Trial Outcomes & Findings for A Study of Daratumumab in Patients With Newly Diagnosed Multiple Myeloma (NCT NCT03290950)
NCT ID: NCT03290950
Last Updated: 2026-05-29
Results Overview
Best Overall Response with MRD status after Upfront HDT-AHCT or End of Induction
Recruitment status
ACTIVE_NOT_RECRUITING
Study phase
PHASE2
Target enrollment
69 participants
Primary outcome timeframe
Up to 8 cycles
Results posted on
2026-05-29
Participant Flow
Participant milestones
| Measure |
Cohort 1
Single arm, two-stage phase II trial of combination therapy (daratumumab, carfilzomib, lenalidomide, and dexamethasone for newly diagnosed multiple myeloma patients. Patients achieving ≥PR at end of 4 cycles will continue to receive the planned total of 8 cycles of combination therapy. Patients may go onto receiving additional maintenance phase therapy with lenalidomide under a separate treatment protocol. Patients ≤ PR after completing 4 cycles will go off study therapy.
daratumumab: Cycle 1 ONLY: Daratumumab 16 mg/kg days 1, 8, 15, and 22, Cycle 2: Daratumumab 16mg/kg days 1, 8, 15, and 22; Cycles 3-6: Daratumumab 16mg/kg days 1 and 15, Cycles 7-8: Daratumumab 16mg/kg day 1; Daratumumab rate of infusion is per MSKCC guidelines.
carfilzomib: Cycle 1 ONLY: Carfilzomib 20 mg/m2 per dose, days 2 and 3; Carfilzomib 36 mg/m2 per dose, days 8, 9, 15, and 16; Cycles 2-8: Carfilzomib 36 mg/m2 per dose, days 1, 2, 8, 9, 15, and 16
lenalidomide: Cycle 1 ONLY: Lenalidomide 25 mg/day, days 2-21 every 28 days; Cycles 2-8: Lenalidomide 25 mg/day, days 1-21 every 28 days
dexamethasone: Cycle 1 ONLY: Dexamethasone 20 mg/dose, days 2, 3, 8, 9, 15, 16, Cycles 2: Dexamethasone 20mg/dose, days 1, 2, 8, 9, 15, 16 and 22; Cycles 3-4: Dexamethasone 20mg/dose, days 1,2,8,9,15 and 16, Cycles 5- 8: Dexamethasone 10mg/dose, days 1, 2, 8, 9, 15, and 16
|
Cohort 2
Single arm, two-stage phase II trial of combination therapy (daratumumab, carfilzomib, lenalidomide, and dexamethasone for newly diagnosed multiple myeloma patients. Patients achieving ≥PR at end of 4 cycles will continue to receive the planned total of 8 cycles of combination therapy. Patients may go onto receiving additional maintenance phase therapy with lenalidomide under a separate treatment protocol. Patients ≤ PR after completing 4 cycles will go off study therapy.
daratumumab: Cycle 1 ONLY: Daratumumab 16 mg/kg days 1, 8, 15, and 22, Cycle 2: Daratumumab 16mg/kg days 1, 8, 15, and 22; Cycles 3-6: Daratumumab 16mg/kg days 1 and 15, Cycles 7-8: Daratumumab 16mg/kg day 1; Daratumumab rate of infusion is per MSKCC guidelines.
carfilzomib: Cycle 1 ONLY: Carfilzomib 20 mg/m2 per dose, days 2 and 3; Carfilzomib 36 mg/m2 per dose, days 8, 9, 15, and 16; Cycles 2-8: Carfilzomib 36 mg/m2 per dose, days 1, 2, 8, 9, 15, and 16
lenalidomide: Cycle 1 ONLY: Lenalidomide 25 mg/day, days 2-21 every 28 days; Cycles 2-8: Lenalidomide 25 mg/day, days 1-21 every 28 days
dexamethasone: Cycle 1 ONLY: Dexamethasone 20 mg/dose, days 1, 2, 22; 40 mg/dose days 8 and 15, Cycles 2: Dexamethasone 40mg/dose, days 1, 8, 15; 20 mg/dose day 22, Cycles 3-4: Dexamethasone 40mg/dose, Days 1, 8 15, Cycles 5-8: Dexamethasone 20mg/dose, Days 1, 8, 15
|
|---|---|---|
|
Overall Study
STARTED
|
28
|
41
|
|
Overall Study
COMPLETED
|
22
|
37
|
|
Overall Study
NOT COMPLETED
|
6
|
4
|
Reasons for withdrawal
| Measure |
Cohort 1
Single arm, two-stage phase II trial of combination therapy (daratumumab, carfilzomib, lenalidomide, and dexamethasone for newly diagnosed multiple myeloma patients. Patients achieving ≥PR at end of 4 cycles will continue to receive the planned total of 8 cycles of combination therapy. Patients may go onto receiving additional maintenance phase therapy with lenalidomide under a separate treatment protocol. Patients ≤ PR after completing 4 cycles will go off study therapy.
daratumumab: Cycle 1 ONLY: Daratumumab 16 mg/kg days 1, 8, 15, and 22, Cycle 2: Daratumumab 16mg/kg days 1, 8, 15, and 22; Cycles 3-6: Daratumumab 16mg/kg days 1 and 15, Cycles 7-8: Daratumumab 16mg/kg day 1; Daratumumab rate of infusion is per MSKCC guidelines.
carfilzomib: Cycle 1 ONLY: Carfilzomib 20 mg/m2 per dose, days 2 and 3; Carfilzomib 36 mg/m2 per dose, days 8, 9, 15, and 16; Cycles 2-8: Carfilzomib 36 mg/m2 per dose, days 1, 2, 8, 9, 15, and 16
lenalidomide: Cycle 1 ONLY: Lenalidomide 25 mg/day, days 2-21 every 28 days; Cycles 2-8: Lenalidomide 25 mg/day, days 1-21 every 28 days
dexamethasone: Cycle 1 ONLY: Dexamethasone 20 mg/dose, days 2, 3, 8, 9, 15, 16, Cycles 2: Dexamethasone 20mg/dose, days 1, 2, 8, 9, 15, 16 and 22; Cycles 3-4: Dexamethasone 20mg/dose, days 1,2,8,9,15 and 16, Cycles 5- 8: Dexamethasone 10mg/dose, days 1, 2, 8, 9, 15, and 16
|
Cohort 2
Single arm, two-stage phase II trial of combination therapy (daratumumab, carfilzomib, lenalidomide, and dexamethasone for newly diagnosed multiple myeloma patients. Patients achieving ≥PR at end of 4 cycles will continue to receive the planned total of 8 cycles of combination therapy. Patients may go onto receiving additional maintenance phase therapy with lenalidomide under a separate treatment protocol. Patients ≤ PR after completing 4 cycles will go off study therapy.
daratumumab: Cycle 1 ONLY: Daratumumab 16 mg/kg days 1, 8, 15, and 22, Cycle 2: Daratumumab 16mg/kg days 1, 8, 15, and 22; Cycles 3-6: Daratumumab 16mg/kg days 1 and 15, Cycles 7-8: Daratumumab 16mg/kg day 1; Daratumumab rate of infusion is per MSKCC guidelines.
