Trial Outcomes & Findings for Trial of VELCADE and Rituxan as Front-line Tx for Low-grade NHL (NCT NCT00369707)
NCT ID: NCT00369707
Last Updated: 2019-09-06
Results Overview
The primary objective of this study is to assess the overall response rate. Overall response rate at this time point will be defined as complete response \[CR\] plus partial response \[PR\]) after 3 cycles of bortezomib/rituximab induction therapy for patients with previously untreated low-grade, B-cell NHL. Complete response requires complete disappearance of all detectable clinical and radiographic evidence of disease and disappearance of all disease-related symptoms if present before therapy, and normalization of those biochemical abnormalities (e.g., lactate dehydrogenase \[LDH\]) definitely assignable to NHL. There must also be complete disappearance of lymphoma involvement in the bone marrow (if initially present). Partial response (PR) requires 50% decrease in SPD of the six largest dominant nodes or nodal masses and no increase in the size of the other nodes, liver, or spleen.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
42 participants
Primary outcome timeframe
At baseline and at the completion of 3 cycles of treatment where 1 cycle equals 35 days.
Results posted on
2019-09-06
Participant Flow
The study opened for accrual on August 8, 2006 with an accrual goal of up to 43 patients. The study was designed to enroll 15 patients initially to do an interim efficacy assessment. Accrual was suspended on November 14 2007 for this analysis and reopened on December 20, 2007. The study was closed on August 10, 2012 after 42 patients were enrolled.
Participant milestones
| Measure |
Bortezomib and Rituximab
Induction Part A will be 1 cycle of 35 days. On days 1, 8, 15 and 22 of the cycle, bortezomib 1.6mg/m2 will be administered intravenously (through a vein) over 3-5 seconds followed by an intravenous infusion of rituximab 375mg/m2 which may take between 3-4 hours.
Induction Part B will be up to 2 cycles of 35 days each. Bortezomib will be given on days 1, 8, 15 and 22. Rituximab will only be given on day 1 of each cycle.
Maintenance period will be up to 4 cycles where 1 cycle= 2 months. Bortezomib and Rituximab will be given on day 1 of each cycle only.
|
|---|---|
|
Induction Part A (1 Cycle -35 Days)
STARTED
|
42
|
|
Induction Part A (1 Cycle -35 Days)
COMPLETED
|
42
|
|
Induction Part A (1 Cycle -35 Days)
NOT COMPLETED
|
0
|
|
Induction Part B (2 Cycles)
STARTED
|
42
|
|
Induction Part B (2 Cycles)
COMPLETED
|
35
|
|
Induction Part B (2 Cycles)
NOT COMPLETED
|
7
|
|
Maintenance Period (up to 4 Cycles)
STARTED
|
35
|
|
Maintenance Period (up to 4 Cycles)
COMPLETED
|
27
|
|
Maintenance Period (up to 4 Cycles)
NOT COMPLETED
|
8
|
|
Follow up for 2 Years After Treatment
STARTED
|
41
|
|
Follow up for 2 Years After Treatment
COMPLETED
|
38
|
|
Follow up for 2 Years After Treatment
NOT COMPLETED
|
3
|
Reasons for withdrawal
| Measure |
Bortezomib and Rituximab
Induction Part A will be 1 cycle of 35 days. On days 1, 8, 15 and 22 of the cycle, bortezomib 1.6mg/m2 will be administered intravenously (through a vein) over 3-5 seconds followed by an intravenous infusion of rituximab 375mg/m2 which may take between 3-4 hours.
Induction Part B will be up to 2 cycles of 35 days each. Bortezomib will be given on days 1, 8, 15 and 22. Rituximab will only be given on day 1 of each cycle.
Maintenance period will be up to 4 cycles where 1 cycle= 2 months. Bortezomib and Rituximab will be given on day 1 of each cycle only.
|
|---|---|
|
Induction Part B (2 Cycles)
Adverse Event
|
3
|
|
Induction Part B (2 Cycles)
Withdrawal by Subject
|
2
|
|
Induction Part B (2 Cycles)
Inadequate response/MD decision
|
1
|
|
Induction Part B (2 Cycles)
Progressive disease
|
1
|
|
Maintenance Period (up to 4 Cycles)
Withdrawal by Subject
|
2
|
|
Maintenance Period (up to 4 Cycles)
inadequate response/MD decision
|
2
|
|
Maintenance Period (up to 4 Cycles)
Progressive disease
|
4
|
|
Follow up for 2 Years After Treatment
Death
|
1
|
|
Follow up for 2 Years After Treatment
Other
|
2
|
Baseline Characteristics
Trial of VELCADE and Rituxan as Front-line Tx for Low-grade NHL
Baseline characteristics by cohort
| Measure |
Bortezomib and Rituximab
n=42 Participants
Induction Part A will be 1 cycle of 35 days. On days 1, 8, 15 and 22 of the cycle, bortezomib 1.6mg/m2 will be administered intravenously (through a vein) over 3-5 seconds followed by an intravenous infusion of rituximab 375mg/m2 which may take between 3-4 hours.
Induction Part B will be up to 2 cycles of 35 days each. Bortezomib will be given on days 1, 8, 15 and 22. Rituximab will only be given on day 1 of each cycle.
