this study.
Gastrointestinal disorders Esophageal pain	3.0% 1/33 • Number of events 1 • Up to 30 days after administration of the last dose of ixazomib citrate (Up to 6 years and 7 months). Adverse events are collected by spontaneous identification by the patient and/or in response to an open question from study personnel or revealed by observation, physical examination, or other diagnostic procedures. AE data was intended to be assessed and reported as a single combined group for this study.
Ear and labyrinth disorders Eye disorders - Other, specify	3.0% 1/33 • Number of events 1 • Up to 30 days after administration of the last dose of ixazomib citrate (Up to 6 years and 7 months). Adverse events are collected by spontaneous identification by the patient and/or in response to an open question from study personnel or revealed by observation, physical examination, or other diagnostic procedures. AE data was intended to be assessed and reported as a single combined group for this study.
Eye disorders Eye disorders - Other, specify	3.0% 1/33 • Number of events 1 • Up to 30 days after administration of the last dose of ixazomib citrate (Up to 6 years and 7 months). Adverse events are collected by spontaneous identification by the patient and/or in response to an open question from study personnel or revealed by observation, physical examination, or other diagnostic procedures. AE data was intended to be assessed and reported as a single combined group for this study.
Eye disorders Floaters	3.0% 1/33 • Number of events 1 • Up to 30 days after administration of the last dose of ixazomib citrate (Up to 6 years and 7 months). Adverse events are collected by spontaneous identification by the patient and/or in response to an open question from study personnel or revealed by observation, physical examination, or other diagnostic procedures. AE data was intended to be assessed and reported as a single combined group for this study.
Eye disorders Blurred vision	3.0% 1/33 • Number of events 1 • Up to 30 days after administration of the last dose of ixazomib citrate (Up to 6 years and 7 months). Adverse events are collected by spontaneous identification by the patient and/or in response to an open question from study personnel or revealed by observation, physical examination, or other diagnostic procedures. AE data was intended to be assessed and reported as a single combined group for this study.
Injury, poisoning and procedural complications Fall	24.2% 8/33 • Number of events 14 • Up to 30 days after administration of the last dose of ixazomib citrate (Up to 6 years and 7 months). Adverse events are collected by spontaneous identification by the patient and/or in response to an open question from study personnel or revealed by observation, physical examination, or other diagnostic procedures. AE data was intended to be assessed and reported as a single combined group for this study.
General disorders Fatigue	30.3% 10/33 • Number of events 18 • Up to 30 days after administration of the last dose of ixazomib citrate (Up to 6 years and 7 months). Adverse events are collected by spontaneous identification by the patient and/or in response to an open question from study personnel or revealed by observation, physical examination, or other diagnostic procedures. AE data was intended to be assessed and reported as a single combined group for this study.
General disorders Fever	15.2% 5/33 • Number of events 8 • Up to 30 days after administration of the last dose of ixazomib citrate (Up to 6 years and 7 months). Adverse events are collected by spontaneous identification by the patient and/or in response to an open question from study personnel or revealed by observation, physical examination, or other diagnostic procedures. AE data was intended to be assessed and reported as a single combined group for this study.
Gastrointestinal disorders Flatulence	3.0% 1/33 • Number of events 1 • Up to 30 days after administration of the last dose of ixazomib citrate (Up to 6 years and 7 months). Adverse events are collected by spontaneous identification by the patient and/or in response to an open question from study personnel or revealed by observation, physical examination, or other diagnostic procedures. AE data was intended to be assessed and reported as a single combined group for this study.
General disorders Flu like symptoms	15.2% 5/33 • Number of events 10 • Up to 30 days after administration of the last dose of ixazomib citrate (Up to 6 years and 7 months). Adverse events are collected by spontaneous identification by the patient and/or in response to an open question from study personnel or revealed by observation, physical examination, or other diagnostic procedures. AE data was intended to be assessed and reported as a single combined group for this study.
Vascular disorders Flushing	3.0% 1/33 • Number of events 1 • Up to 30 days after administration of the last dose of ixazomib citrate (Up to 6 years and 7 months). Adverse events are collected by spontaneous identification by the patient and/or in response to an open question from study personnel or revealed by observation, physical examination, or other diagnostic procedures. AE data was intended to be assessed and reported as a single combined group for this study.
Injury, poisoning and procedural complications Fracture	12.1% 4/33 • Number of events 4 • Up to 30 days after administration of the last dose of ixazomib citrate (Up to 6 years and 7 months). Adverse events are collected by spontaneous identification by the patient and/or in response to an open question from study personnel or revealed by observation, physical examination, or other diagnostic procedures. AE data was intended to be assessed and reported as a single combined group for this study.