carfilzomib: Cycle 1 ONLY: Carfilzomib 20 mg/m2 per dose, days 2 and 3; Carfilzomib 36 mg/m2 per dose, days 8, 9, 15, and 16; Cycles 2-8: Carfilzomib 36 mg/m2 per dose, days 1, 2, 8, 9, 15, and 16
lenalidomide: Cycle 1 ONLY: Lenalidomide 25 mg/day, days 2-21 every 28 days; Cycles 2-8: Lenalidomide 25 mg/day, days 1-21 every 28 days
dexamethasone: Cycle 1 ONLY: Dexamethasone 20 mg/dose, days 1, 2, 22; 40 mg/dose days 8 and 15, Cycles 2: Dexamethasone 40mg/dose, days 1, 8, 15; 20 mg/dose day 22, Cycles 3-4: Dexamethasone 40mg/dose, Days 1, 8 15, Cycles 5-8: Dexamethasone 20mg/dose, Days 1, 8, 15
|
|---|---|---|
|
Overall Study
Adverse Event
|
1
|
1
|
|
Overall Study
Withdrawal by Subject
|
3
|
3
|
|
Overall Study
Removed due to malignancy
|
2
|
0
|
Baseline Characteristics
A Study of Daratumumab in Patients With Newly Diagnosed Multiple Myeloma
Baseline characteristics by cohort
| Measure |
Cohort 1
n=28 Participants
Single arm, two-stage phase II trial of combination therapy (daratumumab, carfilzomib, lenalidomide, and dexamethasone for newly diagnosed multiple myeloma patients. Patients achieving ≥PR at end of 4 cycles will continue to receive the planned total of 8 cycles of combination therapy. Patients may go onto receiving additional maintenance phase therapy with lenalidomide under a separate treatment protocol. Patients ≤ PR after completing 4 cycles will go off study therapy.
daratumumab: Cycle 1 ONLY: Daratumumab 16 mg/kg days 1, 8, 15, and 22, Cycle 2: Daratumumab 16mg/kg days 1, 8, 15, and 22; Cycles 3-6: Daratumumab 16mg/kg days 1 and 15, Cycles 7-8: Daratumumab 16mg/kg day 1; Daratumumab rate of infusion is per MSKCC guidelines.
carfilzomib: Cycle 1 ONLY: Carfilzomib 20 mg/m2 per dose, days 2 and 3; Carfilzomib 36 mg/m2 per dose, days 8, 9, 15, and 16; Cycles 2-8: Carfilzomib 36 mg/m2 per dose, days 1, 2, 8, 9, 15, and 16
lenalidomide: Cycle 1 ONLY: Lenalidomide 25 mg/day, days 2-21 every 28 days; Cycles 2-8: Lenalidomide 25 mg/day, days 1-21 every 28 days
dexamethasone: Cycle 1 ONLY: Dexamethasone 20 mg/dose, days 2, 3, 8, 9, 15, 16, Cycles 2: Dexamethasone 20mg/dose, days 1, 2, 8, 9, 15, 16 and 22; Cycles 3-4: Dexamethasone 20mg/dose, days 1,2,8,9,15 and 16, Cycles 5- 8: Dexamethasone 10mg/dose, days 1, 2, 8, 9, 15, and 16
|
Cohort 2
n=41 Participants
Single arm, two-stage phase II trial of combination therapy (daratumumab, carfilzomib, lenalidomide, and dexamethasone for newly diagnosed multiple myeloma patients. Patients achieving ≥PR at end of 4 cycles will continue to receive the planned total of 8 cycles of combination therapy. Patients may go onto receiving additional maintenance phase therapy with lenalidomide under a separate treatment protocol. Patients ≤ PR after completing 4 cycles will go off study therapy.
daratumumab: Cycle 1 ONLY: Daratumumab 16 mg/kg days 1, 8, 15, and 22, Cycle 2: Daratumumab 16mg/kg days 1, 8, 15, and 22; Cycles 3-6: Daratumumab 16mg/kg days 1 and 15, Cycles 7-8: Daratumumab 16mg/kg day 1; Daratumumab rate of infusion is per MSKCC guidelines.
carfilzomib: Cycle 1 ONLY: Carfilzomib 20 mg/m2 per dose, days 2 and 3; Carfilzomib 36 mg/m2 per dose, days 8, 9, 15, and 16; Cycles 2-8: Carfilzomib 36 mg/m2 per dose, days 1, 2, 8, 9, 15, and 16
lenalidomide: Cycle 1 ONLY: Lenalidomide 25 mg/day, days 2-21 every 28 days; Cycles 2-8: Lenalidomide 25 mg/day, days 1-21 every 28 days
dexamethasone: Cycle 1 ONLY: Dexamethasone 20 mg/dose, days 1, 2, 22; 40 mg/dose days 8 and 15, Cycles 2: Dexamethasone 40mg/dose, days 1, 8, 15; 20 mg/dose day 22, Cycles 3-4: Dexamethasone 40mg/dose, Days 1, 8 15, Cycles 5-8: Dexamethasone 20mg/dose, Days 1, 8, 15
|
Total
n=69 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Sex: Female, Male
Male
|
12 Participants
n=51 Participants
|
16 Participants
n=14 Participants
|
28 Participants
n=65 Participants
|
|
Age, Continuous
|
58 years
n=51 Participants
|
59 years
n=14 Participants
|
59 years
n=65 Participants
|
|
Sex: Female, Male
Female
|
16 Participants
n=51 Participants
|
25 Participants
n=14 Participants
|
41 Participants
n=65 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
4 Participants
n=51 Participants
|
4 Participants
n=14 Participants
|
8 Participants
n=65 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
20 Participants
n=51 Participants
|
31 Participants
n=14 Participants
|
51 Participants
n=65 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
4 Participants
n=51 Participants
|
6 Participants
n=14 Participants
|
10 Participants
n=65 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=51 Participants
|
0 Participants
n=14 Participants
|
0 Participants
n=65 Participants
|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=51 Participants
|
2 Participants
n=14 Participants
|
4 Participants
n=65 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
2 Participants
n=51 Participants
|
2 Participants
n=14 Participants
|
4 Participants
n=65 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=51 Participants
|
5 Participants
n=14 Participants
|
7 Participants
n=65 Participants
|
|
Race (NIH/OMB)
White
|
22 Participants
n=51 Participants
|
32 Participants
n=14 Participants
|
54 Participants
n=65 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=51 Participants
|
0 Participants
n=14 Participants
|
0 Participants
n=65 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=51 Participants
|
0 Participants
n=14 Participants
|
0 Participants
n=65 Participants
|
|
Region of Enrollment
United States
|
28 Participants
n=51 Participants
|
41 Participants
n=14 Participants
|
69 Participants
n=65 Participants
|
PRIMARY outcome
Timeframe: Up to 8 cyclesBest Overall Response with MRD status after Upfront HDT-AHCT or End of Induction
Outcome measures
| Measure |
Cohort 1
n=28 Participants
Single arm, two-stage phase II trial of combination therapy (daratumumab, carfilzomib, lenalidomide, and dexamethasone for newly diagnosed multiple myeloma patients. Patients achieving ≥PR at end of 4 cycles will continue to receive the planned total of 8 cycles of combination therapy. Patients may go onto receiving additional maintenance phase therapy with lenalidomide under a separate treatment protocol. Patients ≤ PR after completing 4 cycles will go off study therapy.
daratumumab: Cycle 1 ONLY: Daratumumab 16 mg/kg days 1, 8, 15, and 22, Cycle 2: Daratumumab 16mg/kg days 1, 8, 15, and 22; Cycles 3-6: Daratumumab 16mg/kg days 1 and 15, Cycles 7-8: Daratumumab 16mg/kg day 1; Daratumumab rate of infusion is per MSKCC guidelines.