Maintenance period will be up to 4 cycles where 1 cycle= 2 months. Bortezomib and Rituximab will be given on day 1 of each cycle only.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
27 Participants
n=99 Participants
|
|
Age, Categorical
>=65 years
|
15 Participants
n=99 Participants
|
|
Sex: Female, Male
Female
|
20 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
22 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
3 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
39 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
1 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Black or African American
|
4 Participants
n=99 Participants
|
|
Race (NIH/OMB)
White
|
37 Participants
n=99 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
|
Region of Enrollment
United States
|
42 Participants
n=99 Participants
|
PRIMARY outcome
Timeframe: At baseline and at the completion of 3 cycles of treatment where 1 cycle equals 35 days.The primary objective of this study is to assess the overall response rate. Overall response rate at this time point will be defined as complete response \[CR\] plus partial response \[PR\]) after 3 cycles of bortezomib/rituximab induction therapy for patients with previously untreated low-grade, B-cell NHL. Complete response requires complete disappearance of all detectable clinical and radiographic evidence of disease and disappearance of all disease-related symptoms if present before therapy, and normalization of those biochemical abnormalities (e.g., lactate dehydrogenase \[LDH\]) definitely assignable to NHL. There must also be complete disappearance of lymphoma involvement in the bone marrow (if initially present). Partial response (PR) requires 50% decrease in SPD of the six largest dominant nodes or nodal masses and no increase in the size of the other nodes, liver, or spleen.
Outcome measures
| Measure |
Bortezomib and Rituximab
n=42 Participants
Induction Part A will be 1 cycle of 35 days. On days 1, 8, 15 and 22 of the cycle, bortezomib 1.6mg/m2 will be administered intravenously (through a vein) over 3-5 seconds followed by an intravenous infusion of rituximab 375mg/m2 which may take between 3-4 hours.
Induction Part B will be up to 2 cycles of 35 days each. Bortezomib will be given on days 1, 8, 15 and 22. Rituximab will only be given on day 1 of each cycle.
Maintenance period will be up to 4 cycles where 1 cycle= 2 months. Bortezomib and Rituximab will be given on day 1 of each cycle only.
|
|---|---|
|
Overall Response Rate (Complete Response and Partial Response) After Three Inductions Cycles of Treatment.
|
71 percentage of patients
|
SECONDARY outcome
Timeframe: At baseline and at the completion of cycle 1 (1 cycle =35 days)Overall response rate (ORR) after 1 cycle of bortezomib/rituximab induction therapy. Overall response rate at this time point will be defined as complete response \[CR\] plus partial response \[PR\]) after 1 cycle of bortezomib/rituximab induction therapy for patients with previously untreated low-grade, B-cell NHL. Complete response requires complete disappearance of all detectable clinical and radiographic evidence of disease and disappearance of all disease-related symptoms if present before therapy, and normalization of those biochemical abnormalities (e.g., lactate dehydrogenase \[LDH\]) definitely assignable to NHL. There must also be complete disappearance of lymphoma involvement in the bone marrow (if initially present). Partial response (PR) requires 50% decrease in SPD of the six largest dominant nodes or nodal masses and no increase in the size of the other nodes, liver, or spleen.
Outcome measures
| Measure |
Bortezomib and Rituximab
n=42 Participants
Induction Part A will be 1 cycle of 35 days. On days 1, 8, 15 and 22 of the cycle, bortezomib 1.6mg/m2 will be administered intravenously (through a vein) over 3-5 seconds followed by an intravenous infusion of rituximab 375mg/m2 which may take between 3-4 hours.
Induction Part B will be up to 2 cycles of 35 days each. Bortezomib will be given on days 1, 8, 15 and 22. Rituximab will only be given on day 1 of each cycle.
Maintenance period will be up to 4 cycles where 1 cycle= 2 months. Bortezomib and Rituximab will be given on day 1 of each cycle only.
|
|---|---|
|
Overall Response Rate After 1 Course of Induction Therapy
|
33 percentage of patients
|
SECONDARY outcome
Timeframe: At baseline and every 2 months during treatment of up to 3 cycles of induction (1 cycle =35days) and 4 cycles of maintenance (1 cycle =2 months) for up to 12 months.Overall response rate at completion of bortezomib/rituximab maintenance therapy. Overall response rate at this time point will be defined as complete response \[CR\] plus partial response \[PR\]) after 3 cycles of bortezomib/rituximab induction therapy and up to 4 cycles of maintenance for patients with previously untreated low-grade, B-cell NHL. Complete response requires complete disappearance of all detectable clinical and radiographic evidence of disease and disappearance of all disease-related symptoms if present before therapy, and normalization of those biochemical abnormalities (e.g., lactate dehydrogenase \[LDH\]) definitely assignable to NHL. There must also be complete disappearance of lymphoma involvement in the bone marrow (if initially present). Partial response (PR) requires 50% decrease in SPD of the six largest dominant nodes or nodal masses and no increase in the size of the other nodes, liver, or spleen.
Outcome measures
| Measure |
Bortezomib and Rituximab
n=42 Participants
Induction Part A will be 1 cycle of 35 days. On days 1, 8, 15 and 22 of the cycle, bortezomib 1.6mg/m2 will be administered intravenously (through a vein) over 3-5 seconds followed by an intravenous infusion of rituximab 375mg/m2 which may take between 3-4 hours.
Induction Part B will be up to 2 cycles of 35 days each. Bortezomib will be given on days 1, 8, 15 and 22. Rituximab will only be given on day 1 of each cycle.