Gastrointestinal disorders Gastroesophageal reflux disease	3.0% 1/33 • Number of events 1 • Up to 30 days after administration of the last dose of ixazomib citrate (Up to 6 years and 7 months). Adverse events are collected by spontaneous identification by the patient and/or in response to an open question from study personnel or revealed by observation, physical examination, or other diagnostic procedures. AE data was intended to be assessed and reported as a single combined group for this study.
Gastrointestinal disorders Gastrointestinal disorders - Other, specify	6.1% 2/33 • Number of events 2 • Up to 30 days after administration of the last dose of ixazomib citrate (Up to 6 years and 7 months). Adverse events are collected by spontaneous identification by the patient and/or in response to an open question from study personnel or revealed by observation, physical examination, or other diagnostic procedures. AE data was intended to be assessed and reported as a single combined group for this study.
Skin and subcutaneous tissue disorders Hyperhidrosis	12.1% 4/33 • Number of events 4 • Up to 30 days after administration of the last dose of ixazomib citrate (Up to 6 years and 7 months). Adverse events are collected by spontaneous identification by the patient and/or in response to an open question from study personnel or revealed by observation, physical examination, or other diagnostic procedures. AE data was intended to be assessed and reported as a single combined group for this study.
Respiratory, thoracic and mediastinal disorders Allergic rhinitis	6.1% 2/33 • Number of events 2 • Up to 30 days after administration of the last dose of ixazomib citrate (Up to 6 years and 7 months). Adverse events are collected by spontaneous identification by the patient and/or in response to an open question from study personnel or revealed by observation, physical examination, or other diagnostic procedures. AE data was intended to be assessed and reported as a single combined group for this study.
General disorders General disorders and administration site conditions - Other, specify	3.0% 1/33 • Number of events 1 • Up to 30 days after administration of the last dose of ixazomib citrate (Up to 6 years and 7 months). Adverse events are collected by spontaneous identification by the patient and/or in response to an open question from study personnel or revealed by observation, physical examination, or other diagnostic procedures. AE data was intended to be assessed and reported as a single combined group for this study.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other, specify	3.0% 1/33 • Number of events 1 • Up to 30 days after administration of the last dose of ixazomib citrate (Up to 6 years and 7 months). Adverse events are collected by spontaneous identification by the patient and/or in response to an open question from study personnel or revealed by observation, physical examination, or other diagnostic procedures. AE data was intended to be assessed and reported as a single combined group for this study.
Infections and infestations Infections and infestations - Other, specify	3.0% 1/33 • Number of events 1 • Up to 30 days after administration of the last dose of ixazomib citrate (Up to 6 years and 7 months). Adverse events are collected by spontaneous identification by the patient and/or in response to an open question from study personnel or revealed by observation, physical examination, or other diagnostic procedures. AE data was intended to be assessed and reported as a single combined group for this study.
Nervous system disorders Paresthesia	3.0% 1/33 • Number of events 2 • Up to 30 days after administration of the last dose of ixazomib citrate (Up to 6 years and 7 months). Adverse events are collected by spontaneous identification by the patient and/or in response to an open question from study personnel or revealed by observation, physical examination, or other diagnostic procedures. AE data was intended to be assessed and reported as a single combined group for this study.
Skin and subcutaneous tissue disorders Erythema multiforme	12.1% 4/33 • Number of events 7 • Up to 30 days after administration of the last dose of ixazomib citrate (Up to 6 years and 7 months). Adverse events are collected by spontaneous identification by the patient and/or in response to an open question from study personnel or revealed by observation, physical examination, or other diagnostic procedures. AE data was intended to be assessed and reported as a single combined group for this study.
Nervous system disorders Headache	39.4% 13/33 • Number of events 13 • Up to 30 days after administration of the last dose of ixazomib citrate (Up to 6 years and 7 months). Adverse events are collected by spontaneous identification by the patient and/or in response to an open question from study personnel or revealed by observation, physical examination, or other diagnostic procedures. AE data was intended to be assessed and reported as a single combined group for this study.
Gastrointestinal disorders Oral pain	3.0% 1/33 • Number of events 1 • Up to 30 days after administration of the last dose of ixazomib citrate (Up to 6 years and 7 months). Adverse events are collected by spontaneous identification by the patient and/or in response to an open question from study personnel or revealed by observation, physical examination, or other diagnostic procedures. AE data was intended to be assessed and reported as a single combined group for this study.
General disorders Pain	12.1% 4/33 • Number of events 7 • Up to 30 days after administration of the last dose of ixazomib citrate (Up to 6 years and 7 months). Adverse events are collected by spontaneous identification by the patient and/or in response to an open question from study personnel or revealed by observation, physical examination, or other diagnostic procedures. AE data was intended to be assessed and reported as a single combined group for this study.
