Trial Outcomes & Findings for Phase 2 Study With Minimal Residual Disease (MRD) Driven Adaptive Strategy in Treatment for Newly Diagnosed Multiple Myeloma (MM) With Upfront Daratumumab-based Therapy (NCT NCT04140162)
NCT ID: NCT04140162
Last Updated: 2026-07-28
Results Overview
Of participants who complete at least one cycle of induction therapy, proportion that achieve MRD-negativity after completion of induction + those who achieve MRD-negativity after completion of consolidation (if still MRD-positive after induction). MRD status determined by International Myeloma Working Group (IMWG) Response Criteria.
Recruitment status
ACTIVE_NOT_RECRUITING
Study phase
PHASE2
Target enrollment
57 participants
Primary outcome timeframe
At the end of week 36 (post-consolidation therapy)
Results posted on
2026-07-28
Participant Flow
15 patients are still active in the Maintenance cohort. Completion data will be updated once all patients have completed treatment
1 subject enrolled, but did not start treatment due to physician discretion.
Participant milestones
| Measure |
Dara-Rd Followed by Dara-RVd
* Induction regimen with Dara-Rd in all study subjects, weeks 1-24
* Consolidation regimen with Dara-RVd in post-induction MRD+ population, weeks 25-36
* Maintenance regimen with Daratumumab and Lenalidomide (Dara-R) in all study subjects, weeks 37-88
* Maintenance regimen with lenalidomide (R) until progression or intolerance Daratumumab: Induction: 16 mg/kg actual body weight IV weekly (weeks 1-8; total of 8 doses) then every 2 weeks (weeks 9-24; total of 8 doses).
Consolidation: 16 mg/kg actual body weight IV every four weeks (weeks 25-36) Maintenance: 16 mg/kg actual body weight IV every eight weeks (weeks 37-88) The sites will then transition existing patient to SQ daratumumab. New patients will be started on SQ 1800mg daratumumab.
Induction- Cycles 1-2 (days 1, 8,15, 22), Cycles 3-6 (Weeks 9-24- two weeks (days 1, 15 ) Consolidation- Every 4 weeks on day 1 Maintenance- Every 8 weeks on day 1 Lenalidomide: Induction: 25 mg PO once daily, on days 1-21 of each 28-day cycle (weeks 1-24). Consolidation: 25 mg PO once daily, on days 1-21 of each 28-day cycle (weeks 25-36). Maintenance: 10 mg PO once daily, on days 1-21 of each 28-day cycle until progression or intolerance Maintenance: 10 mg PO once daily, on days 1-21, weeks 37+ until progression. Bortezomib: Consolidation: 1.5 mg/m2 SQ on day 1, 8, 15 and 22 of each 28-day cycle (weeks 25-36) Dexamethasone: Induction and Consolidation: 40 mg (or reduced dose of 20 mg) PO or IV weekly
|
|---|---|
|
Consolidation
STARTED
|
46
|
|
Induction
STARTED
|
56
|
|
Induction
MRD +
|
46
|
|
Induction
MRD -
|
5
|
|
Induction
COMPLETED
|
51
|
|
Induction
NOT COMPLETED
|
5
|
|
Consolidation
MRD2+ and Received ACST
|
6
|
|
Consolidation
MRD2+ But no ACST
|
28
|
|
Consolidation
MRD-
|
11
|
|
Consolidation
COMPLETED
|
43
|
|
Consolidation
NOT COMPLETED
|
3
|
|
Maintenance
STARTED
|
44
|
|
Maintenance
COMPLETED
|
30
|
|
Maintenance
NOT COMPLETED
|
14
|
Reasons for withdrawal
| Measure |
Dara-Rd Followed by Dara-RVd
* Induction regimen with Dara-Rd in all study subjects, weeks 1-24
* Consolidation regimen with Dara-RVd in post-induction MRD+ population, weeks 25-36
* Maintenance regimen with Daratumumab and Lenalidomide (Dara-R) in all study subjects, weeks 37-88
* Maintenance regimen with lenalidomide (R) until progression or intolerance Daratumumab: Induction: 16 mg/kg actual body weight IV weekly (weeks 1-8; total of 8 doses) then every 2 weeks (weeks 9-24; total of 8 doses).
Consolidation: 16 mg/kg actual body weight IV every four weeks (weeks 25-36) Maintenance: 16 mg/kg actual body weight IV every eight weeks (weeks 37-88) The sites will then transition existing patient to SQ daratumumab. New patients will be started on SQ 1800mg daratumumab.
Induction- Cycles 1-2 (days 1, 8,15, 22), Cycles 3-6 (Weeks 9-24- two weeks (days 1, 15 ) Consolidation- Every 4 weeks on day 1 Maintenance- Every 8 weeks on day 1 Lenalidomide: Induction: 25 mg PO once daily, on days 1-21 of each 28-day cycle (weeks 1-24). Consolidation: 25 mg PO once daily, on days 1-21 of each 28-day cycle (weeks 25-36). Maintenance: 10 mg PO once daily, on days 1-21 of each 28-day cycle until progression or intolerance Maintenance: 10 mg PO once daily, on days 1-21, weeks 37+ until progression. Bortezomib: Consolidation: 1.5 mg/m2 SQ on day 1, 8, 15 and 22 of each 28-day cycle (weeks 25-36) Dexamethasone: Induction and Consolidation: 40 mg (or reduced dose of 20 mg) PO or IV weekly
|
|---|---|
|
Induction
Physician Decision
|
2
|
|
Induction
Noncompliance
|
1
|
|
Induction
Withdrawal by Subject
|
2
|
|
Consolidation
off tx after MRD2, patient chose to go to ASCT off protocol
|
1
|
|
Consolidation
Subject moved out of state
|
1
|
|
Consolidation
Alternative Therapy
|
1
|
|
Maintenance
Physician Decision
|
2
|
|
Maintenance
Withdrawal by Subject
|
2
|
|
Maintenance
Noncompliance
|
3
|
|
Maintenance
Adverse Event
|
2
|
|
Maintenance
Death
|
1
|
|
Maintenance
Other complicating conditions
|
1
|
|
Maintenance
Continue to hold myeloma therapy given high-copay
|
1
|
|
Maintenance
discontinuation of health insurance
|
1
|
|
Maintenance
Moving to transplant
|
1
|
Baseline Characteristics
Phase 2 Study With Minimal Residual Disease (MRD) Driven Adaptive Strategy in Treatment for Newly Diagnosed Multiple Myeloma (MM) With Upfront Daratumumab-based Therapy
Baseline characteristics by cohort
| Measure |
Dara-Rd Followed by Dara-RVd
n=57 Participants
* Induction regimen with Dara-Rd in all study subjects, weeks 1-24
* Consolidation regimen with Dara-RVd in post-induction MRD+ population, weeks 25-36
* Maintenance regimen with Daratumumab and Lenalidomide (Dara-R) in all study subjects, weeks 37-88
* Maintenance regimen with lenalidomide (R) until progression or intolerance Daratumumab: Induction: 16 mg/kg actual body weight IV weekly (weeks 1-8; total of 8 doses) then every 2 weeks (weeks 9-24; total of 8 doses).
Consolidation: 16 mg/kg actual body weight IV every four weeks (weeks 25-36) Maintenance: 16 mg/kg actual body weight IV every eight weeks (weeks 37-88) The sites will then transition existing patient to SQ daratumumab. New patients will be started on SQ 1800mg daratumumab.