Maintenance period will be up to 4 cycles where 1 cycle= 2 months. Bortezomib and Rituximab will be given on day 1 of each cycle only.
|
|---|---|
|
Overall Response Rate After Completion of Maintenance Therapy
|
71 percentage of patients
|
SECONDARY outcome
Timeframe: Every 2 months for up to 12 months then every 6 months for 2 years and annually for 1 yearPopulation: Data was not collected or analyzed for duration of response.
The duration of overall response is measured from the time measurement criteria are met for complete response (CR) or partial response (PR) (whichever is first recorded)until the first date that recurrent or progressive disease is objectively documented. Complete response requires complete disappearance of all detectable clinical and radiographic evidence of disease and disappearance of all disease-related symptoms if present before therapy, and normalization of those biochemical abnormalities (e.g., lactate dehydrogenase \[LDH\]) definitely assignable to NHL. There must also be complete disappearance of lymphoma involvement in the bone marrow (if initially present). Partial response (PR) requires 50% decrease in SPD of the six largest dominant nodes or nodal masses and no increase in the size of the other nodes, liver, or spleen. Progressive disease (PD) requires the appearance of any new lesion or increase by \> 50% in the size of previously involved sites.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Day 1 of each cycle and at the completion of cycles 1 and 3, during treatment up to 12 monthsAssess the safety and tolerance of bortezomib/rituximab as induction and maintenance therapy. Data will be collected for grade 3 and grade 4 adverse events experienced by patients that are determined to be at least possibly related to at least one study drug. Toxicity data for bortezomib/rituximab will be collected on day 1 of every cycle (1 cycle = 35 days) for up to 7 cycles during treatment according to the National Cancer Institute's Common Toxicity Criteria for adverse events version 3.0 (CTCAE v3.0). In general adverse events (AEs) will be graded according to the following: Grade 1 Mild AE Grade 2 Moderate AE Grade 3 Severe AE Grade 4 Life-threatening or disabling AE Grade 5 Death related to AE
Outcome measures
| Measure |
Bortezomib and Rituximab
n=42 Participants
Induction Part A will be 1 cycle of 35 days. On days 1, 8, 15 and 22 of the cycle, bortezomib 1.6mg/m2 will be administered intravenously (through a vein) over 3-5 seconds followed by an intravenous infusion of rituximab 375mg/m2 which may take between 3-4 hours.
Induction Part B will be up to 2 cycles of 35 days each. Bortezomib will be given on days 1, 8, 15 and 22. Rituximab will only be given on day 1 of each cycle.
Maintenance period will be up to 4 cycles where 1 cycle= 2 months. Bortezomib and Rituximab will be given on day 1 of each cycle only.
|
|---|---|
|
Number of Patients That Experience Adverse Events With Bortezomib/Rituximab Combination Treatment
Diarrhea
|
1 Participants
|
|
Number of Patients That Experience Adverse Events With Bortezomib/Rituximab Combination Treatment
Hypokalemia
|
1 Participants
|
|
Number of Patients That Experience Adverse Events With Bortezomib/Rituximab Combination Treatment
Neutropenia
|
2 Participants
|
|
Number of Patients That Experience Adverse Events With Bortezomib/Rituximab Combination Treatment
Fever
|
2 Participants
|
|
Number of Patients That Experience Adverse Events With Bortezomib/Rituximab Combination Treatment
Infection
|
2 Participants
|
|
Number of Patients That Experience Adverse Events With Bortezomib/Rituximab Combination Treatment
Infusion reaction (rituximab)
|
2 Participants
|
|
Number of Patients That Experience Adverse Events With Bortezomib/Rituximab Combination Treatment
Cardiac
|
2 Participants
|
|
Number of Patients That Experience Adverse Events With Bortezomib/Rituximab Combination Treatment
Fatigue
|
2 Participants
|
|
Number of Patients That Experience Adverse Events With Bortezomib/Rituximab Combination Treatment
Throbocytopenia
|
1 Participants
|
|
Number of Patients That Experience Adverse Events With Bortezomib/Rituximab Combination Treatment
Bowel obstruction
|
1 Participants
|
|
Number of Patients That Experience Adverse Events With Bortezomib/Rituximab Combination Treatment
Dehydration
|
1 Participants
|
SECONDARY outcome
Timeframe: At baseline and at response assessment 1 after induction part A, 2, after induction part B and 3, maintenance period.Population: Insufficient tumor samples were submitted for insufficient number of patients. No data was collected or analyzed.
Tissue microarray analysis from paraffin embedded tissue, gene expression profiling from frozen tissue (both from initial node biopsy collected/stored) and whole blood analysis of FCγR polymorphism
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: At the start of treatment and at Median follow up for all patients was 50 months (range 12-78 months) and on intent to treat, PFS and OS for all patients is reported at 4 years.Correlation of tumor burden according to Groupe D'Etude des Lymphomes Follicularies (GELF) with recently developed Follicular Lymphoma International Prognostic Index (FLIPI) prognostic index. All patients enrolled in the study were required to have high tumor burden (HTB) as defined by GELF, where HTB is defined as representing higher risk disease and poorer outcomes than low tumor burden (LTB). Patients were put into low risk or high risk FLIPI groups. Low risk group with a score of 0-2 and high risk group with a score of 3-5. A FLIPI score of 0 to 1 = "low risk" with a 10 year overall survival of 70%. A score of 2= "intermediate risk" with a 10 year overall survival of 50%. Finally, a score of ≥ 3 is considered "high risk" with a 10 year overall survival of 35%. Data was collected in connection with high or low risk FLIPI and Progression Free Survival (PFS) or Overall Survival (OS) and is reported as percentage patient with high/low risk that are progression free or alive.
