Trial Outcomes & Findings for High Dose Carfilzomib for Newly Diagnosed Myeloma (NCT NCT02937571)
NCT ID: NCT02937571
Last Updated: 2025-11-20
Results Overview
To find the maximum tolerated dose.A DLT is defined as any of the below toxicities with attribution to one or more of the study drugs that occur during Cycle 1. All AEs should be considered relevant to determining dose-limiting toxicities and to reporting unless the event can clearly be determined to be UNRELATED to the drug. NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for AE reporting.
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
29 participants
Primary outcome timeframe
Cycle 1, up to 28 days
Results posted on
2025-11-20
Participant Flow
Participant milestones
| Measure |
Dose Level 1: Carfilzomib 45mg/m2/Dose
* Cycle 1 ONLY: Carfilzomib 20 mg/m2 per dose, days 1 and 2; Carfilzomib 45 or 56 mg/m2 per dose, days 8, 9, 15, and 16.
* Cycles 2- up to 12: Carfilzomib 45 or 56 mg/m2 per dose, days 1, 2, 8, 9, 15, and 16
* Cycles 1- up to 12: Lenalidomide 25 mg/day, days 1-21 every 28 days
* Cycles 1-4: Dexamethasone 20 mg/dose, days 1, 2, 8, 9, 15, 16, 22, and 23
* Cycles 5- up to 12: Dexamethasone 10 mg/dose, days 1, 2, 8, 9, 15, 16, 22 and 23
Carfilzomib
Lenalidomide
Dexamethasone
|
Dose Level 2: Carfilzomib 56mg/m2/Dose
* Cycle 1 ONLY: Carfilzomib 20 mg/m2 per dose, days 1 and 2; Carfilzomib 45 or 56 mg/m2 per dose, days 8, 9, 15, and 16.
* Cycles 2- up to 12: Carfilzomib 45 or 56 mg/m2 per dose, days 1, 2, 8, 9, 15, and 16
* Cycles 1- up to 12: Lenalidomide 25 mg/day, days 1-21 every 28 days
* Cycles 1-4: Dexamethasone 20 mg/dose, days 1, 2, 8, 9, 15, 16, 22, and 23
* Cycles 5- up to 12: Dexamethasone 10 mg/dose, days 1, 2, 8, 9, 15, 16, 22 and 23
Carfilzomib
Lenalidomide
Dexamethasone
|
MTD: Carfilzomib 56mg/m^2/Dose
* Cycle 1 ONLY: Carfilzomib 20 mg/m2 per dose, days 1 and 2; Carfilzomib 45 or 56 mg/m2 per dose, days 8, 9, 15, and 16.
* Cycles 2- up to 12: Carfilzomib 45 or 56 mg/m2 per dose, days 1, 2, 8, 9, 15, and 16
* Cycles 1- up to 12: Lenalidomide 25 mg/day, days 1-21 every 28 days
* Cycles 1-4: Dexamethasone 20 mg/dose, days 1, 2, 8, 9, 15, 16, 22, and 23
* Cycles 5- up to 12: Dexamethasone 10 mg/dose, days 1, 2, 8, 9, 15, 16, 22 and 23
Carfilzomib
Lenalidomide
Dexamethasone
|
|---|---|---|---|
|
Overall Study
STARTED
|
3
|
3
|
23
|
|
Overall Study
COMPLETED
|
3
|
3
|
16
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
7
|
Reasons for withdrawal
| Measure |
Dose Level 1: Carfilzomib 45mg/m2/Dose
* Cycle 1 ONLY: Carfilzomib 20 mg/m2 per dose, days 1 and 2; Carfilzomib 45 or 56 mg/m2 per dose, days 8, 9, 15, and 16.
* Cycles 2- up to 12: Carfilzomib 45 or 56 mg/m2 per dose, days 1, 2, 8, 9, 15, and 16
* Cycles 1- up to 12: Lenalidomide 25 mg/day, days 1-21 every 28 days
* Cycles 1-4: Dexamethasone 20 mg/dose, days 1, 2, 8, 9, 15, 16, 22, and 23
* Cycles 5- up to 12: Dexamethasone 10 mg/dose, days 1, 2, 8, 9, 15, 16, 22 and 23
Carfilzomib
Lenalidomide
Dexamethasone
|
Dose Level 2: Carfilzomib 56mg/m2/Dose
* Cycle 1 ONLY: Carfilzomib 20 mg/m2 per dose, days 1 and 2; Carfilzomib 45 or 56 mg/m2 per dose, days 8, 9, 15, and 16.