carfilzomib: Cycle 1 ONLY: Carfilzomib 20 mg/m2 per dose, days 2 and 3; Carfilzomib 36 mg/m2 per dose, days 8, 9, 15, and 16; Cycles 2-8: Carfilzomib 36 mg/m2 per dose, days 1, 2, 8, 9, 15, and 16
lenalidomide: Cycle 1 ONLY: Lenalidomide 25 mg/day, days 2-21 every 28 days; Cycles 2-8: Lenalidomide 25 mg/day, days 1-21 every 28 days
dexamethasone: Cycle 1 ONLY: Dexamethasone 20 mg/dose, days 2, 3, 8, 9, 15, 16, Cycles 2: Dexamethasone 20mg/dose, days 1, 2, 8, 9, 15, 16 and 22; Cycles 3-4: Dexamethasone 20mg/dose, days 1,2,8,9,15 and 16, Cycles 5- 8: Dexamethasone 10mg/dose, days 1, 2, 8, 9, 15, and 16
|
Cohort 2
n=41 Participants
Single arm, two-stage phase II trial of combination therapy (daratumumab, carfilzomib, lenalidomide, and dexamethasone for newly diagnosed multiple myeloma patients. Patients achieving ≥PR at end of 4 cycles will continue to receive the planned total of 8 cycles of combination therapy. Patients may go onto receiving additional maintenance phase therapy with lenalidomide under a separate treatment protocol. Patients ≤ PR after completing 4 cycles will go off study therapy.
daratumumab: Cycle 1 ONLY: Daratumumab 16 mg/kg days 1, 8, 15, and 22, Cycle 2: Daratumumab 16mg/kg days 1, 8, 15, and 22; Cycles 3-6: Daratumumab 16mg/kg days 1 and 15, Cycles 7-8: Daratumumab 16mg/kg day 1; Daratumumab rate of infusion is per MSKCC guidelines.
carfilzomib: Cycle 1 ONLY: Carfilzomib 20 mg/m2 per dose, days 2 and 3; Carfilzomib 36 mg/m2 per dose, days 8, 9, 15, and 16; Cycles 2-8: Carfilzomib 36 mg/m2 per dose, days 1, 2, 8, 9, 15, and 16
lenalidomide: Cycle 1 ONLY: Lenalidomide 25 mg/day, days 2-21 every 28 days; Cycles 2-8: Lenalidomide 25 mg/day, days 1-21 every 28 days
dexamethasone: Cycle 1 ONLY: Dexamethasone 20 mg/dose, days 1, 2, 22; 40 mg/dose days 8 and 15, Cycles 2: Dexamethasone 40mg/dose, days 1, 8, 15; 20 mg/dose day 22, Cycles 3-4: Dexamethasone 40mg/dose, Days 1, 8 15, Cycles 5-8: Dexamethasone 20mg/dose, Days 1, 8, 15
|
|---|---|---|
|
Best Overall Response
CR/MRD positive
|
1 Participants
|
1 Participants
|
|
Best Overall Response
CR/MRD negative
|
9 Participants
|
16 Participants
|
|
Best Overall Response
VGPR MRD negative
|
4 Participants
|
15 Participants
|
|
Best Overall Response
VGPR MRD positive
|
10 Participants
|
9 Participants
|
|
Best Overall Response
VGPR/MRD status unknown
|
2 Participants
|
0 Participants
|
|
Best Overall Response
PR
|
2 Participants
|
0 Participants
|
Adverse Events
Cohort 1
Serious events: 16 serious events
Other events: 28 other events
Deaths: 5 deaths
Cohort 2
Serious events: 14 serious events
Other events: 35 other events
Deaths: 5 deaths
Serious adverse events
| Measure |
Cohort 1
n=28 participants at risk
Single arm, two-stage phase II trial of combination therapy (daratumumab, carfilzomib, lenalidomide, and dexamethasone for newly diagnosed multiple myeloma patients. Patients achieving ≥PR at end of 4 cycles will continue to receive the planned total of 8 cycles of combination therapy. Patients may go onto receiving additional maintenance phase therapy with lenalidomide under a separate treatment protocol. Patients ≤ PR after completing 4 cycles will go off study therapy.
daratumumab: Cycle 1 ONLY: Daratumumab 16 mg/kg days 1, 8, 15, and 22, Cycle 2: Daratumumab 16mg/kg days 1, 8, 15, and 22; Cycles 3-6: Daratumumab 16mg/kg days 1 and 15, Cycles 7-8: Daratumumab 16mg/kg day 1; Daratumumab rate of infusion is per MSKCC guidelines.
carfilzomib: Cycle 1 ONLY: Carfilzomib 20 mg/m2 per dose, days 2 and 3; Carfilzomib 36 mg/m2 per dose, days 8, 9, 15, and 16; Cycles 2-8: Carfilzomib 36 mg/m2 per dose, days 1, 2, 8, 9, 15, and 16
lenalidomide: Cycle 1 ONLY: Lenalidomide 25 mg/day, days 2-21 every 28 days; Cycles 2-8: Lenalidomide 25 mg/day, days 1-21 every 28 days
dexamethasone: Cycle 1 ONLY: Dexamethasone 20 mg/dose, days 2, 3, 8, 9, 15, 16, Cycles 2: Dexamethasone 20mg/dose, days 1, 2, 8, 9, 15, 16 and 22; Cycles 3-4: Dexamethasone 20mg/dose, days 1,2,8,9,15 and 16, Cycles 5- 8: Dexamethasone 10mg/dose, days 1, 2, 8, 9, 15, and 16
|
Cohort 2
n=41 participants at risk
Single arm, two-stage phase II trial of combination therapy (daratumumab, carfilzomib, lenalidomide, and dexamethasone for newly diagnosed multiple myeloma patients. Patients achieving ≥PR at end of 4 cycles will continue to receive the planned total of 8 cycles of combination therapy. Patients may go onto receiving additional maintenance phase therapy with lenalidomide under a separate treatment protocol. Patients ≤ PR after completing 4 cycles will go off study therapy.
daratumumab: Cycle 1 ONLY: Daratumumab 16 mg/kg days 1, 8, 15, and 22, Cycle 2: Daratumumab 16mg/kg days 1, 8, 15, and 22; Cycles 3-6: Daratumumab 16mg/kg days 1 and 15, Cycles 7-8: Daratumumab 16mg/kg day 1; Daratumumab rate of infusion is per MSKCC guidelines.