Outcome measures
| Measure |
Bortezomib and Rituximab
n=42 Participants
Induction Part A will be 1 cycle of 35 days. On days 1, 8, 15 and 22 of the cycle, bortezomib 1.6mg/m2 will be administered intravenously (through a vein) over 3-5 seconds followed by an intravenous infusion of rituximab 375mg/m2 which may take between 3-4 hours.
Induction Part B will be up to 2 cycles of 35 days each. Bortezomib will be given on days 1, 8, 15 and 22. Rituximab will only be given on day 1 of each cycle.
Maintenance period will be up to 4 cycles where 1 cycle= 2 months. Bortezomib and Rituximab will be given on day 1 of each cycle only.
|
|---|---|
|
Correlation of Tumor Burden
4 year PFS high risk FLIPI
|
26 percentage of patients
|
|
Correlation of Tumor Burden
4 year PFS low risk FLIPI
|
60 percentage of patients
|
|
Correlation of Tumor Burden
4 year OS high risk FLIPI
|
81 percentage of patients
|
|
Correlation of Tumor Burden
4 year OS low risk FLIPI
|
92 percentage of patients
|
SECONDARY outcome
Timeframe: Median follow up for all patients was 50 months and on intent to treat, TTF rate for all patients is reported at 4 years.Time to Treatment Failure (TTF) rate measured, from the time of first treatment to disease progression, relapse, second tumor, death from any cause, treatment toxicity requiring termination from the study, or for any reason treatment is discontinued permanently.
Outcome measures
| Measure |
Bortezomib and Rituximab
n=42 Participants
Induction Part A will be 1 cycle of 35 days. On days 1, 8, 15 and 22 of the cycle, bortezomib 1.6mg/m2 will be administered intravenously (through a vein) over 3-5 seconds followed by an intravenous infusion of rituximab 375mg/m2 which may take between 3-4 hours.
Induction Part B will be up to 2 cycles of 35 days each. Bortezomib will be given on days 1, 8, 15 and 22. Rituximab will only be given on day 1 of each cycle.
Maintenance period will be up to 4 cycles where 1 cycle= 2 months. Bortezomib and Rituximab will be given on day 1 of each cycle only.
|
|---|---|
|
Percentage of Patients With Treatment Failure
|
26 percentage of patients
|
SECONDARY outcome
Timeframe: Median follow up for all patients was 50 months (range 12-78 months) and on intent to treat, PFS for all patients is reported at 4 years.Progression Free Survival is measured from the time of first induction infusion to disease progression, relapse, second tumor, or death from any cause. Progressive disease (PD) requires the following: 1. Appearance of any new lesion or increase by \> 50% in the size of previously involved sites. 2. Increase of \> 50% in the SPD from nadir measurement of all involved dominant lymph nodes and liver nodules and spleen nodules or unequivocal progression in any non measurable disease or nondominant site. 3. \> 50% increase in greatest diameter of any previously identified node greater than 1 cm in its short axis or in the SPD of more than one node
Outcome measures
| Measure |
Bortezomib and Rituximab
n=42 Participants
Induction Part A will be 1 cycle of 35 days. On days 1, 8, 15 and 22 of the cycle, bortezomib 1.6mg/m2 will be administered intravenously (through a vein) over 3-5 seconds followed by an intravenous infusion of rituximab 375mg/m2 which may take between 3-4 hours.
Induction Part B will be up to 2 cycles of 35 days each. Bortezomib will be given on days 1, 8, 15 and 22. Rituximab will only be given on day 1 of each cycle.
Maintenance period will be up to 4 cycles where 1 cycle= 2 months. Bortezomib and Rituximab will be given on day 1 of each cycle only.
|
|---|---|
|
Progression Free Survival (PFS) Rate
|
44 percentage of patients
|
POST_HOC outcome
Timeframe: Median follow up for all patients was 50 months (range 12-78 months) and on intent to treat, OS rate for all patients is reported at 4 years.Overall survival (OS) will be measured from the time of first treatment to death from any cause.
Outcome measures
| Measure |
Bortezomib and Rituximab
n=42 Participants
Induction Part A will be 1 cycle of 35 days. On days 1, 8, 15 and 22 of the cycle, bortezomib 1.6mg/m2 will be administered intravenously (through a vein) over 3-5 seconds followed by an intravenous infusion of rituximab 375mg/m2 which may take between 3-4 hours.
Induction Part B will be up to 2 cycles of 35 days each. Bortezomib will be given on days 1, 8, 15 and 22. Rituximab will only be given on day 1 of each cycle.
Maintenance period will be up to 4 cycles where 1 cycle= 2 months. Bortezomib and Rituximab will be given on day 1 of each cycle only.
|
|---|---|
|
Overall Survival Rate
|
87 percentage of patients
|
Adverse Events
Bortezomib and Rituximab
Serious events: 7 serious events
Other events: 42 other events
Deaths: 6 deaths
Serious adverse events
| Measure |
Bortezomib and Rituximab
n=42 participants at risk
Induction Part A will be 1 cycle of 35 days. On days 1, 8, 15 and 22 of the cycle, bortezomib 1.6mg/m2 will be administered intravenously (through a vein) over 3-5 seconds followed by an intravenous infusion of rituximab 375mg/m2 which may take between 3-4 hours.