Induction- Cycles 1-2 (days 1, 8,15, 22), Cycles 3-6 (Weeks 9-24- two weeks (days 1, 15 ) Consolidation- Every 4 weeks on day 1 Maintenance- Every 8 weeks on day 1 Lenalidomide: Induction: 25 mg PO once daily, on days 1-21 of each 28-day cycle (weeks 1-24). Consolidation: 25 mg PO once daily, on days 1-21 of each 28-day cycle (weeks 25-36). Maintenance: 10 mg PO once daily, on days 1-21 of each 28-day cycle until progression or intolerance Maintenance: 10 mg PO once daily, on days 1-21, weeks 37+ until progression. Bortezomib: Consolidation: 1.5 mg/m2 SQ on day 1, 8, 15 and 22 of each 28-day cycle (weeks 25-36) Dexamethasone: Induction and Consolidation: 40 mg (or reduced dose of 20 mg) PO or IV weekly
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=20 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
25 Participants
n=20 Participants
|
|
Age, Categorical
>=65 years
|
32 Participants
n=20 Participants
|
|
Sex: Female, Male
Female
|
25 Participants
n=20 Participants
|
|
Sex: Female, Male
Male
|
32 Participants
n=20 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=20 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
53 Participants
n=20 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=20 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=20 Participants
|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=20 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=20 Participants
|
|
Race (NIH/OMB)
Black or African American
|
9 Participants
n=20 Participants
|
|
Race (NIH/OMB)
White
|
44 Participants
n=20 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=20 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=20 Participants
|
|
Region of Enrollment
United States
|
57 participants
n=20 Participants
|
PRIMARY outcome
Timeframe: At the end of week 36 (post-consolidation therapy)Population: Of 57 enrolled pts, 50 were evaluable for efficacy
Of participants who complete at least one cycle of induction therapy, proportion that achieve MRD-negativity after completion of induction + those who achieve MRD-negativity after completion of consolidation (if still MRD-positive after induction). MRD status determined by International Myeloma Working Group (IMWG) Response Criteria.
Outcome measures
| Measure |
Dara-Rd Followed by Dara-RVd
n=50 Participants
* Induction regimen with Dara-Rd in all study subjects, weeks 1-24
* Consolidation regimen with Dara-RVd in post-induction MRD+ population, weeks 25-36
* Maintenance regimen with Daratumumab and Lenalidomide (Dara-R) in all study subjects, weeks 37-88
* Maintenance regimen with lenalidomide (R) until progression or intolerance Daratumumab: Induction: 16 mg/kg actual body weight IV weekly (weeks 1-8; total of 8 doses) then every 2 weeks (weeks 9-24; total of 8 doses).
Consolidation: 16 mg/kg actual body weight IV every four weeks (weeks 25-36) Maintenance: 16 mg/kg actual body weight IV every eight weeks (weeks 37-88) The sites will then transition existing patient to SQ daratumumab. New patients will be started on SQ 1800mg daratumumab.
Induction- Cycles 1-2 (days 1, 8,15, 22), Cycles 3-6 (Weeks 9-24- two weeks (days 1, 15 ) Consolidation- Every 4 weeks on day 1 Maintenance- Every 8 weeks on day 1 Lenalidomide: Induction: 25 mg PO once daily, on days 1-21 of each 28-day cycle (weeks 1-24). Consolidation: 25 mg PO once daily, on days 1-21 of each 28-day cycle (weeks 25-36). Maintenance: 10 mg PO once daily, on days 1-21 of each 28-day cycle until progression or intolerance Maintenance: 10 mg PO once daily, on days 1-21, weeks 37+ until progression. Bortezomib: Consolidation: 1.5 mg/m2 SQ on day 1, 8, 15 and 22 of each 28-day cycle (weeks 25-36) Dexamethasone: Induction and Consolidation: 40 mg (or reduced dose of 20 mg) PO or IV weekly
|
|---|---|
|
Proportion of Participants Who Achieve MRD Negativity Either After Induction or, if Still MRD-positive After Induction, After Consolidation.
|
15 Participants
|
SECONDARY outcome
Timeframe: Up to 3 years after start of study treatmentTime from initiation of daratumumab-based combination regimen until death or last follow-up date (whichever occurs first).
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 3 years after start of study treatmentTime from initiation of daratumumab-based combination regimen to disease progression, where disease progression is according to the IMWG criteria, death, or last disease evaluation before the start of any subsequent anti-myeloma therapy (whichever occurs first).
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: At the end of week 36 (post-consolidation therapy)Of participants who are still MRD-positive after induction, proportion that achieve MRD-negative after consolidation. Per IMWG Response Criteria
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: At the end of week 36 (post-consolidation therapy)Of participants who achieve post-induction MRD-negativity, proportion that maintain MRD-negativity through completion of consolidation therapy.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: At the end of week 88 (post 1 year of maintenance therapy)Of participants who achieve post-induction MRD-negativity, proportion that maintain MRD-negativity through completion of 1 year of maintenance therapy.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: After week 88, up to 3 years after start of study treatmentOf participants who achieve post-induction MRD-negativity, proportion that maintain MRD-negativity until last follow-up visit (if after week 88).
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline to 16 weeks post-last-dose of study treatment (Dara, R, V or d)EQ-5D is a standardized participant-reported outcome measure developed by the EuroQol Group and used in this trial to assess health-related quality of life.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline to 16 weeks post-last-dose of study treatment (Dara, R, V or d)The FACT/GOG-Ntx is a patient-reported outcome measure used to assess health-related quality of life in patients undergoing cancer therapy, plus an eleven-item subscale (Ntx subscale) that evaluates symptoms and concerns associated specifically with chemotherapy-induced neuropathy.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: From start of study treatment (Dara-Rd) up to 30 days post last dose of study treatment (Dara, R, V or d)Toxicity will be assessed according to the NCI Common Terminology Criteria for Adverse Events (CTCAE), version 5.0.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: At the end of week 24 (post-induction therapy)Of participants who have stem cells collected, proportion who have enough CD34+ cells after mobilization to be able to proceed with an autologous stem cell transplant (ASCT) if needed. Successful mobilization for each participant will be based on standard criteria at the institution where the transplant will be administered.
Outcome measures
Outcome data not reported
Adverse Events
Dara-Rd Followed by Dara-RVd
Serious events: 25 serious events
Other events: 56 other events
Deaths: 5 deaths
Serious adverse events
| Measure |
Dara-Rd Followed by Dara-RVd
n=56 participants at risk
* Induction regimen with Dara-Rd in all study subjects, weeks 1-24
* Consolidation regimen with Dara-RVd in post-induction MRD+ population, weeks 25-36
* Maintenance regimen with Daratumumab and Lenalidomide (Dara-R) in all study subjects, weeks 37-88
* Maintenance regimen with lenalidomide (R) until progression or intolerance Daratumumab: Induction: 16 mg/kg actual body weight IV weekly (weeks 1-8; total of 8 doses) then every 2 weeks (weeks 9-24; total of 8 doses).
Consolidation: 16 mg/kg actual body weight IV every four weeks (weeks 25-36) Maintenance: 16 mg/kg actual body weight IV every eight weeks (weeks 37-88) The sites will then transition existing patient to SQ daratumumab. New patients will be started on SQ 1800mg daratumumab.