carfilzomib: Cycle 1 ONLY: Carfilzomib 20 mg/m2 per dose, days 2 and 3; Carfilzomib 36 mg/m2 per dose, days 8, 9, 15, and 16; Cycles 2-8: Carfilzomib 36 mg/m2 per dose, days 1, 2, 8, 9, 15, and 16
lenalidomide: Cycle 1 ONLY: Lenalidomide 25 mg/day, days 2-21 every 28 days; Cycles 2-8: Lenalidomide 25 mg/day, days 1-21 every 28 days
dexamethasone: Cycle 1 ONLY: Dexamethasone 20 mg/dose, days 1, 2, 22; 40 mg/dose days 8 and 15, Cycles 2: Dexamethasone 40mg/dose, days 1, 8, 15; 20 mg/dose day 22, Cycles 3-4: Dexamethasone 40mg/dose, Days 1, 8 15, Cycles 5-8: Dexamethasone 20mg/dose, Days 1, 8, 15
|
|---|---|---|
|
Nervous system disorders
Vasovagal reaction
|
3.6%
1/28 • 1 year
|
0.00%
0/41 • 1 year
|
|
Gastrointestinal disorders
Constipation
|
3.6%
1/28 • 1 year
|
2.4%
1/41 • 1 year
|
|
Vascular disorders
Hypotension
|
3.6%
1/28 • 1 year
|
0.00%
0/41 • 1 year
|
|
General disorders
Fever
|
3.6%
1/28 • 1 year
|
7.3%
3/41 • 1 year
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal deformity
|
3.6%
1/28 • 1 year
|
0.00%
0/41 • 1 year
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
7.1%
2/28 • 1 year
|
0.00%
0/41 • 1 year
|
|
Infections and infestations
Sepsis
|
7.1%
2/28 • 1 year
|
0.00%
0/41 • 1 year
|
|
Infections and infestations
Lung infection, pneumonia
|
3.6%
1/28 • 1 year
|
0.00%
0/41 • 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary edema
|
3.6%
1/28 • 1 year
|
0.00%
0/41 • 1 year
|
|
Renal and urinary disorders
Acute kidney injury
|
3.6%
1/28 • 1 year
|
2.4%
1/41 • 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
3.6%
1/28 • 1 year
|
2.4%
1/41 • 1 year
|
|
Infections and infestations
Parainfluenza
|
3.6%
1/28 • 1 year
|
0.00%
0/41 • 1 year
|
|
Gastrointestinal disorders
Oral pain
|
3.6%
1/28 • 1 year
|
0.00%
0/41 • 1 year
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
3.6%
1/28 • 1 year
|
0.00%
0/41 • 1 year
|
|
General disorders
Edema limbs
|
3.6%
1/28 • 1 year
|
0.00%
0/41 • 1 year
|
|
Nervous system disorders
Paresthesia
|
3.6%
1/28 • 1 year
|
0.00%
0/41 • 1 year
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness, left-sided
|
3.6%
1/28 • 1 year
|
0.00%
0/41 • 1 year
|
|
Cardiac disorders
Atrial fibrillation
|
3.6%
1/28 • 1 year
|
0.00%
0/41 • 1 year
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
7.1%
2/28 • 1 year
|
2.4%
1/41 • 1 year
|
|
General disorders
Death NOS
|
3.6%
1/28 • 1 year
|
0.00%
0/41 • 1 year
|
|
Gastrointestinal disorders
Abdominal pain
|
3.6%
1/28 • 1 year
|
0.00%
0/41 • 1 year
|
|
Metabolism and nutrition disorders
Hyponatremia
|
3.6%
1/28 • 1 year
|
0.00%
0/41 • 1 year
|
|
Injury, poisoning and procedural complications
Infusion related reaction
|
3.6%
1/28 • 1 year
|
0.00%
0/41 • 1 year
|
|
General disorders
Pain
|
3.6%
1/28 • 1 year
|
2.4%
1/41 • 1 year
|
|
Infections and infestations
Urinary tract infection
|
3.6%
1/28 • 1 year
|
0.00%
0/41 • 1 year
|
|
Infections and infestations
Upper respiratory infection
|
3.6%
1/28 • 1 year
|
0.00%
0/41 • 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
3.6%
1/28 • 1 year
|
0.00%
0/41 • 1 year
|
|
Vascular disorders
Thromboembolic event
|
3.6%
1/28 • 1 year
|
0.00%
0/41 • 1 year
|
|
Musculoskeletal and connective tissue disorders
Generalized muscle weakness
|
3.6%
1/28 • 1 year
|
0.00%
0/41 • 1 year
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
3.6%
1/28 • 1 year
|
0.00%
0/41 • 1 year
|
|
Blood and lymphatic system disorders
Anemia
|
3.6%
1/28 • 1 year
|
0.00%
0/41 • 1 year
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
3.6%
1/28 • 1 year
|
0.00%
0/41 • 1 year
|
|
Cardiac disorders
Chest pain, cardiac
|
0.00%
0/28 • 1 year
|
2.4%
1/41 • 1 year
|
|
Nervous system disorders
Transient ischemic attacks
|
3.6%
1/28 • 1 year
|
0.00%
0/41 • 1 year
|
|
Nervous system disorders
Headache
|
0.00%
0/28 • 1 year
|
2.4%
1/41 • 1 year
|
|
Nervous system disorders
Dizziness
|
0.00%
0/28 • 1 year
|
2.4%
1/41 • 1 year
|
|
Reproductive system and breast disorders
Pelvic pain
|
0.00%
0/28 • 1 year
|
2.4%
1/41 • 1 year
|
|
Infections and infestations
Lung infection
|
0.00%
0/28 • 1 year
|
9.8%
4/41 • 1 year
|
|
Cardiac disorders
Ejection fraction decreased
|
3.6%
1/28 • 1 year
|
0.00%
0/41 • 1 year
|
|
Cardiac disorders
Heart failure
|
3.6%
1/28 • 1 year
|
0.00%
0/41 • 1 year
|
|
Gastrointestinal disorders
Diarrhea
|
3.6%
1/28 • 1 year
|
0.00%
0/41 • 1 year
|
|
Cardiac disorders
Acute coronary syndrome
|
0.00%
0/28 • 1 year
|
2.4%
1/41 • 1 year
|
|
Nervous system disorders
Syncope
|
0.00%
0/28 • 1 year
|
2.4%
1/41 • 1 year
|
|
Musculoskeletal and connective tissue disorders
Spinal fracture
|
0.00%
0/28 • 1 year
|
2.4%
1/41 • 1 year
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasms, olfactory neuroblastoma
|
0.00%
0/28 • 1 year
|
2.4%
1/41 • 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.00%
0/28 • 1 year
|
2.4%
1/41 • 1 year
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasms, other
|
0.00%
0/28 • 1 year
|
2.4%
1/41 • 1 year
|
Other adverse events
| Measure |
Cohort 1
n=28 participants at risk
Single arm, two-stage phase II trial of combination therapy (daratumumab, carfilzomib, lenalidomide, and dexamethasone for newly diagnosed multiple myeloma patients. Patients achieving ≥PR at end of 4 cycles will continue to receive the planned total of 8 cycles of combination therapy. Patients may go onto receiving additional maintenance phase therapy with lenalidomide under a separate treatment protocol. Patients ≤ PR after completing 4 cycles will go off study therapy.
daratumumab: Cycle 1 ONLY: Daratumumab 16 mg/kg days 1, 8, 15, and 22, Cycle 2: Daratumumab 16mg/kg days 1, 8, 15, and 22; Cycles 3-6: Daratumumab 16mg/kg days 1 and 15, Cycles 7-8: Daratumumab 16mg/kg day 1; Daratumumab rate of infusion is per MSKCC guidelines.
carfilzomib: Cycle 1 ONLY: Carfilzomib 20 mg/m2 per dose, days 2 and 3; Carfilzomib 36 mg/m2 per dose, days 8, 9, 15, and 16; Cycles 2-8: Carfilzomib 36 mg/m2 per dose, days 1, 2, 8, 9, 15, and 16
lenalidomide: Cycle 1 ONLY: Lenalidomide 25 mg/day, days 2-21 every 28 days; Cycles 2-8: Lenalidomide 25 mg/day, days 1-21 every 28 days
dexamethasone: Cycle 1 ONLY: Dexamethasone 20 mg/dose, days 2, 3, 8, 9, 15, 16, Cycles 2: Dexamethasone 20mg/dose, days 1, 2, 8, 9, 15, 16 and 22; Cycles 3-4: Dexamethasone 20mg/dose, days 1,2,8,9,15 and 16, Cycles 5- 8: Dexamethasone 10mg/dose, days 1, 2, 8, 9, 15, and 16
|
Cohort 2
n=41 participants at risk
Single arm, two-stage phase II trial of combination therapy (daratumumab, carfilzomib, lenalidomide, and dexamethasone for newly diagnosed multiple myeloma patients. Patients achieving ≥PR at end of 4 cycles will continue to receive the planned total of 8 cycles of combination therapy. Patients may go onto receiving additional maintenance phase therapy with lenalidomide under a separate treatment protocol. Patients ≤ PR after completing 4 cycles will go off study therapy.