Musculoskeletal and connective tissue disorders Pain in extremity	15.2% 5/33 • Number of events 9 • Up to 30 days after administration of the last dose of ixazomib citrate (Up to 6 years and 7 months). Adverse events are collected by spontaneous identification by the patient and/or in response to an open question from study personnel or revealed by observation, physical examination, or other diagnostic procedures. AE data was intended to be assessed and reported as a single combined group for this study.
Gastrointestinal disorders Hemorrhoids	3.0% 1/33 • Number of events 1 • Up to 30 days after administration of the last dose of ixazomib citrate (Up to 6 years and 7 months). Adverse events are collected by spontaneous identification by the patient and/or in response to an open question from study personnel or revealed by observation, physical examination, or other diagnostic procedures. AE data was intended to be assessed and reported as a single combined group for this study.
Cardiac disorders Heart failure	3.0% 1/33 • Number of events 1 • Up to 30 days after administration of the last dose of ixazomib citrate (Up to 6 years and 7 months). Adverse events are collected by spontaneous identification by the patient and/or in response to an open question from study personnel or revealed by observation, physical examination, or other diagnostic procedures. AE data was intended to be assessed and reported as a single combined group for this study.
Hepatobiliary disorders Hepatic pain	3.0% 1/33 • Number of events 1 • Up to 30 days after administration of the last dose of ixazomib citrate (Up to 6 years and 7 months). Adverse events are collected by spontaneous identification by the patient and/or in response to an open question from study personnel or revealed by observation, physical examination, or other diagnostic procedures. AE data was intended to be assessed and reported as a single combined group for this study.
Musculoskeletal and connective tissue disorders Generalized muscle weakness	3.0% 1/33 • Number of events 1 • Up to 30 days after administration of the last dose of ixazomib citrate (Up to 6 years and 7 months). Adverse events are collected by spontaneous identification by the patient and/or in response to an open question from study personnel or revealed by observation, physical examination, or other diagnostic procedures. AE data was intended to be assessed and reported as a single combined group for this study.
Respiratory, thoracic and mediastinal disorders Hoarseness	3.0% 1/33 • Number of events 2 • Up to 30 days after administration of the last dose of ixazomib citrate (Up to 6 years and 7 months). Adverse events are collected by spontaneous identification by the patient and/or in response to an open question from study personnel or revealed by observation, physical examination, or other diagnostic procedures. AE data was intended to be assessed and reported as a single combined group for this study.
Metabolism and nutrition disorders Hypercalcemia	3.0% 1/33 • Number of events 1 • Up to 30 days after administration of the last dose of ixazomib citrate (Up to 6 years and 7 months). Adverse events are collected by spontaneous identification by the patient and/or in response to an open question from study personnel or revealed by observation, physical examination, or other diagnostic procedures. AE data was intended to be assessed and reported as a single combined group for this study.
Metabolism and nutrition disorders Hyperglycemia	6.1% 2/33 • Number of events 2 • Up to 30 days after administration of the last dose of ixazomib citrate (Up to 6 years and 7 months). Adverse events are collected by spontaneous identification by the patient and/or in response to an open question from study personnel or revealed by observation, physical examination, or other diagnostic procedures. AE data was intended to be assessed and reported as a single combined group for this study.
Metabolism and nutrition disorders Hyperkalemia	3.0% 1/33 • Number of events 1 • Up to 30 days after administration of the last dose of ixazomib citrate (Up to 6 years and 7 months). Adverse events are collected by spontaneous identification by the patient and/or in response to an open question from study personnel or revealed by observation, physical examination, or other diagnostic procedures. AE data was intended to be assessed and reported as a single combined group for this study.
Nervous system disorders Hypersomnia	3.0% 1/33 • Number of events 1 • Up to 30 days after administration of the last dose of ixazomib citrate (Up to 6 years and 7 months). Adverse events are collected by spontaneous identification by the patient and/or in response to an open question from study personnel or revealed by observation, physical examination, or other diagnostic procedures. AE data was intended to be assessed and reported as a single combined group for this study.
Vascular disorders Hypertension	9.1% 3/33 • Number of events 3 • Up to 30 days after administration of the last dose of ixazomib citrate (Up to 6 years and 7 months). Adverse events are collected by spontaneous identification by the patient and/or in response to an open question from study personnel or revealed by observation, physical examination, or other diagnostic procedures. AE data was intended to be assessed and reported as a single combined group for this study.
Metabolism and nutrition disorders Hypocalcemia	3.0% 1/33 • Number of events 1 • Up to 30 days after administration of the last dose of ixazomib citrate (Up to 6 years and 7 months). Adverse events are collected by spontaneous identification by the patient and/or in response to an open question from study personnel or revealed by observation, physical examination, or other diagnostic procedures. AE data was intended to be assessed and reported as a single combined group for this study.