Induction- Cycles 1-2 (days 1, 8,15, 22), Cycles 3-6 (Weeks 9-24- two weeks (days 1, 15 ) Consolidation- Every 4 weeks on day 1 Maintenance- Every 8 weeks on day 1 Lenalidomide: Induction: 25 mg PO once daily, on days 1-21 of each 28-day cycle (weeks 1-24). Consolidation: 25 mg PO once daily, on days 1-21 of each 28-day cycle (weeks 25-36). Maintenance: 10 mg PO once daily, on days 1-21 of each 28-day cycle until progression or intolerance Maintenance: 10 mg PO once daily, on days 1-21, weeks 37+ until progression. Bortezomib: Consolidation: 1.5 mg/m2 SQ on day 1, 8, 15 and 22 of each 28-day cycle (weeks 25-36) Dexamethasone: Induction and Consolidation: 40 mg (or reduced dose of 20 mg) PO or IV weekly
|
|---|---|
|
General disorders
Back pain
|
1.8%
1/56 • Number of events 1 • Events are still being collected, events currently are reported through 4 years. All AEs are combined, regardless of phase of study, per protocol, as subjects followed the appropriate treatment pathway. Data by phase is not available as the protocol did not mandate the collection be separated by phase of study.
|
|
General disorders
Fall
|
1.8%
1/56 • Number of events 1 • Events are still being collected, events currently are reported through 4 years. All AEs are combined, regardless of phase of study, per protocol, as subjects followed the appropriate treatment pathway. Data by phase is not available as the protocol did not mandate the collection be separated by phase of study.
|
|
General disorders
Fever
|
3.6%
2/56 • Number of events 3 • Events are still being collected, events currently are reported through 4 years. All AEs are combined, regardless of phase of study, per protocol, as subjects followed the appropriate treatment pathway. Data by phase is not available as the protocol did not mandate the collection be separated by phase of study.
|
|
Gastrointestinal disorders
Gastrointestinal disorders - Other, specify
|
1.8%
1/56 • Number of events 1 • Events are still being collected, events currently are reported through 4 years. All AEs are combined, regardless of phase of study, per protocol, as subjects followed the appropriate treatment pathway. Data by phase is not available as the protocol did not mandate the collection be separated by phase of study.
|
|
Vascular disorders
Hypotension
|
1.8%
1/56 • Number of events 1 • Events are still being collected, events currently are reported through 4 years. All AEs are combined, regardless of phase of study, per protocol, as subjects followed the appropriate treatment pathway. Data by phase is not available as the protocol did not mandate the collection be separated by phase of study.
|
|
Infections and infestations
Infections and infestations - Other, specify
|
1.8%
1/56 • Number of events 1 • Events are still being collected, events currently are reported through 4 years. All AEs are combined, regardless of phase of study, per protocol, as subjects followed the appropriate treatment pathway. Data by phase is not available as the protocol did not mandate the collection be separated by phase of study.
|
|
Investigations
Lymphocyte count decreased
|
3.6%
2/56 • Number of events 4 • Events are still being collected, events currently are reported through 4 years. All AEs are combined, regardless of phase of study, per protocol, as subjects followed the appropriate treatment pathway. Data by phase is not available as the protocol did not mandate the collection be separated by phase of study.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal and connective tissue disorder - Other, specify
|
1.8%
1/56 • Number of events 1 • Events are still being collected, events currently are reported through 4 years. All AEs are combined, regardless of phase of study, per protocol, as subjects followed the appropriate treatment pathway. Data by phase is not available as the protocol did not mandate the collection be separated by phase of study.
|
|
Investigations
Neutrophil count decreased
|
8.9%
5/56 • Number of events 5 • Events are still being collected, events currently are reported through 4 years. All AEs are combined, regardless of phase of study, per protocol, as subjects followed the appropriate treatment pathway. Data by phase is not available as the protocol did not mandate the collection be separated by phase of study.
|
|
Infections and infestations
Skin infection
|
1.8%
1/56 • Number of events 2 • Events are still being collected, events currently are reported through 4 years. All AEs are combined, regardless of phase of study, per protocol, as subjects followed the appropriate treatment pathway. Data by phase is not available as the protocol did not mandate the collection be separated by phase of study.
|
|
Infections and infestations
Upper respiratory infection
|
3.6%
2/56 • Number of events 2 • Events are still being collected, events currently are reported through 4 years. All AEs are combined, regardless of phase of study, per protocol, as subjects followed the appropriate treatment pathway. Data by phase is not available as the protocol did not mandate the collection be separated by phase of study.
|
|
Renal and urinary disorders
Acute kidney injury
|
1.8%
1/56 • Number of events 1 • Events are still being collected, events currently are reported through 4 years. All AEs are combined, regardless of phase of study, per protocol, as subjects followed the appropriate treatment pathway. Data by phase is not available as the protocol did not mandate the collection be separated by phase of study.
|
|
Injury, poisoning and procedural complications
Appendicitis perforated
|
1.8%
1/56 • Number of events 1 • Events are still being collected, events currently are reported through 4 years. All AEs are combined, regardless of phase of study, per protocol, as subjects followed the appropriate treatment pathway. Data by phase is not available as the protocol did not mandate the collection be separated by phase of study.
|
|
Cardiac disorders
Atrial fibrillation
|
1.8%
1/56 • Number of events 1 • Events are still being collected, events currently are reported through 4 years. All AEs are combined, regardless of phase of study, per protocol, as subjects followed the appropriate treatment pathway. Data by phase is not available as the protocol did not mandate the collection be separated by phase of study.
|
|
General disorders
Confusion
|
1.8%
1/56 • Number of events 1 • Events are still being collected, events currently are reported through 4 years. All AEs are combined, regardless of phase of study, per protocol, as subjects followed the appropriate treatment pathway. Data by phase is not available as the protocol did not mandate the collection be separated by phase of study.
|
|
General disorders
Dehydration
|
1.8%
1/56 • Number of events 1 • Events are still being collected, events currently are reported through 4 years. All AEs are combined, regardless of phase of study, per protocol, as subjects followed the appropriate treatment pathway. Data by phase is not available as the protocol did not mandate the collection be separated by phase of study.
|
|
Injury, poisoning and procedural complications
Fracture
|
1.8%
1/56 • Number of events 1 • Events are still being collected, events currently are reported through 4 years. All AEs are combined, regardless of phase of study, per protocol, as subjects followed the appropriate treatment pathway. Data by phase is not available as the protocol did not mandate the collection be separated by phase of study.
|
|
Injury, poisoning and procedural complications
Hemorrhoidal hemorrhage
|
1.8%
1/56 • Number of events 1 • Events are still being collected, events currently are reported through 4 years. All AEs are combined, regardless of phase of study, per protocol, as subjects followed the appropriate treatment pathway. Data by phase is not available as the protocol did not mandate the collection be separated by phase of study.
|
|
Investigations
Hypoglycemia
|
1.8%
1/56 • Number of events 1 • Events are still being collected, events currently are reported through 4 years. All AEs are combined, regardless of phase of study, per protocol, as subjects followed the appropriate treatment pathway. Data by phase is not available as the protocol did not mandate the collection be separated by phase of study.
|
|
Blood and lymphatic system disorders
Leukemia secondary to oncology chemotherapy
|
1.8%
1/56 • Number of events 1 • Events are still being collected, events currently are reported through 4 years. All AEs are combined, regardless of phase of study, per protocol, as subjects followed the appropriate treatment pathway. Data by phase is not available as the protocol did not mandate the collection be separated by phase of study.