daratumumab: Cycle 1 ONLY: Daratumumab 16 mg/kg days 1, 8, 15, and 22, Cycle 2: Daratumumab 16mg/kg days 1, 8, 15, and 22; Cycles 3-6: Daratumumab 16mg/kg days 1 and 15, Cycles 7-8: Daratumumab 16mg/kg day 1; Daratumumab rate of infusion is per MSKCC guidelines.
carfilzomib: Cycle 1 ONLY: Carfilzomib 20 mg/m2 per dose, days 2 and 3; Carfilzomib 36 mg/m2 per dose, days 8, 9, 15, and 16; Cycles 2-8: Carfilzomib 36 mg/m2 per dose, days 1, 2, 8, 9, 15, and 16
lenalidomide: Cycle 1 ONLY: Lenalidomide 25 mg/day, days 2-21 every 28 days; Cycles 2-8: Lenalidomide 25 mg/day, days 1-21 every 28 days
dexamethasone: Cycle 1 ONLY: Dexamethasone 20 mg/dose, days 1, 2, 22; 40 mg/dose days 8 and 15, Cycles 2: Dexamethasone 40mg/dose, days 1, 8, 15; 20 mg/dose day 22, Cycles 3-4: Dexamethasone 40mg/dose, Days 1, 8 15, Cycles 5-8: Dexamethasone 20mg/dose, Days 1, 8, 15
|
|---|---|---|
|
Reproductive system and breast disorders
Irregular menstruation
|
3.6%
1/28 • 1 year
|
0.00%
0/41 • 1 year
|
|
Psychiatric disorders
Irritation
|
0.00%
0/28 • 1 year
|
2.4%
1/41 • 1 year
|
|
Musculoskeletal and connective tissue disorders
Joint tightness
|
3.6%
1/28 • 1 year
|
0.00%
0/41 • 1 year
|
|
Reproductive system and breast disorders
Labia pain
|
0.00%
0/28 • 1 year
|
2.4%
1/41 • 1 year
|
|
Nervous system disorders
Lethargy
|
3.6%
1/28 • 1 year
|
0.00%
0/41 • 1 year
|
|
Skin and subcutaneous tissue disorders
Lipoma
|
0.00%
0/28 • 1 year
|
2.4%
1/41 • 1 year
|
|
General disorders
Localized edema
|
0.00%
0/28 • 1 year
|
4.9%
2/41 • 1 year
|
|
Infections and infestations
Lung infection
|
21.4%
6/28 • 1 year
|
14.6%
6/41 • 1 year
|
|
Reproductive system and breast disorders
Menorrhagia
|
3.6%
1/28 • 1 year
|
0.00%
0/41 • 1 year
|
|
Infections and infestations
Metapneumovirus
|
3.6%
1/28 • 1 year
|
0.00%
0/41 • 1 year
|
|
Cardiac disorders
Mitral valve disease
|
0.00%
0/28 • 1 year
|
2.4%
1/41 • 1 year
|
|
Injury, poisoning and procedural complications
Mohs procedure
|
3.6%
1/28 • 1 year
|
0.00%
0/41 • 1 year
|
|
Infections and infestations
Mucosal infection
|
10.7%
3/28 • 1 year
|
0.00%
0/41 • 1 year
|
|
Gastrointestinal disorders
Mucositis oral
|
14.3%
4/28 • 1 year
|
0.00%
0/41 • 1 year
|
|
Musculoskeletal and connective tissue disorders
Muscle cramps
|
0.00%
0/28 • 1 year
|
4.9%
2/41 • 1 year
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness left side
|
3.6%
1/28 • 1 year
|
0.00%
0/41 • 1 year
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness lower limb
|
3.6%
1/28 • 1 year
|
0.00%
0/41 • 1 year
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal deformity
|
3.6%
1/28 • 1 year
|
0.00%
0/41 • 1 year
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
28.6%
8/28 • 1 year
|
9.8%
4/41 • 1 year
|
|
Cardiac disorders
Myocardial infarction
|
0.00%
0/28 • 1 year
|
2.4%
1/41 • 1 year
|
|
Skin and subcutaneous tissue disorders
Nail discoloration
|
0.00%
0/28 • 1 year
|
2.4%
1/41 • 1 year
|
|
Infections and infestations
Nail infection
|
0.00%
0/28 • 1 year
|
2.4%
1/41 • 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
17.9%
5/28 • 1 year
|
17.1%
7/41 • 1 year
|
|
Skin and subcutaneous tissue disorders
Nasal sore
|
0.00%
0/28 • 1 year
|
2.4%
1/41 • 1 year
|
|
Gastrointestinal disorders
Nausea
|
3.6%
1/28 • 1 year
|
46.3%
19/41 • 1 year
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
3.6%
1/28 • 1 year
|
2.4%
1/41 • 1 year
|
|
Nervous system disorders
Neuralgia
|
3.6%
1/28 • 1 year
|
0.00%
0/41 • 1 year
|
|
Investigations
Neutrophil count decreased
|
21.4%
6/28 • 1 year
|
41.5%
17/41 • 1 year
|
|
General disorders
Non-cardiac chest pain
|
3.6%
1/28 • 1 year
|
7.3%
3/41 • 1 year
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
14.3%
4/28 • 1 year
|
22.0%
9/41 • 1 year
|
|
Gastrointestinal disorders
Bilateral swollen gland to submandibular regions
|
3.6%
1/28 • 1 year
|
0.00%
0/41 • 1 year
|
|
Gastrointestinal disorders
Bloating
|
0.00%
0/28 • 1 year
|
2.4%
1/41 • 1 year
|
|
Investigations
Blood bilirubin increased
|
14.3%
4/28 • 1 year
|
4.9%
2/41 • 1 year
|
|
Eye disorders
Blurred vision
|
10.7%
3/28 • 1 year
|
2.4%
1/41 • 1 year
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
3.6%
1/28 • 1 year
|
4.9%
2/41 • 1 year
|
|
Reproductive system and breast disorders
Breast tenderness
|
3.6%
1/28 • 1 year
|
0.00%
0/41 • 1 year
|
|
Infections and infestations
Bronchial infection
|
0.00%
0/28 • 1 year
|
2.4%
1/41 • 1 year
|
|
Injury, poisoning and procedural complications
Bruising
|
0.00%
0/28 • 1 year
|
2.4%
1/41 • 1 year
|
|
Infections and infestations
Campylobacteriosis
|
3.6%
1/28 • 1 year
|
0.00%
0/41 • 1 year
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Carcinoid bronchial mass
|
0.00%
0/28 • 1 year
|
2.4%
1/41 • 1 year
|
|
Cardiac disorders
Chest pain- cardiac
|
3.6%
1/28 • 1 year
|
4.9%
2/41 • 1 year
|
|
Musculoskeletal and connective tissue disorders
Chest wall pain
|
0.00%
0/28 • 1 year
|
2.4%
1/41 • 1 year
|
|
General disorders
Chills
|
7.1%
2/28 • 1 year
|
2.4%
1/41 • 1 year
|
|
Ear and labyrinth disorders
Clogged ear (left)
|
0.00%
0/28 • 1 year
|
2.4%
1/41 • 1 year
|
|
Nervous system disorders
Cognitive disturbance
|
10.7%
3/28 • 1 year
|
0.00%
0/41 • 1 year
|
|
Gastrointestinal disorders
Colitis
|
0.00%
0/28 • 1 year
|
2.4%
1/41 • 1 year
|
|