Metabolism and nutrition disorders Hypomagnesemia	3.0% 1/33 • Number of events 1 • Up to 30 days after administration of the last dose of ixazomib citrate (Up to 6 years and 7 months). Adverse events are collected by spontaneous identification by the patient and/or in response to an open question from study personnel or revealed by observation, physical examination, or other diagnostic procedures. AE data was intended to be assessed and reported as a single combined group for this study.
Metabolism and nutrition disorders Hyponatremia	9.1% 3/33 • Number of events 3 • Up to 30 days after administration of the last dose of ixazomib citrate (Up to 6 years and 7 months). Adverse events are collected by spontaneous identification by the patient and/or in response to an open question from study personnel or revealed by observation, physical examination, or other diagnostic procedures. AE data was intended to be assessed and reported as a single combined group for this study.
Vascular disorders Hypotension	6.1% 2/33 • Number of events 3 • Up to 30 days after administration of the last dose of ixazomib citrate (Up to 6 years and 7 months). Adverse events are collected by spontaneous identification by the patient and/or in response to an open question from study personnel or revealed by observation, physical examination, or other diagnostic procedures. AE data was intended to be assessed and reported as a single combined group for this study.
Endocrine disorders Hypothyroidism	3.0% 1/33 • Number of events 1 • Up to 30 days after administration of the last dose of ixazomib citrate (Up to 6 years and 7 months). Adverse events are collected by spontaneous identification by the patient and/or in response to an open question from study personnel or revealed by observation, physical examination, or other diagnostic procedures. AE data was intended to be assessed and reported as a single combined group for this study.
Respiratory, thoracic and mediastinal disorders Hypoxia	3.0% 1/33 • Number of events 1 • Up to 30 days after administration of the last dose of ixazomib citrate (Up to 6 years and 7 months). Adverse events are collected by spontaneous identification by the patient and/or in response to an open question from study personnel or revealed by observation, physical examination, or other diagnostic procedures. AE data was intended to be assessed and reported as a single combined group for this study.
General disorders Infusion related reaction	9.1% 3/33 • Number of events 3 • Up to 30 days after administration of the last dose of ixazomib citrate (Up to 6 years and 7 months). Adverse events are collected by spontaneous identification by the patient and/or in response to an open question from study personnel or revealed by observation, physical examination, or other diagnostic procedures. AE data was intended to be assessed and reported as a single combined group for this study.
Psychiatric disorders Insomnia	9.1% 3/33 • Number of events 4 • Up to 30 days after administration of the last dose of ixazomib citrate (Up to 6 years and 7 months). Adverse events are collected by spontaneous identification by the patient and/or in response to an open question from study personnel or revealed by observation, physical examination, or other diagnostic procedures. AE data was intended to be assessed and reported as a single combined group for this study.
Infections and infestations Lung infection	3.0% 1/33 • Number of events 1 • Up to 30 days after administration of the last dose of ixazomib citrate (Up to 6 years and 7 months). Adverse events are collected by spontaneous identification by the patient and/or in response to an open question from study personnel or revealed by observation, physical examination, or other diagnostic procedures. AE data was intended to be assessed and reported as a single combined group for this study.
Investigations Lymphocyte count decreased	3.0% 1/33 • Number of events 1 • Up to 30 days after administration of the last dose of ixazomib citrate (Up to 6 years and 7 months). Adverse events are collected by spontaneous identification by the patient and/or in response to an open question from study personnel or revealed by observation, physical examination, or other diagnostic procedures. AE data was intended to be assessed and reported as a single combined group for this study.
Gastrointestinal disorders Mucositis oral	9.1% 3/33 • Number of events 3 • Up to 30 days after administration of the last dose of ixazomib citrate (Up to 6 years and 7 months). Adverse events are collected by spontaneous identification by the patient and/or in response to an open question from study personnel or revealed by observation, physical examination, or other diagnostic procedures. AE data was intended to be assessed and reported as a single combined group for this study.
Musculoskeletal and connective tissue disorders Muscle weakness lower limb	6.1% 2/33 • Number of events 2 • Up to 30 days after administration of the last dose of ixazomib citrate (Up to 6 years and 7 months). Adverse events are collected by spontaneous identification by the patient and/or in response to an open question from study personnel or revealed by observation, physical examination, or other diagnostic procedures. AE data was intended to be assessed and reported as a single combined group for this study.
Investigations Investigations - Other, specify	3.0% 1/33 • Number of events 1 • Up to 30 days after administration of the last dose of ixazomib citrate (Up to 6 years and 7 months). Adverse events are collected by spontaneous identification by the patient and/or in response to an open question from study personnel or revealed by observation, physical examination, or other diagnostic procedures. AE data was intended to be assessed and reported as a single combined group for this study.
Investigations Investigations, Other - specify	3.0% 1/33 • Number of events 1 • Up to 30 days after administration of the last dose of ixazomib citrate (Up to 6 years and 7 months). Adverse events are collected by spontaneous identification by the patient and/or in response to an open question from study personnel or revealed by observation, physical examination, or other diagnostic procedures. AE data was intended to be assessed and reported as a single combined group for this study.