Induction Part B will be up to 2 cycles of 35 days each. Bortezomib will be given on days 1, 8, 15 and 22. Rituximab will only be given on day 1 of each cycle.
Maintenance period will be up to 4 cycles where 1 cycle= 2 months. Bortezomib and Rituximab will be given on day 1 of each cycle only.
|
|---|---|
|
Cardiac disorders
Diastolic heart failure
|
2.4%
1/42 • Number of events 1 • Adverse events were collected for the whole study over a 6 year and 4 month period. On average adverse event information for each patient was collected during patients treatment, for a maximum of 12 months.
Adverse events were collected via systematic assessment during patients treatment visit days.
|
|
Cardiac disorders
Congestive Heart Failure exacerbation
|
2.4%
1/42 • Number of events 1 • Adverse events were collected for the whole study over a 6 year and 4 month period. On average adverse event information for each patient was collected during patients treatment, for a maximum of 12 months.
Adverse events were collected via systematic assessment during patients treatment visit days.
|
|
Congenital, familial and genetic disorders
Anal squamous cell carcinoma
|
2.4%
1/42 • Number of events 1 • Adverse events were collected for the whole study over a 6 year and 4 month period. On average adverse event information for each patient was collected during patients treatment, for a maximum of 12 months.
Adverse events were collected via systematic assessment during patients treatment visit days.
|
|
Gastrointestinal disorders
Dehydration
|
2.4%
1/42 • Number of events 1 • Adverse events were collected for the whole study over a 6 year and 4 month period. On average adverse event information for each patient was collected during patients treatment, for a maximum of 12 months.
Adverse events were collected via systematic assessment during patients treatment visit days.
|
|
General disorders
Fever with normal ANC
|
4.8%
2/42 • Number of events 2 • Adverse events were collected for the whole study over a 6 year and 4 month period. On average adverse event information for each patient was collected during patients treatment, for a maximum of 12 months.
Adverse events were collected via systematic assessment during patients treatment visit days.
|
|
Infections and infestations
Pneumonia
|
2.4%
1/42 • Number of events 1 • Adverse events were collected for the whole study over a 6 year and 4 month period. On average adverse event information for each patient was collected during patients treatment, for a maximum of 12 months.
Adverse events were collected via systematic assessment during patients treatment visit days.
|
|
Musculoskeletal and connective tissue disorders
Lumbar disk pain
|
2.4%
1/42 • Number of events 1 • Adverse events were collected for the whole study over a 6 year and 4 month period. On average adverse event information for each patient was collected during patients treatment, for a maximum of 12 months.
Adverse events were collected via systematic assessment during patients treatment visit days.
|
|
Nervous system disorders
Fainting episode (Syncope)
|
2.4%
1/42 • Number of events 1 • Adverse events were collected for the whole study over a 6 year and 4 month period. On average adverse event information for each patient was collected during patients treatment, for a maximum of 12 months.
Adverse events were collected via systematic assessment during patients treatment visit days.
|
Other adverse events
| Measure |
Bortezomib and Rituximab
n=42 participants at risk
Induction Part A will be 1 cycle of 35 days. On days 1, 8, 15 and 22 of the cycle, bortezomib 1.6mg/m2 will be administered intravenously (through a vein) over 3-5 seconds followed by an intravenous infusion of rituximab 375mg/m2 which may take between 3-4 hours.
Induction Part B will be up to 2 cycles of 35 days each. Bortezomib will be given on days 1, 8, 15 and 22. Rituximab will only be given on day 1 of each cycle.
Maintenance period will be up to 4 cycles where 1 cycle= 2 months. Bortezomib and Rituximab will be given on day 1 of each cycle only.
|
|---|---|
|
Immune system disorders
Allergic reaction/hypersensitivity
|
33.3%
14/42 • Number of events 16 • Adverse events were collected for the whole study over a 6 year and 4 month period. On average adverse event information for each patient was collected during patients treatment, for a maximum of 12 months.
Adverse events were collected via systematic assessment during patients treatment visit days.
|
|
Immune system disorders
Allergic rhinitis
|
23.8%
10/42 • Number of events 10 • Adverse events were collected for the whole study over a 6 year and 4 month period. On average adverse event information for each patient was collected during patients treatment, for a maximum of 12 months.
Adverse events were collected via systematic assessment during patients treatment visit days.
|
|
Blood and lymphatic system disorders
Hemoglobin (anemia)
|
42.9%
18/42 • Number of events 28 • Adverse events were collected for the whole study over a 6 year and 4 month period. On average adverse event information for each patient was collected during patients treatment, for a maximum of 12 months.
Adverse events were collected via systematic assessment during patients treatment visit days.
|
|
Blood and lymphatic system disorders
Neutrophils (neutropenia)
|
23.8%
10/42 • Number of events 15 • Adverse events were collected for the whole study over a 6 year and 4 month period. On average adverse event information for each patient was collected during patients treatment, for a maximum of 12 months.
Adverse events were collected via systematic assessment during patients treatment visit days.
|
|
Blood and lymphatic system disorders
Leukocytes (total white blood cells)
|
45.2%
19/42 • Number of events 27 • Adverse events were collected for the whole study over a 6 year and 4 month period. On average adverse event information for each patient was collected during patients treatment, for a maximum of 12 months.