|
|
Infections and infestations
Lung infection
|
3.6%
2/56 • Number of events 2 • Events are still being collected, events currently are reported through 4 years. All AEs are combined, regardless of phase of study, per protocol, as subjects followed the appropriate treatment pathway. Data by phase is not available as the protocol did not mandate the collection be separated by phase of study.
|
|
General disorders
Muscle weakness lower limb
|
1.8%
1/56 • Number of events 1 • Events are still being collected, events currently are reported through 4 years. All AEs are combined, regardless of phase of study, per protocol, as subjects followed the appropriate treatment pathway. Data by phase is not available as the protocol did not mandate the collection be separated by phase of study.
|
|
General disorders
Pneumothorax
|
1.8%
1/56 • Number of events 1 • Events are still being collected, events currently are reported through 4 years. All AEs are combined, regardless of phase of study, per protocol, as subjects followed the appropriate treatment pathway. Data by phase is not available as the protocol did not mandate the collection be separated by phase of study.
|
|
Injury, poisoning and procedural complications
Spinal cord compression
|
1.8%
1/56 • Number of events 1 • Events are still being collected, events currently are reported through 4 years. All AEs are combined, regardless of phase of study, per protocol, as subjects followed the appropriate treatment pathway. Data by phase is not available as the protocol did not mandate the collection be separated by phase of study.
|
|
General disorders
Stroke
|
1.8%
1/56 • Number of events 1 • Events are still being collected, events currently are reported through 4 years. All AEs are combined, regardless of phase of study, per protocol, as subjects followed the appropriate treatment pathway. Data by phase is not available as the protocol did not mandate the collection be separated by phase of study.
|
|
Cardiac disorders
Syncope
|
1.8%
1/56 • Number of events 2 • Events are still being collected, events currently are reported through 4 years. All AEs are combined, regardless of phase of study, per protocol, as subjects followed the appropriate treatment pathway. Data by phase is not available as the protocol did not mandate the collection be separated by phase of study.
|
|
Vascular disorders
Thromboembolic event
|
5.4%
3/56 • Number of events 3 • Events are still being collected, events currently are reported through 4 years. All AEs are combined, regardless of phase of study, per protocol, as subjects followed the appropriate treatment pathway. Data by phase is not available as the protocol did not mandate the collection be separated by phase of study.
|
|
Injury, poisoning and procedural complications
Upper gastrointestinal hemorrhage
|
1.8%
1/56 • Number of events 1 • Events are still being collected, events currently are reported through 4 years. All AEs are combined, regardless of phase of study, per protocol, as subjects followed the appropriate treatment pathway. Data by phase is not available as the protocol did not mandate the collection be separated by phase of study.
|
Other adverse events
| Measure |
Dara-Rd Followed by Dara-RVd
n=56 participants at risk
* Induction regimen with Dara-Rd in all study subjects, weeks 1-24
* Consolidation regimen with Dara-RVd in post-induction MRD+ population, weeks 25-36
* Maintenance regimen with Daratumumab and Lenalidomide (Dara-R) in all study subjects, weeks 37-88
* Maintenance regimen with lenalidomide (R) until progression or intolerance Daratumumab: Induction: 16 mg/kg actual body weight IV weekly (weeks 1-8; total of 8 doses) then every 2 weeks (weeks 9-24; total of 8 doses).
Consolidation: 16 mg/kg actual body weight IV every four weeks (weeks 25-36) Maintenance: 16 mg/kg actual body weight IV every eight weeks (weeks 37-88) The sites will then transition existing patient to SQ daratumumab. New patients will be started on SQ 1800mg daratumumab.
Induction- Cycles 1-2 (days 1, 8,15, 22), Cycles 3-6 (Weeks 9-24- two weeks (days 1, 15 ) Consolidation- Every 4 weeks on day 1 Maintenance- Every 8 weeks on day 1 Lenalidomide: Induction: 25 mg PO once daily, on days 1-21 of each 28-day cycle (weeks 1-24). Consolidation: 25 mg PO once daily, on days 1-21 of each 28-day cycle (weeks 25-36). Maintenance: 10 mg PO once daily, on days 1-21 of each 28-day cycle until progression or intolerance Maintenance: 10 mg PO once daily, on days 1-21, weeks 37+ until progression. Bortezomib: Consolidation: 1.5 mg/m2 SQ on day 1, 8, 15 and 22 of each 28-day cycle (weeks 25-36) Dexamethasone: Induction and Consolidation: 40 mg (or reduced dose of 20 mg) PO or IV weekly
|
|---|---|
|
General disorders
Allergic rhinitis
|
10.7%
6/56 • Number of events 6 • Events are still being collected, events currently are reported through 4 years. All AEs are combined, regardless of phase of study, per protocol, as subjects followed the appropriate treatment pathway. Data by phase is not available as the protocol did not mandate the collection be separated by phase of study.
|
|
Investigations
Anemia
|
19.6%
11/56 • Number of events 36 • Events are still being collected, events currently are reported through 4 years. All AEs are combined, regardless of phase of study, per protocol, as subjects followed the appropriate treatment pathway. Data by phase is not available as the protocol did not mandate the collection be separated by phase of study.
|
|
General disorders
Anorexia
|
16.1%
9/56 • Number of events 11 • Events are still being collected, events currently are reported through 4 years. All AEs are combined, regardless of phase of study, per protocol, as subjects followed the appropriate treatment pathway. Data by phase is not available as the protocol did not mandate the collection be separated by phase of study.
|
|
Psychiatric disorders
Anxiety
|
12.5%
7/56 • Number of events 7 • Events are still being collected, events currently are reported through 4 years. All AEs are combined, regardless of phase of study, per protocol, as subjects followed the appropriate treatment pathway. Data by phase is not available as the protocol did not mandate the collection be separated by phase of study.
|
|
General disorders
Arthralgia
|
17.9%
10/56 • Number of events 13 • Events are still being collected, events currently are reported through 4 years. All AEs are combined, regardless of phase of study, per protocol, as subjects followed the appropriate treatment pathway. Data by phase is not available as the protocol did not mandate the collection be separated by phase of study.
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
12.5%
7/56 • Number of events 8 • Events are still being collected, events currently are reported through 4 years. All AEs are combined, regardless of phase of study, per protocol, as subjects followed the appropriate treatment pathway. Data by phase is not available as the protocol did not mandate the collection be separated by phase of study.
|
|
General disorders
Back pain
|
39.3%
22/56 • Number of events 31 • Events are still being collected, events currently are reported through 4 years. All AEs are combined, regardless of phase of study, per protocol, as subjects followed the appropriate treatment pathway. Data by phase is not available as the protocol did not mandate the collection be separated by phase of study.
|
|
Investigations
Aspartate aminotransferase increased
|
5.4%
3/56 • Number of events 3 • Events are still being collected, events currently are reported through 4 years. All AEs are combined, regardless of phase of study, per protocol, as subjects followed the appropriate treatment pathway. Data by phase is not available as the protocol did not mandate the collection be separated by phase of study.
|
|
Gastrointestinal disorders
Abdominal distension
|
5.4%
3/56 • Number of events 3 • Events are still being collected, events currently are reported through 4 years. All AEs are combined, regardless of phase of study, per protocol, as subjects followed the appropriate treatment pathway. Data by phase is not available as the protocol did not mandate the collection be separated by phase of study.