Metabolism and nutrition disorders Metabolism and nutrition disorders - Other, specify	3.0% 1/33 • Number of events 1 • Up to 30 days after administration of the last dose of ixazomib citrate (Up to 6 years and 7 months). Adverse events are collected by spontaneous identification by the patient and/or in response to an open question from study personnel or revealed by observation, physical examination, or other diagnostic procedures. AE data was intended to be assessed and reported as a single combined group for this study.
Musculoskeletal and connective tissue disorders Myalgia	15.2% 5/33 • Number of events 5 • Up to 30 days after administration of the last dose of ixazomib citrate (Up to 6 years and 7 months). Adverse events are collected by spontaneous identification by the patient and/or in response to an open question from study personnel or revealed by observation, physical examination, or other diagnostic procedures. AE data was intended to be assessed and reported as a single combined group for this study.
Respiratory, thoracic and mediastinal disorders Nasal congestion	9.1% 3/33 • Number of events 5 • Up to 30 days after administration of the last dose of ixazomib citrate (Up to 6 years and 7 months). Adverse events are collected by spontaneous identification by the patient and/or in response to an open question from study personnel or revealed by observation, physical examination, or other diagnostic procedures. AE data was intended to be assessed and reported as a single combined group for this study.
Gastrointestinal disorders Nausea	66.7% 22/33 • Number of events 28 • Up to 30 days after administration of the last dose of ixazomib citrate (Up to 6 years and 7 months). Adverse events are collected by spontaneous identification by the patient and/or in response to an open question from study personnel or revealed by observation, physical examination, or other diagnostic procedures. AE data was intended to be assessed and reported as a single combined group for this study.
Musculoskeletal and connective tissue disorders Neck pain	6.1% 2/33 • Number of events 2 • Up to 30 days after administration of the last dose of ixazomib citrate (Up to 6 years and 7 months). Adverse events are collected by spontaneous identification by the patient and/or in response to an open question from study personnel or revealed by observation, physical examination, or other diagnostic procedures. AE data was intended to be assessed and reported as a single combined group for this study.
Investigations Neutrophil count decreased	9.1% 3/33 • Number of events 13 • Up to 30 days after administration of the last dose of ixazomib citrate (Up to 6 years and 7 months). Adverse events are collected by spontaneous identification by the patient and/or in response to an open question from study personnel or revealed by observation, physical examination, or other diagnostic procedures. AE data was intended to be assessed and reported as a single combined group for this study.
General disorders Non-cardiac chest pain	6.1% 2/33 • Number of events 2 • Up to 30 days after administration of the last dose of ixazomib citrate (Up to 6 years and 7 months). Adverse events are collected by spontaneous identification by the patient and/or in response to an open question from study personnel or revealed by observation, physical examination, or other diagnostic procedures. AE data was intended to be assessed and reported as a single combined group for this study.
Skin and subcutaneous tissue disorders Palmar-plantar erythrodysesthesia syndrome	9.1% 3/33 • Number of events 8 • Up to 30 days after administration of the last dose of ixazomib citrate (Up to 6 years and 7 months). Adverse events are collected by spontaneous identification by the patient and/or in response to an open question from study personnel or revealed by observation, physical examination, or other diagnostic procedures. AE data was intended to be assessed and reported as a single combined group for this study.
Infections and infestations Papulopustular rash	3.0% 1/33 • Number of events 1 • Up to 30 days after administration of the last dose of ixazomib citrate (Up to 6 years and 7 months). Adverse events are collected by spontaneous identification by the patient and/or in response to an open question from study personnel or revealed by observation, physical examination, or other diagnostic procedures. AE data was intended to be assessed and reported as a single combined group for this study.
Skin and subcutaneous tissue disorders Periorbital edema	6.1% 2/33 • Number of events 4 • Up to 30 days after administration of the last dose of ixazomib citrate (Up to 6 years and 7 months). Adverse events are collected by spontaneous identification by the patient and/or in response to an open question from study personnel or revealed by observation, physical examination, or other diagnostic procedures. AE data was intended to be assessed and reported as a single combined group for this study.
Nervous system disorders Peripheral motor neuropathy	12.1% 4/33 • Number of events 6 • Up to 30 days after administration of the last dose of ixazomib citrate (Up to 6 years and 7 months). Adverse events are collected by spontaneous identification by the patient and/or in response to an open question from study personnel or revealed by observation, physical examination, or other diagnostic procedures. AE data was intended to be assessed and reported as a single combined group for this study.
Nervous system disorders Peripheral sensory neuropathy	18.2% 6/33 • Number of events 7 • Up to 30 days after administration of the last dose of ixazomib citrate (Up to 6 years and 7 months). Adverse events are collected by spontaneous identification by the patient and/or in response to an open question from study personnel or revealed by observation, physical examination, or other diagnostic procedures. AE data was intended to be assessed and reported as a single combined group for this study.