Adverse events were collected via systematic assessment during patients treatment visit days.
|
|
Blood and lymphatic system disorders
Lymphopenia
|
57.1%
24/42 • Number of events 38 • Adverse events were collected for the whole study over a 6 year and 4 month period. On average adverse event information for each patient was collected during patients treatment, for a maximum of 12 months.
Adverse events were collected via systematic assessment during patients treatment visit days.
|
|
Blood and lymphatic system disorders
Platelets (thrombocytopenia)
|
33.3%
14/42 • Number of events 15 • Adverse events were collected for the whole study over a 6 year and 4 month period. On average adverse event information for each patient was collected during patients treatment, for a maximum of 12 months.
Adverse events were collected via systematic assessment during patients treatment visit days.
|
|
General disorders
Fatigue
|
57.1%
24/42 • Number of events 24 • Adverse events were collected for the whole study over a 6 year and 4 month period. On average adverse event information for each patient was collected during patients treatment, for a maximum of 12 months.
Adverse events were collected via systematic assessment during patients treatment visit days.
|
|
General disorders
Fever
|
19.0%
8/42 • Number of events 9 • Adverse events were collected for the whole study over a 6 year and 4 month period. On average adverse event information for each patient was collected during patients treatment, for a maximum of 12 months.
Adverse events were collected via systematic assessment during patients treatment visit days.
|
|
General disorders
Insomnia
|
11.9%
5/42 • Number of events 5 • Adverse events were collected for the whole study over a 6 year and 4 month period. On average adverse event information for each patient was collected during patients treatment, for a maximum of 12 months.
Adverse events were collected via systematic assessment during patients treatment visit days.
|
|
General disorders
Rigors
|
7.1%
3/42 • Number of events 3 • Adverse events were collected for the whole study over a 6 year and 4 month period. On average adverse event information for each patient was collected during patients treatment, for a maximum of 12 months.
Adverse events were collected via systematic assessment during patients treatment visit days.
|
|
General disorders
Sweating
|
16.7%
7/42 • Number of events 8 • Adverse events were collected for the whole study over a 6 year and 4 month period. On average adverse event information for each patient was collected during patients treatment, for a maximum of 12 months.
Adverse events were collected via systematic assessment during patients treatment visit days.
|
|
General disorders
Weight loss
|
16.7%
7/42 • Number of events 7 • Adverse events were collected for the whole study over a 6 year and 4 month period. On average adverse event information for each patient was collected during patients treatment, for a maximum of 12 months.
Adverse events were collected via systematic assessment during patients treatment visit days.
|
|
Skin and subcutaneous tissue disorders
Flushing
|
7.1%
3/42 • Number of events 3 • Adverse events were collected for the whole study over a 6 year and 4 month period. On average adverse event information for each patient was collected during patients treatment, for a maximum of 12 months.
Adverse events were collected via systematic assessment during patients treatment visit days.
|
|
Skin and subcutaneous tissue disorders
Pruritus/itching
|
16.7%
7/42 • Number of events 7 • Adverse events were collected for the whole study over a 6 year and 4 month period. On average adverse event information for each patient was collected during patients treatment, for a maximum of 12 months.
Adverse events were collected via systematic assessment during patients treatment visit days.
|
|
Skin and subcutaneous tissue disorders
Rash/desquamation
|
26.2%
11/42 • Number of events 13 • Adverse events were collected for the whole study over a 6 year and 4 month period. On average adverse event information for each patient was collected during patients treatment, for a maximum of 12 months.
Adverse events were collected via systematic assessment during patients treatment visit days.
|
|
Gastrointestinal disorders
Anorexia
|
14.3%
6/42 • Number of events 7 • Adverse events were collected for the whole study over a 6 year and 4 month period. On average adverse event information for each patient was collected during patients treatment, for a maximum of 12 months.
Adverse events were collected via systematic assessment during patients treatment visit days.
|
|
Gastrointestinal disorders
Constipation
|
21.4%
9/42 • Number of events 10 • Adverse events were collected for the whole study over a 6 year and 4 month period. On average adverse event information for each patient was collected during patients treatment, for a maximum of 12 months.
Adverse events were collected via systematic assessment during patients treatment visit days.
|
|
Gastrointestinal disorders
Diarrhea
|
52.4%
22/42 • Number of events 29 • Adverse events were collected for the whole study over a 6 year and 4 month period. On average adverse event information for each patient was collected during patients treatment, for a maximum of 12 months.
Adverse events were collected via systematic assessment during patients treatment visit days.
|
|
Gastrointestinal disorders
Abdominal distension/bloating
|
7.1%
3/42 • Number of events 3 • Adverse events were collected for the whole study over a 6 year and 4 month period. On average adverse event information for each patient was collected during patients treatment, for a maximum of 12 months.
Adverse events were collected via systematic assessment during patients treatment visit days.
|
|
Gastrointestinal disorders
Mucositis/stomatitis
|
9.5%
4/42 • Number of events 4 • Adverse events were collected for the whole study over a 6 year and 4 month period. On average adverse event information for each patient was collected during patients treatment, for a maximum of 12 months.
Adverse events were collected via systematic assessment during patients treatment visit days.
|
|
Gastrointestinal disorders
Heartburn/dyspepsia
|
7.1%
3/42 • Number of events 4 • Adverse events were collected for the whole study over a 6 year and 4 month period. On average adverse event information for each patient was collected during patients treatment, for a maximum of 12 months.