* Cycles 2- up to 12: Carfilzomib 45 or 56 mg/m2 per dose, days 1, 2, 8, 9, 15, and 16
* Cycles 1- up to 12: Lenalidomide 25 mg/day, days 1-21 every 28 days
* Cycles 1-4: Dexamethasone 20 mg/dose, days 1, 2, 8, 9, 15, 16, 22, and 23
* Cycles 5- up to 12: Dexamethasone 10 mg/dose, days 1, 2, 8, 9, 15, 16, 22 and 23
Carfilzomib
Lenalidomide
Dexamethasone
|
MTD: Carfilzomib 56mg/m^2/Dose
* Cycle 1 ONLY: Carfilzomib 20 mg/m2 per dose, days 1 and 2; Carfilzomib 45 or 56 mg/m2 per dose, days 8, 9, 15, and 16.
* Cycles 2- up to 12: Carfilzomib 45 or 56 mg/m2 per dose, days 1, 2, 8, 9, 15, and 16
* Cycles 1- up to 12: Lenalidomide 25 mg/day, days 1-21 every 28 days
* Cycles 1-4: Dexamethasone 20 mg/dose, days 1, 2, 8, 9, 15, 16, 22, and 23
* Cycles 5- up to 12: Dexamethasone 10 mg/dose, days 1, 2, 8, 9, 15, 16, 22 and 23
Carfilzomib
Lenalidomide
Dexamethasone
|
|---|---|---|---|
|
Overall Study
Adverse Event
|
0
|
0
|
4
|
|
Overall Study
Withdrawal by Subject
|
0
|
0
|
3
|
Baseline Characteristics
High Dose Carfilzomib for Newly Diagnosed Myeloma
Baseline characteristics by cohort
| Measure |
Dose Level 1: Carfilzomib 45mg/m2/Dose
n=3 Participants
* Cycle 1 ONLY: Carfilzomib 20 mg/m2 per dose, days 1 and 2; Carfilzomib 45 or 56 mg/m2 per dose, days 8, 9, 15, and 16.
* Cycles 2- up to 12: Carfilzomib 45 or 56 mg/m2 per dose, days 1, 2, 8, 9, 15, and 16
* Cycles 1- up to 12: Lenalidomide 25 mg/day, days 1-21 every 28 days
* Cycles 1-4: Dexamethasone 20 mg/dose, days 1, 2, 8, 9, 15, 16, 22, and 23
* Cycles 5- up to 12: Dexamethasone 10 mg/dose, days 1, 2, 8, 9, 15, 16, 22 and 23
Carfilzomib
Lenalidomide
Dexamethasone
|
Dose Level 2: Carfilzomib 56mg/m2/Dose
n=3 Participants
* Cycle 1 ONLY: Carfilzomib 20 mg/m2 per dose, days 1 and 2; Carfilzomib 45 or 56 mg/m2 per dose, days 8, 9, 15, and 16.
* Cycles 2- up to 12: Carfilzomib 45 or 56 mg/m2 per dose, days 1, 2, 8, 9, 15, and 16
* Cycles 1- up to 12: Lenalidomide 25 mg/day, days 1-21 every 28 days
* Cycles 1-4: Dexamethasone 20 mg/dose, days 1, 2, 8, 9, 15, 16, 22, and 23
* Cycles 5- up to 12: Dexamethasone 10 mg/dose, days 1, 2, 8, 9, 15, 16, 22 and 23
Carfilzomib
Lenalidomide
Dexamethasone
|
MTD: Carfilzomib
n=23 Participants
* Cycle 1 ONLY: Carfilzomib 20 mg/m2 per dose, days 1 and 2; Carfilzomib 45 or 56 mg/m2 per dose, days 8, 9, 15, and 16.