|
|
Gastrointestinal disorders
Abdominal pain
|
23.2%
13/56 • Number of events 14 • Events are still being collected, events currently are reported through 4 years. All AEs are combined, regardless of phase of study, per protocol, as subjects followed the appropriate treatment pathway. Data by phase is not available as the protocol did not mandate the collection be separated by phase of study.
|
|
General disorders
Agitation
|
8.9%
5/56 • Number of events 6 • Events are still being collected, events currently are reported through 4 years. All AEs are combined, regardless of phase of study, per protocol, as subjects followed the appropriate treatment pathway. Data by phase is not available as the protocol did not mandate the collection be separated by phase of study.
|
|
Investigations
Alanine aminotransferase increased
|
7.1%
4/56 • Number of events 4 • Events are still being collected, events currently are reported through 4 years. All AEs are combined, regardless of phase of study, per protocol, as subjects followed the appropriate treatment pathway. Data by phase is not available as the protocol did not mandate the collection be separated by phase of study.
|
|
Investigations
Alkaline phosphatase increased
|
8.9%
5/56 • Number of events 6 • Events are still being collected, events currently are reported through 4 years. All AEs are combined, regardless of phase of study, per protocol, as subjects followed the appropriate treatment pathway. Data by phase is not available as the protocol did not mandate the collection be separated by phase of study.
|
|
Blood and lymphatic system disorders
Blood bilirubin increased
|
10.7%
6/56 • Number of events 19 • Events are still being collected, events currently are reported through 4 years. All AEs are combined, regardless of phase of study, per protocol, as subjects followed the appropriate treatment pathway. Data by phase is not available as the protocol did not mandate the collection be separated by phase of study.
|
|
Eye disorders
Blurred vision
|
21.4%
12/56 • Number of events 13 • Events are still being collected, events currently are reported through 4 years. All AEs are combined, regardless of phase of study, per protocol, as subjects followed the appropriate treatment pathway. Data by phase is not available as the protocol did not mandate the collection be separated by phase of study.
|
|
General disorders
Bone pain
|
25.0%
14/56 • Number of events 22 • Events are still being collected, events currently are reported through 4 years. All AEs are combined, regardless of phase of study, per protocol, as subjects followed the appropriate treatment pathway. Data by phase is not available as the protocol did not mandate the collection be separated by phase of study.
|
|
General disorders
Bruising
|
10.7%
6/56 • Number of events 6 • Events are still being collected, events currently are reported through 4 years. All AEs are combined, regardless of phase of study, per protocol, as subjects followed the appropriate treatment pathway. Data by phase is not available as the protocol did not mandate the collection be separated by phase of study.
|
|
Investigations
CD4 lymphocytes decreased
|
7.1%
4/56 • Number of events 6 • Events are still being collected, events currently are reported through 4 years. All AEs are combined, regardless of phase of study, per protocol, as subjects followed the appropriate treatment pathway. Data by phase is not available as the protocol did not mandate the collection be separated by phase of study.
|
|
Eye disorders
Cataract
|
8.9%
5/56 • Number of events 5 • Events are still being collected, events currently are reported through 4 years. All AEs are combined, regardless of phase of study, per protocol, as subjects followed the appropriate treatment pathway. Data by phase is not available as the protocol did not mandate the collection be separated by phase of study.
|
|
General disorders
Chest wall pain
|
5.4%
3/56 • Number of events 3 • Events are still being collected, events currently are reported through 4 years. All AEs are combined, regardless of phase of study, per protocol, as subjects followed the appropriate treatment pathway. Data by phase is not available as the protocol did not mandate the collection be separated by phase of study.
|
|
General disorders
Chills
|
19.6%
11/56 • Number of events 12 • Events are still being collected, events currently are reported through 4 years. All AEs are combined, regardless of phase of study, per protocol, as subjects followed the appropriate treatment pathway. Data by phase is not available as the protocol did not mandate the collection be separated by phase of study.
|
|
Gastrointestinal disorders
Constipation
|
35.7%
20/56 • Number of events 22 • Events are still being collected, events currently are reported through 4 years. All AEs are combined, regardless of phase of study, per protocol, as subjects followed the appropriate treatment pathway. Data by phase is not available as the protocol did not mandate the collection be separated by phase of study.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
39.3%
22/56 • Number of events 34 • Events are still being collected, events currently are reported through 4 years. All AEs are combined, regardless of phase of study, per protocol, as subjects followed the appropriate treatment pathway. Data by phase is not available as the protocol did not mandate the collection be separated by phase of study.
|
|
Investigations
Creatinine increased
|
14.3%
8/56 • Number of events 14 • Events are still being collected, events currently are reported through 4 years. All AEs are combined, regardless of phase of study, per protocol, as subjects followed the appropriate treatment pathway. Data by phase is not available as the protocol did not mandate the collection be separated by phase of study.
|
|
General disorders
Dental caries
|
5.4%
3/56 • Number of events 4 • Events are still being collected, events currently are reported through 4 years. All AEs are combined, regardless of phase of study, per protocol, as subjects followed the appropriate treatment pathway. Data by phase is not available as the protocol did not mandate the collection be separated by phase of study.
|
|
Psychiatric disorders
Depression
|
8.9%
5/56 • Number of events 6 • Events are still being collected, events currently are reported through 4 years. All AEs are combined, regardless of phase of study, per protocol, as subjects followed the appropriate treatment pathway. Data by phase is not available as the protocol did not mandate the collection be separated by phase of study.
|
|
Gastrointestinal disorders
Diarrhea
|
53.6%
30/56 • Number of events 56 • Events are still being collected, events currently are reported through 4 years. All AEs are combined, regardless of phase of study, per protocol, as subjects followed the appropriate treatment pathway. Data by phase is not available as the protocol did not mandate the collection be separated by phase of study.
|
|
General disorders
Dizziness
|
19.6%
11/56 • Number of events 13 • Events are still being collected, events currently are reported through 4 years. All AEs are combined, regardless of phase of study, per protocol, as subjects followed the appropriate treatment pathway. Data by phase is not available as the protocol did not mandate the collection be separated by phase of study.
|
|
General disorders
Dry mouth
|
5.4%
3/56 • Number of events 4 • Events are still being collected, events currently are reported through 4 years. All AEs are combined, regardless of phase of study, per protocol, as subjects followed the appropriate treatment pathway. Data by phase is not available as the protocol did not mandate the collection be separated by phase of study.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
12.5%
7/56 • Number of events 7 • Events are still being collected, events currently are reported through 4 years. All AEs are combined, regardless of phase of study, per protocol, as subjects followed the appropriate treatment pathway. Data by phase is not available as the protocol did not mandate the collection be separated by phase of study.
|
|
General disorders
Dysgeusia
|
16.1%
9/56 • Number of events 11 • Events are still being collected, events currently are reported through 4 years. All AEs are combined, regardless of phase of study, per protocol, as subjects followed the appropriate treatment pathway. Data by phase is not available as the protocol did not mandate the collection be separated by phase of study.
|
|
General disorders
Dyspepsia
|
7.1%
4/56 • Number of events 5 • Events are still being collected, events currently are reported through 4 years. All AEs are combined, regardless of phase of study, per protocol, as subjects followed the appropriate treatment pathway. Data by phase is not available as the protocol did not mandate the collection be separated by phase of study.