Adverse events were collected via systematic assessment during patients treatment visit days.
|
|
Gastrointestinal disorders
Nausea
|
59.5%
25/42 • Number of events 30 • Adverse events were collected for the whole study over a 6 year and 4 month period. On average adverse event information for each patient was collected during patients treatment, for a maximum of 12 months.
Adverse events were collected via systematic assessment during patients treatment visit days.
|
|
Gastrointestinal disorders
Vomiting
|
23.8%
10/42 • Number of events 11 • Adverse events were collected for the whole study over a 6 year and 4 month period. On average adverse event information for each patient was collected during patients treatment, for a maximum of 12 months.
Adverse events were collected via systematic assessment during patients treatment visit days.
|
|
Infections and infestations
Upper airway infection
|
7.1%
3/42 • Number of events 3 • Adverse events were collected for the whole study over a 6 year and 4 month period. On average adverse event information for each patient was collected during patients treatment, for a maximum of 12 months.
Adverse events were collected via systematic assessment during patients treatment visit days.
|
|
Infections and infestations
Eye infection
|
9.5%
4/42 • Number of events 4 • Adverse events were collected for the whole study over a 6 year and 4 month period. On average adverse event information for each patient was collected during patients treatment, for a maximum of 12 months.
Adverse events were collected via systematic assessment during patients treatment visit days.
|
|
Infections and infestations
Infection (NOS)
|
7.1%
3/42 • Number of events 3 • Adverse events were collected for the whole study over a 6 year and 4 month period. On average adverse event information for each patient was collected during patients treatment, for a maximum of 12 months.
Adverse events were collected via systematic assessment during patients treatment visit days.
|
|
Blood and lymphatic system disorders
Edema
|
9.5%
4/42 • Number of events 4 • Adverse events were collected for the whole study over a 6 year and 4 month period. On average adverse event information for each patient was collected during patients treatment, for a maximum of 12 months.
Adverse events were collected via systematic assessment during patients treatment visit days.
|
|
Blood and lymphatic system disorders
Edema in limbs
|
11.9%
5/42 • Number of events 6 • Adverse events were collected for the whole study over a 6 year and 4 month period. On average adverse event information for each patient was collected during patients treatment, for a maximum of 12 months.
Adverse events were collected via systematic assessment during patients treatment visit days.
|
|
Metabolism and nutrition disorders
Transaminase
|
14.3%
6/42 • Number of events 6 • Adverse events were collected for the whole study over a 6 year and 4 month period. On average adverse event information for each patient was collected during patients treatment, for a maximum of 12 months.
Adverse events were collected via systematic assessment during patients treatment visit days.
|
|
Metabolism and nutrition disorders
ALT, SGPT (serum glutamic pyruvic transaminase)
|
9.5%
4/42 • Number of events 4 • Adverse events were collected for the whole study over a 6 year and 4 month period. On average adverse event information for each patient was collected during patients treatment, for a maximum of 12 months.
Adverse events were collected via systematic assessment during patients treatment visit days.
|
|
Metabolism and nutrition disorders
AST, SGOT (serum glutamic oxaloacetic transaminase)
|
11.9%
5/42 • Number of events 5 • Adverse events were collected for the whole study over a 6 year and 4 month period. On average adverse event information for each patient was collected during patients treatment, for a maximum of 12 months.
Adverse events were collected via systematic assessment during patients treatment visit days.
|
|
Metabolism and nutrition disorders
Albumin, serum low
|
11.9%
5/42 • Number of events 5 • Adverse events were collected for the whole study over a 6 year and 4 month period. On average adverse event information for each patient was collected during patients treatment, for a maximum of 12 months.
Adverse events were collected via systematic assessment during patients treatment visit days.
|
|
Metabolism and nutrition disorders
Bilirubin, serum high
|
19.0%
8/42 • Number of events 8 • Adverse events were collected for the whole study over a 6 year and 4 month period. On average adverse event information for each patient was collected during patients treatment, for a maximum of 12 months.
Adverse events were collected via systematic assessment during patients treatment visit days.
|
|
Metabolism and nutrition disorders
Bicarbonate- low
|
7.1%
3/42 • Number of events 3 • Adverse events were collected for the whole study over a 6 year and 4 month period. On average adverse event information for each patient was collected during patients treatment, for a maximum of 12 months.
Adverse events were collected via systematic assessment during patients treatment visit days.
|
|
Metabolism and nutrition disorders
Creatinine, serum high
|
7.1%
3/42 • Number of events 5 • Adverse events were collected for the whole study over a 6 year and 4 month period. On average adverse event information for each patient was collected during patients treatment, for a maximum of 12 months.
Adverse events were collected via systematic assessment during patients treatment visit days.
|
|
Metabolism and nutrition disorders
Calcium, serum low
|
11.9%
5/42 • Number of events 6 • Adverse events were collected for the whole study over a 6 year and 4 month period. On average adverse event information for each patient was collected during patients treatment, for a maximum of 12 months.
Adverse events were collected via systematic assessment during patients treatment visit days.
|
|
Metabolism and nutrition disorders
Glucose, serum high
|
42.9%
18/42 • Number of events 24 • Adverse events were collected for the whole study over a 6 year and 4 month period. On average adverse event information for each patient was collected during patients treatment, for a maximum of 12 months.