* Cycles 2- up to 12: Carfilzomib 45 or 56 mg/m2 per dose, days 1, 2, 8, 9, 15, and 16
* Cycles 1- up to 12: Lenalidomide 25 mg/day, days 1-21 every 28 days
* Cycles 1-4: Dexamethasone 20 mg/dose, days 1, 2, 8, 9, 15, 16, 22, and 23
* Cycles 5- up to 12: Dexamethasone 10 mg/dose, days 1, 2, 8, 9, 15, 16, 22 and 23
Carfilzomib
Lenalidomide
Dexamethasone
|
Total
n=29 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
63 years
|
68 years
n=4 Participants
|
60 years
n=8 Participants
|
61 years
n=19 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
|
2 Participants
n=4 Participants
|
10 Participants
n=8 Participants
|
14 Participants
n=19 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
|
1 Participants
n=4 Participants
|
13 Participants
n=8 Participants
|
15 Participants
n=19 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
|
0 Participants
n=4 Participants
|
2 Participants
n=8 Participants
|
2 Participants
n=19 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
3 Participants
|
3 Participants
n=4 Participants
|
21 Participants
n=8 Participants
|
27 Participants
n=19 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=19 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=19 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=19 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=19 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
|
0 Participants
n=4 Participants
|
3 Participants
n=8 Participants
|
4 Participants
n=19 Participants
|
|
Race (NIH/OMB)
White
|
2 Participants
|
3 Participants
n=4 Participants
|
16 Participants
n=8 Participants
|
21 Participants
n=19 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=19 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
|
0 Participants
n=4 Participants
|
4 Participants
n=8 Participants
|
4 Participants
n=19 Participants
|
|
Region of Enrollment
United States
|
3 Participants
|
3 Participants
n=4 Participants
|
23 Participants
n=8 Participants
|
29 Participants
n=19 Participants
|
PRIMARY outcome
Timeframe: Cycle 1, up to 28 daysTo find the maximum tolerated dose.A DLT is defined as any of the below toxicities with attribution to one or more of the study drugs that occur during Cycle 1. All AEs should be considered relevant to determining dose-limiting toxicities and to reporting unless the event can clearly be determined to be UNRELATED to the drug. NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for AE reporting.
Outcome measures
| Measure |
Dose Level 1: Carfilzomib 45mg/m2/Dose
n=3 Participants
* Cycle 1 ONLY: Carfilzomib 20 mg/m2 per dose, days 1 and 2; Carfilzomib 45 or 56 mg/m2 per dose, days 8, 9, 15, and 16.
* Cycles 2- up to 12: Carfilzomib 45 or 56 mg/m2 per dose, days 1, 2, 8, 9, 15, and 16
* Cycles 1- up to 12: Lenalidomide 25 mg/day, days 1-21 every 28 days
* Cycles 1-4: Dexamethasone 20 mg/dose, days 1, 2, 8, 9, 15, 16, 22, and 23
* Cycles 5- up to 12: Dexamethasone 10 mg/dose, days 1, 2, 8, 9, 15, 16, 22 and 23
Carfilzomib
Lenalidomide
Dexamethasone
|
Dose Level 2: Carfilzomib 56mg/m2/Dose
n=3 Participants
* Cycle 1 ONLY: Carfilzomib 20 mg/m2 per dose, days 1 and 2; Carfilzomib 45 or 56 mg/m2 per dose, days 8, 9, 15, and 16.
* Cycles 2- up to 12: Carfilzomib 45 or 56 mg/m2 per dose, days 1, 2, 8, 9, 15, and 16
* Cycles 1- up to 12: Lenalidomide 25 mg/day, days 1-21 every 28 days
* Cycles 1-4: Dexamethasone 20 mg/dose, days 1, 2, 8, 9, 15, 16, 22, and 23
* Cycles 5- up to 12: Dexamethasone 10 mg/dose, days 1, 2, 8, 9, 15, 16, 22 and 23
Carfilzomib
Lenalidomide
Dexamethasone
|
MTD: Carfilzomib
n=23 Participants
* Cycle 1 ONLY: Carfilzomib 20 mg/m2 per dose, days 1 and 2; Carfilzomib 45 or 56 mg/m2 per dose, days 8, 9, 15, and 16.