|
|
General disorders
Dysphagia
|
7.1%
4/56 • Number of events 6 • Events are still being collected, events currently are reported through 4 years. All AEs are combined, regardless of phase of study, per protocol, as subjects followed the appropriate treatment pathway. Data by phase is not available as the protocol did not mandate the collection be separated by phase of study.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
14.3%
8/56 • Number of events 10 • Events are still being collected, events currently are reported through 4 years. All AEs are combined, regardless of phase of study, per protocol, as subjects followed the appropriate treatment pathway. Data by phase is not available as the protocol did not mandate the collection be separated by phase of study.
|
|
General disorders
Dysuria
|
7.1%
4/56 • Number of events 5 • Events are still being collected, events currently are reported through 4 years. All AEs are combined, regardless of phase of study, per protocol, as subjects followed the appropriate treatment pathway. Data by phase is not available as the protocol did not mandate the collection be separated by phase of study.
|
|
General disorders
Edema limbs
|
57.1%
32/56 • Number of events 50 • Events are still being collected, events currently are reported through 4 years. All AEs are combined, regardless of phase of study, per protocol, as subjects followed the appropriate treatment pathway. Data by phase is not available as the protocol did not mandate the collection be separated by phase of study.
|
|
General disorders
Fall
|
8.9%
5/56 • Number of events 6 • Events are still being collected, events currently are reported through 4 years. All AEs are combined, regardless of phase of study, per protocol, as subjects followed the appropriate treatment pathway. Data by phase is not available as the protocol did not mandate the collection be separated by phase of study.
|
|
General disorders
Fatigue
|
62.5%
35/56 • Number of events 50 • Events are still being collected, events currently are reported through 4 years. All AEs are combined, regardless of phase of study, per protocol, as subjects followed the appropriate treatment pathway. Data by phase is not available as the protocol did not mandate the collection be separated by phase of study.
|
|
General disorders
Fever
|
17.9%
10/56 • Number of events 12 • Events are still being collected, events currently are reported through 4 years. All AEs are combined, regardless of phase of study, per protocol, as subjects followed the appropriate treatment pathway. Data by phase is not available as the protocol did not mandate the collection be separated by phase of study.
|
|
General disorders
Flu like symptoms
|
17.9%
10/56 • Number of events 11 • Events are still being collected, events currently are reported through 4 years. All AEs are combined, regardless of phase of study, per protocol, as subjects followed the appropriate treatment pathway. Data by phase is not available as the protocol did not mandate the collection be separated by phase of study.
|
|
General disorders
Flushing
|
5.4%
3/56 • Number of events 3 • Events are still being collected, events currently are reported through 4 years. All AEs are combined, regardless of phase of study, per protocol, as subjects followed the appropriate treatment pathway. Data by phase is not available as the protocol did not mandate the collection be separated by phase of study.
|
|
Gastrointestinal disorders
Gastroesophageal reflux disease
|
7.1%
4/56 • Number of events 4 • Events are still being collected, events currently are reported through 4 years. All AEs are combined, regardless of phase of study, per protocol, as subjects followed the appropriate treatment pathway. Data by phase is not available as the protocol did not mandate the collection be separated by phase of study.
|
|
General disorders
Generalized edema
|
5.4%
3/56 • Number of events 4 • Events are still being collected, events currently are reported through 4 years. All AEs are combined, regardless of phase of study, per protocol, as subjects followed the appropriate treatment pathway. Data by phase is not available as the protocol did not mandate the collection be separated by phase of study.
|
|
General disorders
Generalized muscle weakness
|
8.9%
5/56 • Number of events 6 • Events are still being collected, events currently are reported through 4 years. All AEs are combined, regardless of phase of study, per protocol, as subjects followed the appropriate treatment pathway. Data by phase is not available as the protocol did not mandate the collection be separated by phase of study.
|
|
General disorders
Headache
|
23.2%
13/56 • Number of events 22 • Events are still being collected, events currently are reported through 4 years. All AEs are combined, regardless of phase of study, per protocol, as subjects followed the appropriate treatment pathway. Data by phase is not available as the protocol did not mandate the collection be separated by phase of study.
|
|
Ear and labyrinth disorders
Hearing impaired
|
8.9%
5/56 • Number of events 5 • Events are still being collected, events currently are reported through 4 years. All AEs are combined, regardless of phase of study, per protocol, as subjects followed the appropriate treatment pathway. Data by phase is not available as the protocol did not mandate the collection be separated by phase of study.
|
|
Investigations
Hypercalcemia
|
5.4%
3/56 • Number of events 5 • Events are still being collected, events currently are reported through 4 years. All AEs are combined, regardless of phase of study, per protocol, as subjects followed the appropriate treatment pathway. Data by phase is not available as the protocol did not mandate the collection be separated by phase of study.
|
|
Investigations
Hyperglycemia
|
14.3%
8/56 • Number of events 21 • Events are still being collected, events currently are reported through 4 years. All AEs are combined, regardless of phase of study, per protocol, as subjects followed the appropriate treatment pathway. Data by phase is not available as the protocol did not mandate the collection be separated by phase of study.
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
5.4%
3/56 • Number of events 4 • Events are still being collected, events currently are reported through 4 years. All AEs are combined, regardless of phase of study, per protocol, as subjects followed the appropriate treatment pathway. Data by phase is not available as the protocol did not mandate the collection be separated by phase of study.
|
|
Vascular disorders
Hypertension
|
5.4%
3/56 • Number of events 3 • Events are still being collected, events currently are reported through 4 years. All AEs are combined, regardless of phase of study, per protocol, as subjects followed the appropriate treatment pathway. Data by phase is not available as the protocol did not mandate the collection be separated by phase of study.
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
8.9%
5/56 • Number of events 6 • Events are still being collected, events currently are reported through 4 years. All AEs are combined, regardless of phase of study, per protocol, as subjects followed the appropriate treatment pathway. Data by phase is not available as the protocol did not mandate the collection be separated by phase of study.
|
|
Metabolism and nutrition disorders
Hypokalemia
|
8.9%
5/56 • Number of events 9 • Events are still being collected, events currently are reported through 4 years. All AEs are combined, regardless of phase of study, per protocol, as subjects followed the appropriate treatment pathway. Data by phase is not available as the protocol did not mandate the collection be separated by phase of study.
|
|
Vascular disorders
Hypotension
|
12.5%
7/56 • Number of events 9 • Events are still being collected, events currently are reported through 4 years. All AEs are combined, regardless of phase of study, per protocol, as subjects followed the appropriate treatment pathway. Data by phase is not available as the protocol did not mandate the collection be separated by phase of study.
|
|
Injury, poisoning and procedural complications
Infusion related reaction
|
17.9%
10/56 • Number of events 11 • Events are still being collected, events currently are reported through 4 years. All AEs are combined, regardless of phase of study, per protocol, as subjects followed the appropriate treatment pathway. Data by phase is not available as the protocol did not mandate the collection be separated by phase of study.
|
|
Injury, poisoning and procedural complications
Injection site reaction
|
14.3%
8/56 • Number of events 9 • Events are still being collected, events currently are reported through 4 years. All AEs are combined, regardless of phase of study, per protocol, as subjects followed the appropriate treatment pathway. Data by phase is not available as the protocol did not mandate the collection be separated by phase of study.