Adverse events were collected via systematic assessment during patients treatment visit days.
|
|
Metabolism and nutrition disorders
Glucose, serum low
|
14.3%
6/42 • Number of events 6 • Adverse events were collected for the whole study over a 6 year and 4 month period. On average adverse event information for each patient was collected during patients treatment, for a maximum of 12 months.
Adverse events were collected via systematic assessment during patients treatment visit days.
|
|
Metabolism and nutrition disorders
Lactic acid dehydrogenase (LDH)
|
9.5%
4/42 • Number of events 9 • Adverse events were collected for the whole study over a 6 year and 4 month period. On average adverse event information for each patient was collected during patients treatment, for a maximum of 12 months.
Adverse events were collected via systematic assessment during patients treatment visit days.
|
|
Metabolism and nutrition disorders
Magnesium, serum low
|
7.1%
3/42 • Number of events 3 • Adverse events were collected for the whole study over a 6 year and 4 month period. On average adverse event information for each patient was collected during patients treatment, for a maximum of 12 months.
Adverse events were collected via systematic assessment during patients treatment visit days.
|
|
Metabolism and nutrition disorders
Potassium, serum high
|
9.5%
4/42 • Number of events 8 • Adverse events were collected for the whole study over a 6 year and 4 month period. On average adverse event information for each patient was collected during patients treatment, for a maximum of 12 months.
Adverse events were collected via systematic assessment during patients treatment visit days.
|
|
Metabolism and nutrition disorders
Potassium, serum low
|
14.3%
6/42 • Number of events 10 • Adverse events were collected for the whole study over a 6 year and 4 month period. On average adverse event information for each patient was collected during patients treatment, for a maximum of 12 months.
Adverse events were collected via systematic assessment during patients treatment visit days.
|
|
Metabolism and nutrition disorders
Sodium, serum high
|
7.1%
3/42 • Number of events 3 • Adverse events were collected for the whole study over a 6 year and 4 month period. On average adverse event information for each patient was collected during patients treatment, for a maximum of 12 months.
Adverse events were collected via systematic assessment during patients treatment visit days.
|
|
Metabolism and nutrition disorders
Uric acid, serum high
|
7.1%
3/42 • Number of events 3 • Adverse events were collected for the whole study over a 6 year and 4 month period. On average adverse event information for each patient was collected during patients treatment, for a maximum of 12 months.
Adverse events were collected via systematic assessment during patients treatment visit days.
|
|
Nervous system disorders
Sensory neuropathy
|
23.8%
10/42 • Number of events 11 • Adverse events were collected for the whole study over a 6 year and 4 month period. On average adverse event information for each patient was collected during patients treatment, for a maximum of 12 months.
Adverse events were collected via systematic assessment during patients treatment visit days.
|
|
Gastrointestinal disorders
Pain in abdomen
|
11.9%
5/42 • Number of events 6 • Adverse events were collected for the whole study over a 6 year and 4 month period. On average adverse event information for each patient was collected during patients treatment, for a maximum of 12 months.
Adverse events were collected via systematic assessment during patients treatment visit days.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity - limb
|
9.5%
4/42 • Number of events 4 • Adverse events were collected for the whole study over a 6 year and 4 month period. On average adverse event information for each patient was collected during patients treatment, for a maximum of 12 months.
Adverse events were collected via systematic assessment during patients treatment visit days.
|
|
Musculoskeletal and connective tissue disorders
Pain in joints
|
9.5%
4/42 • Number of events 5 • Adverse events were collected for the whole study over a 6 year and 4 month period. On average adverse event information for each patient was collected during patients treatment, for a maximum of 12 months.
Adverse events were collected via systematic assessment during patients treatment visit days.
|
|
Nervous system disorders
Headache
|
16.7%
7/42 • Number of events 7 • Adverse events were collected for the whole study over a 6 year and 4 month period. On average adverse event information for each patient was collected during patients treatment, for a maximum of 12 months.
Adverse events were collected via systematic assessment during patients treatment visit days.
|
|
General disorders
General pain NOS
|
14.3%
6/42 • Number of events 9 • Adverse events were collected for the whole study over a 6 year and 4 month period. On average adverse event information for each patient was collected during patients treatment, for a maximum of 12 months.
Adverse events were collected via systematic assessment during patients treatment visit days.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
23.8%
10/42 • Number of events 11 • Adverse events were collected for the whole study over a 6 year and 4 month period. On average adverse event information for each patient was collected during patients treatment, for a maximum of 12 months.
Adverse events were collected via systematic assessment during patients treatment visit days.
|
|
Respiratory, thoracic and mediastinal disorders
Shortness of breath (dyspnea)
|
14.3%
6/42 • Number of events 7 • Adverse events were collected for the whole study over a 6 year and 4 month period. On average adverse event information for each patient was collected during patients treatment, for a maximum of 12 months.
Adverse events were collected via systematic assessment during patients treatment visit days.
|
|
Eye disorders
Swelling of the eye
|
9.5%
4/42 • Number of events 5 • Adverse events were collected for the whole study over a 6 year and 4 month period. On average adverse event information for each patient was collected during patients treatment, for a maximum of 12 months.
Adverse events were collected via systematic assessment during patients treatment visit days.
|
|
General disorders
Flu like syndrome
|
14.3%
6/42 • Number of events 7 • Adverse events were collected for the whole study over a 6 year and 4 month period. On average adverse event information for each patient was collected during patients treatment, for a maximum of 12 months.
Adverse events were collected via systematic assessment during patients treatment visit days.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place