Cardiac disorders
Conduction disorder
|
3.6%
1/28 • 1 year
|
0.00%
0/41 • 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Congestion, chest
|
0.00%
0/28 • 1 year
|
2.4%
1/41 • 1 year
|
|
Infections and infestations
Conjunctivitis
|
3.6%
1/28 • 1 year
|
0.00%
0/41 • 1 year
|
|
Gastrointestinal disorders
Constipation
|
53.6%
15/28 • 1 year
|
56.1%
23/41 • 1 year
|
|
Respiratory, thoracic and mediastinal disorders
COPD exacerbation
|
3.6%
1/28 • 1 year
|
0.00%
0/41 • 1 year
|
|
Infections and infestations
Coronavirus
|
3.6%
1/28 • 1 year
|
0.00%
0/41 • 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
42.9%
12/28 • 1 year
|
22.0%
9/41 • 1 year
|
|
Investigations
Creatinine increased
|
0.00%
0/28 • 1 year
|
2.4%
1/41 • 1 year
|
|
Infections and infestations
Cutaneous candidiasis to bilateral axilla
|
3.6%
1/28 • 1 year
|
0.00%
0/41 • 1 year
|
|
Investigations
Decreased neutrophils
|
0.00%
0/28 • 1 year
|
2.4%
1/41 • 1 year
|
|
Vascular disorders
Deep vein thrombosis (left leg)
|
0.00%
0/28 • 1 year
|
2.4%
1/41 • 1 year
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/28 • 1 year
|
2.4%
1/41 • 1 year
|
|
Gastrointestinal disorders
Dental caries
|
3.6%
1/28 • 1 year
|
0.00%
0/41 • 1 year
|
|
Psychiatric disorders
Depression
|
7.1%
2/28 • 1 year
|
2.4%
1/41 • 1 year
|
|
Gastrointestinal disorders
Diarrhea
|
53.6%
15/28 • 1 year
|
63.4%
26/41 • 1 year
|
|
Nervous system disorders
Dizziness
|
7.1%
2/28 • 1 year
|
19.5%
8/41 • 1 year
|
|
Eye disorders
Dry eye
|
0.00%
0/28 • 1 year
|
2.4%
1/41 • 1 year
|
|
Gastrointestinal disorders
Dry mouth
|
3.6%
1/28 • 1 year
|
0.00%
0/41 • 1 year
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
0.00%
0/28 • 1 year
|
12.2%
5/41 • 1 year
|
|
Nervous system disorders
Dysesthesia
|
3.6%
1/28 • 1 year
|
0.00%
0/41 • 1 year
|
|
Nervous system disorders
Dysgeusia
|
17.9%
5/28 • 1 year
|
14.6%
6/41 • 1 year
|
|
Gastrointestinal disorders
Dyspepsia
|
3.6%
1/28 • 1 year
|
2.4%
1/41 • 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
39.3%
11/28 • 1 year
|
22.0%
9/41 • 1 year
|
|
Ear and labyrinth disorders
Ear itching
|
0.00%
0/28 • 1 year
|
2.4%
1/41 • 1 year
|
|
Reproductive system and breast disorders
Early menstruation
|
0.00%
0/28 • 1 year
|
2.4%
1/41 • 1 year
|
|
General disorders
Edema face
|
0.00%
0/28 • 1 year
|
2.4%
1/41 • 1 year
|
|
General disorders
Edema limbs
|
21.4%
6/28 • 1 year
|
17.1%
7/41 • 1 year
|
|
Cardiac disorders
Ejection fraction decreased
|
3.6%
1/28 • 1 year
|
2.4%
1/41 • 1 year
|
|
Metabolism and nutrition disorders
Elevated LFTs
|
0.00%
0/28 • 1 year
|
2.4%
1/41 • 1 year
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Endobronchial mass
|
0.00%
0/28 • 1 year
|
2.4%
1/41 • 1 year
|
|
Gastrointestinal disorders
Enterocolitis
|
0.00%
0/28 • 1 year
|
2.4%
1/41 • 1 year
|
|
Infections and infestations
Enterocolitis infectious
|
0.00%
0/28 • 1 year
|
2.4%
1/41 • 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
7.1%
2/28 • 1 year
|
0.00%
0/41 • 1 year
|
|
Skin and subcutaneous tissue disorders
Erythema and swelling to right hand
|
3.6%
1/28 • 1 year
|
0.00%
0/41 • 1 year
|
|
Skin and subcutaneous tissue disorders
Erythema multiforme
|
3.6%
1/28 • 1 year
|
0.00%
0/41 • 1 year
|
|
Infections and infestations
Eye infection
|
3.6%
1/28 • 1 year
|
2.4%
1/41 • 1 year
|
|
Eye disorders
Eye pain
|
0.00%
0/28 • 1 year
|
2.4%
1/41 • 1 year
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/28 • 1 year
|
2.4%
1/41 • 1 year
|
|
General disorders
Fatigue
|
67.9%
19/28 • 1 year
|
48.8%
20/41 • 1 year
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
3.6%
1/28 • 1 year
|
2.4%
1/41 • 1 year
|
|
General disorders
Fever
|
42.9%
12/28 • 1 year
|
29.3%
12/41 • 1 year
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
3.6%
1/28 • 1 year
|
0.00%
0/41 • 1 year
|
|
Gastrointestinal disorders
Flatulence
|
0.00%
0/28 • 1 year
|
4.9%
2/41 • 1 year
|
|
Eye disorders
Floaters
|
3.6%
1/28 • 1 year
|
0.00%
0/41 • 1 year
|
|
Vascular disorders
Flushing
|
0.00%
0/28 • 1 year
|
4.9%
2/41 • 1 year
|
|
Infections and infestations
Fracture
|
0.00%
0/28 • 1 year
|
2.4%
1/41 • 1 year
|
|
General disorders
Gait disturbance
|
0.00%
0/28 • 1 year
|
2.4%
1/41 • 1 year
|
|
Gastrointestinal disorders
Gastroesophageal reflux disease
|
17.9%
5/28 • 1 year
|
7.3%
3/41 • 1 year
|
|
Musculoskeletal and connective tissue disorders
Generalized muscle weakness
|
7.1%
2/28 • 1 year
|
4.9%
2/41 • 1 year
|
|
Skin and subcutaneous tissue disorders
Hair thinning
|
3.6%
1/28 • 1 year
|
0.00%
0/41 • 1 year
|
|
Nervous system disorders
Headache
|
14.3%
4/28 • 1 year
|
14.6%
6/41 • 1 year
|
|
Ear and labyrinth disorders
Hearing impaired
|
3.6%
1/28 • 1 year
|
0.00%
0/41 • 1 year
|
|
Cardiac disorders
Heart failure
|
3.6%
1/28 • 1 year
|
0.00%
0/41 • 1 year
|
|
Gastrointestinal disorders
Hematochezia
|
3.6%
1/28 • 1 year
|
0.00%
0/41 • 1 year
|
|
Renal and urinary disorders
Hematuria
|
3.6%
1/28 • 1 year
|
0.00%
0/41 • 1 year
|
|
Gastrointestinal disorders
Hemorrhoidal hemorrhage
|
0.00%
0/28 • 1 year
|
2.4%
1/41 • 1 year
|
|
Gastrointestinal disorders
Hemorrhoids
|
3.6%
1/28 • 1 year
|
4.9%
2/41 • 1 year
|
|
Infections and infestations
Herpes zoster
|
3.6%
1/28 • 1 year
|
0.00%
0/41 • 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Hiccups
|