|
|
Psychiatric disorders
Insomnia
|
28.6%
16/56 • Number of events 24 • Events are still being collected, events currently are reported through 4 years. All AEs are combined, regardless of phase of study, per protocol, as subjects followed the appropriate treatment pathway. Data by phase is not available as the protocol did not mandate the collection be separated by phase of study.
|
|
Psychiatric disorders
Irritability
|
8.9%
5/56 • Number of events 5 • Events are still being collected, events currently are reported through 4 years. All AEs are combined, regardless of phase of study, per protocol, as subjects followed the appropriate treatment pathway. Data by phase is not available as the protocol did not mandate the collection be separated by phase of study.
|
|
Blood and lymphatic system disorders
Leukocytosis
|
5.4%
3/56 • Number of events 5 • Events are still being collected, events currently are reported through 4 years. All AEs are combined, regardless of phase of study, per protocol, as subjects followed the appropriate treatment pathway. Data by phase is not available as the protocol did not mandate the collection be separated by phase of study.
|
|
General disorders
Localized edema
|
5.4%
3/56 • Number of events 4 • Events are still being collected, events currently are reported through 4 years. All AEs are combined, regardless of phase of study, per protocol, as subjects followed the appropriate treatment pathway. Data by phase is not available as the protocol did not mandate the collection be separated by phase of study.
|
|
Investigations
Lymphocyte count decreased
|
17.9%
10/56 • Number of events 37 • Events are still being collected, events currently are reported through 4 years. All AEs are combined, regardless of phase of study, per protocol, as subjects followed the appropriate treatment pathway. Data by phase is not available as the protocol did not mandate the collection be separated by phase of study.
|
|
Investigations
Lymphocyte count increased
|
5.4%
3/56 • Number of events 4 • Events are still being collected, events currently are reported through 4 years. All AEs are combined, regardless of phase of study, per protocol, as subjects followed the appropriate treatment pathway. Data by phase is not available as the protocol did not mandate the collection be separated by phase of study.
|
|
Musculoskeletal and connective tissue disorders
Muscle cramp
|
19.6%
11/56 • Number of events 14 • Events are still being collected, events currently are reported through 4 years. All AEs are combined, regardless of phase of study, per protocol, as subjects followed the appropriate treatment pathway. Data by phase is not available as the protocol did not mandate the collection be separated by phase of study.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
17.9%
10/56 • Number of events 13 • Events are still being collected, events currently are reported through 4 years. All AEs are combined, regardless of phase of study, per protocol, as subjects followed the appropriate treatment pathway. Data by phase is not available as the protocol did not mandate the collection be separated by phase of study.
|
|
General disorders
Nasal congestion
|
17.9%
10/56 • Number of events 12 • Events are still being collected, events currently are reported through 4 years. All AEs are combined, regardless of phase of study, per protocol, as subjects followed the appropriate treatment pathway. Data by phase is not available as the protocol did not mandate the collection be separated by phase of study.
|
|
Gastrointestinal disorders
Nausea
|
42.9%
24/56 • Number of events 41 • Events are still being collected, events currently are reported through 4 years. All AEs are combined, regardless of phase of study, per protocol, as subjects followed the appropriate treatment pathway. Data by phase is not available as the protocol did not mandate the collection be separated by phase of study.
|
|
General disorders
Neck pain
|
10.7%
6/56 • Number of events 6 • Events are still being collected, events currently are reported through 4 years. All AEs are combined, regardless of phase of study, per protocol, as subjects followed the appropriate treatment pathway. Data by phase is not available as the protocol did not mandate the collection be separated by phase of study.
|
|
Investigations
Neutrophil count decreased
|
26.8%
15/56 • Number of events 48 • Events are still being collected, events currently are reported through 4 years. All AEs are combined, regardless of phase of study, per protocol, as subjects followed the appropriate treatment pathway. Data by phase is not available as the protocol did not mandate the collection be separated by phase of study.
|
|
General disorders
Non-cardiac chest pain
|
8.9%
5/56 • Number of events 6 • Events are still being collected, events currently are reported through 4 years. All AEs are combined, regardless of phase of study, per protocol, as subjects followed the appropriate treatment pathway. Data by phase is not available as the protocol did not mandate the collection be separated by phase of study.
|
|
General disorders
Oral pain
|
8.9%
5/56 • Number of events 5 • Events are still being collected, events currently are reported through 4 years. All AEs are combined, regardless of phase of study, per protocol, as subjects followed the appropriate treatment pathway. Data by phase is not available as the protocol did not mandate the collection be separated by phase of study.
|
|
General disorders
Pain
|
41.1%
23/56 • Number of events 38 • Events are still being collected, events currently are reported through 4 years. All AEs are combined, regardless of phase of study, per protocol, as subjects followed the appropriate treatment pathway. Data by phase is not available as the protocol did not mandate the collection be separated by phase of study.
|
|
General disorders
Pain in extremity
|
25.0%
14/56 • Number of events 17 • Events are still being collected, events currently are reported through 4 years. All AEs are combined, regardless of phase of study, per protocol, as subjects followed the appropriate treatment pathway. Data by phase is not available as the protocol did not mandate the collection be separated by phase of study.
|
|
Nervous system disorders
Paresthesia
|
17.9%
10/56 • Number of events 10 • Events are still being collected, events currently are reported through 4 years. All AEs are combined, regardless of phase of study, per protocol, as subjects followed the appropriate treatment pathway. Data by phase is not available as the protocol did not mandate the collection be separated by phase of study.
|
|
Nervous system disorders
Peripheral motor neuropathy
|
5.4%
3/56 • Number of events 4 • Events are still being collected, events currently are reported through 4 years. All AEs are combined, regardless of phase of study, per protocol, as subjects followed the appropriate treatment pathway. Data by phase is not available as the protocol did not mandate the collection be separated by phase of study.
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
39.3%
22/56 • Number of events 32 • Events are still being collected, events currently are reported through 4 years. All AEs are combined, regardless of phase of study, per protocol, as subjects followed the appropriate treatment pathway. Data by phase is not available as the protocol did not mandate the collection be separated by phase of study.
|
|
Investigations
Platelet count decreased
|
14.3%
8/56 • Number of events 24 • Events are still being collected, events currently are reported through 4 years. All AEs are combined, regardless of phase of study, per protocol, as subjects followed the appropriate treatment pathway. Data by phase is not available as the protocol did not mandate the collection be separated by phase of study.
|
|
General disorders
Postnasal drip
|
7.1%
4/56 • Number of events 5 • Events are still being collected, events currently are reported through 4 years. All AEs are combined, regardless of phase of study, per protocol, as subjects followed the appropriate treatment pathway. Data by phase is not available as the protocol did not mandate the collection be separated by phase of study.