* Cycles 2- up to 12: Carfilzomib 45 or 56 mg/m2 per dose, days 1, 2, 8, 9, 15, and 16
* Cycles 1- up to 12: Lenalidomide 25 mg/day, days 1-21 every 28 days
* Cycles 1-4: Dexamethasone 20 mg/dose, days 1, 2, 8, 9, 15, 16, 22, and 23
* Cycles 5- up to 12: Dexamethasone 10 mg/dose, days 1, 2, 8, 9, 15, 16, 22 and 23
Carfilzomib
Lenalidomide
Dexamethasone
|
|---|---|---|---|
|
Number of Patients With Dose Limiting Toxicity
Number of participants with DLT
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Patients With Dose Limiting Toxicity
Number of participants without DLT
|
3 Participants
|
3 Participants
|
23 Participants
|
Adverse Events
Dose Level 1: Carfilzomib 45mg/m2/Dose
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Dose Level 2: Carfilzomib 56mg/m2/Dose
Serious events: 1 serious events
Other events: 3 other events
Deaths: 0 deaths
MTD: Carfilzomib
Serious events: 15 serious events
Other events: 23 other events
Deaths: 4 deaths
Serious adverse events
| Measure |
Dose Level 1: Carfilzomib 45mg/m2/Dose
n=3 participants at risk
* Cycle 1 ONLY: Carfilzomib 20 mg/m2 per dose, days 1 and 2; Carfilzomib 45 or 56 mg/m2 per dose, days 8, 9, 15, and 16.
* Cycles 2- up to 12: Carfilzomib 45 or 56 mg/m2 per dose, days 1, 2, 8, 9, 15, and 16
* Cycles 1- up to 12: Lenalidomide 25 mg/day, days 1-21 every 28 days
* Cycles 1-4: Dexamethasone 20 mg/dose, days 1, 2, 8, 9, 15, 16, 22, and 23
* Cycles 5- up to 12: Dexamethasone 10 mg/dose, days 1, 2, 8, 9, 15, 16, 22 and 23
Carfilzomib
Lenalidomide
Dexamethasone
|
Dose Level 2: Carfilzomib 56mg/m2/Dose
n=3 participants at risk
* Cycle 1 ONLY: Carfilzomib 20 mg/m2 per dose, days 1 and 2; Carfilzomib 45 or 56 mg/m2 per dose, days 8, 9, 15, and 16.
* Cycles 2- up to 12: Carfilzomib 45 or 56 mg/m2 per dose, days 1, 2, 8, 9, 15, and 16
* Cycles 1- up to 12: Lenalidomide 25 mg/day, days 1-21 every 28 days
* Cycles 1-4: Dexamethasone 20 mg/dose, days 1, 2, 8, 9, 15, 16, 22, and 23
* Cycles 5- up to 12: Dexamethasone 10 mg/dose, days 1, 2, 8, 9, 15, 16, 22 and 23
Carfilzomib
Lenalidomide
Dexamethasone
|
MTD: Carfilzomib
n=23 participants at risk
* Cycle 1 ONLY: Carfilzomib 20 mg/m2 per dose, days 1 and 2; Carfilzomib 45 or 56 mg/m2 per dose, days 8, 9, 15, and 16.