7.1%
2/28 • 1 year
|
0.00%
0/41 • 1 year
|
|
Skin and subcutaneous tissue disorders
Hirsutism
|
3.6%
1/28 • 1 year
|
0.00%
0/41 • 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Hoarseness
|
3.6%
1/28 • 1 year
|
4.9%
2/41 • 1 year
|
|
Eye disorders
Hordeolum
|
0.00%
0/28 • 1 year
|
2.4%
1/41 • 1 year
|
|
Vascular disorders
Hot flashes
|
3.6%
1/28 • 1 year
|
4.9%
2/41 • 1 year
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
7.1%
2/28 • 1 year
|
2.4%
1/41 • 1 year
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
0.00%
0/28 • 1 year
|
2.4%
1/41 • 1 year
|
|
Vascular disorders
Hypertension
|
35.7%
10/28 • 1 year
|
12.2%
5/41 • 1 year
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
3.6%
1/28 • 1 year
|
2.4%
1/41 • 1 year
|
|
Metabolism and nutrition disorders
Hypokalemia
|
7.1%
2/28 • 1 year
|
9.8%
4/41 • 1 year
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
0.00%
0/28 • 1 year
|
2.4%
1/41 • 1 year
|
|
Metabolism and nutrition disorders
Hyponatremia
|
3.6%
1/28 • 1 year
|
0.00%
0/41 • 1 year
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
10.7%
3/28 • 1 year
|
4.9%
2/41 • 1 year
|
|
Vascular disorders
Hypotension
|
3.6%
1/28 • 1 year
|
2.4%
1/41 • 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
3.6%
1/28 • 1 year
|
4.9%
2/41 • 1 year
|
|
Gastrointestinal disorders
Ileitis
|
0.00%
0/28 • 1 year
|
2.4%
1/41 • 1 year
|
|
Infections and infestations
Influenza
|
3.6%
1/28 • 1 year
|
0.00%
0/41 • 1 year
|
|
Injury, poisoning and procedural complications
Infusion related reaction
|
17.9%
5/28 • 1 year
|
19.5%
8/41 • 1 year
|
|
Psychiatric disorders
Insomnia
|
32.1%
9/28 • 1 year
|
48.8%
20/41 • 1 year
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tubular adenoma, benign
|
0.00%
0/28 • 1 year
|
2.4%
1/41 • 1 year
|
|
Infections and infestations
Upper respiratory infection
|
35.7%
10/28 • 1 year
|
41.5%
17/41 • 1 year
|
|
Renal and urinary disorders
Urinary difficulty
|
0.00%
0/28 • 1 year
|
2.4%
1/41 • 1 year
|
|
Renal and urinary disorders
Urinary frequency
|
3.6%
1/28 • 1 year
|
2.4%
1/41 • 1 year
|
|
Infections and infestations
Urinary tract infection
|
7.1%
2/28 • 1 year
|
12.2%
5/41 • 1 year
|
|
Renal and urinary disorders
Urinary tract pain
|
3.6%
1/28 • 1 year
|
0.00%
0/41 • 1 year
|
|
Reproductive system and breast disorders
Vaginal dryness
|
3.6%
1/28 • 1 year
|
2.4%
1/41 • 1 year
|
|
Reproductive system and breast disorders
Vaginal itching
|
0.00%
0/28 • 1 year
|
2.4%
1/41 • 1 year
|
|
Nervous system disorders
Vasovagal reaction
|
3.6%
1/28 • 1 year
|
0.00%
0/41 • 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Voice alteration
|
0.00%
0/28 • 1 year
|
2.4%
1/41 • 1 year
|
|
Gastrointestinal disorders
Vomiting
|
3.6%
1/28 • 1 year
|
24.4%
10/41 • 1 year
|
|
Renal and urinary disorders
Weak urinary stream
|
3.6%
1/28 • 1 year
|
0.00%
0/41 • 1 year
|
|
Investigations
Weight gain
|
0.00%
0/28 • 1 year
|
2.4%
1/41 • 1 year
|
|
Investigations
Weight loss
|
10.7%
3/28 • 1 year
|
4.9%
2/41 • 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
3.6%
1/28 • 1 year
|
0.00%
0/41 • 1 year
|
|
Investigations
White blood cell decreased
|
3.6%
1/28 • 1 year
|
9.8%
4/41 • 1 year
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Olfactory neuroblastoma
|
0.00%
0/28 • 1 year
|
2.4%
1/41 • 1 year
|
|
Infections and infestations
Oral candidiasis
|
0.00%
0/28 • 1 year
|
2.4%
1/41 • 1 year
|
|
General disorders
Pain
|
25.0%
7/28 • 1 year
|
22.0%
9/41 • 1 year
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
7.1%
2/28 • 1 year
|
7.3%
3/41 • 1 year
|
|
Cardiac disorders
Palpitations
|
7.1%
2/28 • 1 year
|
2.4%
1/41 • 1 year
|
|
Gastrointestinal disorders
Papillae on tongue
|
3.6%
1/28 • 1 year
|
0.00%
0/41 • 1 year
|
|
Skin and subcutaneous tissue disorders
Papule
|
0.00%
0/28 • 1 year
|
2.4%
1/41 • 1 year
|
|
Skin and subcutaneous tissue disorders
Papulopustular rash
|
0.00%
0/28 • 1 year
|
2.4%
1/41 • 1 year
|
|
Infections and infestations
Parainfluenza
|
3.6%
1/28 • 1 year
|
0.00%
0/41 • 1 year
|
|
Nervous system disorders
Parasthesia
|
7.1%
2/28 • 1 year
|
9.8%
4/41 • 1 year
|
|
Reproductive system and breast disorders
Pelvic pain
|
0.00%
0/28 • 1 year
|
2.4%
1/41 • 1 year
|
|
Gastrointestinal disorders
Perforated diverticulitis
|
3.6%
1/28 • 1 year
|
0.00%
0/41 • 1 year
|
|
Gastrointestinal disorders
Periodontal disease
|
3.6%
1/28 • 1 year
|
0.00%
0/41 • 1 year
|
|
General disorders
Peripheral edema
|
0.00%
0/28 • 1 year
|
4.9%
2/41 • 1 year
|
|
Nervous system disorders
Peripheral motor neuropathy
|
3.6%
1/28 • 1 year
|
2.4%
1/41 • 1 year
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
14.3%
4/28 • 1 year
|
14.6%
6/41 • 1 year
|
|
Infections and infestations
Pharyngitis
|
0.00%
0/28 • 1 year
|
2.4%
1/41 • 1 year
|
|
Infections and infestations
Phlebitis
|
0.00%
0/28 • 1 year
|
2.4%
1/41 • 1 year
|
|
Blood and lymphatic system disorders
Platelet count decreased
|
14.3%
4/28 • 1 year
|
14.6%
6/41 • 1 year
|
|
Infections and infestations
Pneumonia
|
3.6%
1/28 • 1 year
|
0.00%
0/41 • 1 year
|
|
Surgical and medical procedures
Port placement
|
0.00%
0/28 • 1 year
|
2.4%
1/41 • 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Postnasal drip
|
0.00%
0/28 • 1 year
|
2.4%
1/41 • 1 year
|
|
Nervous system disorders
Presyncope