Eye disorders Photophobia	3.0% 1/33 • Number of events 1 • Up to 30 days after administration of the last dose of ixazomib citrate (Up to 6 years and 7 months). Adverse events are collected by spontaneous identification by the patient and/or in response to an open question from study personnel or revealed by observation, physical examination, or other diagnostic procedures. AE data was intended to be assessed and reported as a single combined group for this study.
Investigations Platelet count decreased	21.2% 7/33 • Number of events 28 • Up to 30 days after administration of the last dose of ixazomib citrate (Up to 6 years and 7 months). Adverse events are collected by spontaneous identification by the patient and/or in response to an open question from study personnel or revealed by observation, physical examination, or other diagnostic procedures. AE data was intended to be assessed and reported as a single combined group for this study.
Respiratory, thoracic and mediastinal disorders Pleural effusion	3.0% 1/33 • Number of events 1 • Up to 30 days after administration of the last dose of ixazomib citrate (Up to 6 years and 7 months). Adverse events are collected by spontaneous identification by the patient and/or in response to an open question from study personnel or revealed by observation, physical examination, or other diagnostic procedures. AE data was intended to be assessed and reported as a single combined group for this study.
Respiratory, thoracic and mediastinal disorders Productive cough	6.1% 2/33 • Number of events 2 • Up to 30 days after administration of the last dose of ixazomib citrate (Up to 6 years and 7 months). Adverse events are collected by spontaneous identification by the patient and/or in response to an open question from study personnel or revealed by observation, physical examination, or other diagnostic procedures. AE data was intended to be assessed and reported as a single combined group for this study.
Skin and subcutaneous tissue disorders Pruritis	21.2% 7/33 • Number of events 8 • Up to 30 days after administration of the last dose of ixazomib citrate (Up to 6 years and 7 months). Adverse events are collected by spontaneous identification by the patient and/or in response to an open question from study personnel or revealed by observation, physical examination, or other diagnostic procedures. AE data was intended to be assessed and reported as a single combined group for this study.
Skin and subcutaneous tissue disorders Rash maculo-papular	39.4% 13/33 • Number of events 23 • Up to 30 days after administration of the last dose of ixazomib citrate (Up to 6 years and 7 months). Adverse events are collected by spontaneous identification by the patient and/or in response to an open question from study personnel or revealed by observation, physical examination, or other diagnostic procedures. AE data was intended to be assessed and reported as a single combined group for this study.
Investigations White blood cell decreased	9.1% 3/33 • Number of events 6 • Up to 30 days after administration of the last dose of ixazomib citrate (Up to 6 years and 7 months). Adverse events are collected by spontaneous identification by the patient and/or in response to an open question from study personnel or revealed by observation, physical examination, or other diagnostic procedures. AE data was intended to be assessed and reported as a single combined group for this study.
Gastrointestinal disorders Vomiting	33.3% 11/33 • Number of events 12 • Up to 30 days after administration of the last dose of ixazomib citrate (Up to 6 years and 7 months). Adverse events are collected by spontaneous identification by the patient and/or in response to an open question from study personnel or revealed by observation, physical examination, or other diagnostic procedures. AE data was intended to be assessed and reported as a single combined group for this study.
Investigations Weight gain	3.0% 1/33 • Number of events 1 • Up to 30 days after administration of the last dose of ixazomib citrate (Up to 6 years and 7 months). Adverse events are collected by spontaneous identification by the patient and/or in response to an open question from study personnel or revealed by observation, physical examination, or other diagnostic procedures. AE data was intended to be assessed and reported as a single combined group for this study.
Investigations Weight loss	9.1% 3/33 • Number of events 3 • Up to 30 days after administration of the last dose of ixazomib citrate (Up to 6 years and 7 months). Adverse events are collected by spontaneous identification by the patient and/or in response to an open question from study personnel or revealed by observation, physical examination, or other diagnostic procedures. AE data was intended to be assessed and reported as a single combined group for this study.
Respiratory, thoracic and mediastinal disorders Wheezing	3.0% 1/33 • Number of events 1 • Up to 30 days after administration of the last dose of ixazomib citrate (Up to 6 years and 7 months). Adverse events are collected by spontaneous identification by the patient and/or in response to an open question from study personnel or revealed by observation, physical examination, or other diagnostic procedures. AE data was intended to be assessed and reported as a single combined group for this study.
Infections and infestations Upper respiratory infection	18.2% 6/33 • Number of events 12 • Up to 30 days after administration of the last dose of ixazomib citrate (Up to 6 years and 7 months). Adverse events are collected by spontaneous identification by the patient and/or in response to an open question from study personnel or revealed by observation, physical examination, or other diagnostic procedures. AE data was intended to be assessed and reported as a single combined group for this study.