* Cycles 2- up to 12: Carfilzomib 45 or 56 mg/m2 per dose, days 1, 2, 8, 9, 15, and 16
* Cycles 1- up to 12: Lenalidomide 25 mg/day, days 1-21 every 28 days
* Cycles 1-4: Dexamethasone 20 mg/dose, days 1, 2, 8, 9, 15, 16, 22, and 23
* Cycles 5- up to 12: Dexamethasone 10 mg/dose, days 1, 2, 8, 9, 15, 16, 22 and 23
Carfilzomib
Lenalidomide
Dexamethasone
|
|---|---|---|---|
|
Blood and lymphatic system disorders
Febrile Neutropenia
|
0.00%
0/3 • 1 year
|
0.00%
0/3 • 1 year
|
4.3%
1/23 • 1 year
|
|
Infections and infestations
Upper respiratory Infection
|
0.00%
0/3 • 1 year
|
0.00%
0/3 • 1 year
|
4.3%
1/23 • 1 year
|
|
Gastrointestinal disorders
Gastrointestinal Perforation
|
0.00%
0/3 • 1 year
|
0.00%
0/3 • 1 year
|
4.3%
1/23 • 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary hypertension
|
0.00%
0/3 • 1 year
|
0.00%
0/3 • 1 year
|
4.3%
1/23 • 1 year
|
|
Investigations
Platelet count decrease
|
0.00%
0/3 • 1 year
|
0.00%
0/3 • 1 year
|
4.3%
1/23 • 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.00%
0/3 • 1 year
|
0.00%
0/3 • 1 year
|
4.3%
1/23 • 1 year
|
|
Cardiac disorders
Ejection fraction decreased
|
0.00%
0/3 • 1 year
|
0.00%
0/3 • 1 year
|
4.3%
1/23 • 1 year
|
|
Cardiac disorders
Right ventricular dysfunction
|
0.00%
0/3 • 1 year
|
0.00%
0/3 • 1 year
|
4.3%
1/23 • 1 year
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/3 • 1 year
|
0.00%
0/3 • 1 year
|
4.3%
1/23 • 1 year
|
|
Investigations
Blood bilirubin increased
|
0.00%
0/3 • 1 year
|
0.00%
0/3 • 1 year
|
4.3%
1/23 • 1 year
|
|
Renal and urinary disorders
Acute kidney Injury
|
0.00%
0/3 • 1 year
|
0.00%
0/3 • 1 year
|
4.3%
1/23 • 1 year
|
|
Vascular disorders
Thromboembolic Event
|
0.00%
0/3 • 1 year
|
0.00%
0/3 • 1 year
|
8.7%
2/23 • 1 year
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/3 • 1 year
|
0.00%
0/3 • 1 year
|
8.7%
2/23 • 1 year
|
|
Cardiac disorders
Myocardial infarction
|
0.00%
0/3 • 1 year
|
0.00%
0/3 • 1 year
|
4.3%
1/23 • 1 year
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/3 • 1 year
|
0.00%
0/3 • 1 year
|
4.3%
1/23 • 1 year
|
|
Gastrointestinal disorders
Rectal Hemorrhage
|
0.00%
0/3 • 1 year
|
0.00%
0/3 • 1 year
|
4.3%
1/23 • 1 year
|
|
Infections and infestations
Tooth infection
|
0.00%
0/3 • 1 year
|
33.3%
1/3 • 1 year
|
0.00%
0/23 • 1 year
|
|
Renal and urinary disorders
Urinary Retention
|
0.00%
0/3 • 1 year
|
0.00%
0/3 • 1 year
|
4.3%
1/23 • 1 year
|
|
Cardiac disorders
Chest Pain- Cardiac
|
0.00%
0/3 • 1 year
|
0.00%
0/3 • 1 year
|
4.3%
1/23 • 1 year
|
|
Infections and infestations
Lung Infection
|
0.00%
0/3 • 1 year
|
0.00%
0/3 • 1 year
|
17.4%
4/23 • 1 year
|
|
Gastrointestinal disorders
Diarrhea
|
0.00%
0/3 • 1 year
|
0.00%
0/3 • 1 year
|
4.3%
1/23 • 1 year
|
|
Investigations
White Blood Cell Decrease
|
0.00%
0/3 • 1 year
|
0.00%
0/3 • 1 year
|
4.3%
1/23 • 1 year
|
|
Infections and infestations
Hepatitis Viral
|
0.00%
0/3 • 1 year
|
0.00%
0/3 • 1 year
|
4.3%
1/23 • 1 year
|
Other adverse events
| Measure |
Dose Level 1: Carfilzomib 45mg/m2/Dose
n=3 participants at risk
* Cycle 1 ONLY: Carfilzomib 20 mg/m2 per dose, days 1 and 2; Carfilzomib 45 or 56 mg/m2 per dose, days 8, 9, 15, and 16.