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
7.1%
4/56 • Number of events 7 • Events are still being collected, events currently are reported through 4 years. All AEs are combined, regardless of phase of study, per protocol, as subjects followed the appropriate treatment pathway. Data by phase is not available as the protocol did not mandate the collection be separated by phase of study.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
10.7%
6/56 • Number of events 9 • Events are still being collected, events currently are reported through 4 years. All AEs are combined, regardless of phase of study, per protocol, as subjects followed the appropriate treatment pathway. Data by phase is not available as the protocol did not mandate the collection be separated by phase of study.
|
|
Skin and subcutaneous tissue disorders
Rash acneiform
|
8.9%
5/56 • Number of events 5 • Events are still being collected, events currently are reported through 4 years. All AEs are combined, regardless of phase of study, per protocol, as subjects followed the appropriate treatment pathway. Data by phase is not available as the protocol did not mandate the collection be separated by phase of study.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
25.0%
14/56 • Number of events 16 • Events are still being collected, events currently are reported through 4 years. All AEs are combined, regardless of phase of study, per protocol, as subjects followed the appropriate treatment pathway. Data by phase is not available as the protocol did not mandate the collection be separated by phase of study.
|
|
Cardiac disorders
Sinus bradycardia
|
5.4%
3/56 • Number of events 3 • Events are still being collected, events currently are reported through 4 years. All AEs are combined, regardless of phase of study, per protocol, as subjects followed the appropriate treatment pathway. Data by phase is not available as the protocol did not mandate the collection be separated by phase of study.
|
|
General disorders
Sinus pain
|
7.1%
4/56 • Number of events 4 • Events are still being collected, events currently are reported through 4 years. All AEs are combined, regardless of phase of study, per protocol, as subjects followed the appropriate treatment pathway. Data by phase is not available as the protocol did not mandate the collection be separated by phase of study.
|
|
Cardiac disorders
Sinus tachycardia
|
5.4%
3/56 • Number of events 3 • Events are still being collected, events currently are reported through 4 years. All AEs are combined, regardless of phase of study, per protocol, as subjects followed the appropriate treatment pathway. Data by phase is not available as the protocol did not mandate the collection be separated by phase of study.
|
|
General disorders
Sinusitis
|
5.4%
3/56 • Number of events 3 • Events are still being collected, events currently are reported through 4 years. All AEs are combined, regardless of phase of study, per protocol, as subjects followed the appropriate treatment pathway. Data by phase is not available as the protocol did not mandate the collection be separated by phase of study.
|
|
Infections and infestations
Skin infection
|
7.1%
4/56 • Number of events 5 • Events are still being collected, events currently are reported through 4 years. All AEs are combined, regardless of phase of study, per protocol, as subjects followed the appropriate treatment pathway. Data by phase is not available as the protocol did not mandate the collection be separated by phase of study.
|
|
General disorders
Sore throat
|
16.1%
9/56 • Number of events 11 • Events are still being collected, events currently are reported through 4 years. All AEs are combined, regardless of phase of study, per protocol, as subjects followed the appropriate treatment pathway. Data by phase is not available as the protocol did not mandate the collection be separated by phase of study.
|
|
General disorders
Stomach pain
|
5.4%
3/56 • Number of events 3 • Events are still being collected, events currently are reported through 4 years. All AEs are combined, regardless of phase of study, per protocol, as subjects followed the appropriate treatment pathway. Data by phase is not available as the protocol did not mandate the collection be separated by phase of study.
|
|
Ear and labyrinth disorders
Tinnitus
|
8.9%
5/56 • Number of events 6 • Events are still being collected, events currently are reported through 4 years. All AEs are combined, regardless of phase of study, per protocol, as subjects followed the appropriate treatment pathway. Data by phase is not available as the protocol did not mandate the collection be separated by phase of study.
|
|
Infections and infestations
Tooth infection
|
5.4%
3/56 • Number of events 3 • Events are still being collected, events currently are reported through 4 years. All AEs are combined, regardless of phase of study, per protocol, as subjects followed the appropriate treatment pathway. Data by phase is not available as the protocol did not mandate the collection be separated by phase of study.
|
|
Nervous system disorders
Tremor
|
8.9%
5/56 • Number of events 5 • Events are still being collected, events currently are reported through 4 years. All AEs are combined, regardless of phase of study, per protocol, as subjects followed the appropriate treatment pathway. Data by phase is not available as the protocol did not mandate the collection be separated by phase of study.
|
|
Infections and infestations
Upper respiratory infection
|
26.8%
15/56 • Number of events 21 • Events are still being collected, events currently are reported through 4 years. All AEs are combined, regardless of phase of study, per protocol, as subjects followed the appropriate treatment pathway. Data by phase is not available as the protocol did not mandate the collection be separated by phase of study.
|
|
Renal and urinary disorders
Urinary frequency
|
12.5%
7/56 • Number of events 7 • Events are still being collected, events currently are reported through 4 years. All AEs are combined, regardless of phase of study, per protocol, as subjects followed the appropriate treatment pathway. Data by phase is not available as the protocol did not mandate the collection be separated by phase of study.
|
|
Infections and infestations
Urinary tract infection
|
7.1%
4/56 • Number of events 5 • Events are still being collected, events currently are reported through 4 years. All AEs are combined, regardless of phase of study, per protocol, as subjects followed the appropriate treatment pathway. Data by phase is not available as the protocol did not mandate the collection be separated by phase of study.
|
|
Ear and labyrinth disorders
Vertigo
|
5.4%
3/56 • Number of events 3 • Events are still being collected, events currently are reported through 4 years. All AEs are combined, regardless of phase of study, per protocol, as subjects followed the appropriate treatment pathway. Data by phase is not available as the protocol did not mandate the collection be separated by phase of study.
|
|
Gastrointestinal disorders
Vomiting
|
19.6%
11/56 • Number of events 11 • Events are still being collected, events currently are reported through 4 years. All AEs are combined, regardless of phase of study, per protocol, as subjects followed the appropriate treatment pathway. Data by phase is not available as the protocol did not mandate the collection be separated by phase of study.
|
|
Eye disorders
Watering eyes
|
5.4%
3/56 • Number of events 3 • Events are still being collected, events currently are reported through 4 years. All AEs are combined, regardless of phase of study, per protocol, as subjects followed the appropriate treatment pathway. Data by phase is not available as the protocol did not mandate the collection be separated by phase of study.
|
|
Investigations
Weight gain
|
10.7%
6/56 • Number of events 8 • Events are still being collected, events currently are reported through 4 years. All AEs are combined, regardless of phase of study, per protocol, as subjects followed the appropriate treatment pathway. Data by phase is not available as the protocol did not mandate the collection be separated by phase of study.
|
|
Investigations
Weight loss
|
16.1%
9/56 • Number of events 13 • Events are still being collected, events currently are reported through 4 years. All AEs are combined, regardless of phase of study, per protocol, as subjects followed the appropriate treatment pathway. Data by phase is not available as the protocol did not mandate the collection be separated by phase of study.
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
5.4%
3/56 • Number of events 4 • Events are still being collected, events currently are reported through 4 years. All AEs are combined, regardless of phase of study, per protocol, as subjects followed the appropriate treatment pathway. Data by phase is not available as the protocol did not mandate the collection be separated by phase of study.
|
|
Investigations
White blood cell decreased
|
17.9%
10/56 • Number of events 31 • Events are still being collected, events currently are reported through 4 years. All AEs are combined, regardless of phase of study, per protocol, as subjects followed the appropriate treatment pathway. Data by phase is not available as the protocol did not mandate the collection be separated by phase of study.
|
Additional Information
University of Michigan Rogel Cancer Center ClinicalTrials.gov Admin
University of Michigan Rogel Cancer Center
Phone: 734-936-9499
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee Participating Sites agree not to independently publish its Data or results from any analysis and disseminate information until the earlier of the date Michigan has published the results, one year after the termination of the study, or Michigan chooses not to proceed with publication. The sponsor will receive no less than 30 days to review any manuscript, abstract, poster, publication or presentation.
- Publication restrictions are in place
Restriction type: OTHER