Infections and infestations Urinary tract infection	6.1% 2/33 • Number of events 2 • Up to 30 days after administration of the last dose of ixazomib citrate (Up to 6 years and 7 months). Adverse events are collected by spontaneous identification by the patient and/or in response to an open question from study personnel or revealed by observation, physical examination, or other diagnostic procedures. AE data was intended to be assessed and reported as a single combined group for this study.
Infections and infestations Tooth infection	3.0% 1/33 • Number of events 1 • Up to 30 days after administration of the last dose of ixazomib citrate (Up to 6 years and 7 months). Adverse events are collected by spontaneous identification by the patient and/or in response to an open question from study personnel or revealed by observation, physical examination, or other diagnostic procedures. AE data was intended to be assessed and reported as a single combined group for this study.
Respiratory, thoracic and mediastinal disorders Sore throat	12.1% 4/33 • Number of events 5 • Up to 30 days after administration of the last dose of ixazomib citrate (Up to 6 years and 7 months). Adverse events are collected by spontaneous identification by the patient and/or in response to an open question from study personnel or revealed by observation, physical examination, or other diagnostic procedures. AE data was intended to be assessed and reported as a single combined group for this study.
Nervous system disorders Syncope	12.1% 4/33 • Number of events 4 • Up to 30 days after administration of the last dose of ixazomib citrate (Up to 6 years and 7 months). Adverse events are collected by spontaneous identification by the patient and/or in response to an open question from study personnel or revealed by observation, physical examination, or other diagnostic procedures. AE data was intended to be assessed and reported as a single combined group for this study.
Infections and infestations Skin infection	6.1% 2/33 • Number of events 2 • Up to 30 days after administration of the last dose of ixazomib citrate (Up to 6 years and 7 months). Adverse events are collected by spontaneous identification by the patient and/or in response to an open question from study personnel or revealed by observation, physical examination, or other diagnostic procedures. AE data was intended to be assessed and reported as a single combined group for this study.
Respiratory, thoracic and mediastinal disorders Sleep apnea	3.0% 1/33 • Number of events 1 • Up to 30 days after administration of the last dose of ixazomib citrate (Up to 6 years and 7 months). Adverse events are collected by spontaneous identification by the patient and/or in response to an open question from study personnel or revealed by observation, physical examination, or other diagnostic procedures. AE data was intended to be assessed and reported as a single combined group for this study.
Gastrointestinal disorders Stomach pain	6.1% 2/33 • Number of events 2 • Up to 30 days after administration of the last dose of ixazomib citrate (Up to 6 years and 7 months). Adverse events are collected by spontaneous identification by the patient and/or in response to an open question from study personnel or revealed by observation, physical examination, or other diagnostic procedures. AE data was intended to be assessed and reported as a single combined group for this study.
Surgical and medical procedures Surgical and medical procedures - Other, specify	3.0% 1/33 • Number of events 1 • Up to 30 days after administration of the last dose of ixazomib citrate (Up to 6 years and 7 months). Adverse events are collected by spontaneous identification by the patient and/or in response to an open question from study personnel or revealed by observation, physical examination, or other diagnostic procedures. AE data was intended to be assessed and reported as a single combined group for this study.
Reproductive system and breast disorders Testicular pain	3.0% 1/33 • Number of events 1 • Up to 30 days after administration of the last dose of ixazomib citrate (Up to 6 years and 7 months). Adverse events are collected by spontaneous identification by the patient and/or in response to an open question from study personnel or revealed by observation, physical examination, or other diagnostic procedures. AE data was intended to be assessed and reported as a single combined group for this study.
Vascular disorders Thromboembolic event	3.0% 1/33 • Number of events 1 • Up to 30 days after administration of the last dose of ixazomib citrate (Up to 6 years and 7 months). Adverse events are collected by spontaneous identification by the patient and/or in response to an open question from study personnel or revealed by observation, physical examination, or other diagnostic procedures. AE data was intended to be assessed and reported as a single combined group for this study.
Renal and urinary disorders Urinary frequency	3.0% 1/33 • Number of events 2 • Up to 30 days after administration of the last dose of ixazomib citrate (Up to 6 years and 7 months). Adverse events are collected by spontaneous identification by the patient and/or in response to an open question from study personnel or revealed by observation, physical examination, or other diagnostic procedures. AE data was intended to be assessed and reported as a single combined group for this study.
Skin and subcutaneous tissue disorders Uticaria	3.0% 1/33 • Number of events 2 • Up to 30 days after administration of the last dose of ixazomib citrate (Up to 6 years and 7 months). Adverse events are collected by spontaneous identification by the patient and/or in response to an open question from study personnel or revealed by observation, physical examination, or other diagnostic procedures. AE data was intended to be assessed and reported as a single combined group for this study.