* Cycles 2- up to 12: Carfilzomib 45 or 56 mg/m2 per dose, days 1, 2, 8, 9, 15, and 16
* Cycles 1- up to 12: Lenalidomide 25 mg/day, days 1-21 every 28 days
* Cycles 1-4: Dexamethasone 20 mg/dose, days 1, 2, 8, 9, 15, 16, 22, and 23
* Cycles 5- up to 12: Dexamethasone 10 mg/dose, days 1, 2, 8, 9, 15, 16, 22 and 23
Carfilzomib
Lenalidomide
Dexamethasone
|
Dose Level 2: Carfilzomib 56mg/m2/Dose
n=3 participants at risk
* Cycle 1 ONLY: Carfilzomib 20 mg/m2 per dose, days 1 and 2; Carfilzomib 45 or 56 mg/m2 per dose, days 8, 9, 15, and 16.
* Cycles 2- up to 12: Carfilzomib 45 or 56 mg/m2 per dose, days 1, 2, 8, 9, 15, and 16
* Cycles 1- up to 12: Lenalidomide 25 mg/day, days 1-21 every 28 days
* Cycles 1-4: Dexamethasone 20 mg/dose, days 1, 2, 8, 9, 15, 16, 22, and 23
* Cycles 5- up to 12: Dexamethasone 10 mg/dose, days 1, 2, 8, 9, 15, 16, 22 and 23
Carfilzomib
Lenalidomide
Dexamethasone
|
MTD: Carfilzomib
n=23 participants at risk
* Cycle 1 ONLY: Carfilzomib 20 mg/m2 per dose, days 1 and 2; Carfilzomib 45 or 56 mg/m2 per dose, days 8, 9, 15, and 16.
* Cycles 2- up to 12: Carfilzomib 45 or 56 mg/m2 per dose, days 1, 2, 8, 9, 15, and 16
* Cycles 1- up to 12: Lenalidomide 25 mg/day, days 1-21 every 28 days
* Cycles 1-4: Dexamethasone 20 mg/dose, days 1, 2, 8, 9, 15, 16, 22, and 23
* Cycles 5- up to 12: Dexamethasone 10 mg/dose, days 1, 2, 8, 9, 15, 16, 22 and 23
Carfilzomib
Lenalidomide
Dexamethasone
|
|---|---|---|---|
|
Investigations
Fibrinogen decreased
|
0.00%
0/3 • 1 year
|
0.00%
0/3 • 1 year
|
4.3%
1/23 • 1 year
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
0.00%
0/3 • 1 year
|
0.00%
0/3 • 1 year
|
13.0%
3/23 • 1 year
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
0.00%
0/3 • 1 year
|
33.3%
1/3 • 1 year
|
0.00%
0/23 • 1 year
|
|
Vascular disorders
Hypertension
|
0.00%
0/3 • 1 year
|
33.3%
1/3 • 1 year
|
8.7%
2/23 • 1 year
|
|
Metabolism and nutrition disorders
Hyperuricemia
|
0.00%
0/3 • 1 year
|
0.00%
0/3 • 1 year
|
4.3%
1/23 • 1 year
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
0.00%
0/3 • 1 year
|
33.3%
1/3 • 1 year
|
26.1%
6/23 • 1 year
|
|
Metabolism and nutrition disorders
Hypokalemia
|
33.3%
1/3 • 1 year
|
0.00%
0/3 • 1 year
|
8.7%
2/23 • 1 year
|
|
Metabolism and nutrition disorders
Hyponatremia
|
33.3%
1/3 • 1 year
|
0.00%
0/3 • 1 year
|
17.4%
4/23 • 1 year
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
33.3%
1/3 • 1 year
|
33.3%
1/3 • 1 year
|
47.8%
11/23 • 1 year
|
|
Infections and infestations
Lung infection
|
0.00%
0/3 • 1 year
|
0.00%
0/3 • 1 year
|
17.4%
4/23 • 1 year
|
|
Investigations
Lymphocyte count decreased
|
66.7%
2/3 • 1 year
|
33.3%
1/3 • 1 year
|
73.9%
17/23 • 1 year
|
|
Cardiac disorders
Myocardial infarction
|
0.00%
0/3 • 1 year
|
0.00%
0/3 • 1 year
|
4.3%
1/23 • 1 year
|
|
Investigations
Neutrophil count decreased
|
0.00%
0/3 • 1 year
|