|
0.00%
0/28 • 1 year
|
4.9%
2/41 • 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
3.6%
1/28 • 1 year
|
7.3%
3/41 • 1 year
|
|
Reproductive system and breast disorders
Prostatic hemorrhage
|
0.00%
0/28 • 1 year
|
2.4%
1/41 • 1 year
|
|
Investigations
Proteinuria
|
3.6%
1/28 • 1 year
|
0.00%
0/41 • 1 year
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
32.1%
9/28 • 1 year
|
19.5%
8/41 • 1 year
|
|
Reproductive system and breast disorders
PSA elevation
|
0.00%
0/28 • 1 year
|
2.4%
1/41 • 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary edema
|
3.6%
1/28 • 1 year
|
0.00%
0/41 • 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary hypertension
|
3.6%
1/28 • 1 year
|
4.9%
2/41 • 1 year
|
|
Skin and subcutaneous tissue disorders
Purpura
|
3.6%
1/28 • 1 year
|
2.4%
1/41 • 1 year
|
|
Skin and subcutaneous tissue disorders
Rash acneiform
|
7.1%
2/28 • 1 year
|
4.9%
2/41 • 1 year
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
42.9%
12/28 • 1 year
|
43.9%
18/41 • 1 year
|
|
Skin and subcutaneous tissue disorders
Rash, annular/flat
|
0.00%
0/28 • 1 year
|
2.4%
1/41 • 1 year
|
|
Gastrointestinal disorders
Rectal hemorrhage
|
0.00%
0/28 • 1 year
|
2.4%
1/41 • 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory congestion
|
0.00%
0/28 • 1 year
|
2.4%
1/41 • 1 year
|
|
Eye disorders
Retinal detachment
|
3.6%
1/28 • 1 year
|
0.00%
0/41 • 1 year
|
|
Musculoskeletal and connective tissue disorders
Rib pain
|
0.00%
0/28 • 1 year
|
2.4%
1/41 • 1 year
|
|
Ear and labyrinth disorders
Right ear cerumen impaction
|
3.6%
1/28 • 1 year
|
0.00%
0/41 • 1 year
|
|
Eye disorders
Right eye strabismus
|
3.6%
1/28 • 1 year
|
0.00%
0/41 • 1 year
|
|
Musculoskeletal and connective tissue disorders
Right knee pain
|
0.00%
0/28 • 1 year
|
2.4%
1/41 • 1 year
|
|
Surgical and medical procedures
Root canal
|
3.6%
1/28 • 1 year
|
0.00%
0/41 • 1 year
|
|
Infections and infestations
Scrotal infection
|
0.00%
0/28 • 1 year
|
2.4%
1/41 • 1 year
|
|
Skin and subcutaneous tissue disorders
Seborrheic dermatitis
|
0.00%
0/28 • 1 year
|
2.4%
1/41 • 1 year
|
|
Infections and infestations
Sepsis
|
3.6%
1/28 • 1 year
|
0.00%
0/41 • 1 year
|
|
Cardiac disorders
Sinus bradycardia
|
3.6%
1/28 • 1 year
|
4.9%
2/41 • 1 year
|
|
Cardiac disorders
Sinus tachycardia
|
3.6%
1/28 • 1 year
|
2.4%
1/41 • 1 year
|
|
Infections and infestations
Sinusitis
|
3.6%
1/28 • 1 year
|
4.9%
2/41 • 1 year
|
|
Skin and subcutaneous tissue disorders
Skin hyperpigmentation
|
3.6%
1/28 • 1 year
|
0.00%
0/41 • 1 year
|
|
Infections and infestations
Skin infection
|
3.6%
1/28 • 1 year
|
4.9%
2/41 • 1 year
|
|
Skin and subcutaneous tissue disorders
Skin nodules
|
3.6%
1/28 • 1 year
|
0.00%
0/41 • 1 year
|
|
Skin and subcutaneous tissue disorders
Skin sensitivity
|
0.00%
0/28 • 1 year
|
2.4%
1/41 • 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Sore throat
|
0.00%
0/28 • 1 year
|
9.8%
4/41 • 1 year
|
|
Skin and subcutaneous tissue disorders
Sore right nostril
|
0.00%
0/28 • 1 year
|
2.4%
1/41 • 1 year
|
|
Injury, poisoning and procedural complications
Spinal fracture
|
0.00%
0/28 • 1 year
|
2.4%
1/41 • 1 year
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma
|
3.6%
1/28 • 1 year
|
0.00%
0/41 • 1 year
|
|
Nervous system disorders
Syncope
|
3.6%
1/28 • 1 year
|
4.9%
2/41 • 1 year
|
|
Vascular disorders
Thromboembolic event
|
0.00%
0/28 • 1 year
|
2.4%
1/41 • 1 year
|
|
Infections and infestations
Tick bite infection
|
3.6%
1/28 • 1 year
|
0.00%
0/41 • 1 year
|
|
Infections and infestations
Tooth infection
|
3.6%
1/28 • 1 year
|
2.4%
1/41 • 1 year
|
|
Nervous system disorders
Tremor
|
10.7%
3/28 • 1 year
|
4.9%
2/41 • 1 year
|
|
Psychiatric disorders
Anxiety
|
10.7%
3/28 • 1 year
|
9.8%
4/41 • 1 year
|
|
Investigations
Aspartate aminotransferase increased
|
3.6%
1/28 • 1 year
|
9.8%
4/41 • 1 year
|
|
Cardiac disorders
Atrial enlargement
|
3.6%
1/28 • 1 year
|
0.00%
0/41 • 1 year
|
|
Cardiac disorders
Atrial fibrillation
|
7.1%
2/28 • 1 year
|
0.00%
0/41 • 1 year
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
10.7%
3/28 • 1 year
|
2.4%
1/41 • 1 year
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.00%
0/28 • 1 year
|
2.4%
1/41 • 1 year
|
|
Renal and urinary disorders
Acute kidney injury
|
7.1%
2/28 • 1 year
|
2.4%
1/41 • 1 year
|
|
Psychiatric disorders
Agitation
|
10.7%
3/28 • 1 year
|
0.00%
0/41 • 1 year
|
|
Investigations
Alanine aminotransferase increased
|
3.6%
1/28 • 1 year
|
19.5%
8/41 • 1 year
|
|
Investigations
Alkanine phosphatase increased
|
14.3%
4/28 • 1 year
|
9.8%
4/41 • 1 year
|
|
Immune system disorders
Allergic reaction
|
0.00%
0/28 • 1 year
|
2.4%
1/41 • 1 year
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
0.00%
0/28 • 1 year
|
4.9%
2/41 • 1 year
|
|
Blood and lymphatic system disorders
Anemia
|
32.1%
9/28 • 1 year
|
26.8%
11/41 • 1 year
|
|
Metabolism and nutrition disorders
Anorexia
|
14.3%
4/28 • 1 year
|
14.6%
6/41 • 1 year
|
|
Gastrointestinal disorders
Abdominal pain
|
14.3%
4/28 • 1 year
|
14.6%
6/41 • 1 year
|
|
Cardiac disorders
Acute coronary syndrome
|
0.00%
0/28 • 1 year
|
7.3%
3/41 • 1 year
|
Additional Information
Dr. Neha Korde, MD
Memorial Sloan Kettering Cancer Center
Phone: 212-639-7664
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place