Nervous system disorders Vasovagal reaction	3.0% 1/33 • Number of events 1 • Up to 30 days after administration of the last dose of ixazomib citrate (Up to 6 years and 7 months). Adverse events are collected by spontaneous identification by the patient and/or in response to an open question from study personnel or revealed by observation, physical examination, or other diagnostic procedures. AE data was intended to be assessed and reported as a single combined group for this study.
Renal and urinary disorders Renal and urinary disorders - Other, specify	3.0% 1/33 • Number of events 1 • Up to 30 days after administration of the last dose of ixazomib citrate (Up to 6 years and 7 months). Adverse events are collected by spontaneous identification by the patient and/or in response to an open question from study personnel or revealed by observation, physical examination, or other diagnostic procedures. AE data was intended to be assessed and reported as a single combined group for this study.
Skin and subcutaneous tissue disorders Skin and subcutaneous tissue disorders - Other, specify	3.0% 1/33 • Number of events 1 • Up to 30 days after administration of the last dose of ixazomib citrate (Up to 6 years and 7 months). Adverse events are collected by spontaneous identification by the patient and/or in response to an open question from study personnel or revealed by observation, physical examination, or other diagnostic procedures. AE data was intended to be assessed and reported as a single combined group for this study.
Skin and subcutaneous tissue disorders Nail loss	3.0% 1/33 • Number of events 1 • Up to 30 days after administration of the last dose of ixazomib citrate (Up to 6 years and 7 months). Adverse events are collected by spontaneous identification by the patient and/or in response to an open question from study personnel or revealed by observation, physical examination, or other diagnostic procedures. AE data was intended to be assessed and reported as a single combined group for this study.
Skin and subcutaneous tissue disorders Nail infection	3.0% 1/33 • Number of events 1 • Up to 30 days after administration of the last dose of ixazomib citrate (Up to 6 years and 7 months). Adverse events are collected by spontaneous identification by the patient and/or in response to an open question from study personnel or revealed by observation, physical examination, or other diagnostic procedures. AE data was intended to be assessed and reported as a single combined group for this study.
Respiratory, thoracic and mediastinal disorders Respiratory, thoracic and mediastinal disorders - Other, specify	3.0% 1/33 • Number of events 1 • Up to 30 days after administration of the last dose of ixazomib citrate (Up to 6 years and 7 months). Adverse events are collected by spontaneous identification by the patient and/or in response to an open question from study personnel or revealed by observation, physical examination, or other diagnostic procedures. AE data was intended to be assessed and reported as a single combined group for this study.
Nervous system disorders Nervous system disorders - Other, specify	3.0% 1/33 • Number of events 1 • Up to 30 days after administration of the last dose of ixazomib citrate (Up to 6 years and 7 months). Adverse events are collected by spontaneous identification by the patient and/or in response to an open question from study personnel or revealed by observation, physical examination, or other diagnostic procedures. AE data was intended to be assessed and reported as a single combined group for this study.
Respiratory, thoracic and mediastinal disorders Sinus disorder	3.0% 1/33 • Number of events 1 • Up to 30 days after administration of the last dose of ixazomib citrate (Up to 6 years and 7 months). Adverse events are collected by spontaneous identification by the patient and/or in response to an open question from study personnel or revealed by observation, physical examination, or other diagnostic procedures. AE data was intended to be assessed and reported as a single combined group for this study.
Infections and infestations Sinusitis	6.1% 2/33 • Number of events 2 • Up to 30 days after administration of the last dose of ixazomib citrate (Up to 6 years and 7 months). Adverse events are collected by spontaneous identification by the patient and/or in response to an open question from study personnel or revealed by observation, physical examination, or other diagnostic procedures. AE data was intended to be assessed and reported as a single combined group for this study.
Injury, poisoning and procedural complications Injury, Injury, Poisoning, and Procedural Complications - Other, specify	3.0% 1/33 • Number of events 1 • Up to 30 days after administration of the last dose of ixazomib citrate (Up to 6 years and 7 months). Adverse events are collected by spontaneous identification by the patient and/or in response to an open question from study personnel or revealed by observation, physical examination, or other diagnostic procedures. AE data was intended to be assessed and reported as a single combined group for this study.
Musculoskeletal and connective tissue disorders Musculoskeletal and connective tissue disorder - Other, specify	3.0% 1/33 • Number of events 1 • Up to 30 days after administration of the last dose of ixazomib citrate (Up to 6 years and 7 months). Adverse events are collected by spontaneous identification by the patient and/or in response to an open question from study personnel or revealed by observation, physical examination, or other diagnostic procedures. AE data was intended to be assessed and reported as a single combined group for this study.

Additional Information

Ajay Gopal, MD

University of Washington

Phone: 2066062037

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place