0.00%
0/3 • 1 year
|
65.2%
15/23 • 1 year
|
|
General disorders
Pain
|
0.00%
0/3 • 1 year
|
0.00%
0/3 • 1 year
|
4.3%
1/23 • 1 year
|
|
Investigations
Platelet count decreased
|
0.00%
0/3 • 1 year
|
33.3%
1/3 • 1 year
|
56.5%
13/23 • 1 year
|
|
Nervous system disorders
Syncope
|
0.00%
0/3 • 1 year
|
0.00%
0/3 • 1 year
|
4.3%
1/23 • 1 year
|
|
Vascular disorders
Thromboembolic event
|
0.00%
0/3 • 1 year
|
0.00%
0/3 • 1 year
|
8.7%
2/23 • 1 year
|
|
Infections and infestations
Tooth infection
|
0.00%
0/3 • 1 year
|
33.3%
1/3 • 1 year
|
0.00%
0/23 • 1 year
|
|
Investigations
White blood cell decreased
|
0.00%
0/3 • 1 year
|
33.3%
1/3 • 1 year
|
60.9%
14/23 • 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary hypertension
|
0.00%
0/3 • 1 year
|
0.00%
0/3 • 1 year
|
4.3%
1/23 • 1 year
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
0.00%
0/3 • 1 year
|
33.3%
1/3 • 1 year
|
26.1%
6/23 • 1 year
|
|
Renal and urinary disorders
Renal and urinary disorders - Other, specify
|
0.00%
0/3 • 1 year
|
0.00%
0/3 • 1 year
|
4.3%
1/23 • 1 year
|
|
Infections and infestations
Skin infection
|
66.7%
2/3 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/23 • 1 year
|
|
Investigations
Blood bilirubin increased
|
0.00%
0/3 • 1 year
|
0.00%
0/3 • 1 year
|
4.3%
1/23 • 1 year
|
|
Eye disorders
Cataract
|
0.00%
0/3 • 1 year
|
0.00%
0/3 • 1 year
|
8.7%
2/23 • 1 year
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/3 • 1 year
|
0.00%
0/3 • 1 year
|
4.3%
1/23 • 1 year
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/3 • 1 year
|
0.00%
0/3 • 1 year
|
8.7%
2/23 • 1 year
|
|
Gastrointestinal disorders
Diarrhea
|
0.00%
0/3 • 1 year
|
0.00%
0/3 • 1 year
|
4.3%
1/23 • 1 year
|
|
Cardiac disorders
Ejection fraction decreased
|
0.00%
0/3 • 1 year
|
0.00%
0/3 • 1 year
|
4.3%
1/23 • 1 year
|
|
General disorders
Fatigue
|
0.00%
0/3 • 1 year
|
0.00%
0/3 • 1 year
|
8.7%
2/23 • 1 year
|
|
Investigations
Activated partial thromboplastin time prolonged
|
0.00%
0/3 • 1 year
|
0.00%
0/3 • 1 year
|
4.3%
1/23 • 1 year
|
|
Investigations
Alanine aminotransferase increased
|
33.3%
1/3 • 1 year
|
0.00%
0/3 • 1 year
|
8.7%
2/23 • 1 year
|
|
Blood and lymphatic system disorders
Anemia
|
0.00%
0/3 • 1 year
|
0.00%
0/3 • 1 year
|
52.2%
12/23 • 1 year
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/3 • 1 year
|
33.3%
1/3 • 1 year
|
4.3%
1/23 • 1 year
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/3 • 1 year
|
0.00%
0/3 • 1 year
|
8.7%
2/23 • 1 year
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/3 • 1 year
|
0.00%
0/3 • 1 year
|
4.3%
1/23 • 1 year
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/3 • 1 year
|
0.00%
0/3 • 1 year
|
4.3%
1/23 • 1 year
|
Additional Information
Dr. Neha Korde, MD
Memorial Sloan Kettering Cancer Center
Phone: 646-608-3708
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place