Trial Outcomes & Findings for Study of Pomalidomide, Dexamethasone, and Romidepsin for Rel/Ref Myeloma (NCT NCT01979276)
NCT ID: NCT01979276
Last Updated: 2018-06-06
Results Overview
Establish a maximum tolerated dose (MTD) of romidepsin in combination with pomalidomide and dexamethasone in patients with relapsed or refractory multiple myeloma (phase I)
Recruitment status
TERMINATED
Study phase
PHASE1/PHASE2
Target enrollment
4 participants
Primary outcome timeframe
During the duration of the study (from first to last dose of study drug, on average ten 28-day cycles)
Results posted on
2018-06-06
Participant Flow
Two subjects were ineligible and therefore never started treatment.
Participant milestones
| Measure |
ALL Patients
Pomalidomide, 4 mg by mouth daily on days 1-21 of 28 day cycle Dexamethasone, 40 mg by mouth on days 1, 8, 15, and 22 of 28 day cycle Romidepsin, IV on days 1 and 15 of 28 day cycle, dose level to be determined (9mg/m2, 12 mg/m2, 15 mg/m2 or 18 mg/m2)
|
|---|---|
|
Overall Study
STARTED
|
2
|
|
Overall Study
COMPLETED
|
2
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Study of Pomalidomide, Dexamethasone, and Romidepsin for Rel/Ref Myeloma
Baseline characteristics by cohort
| Measure |
ALL Patients
n=2 Participants
Pomalidomide, 4 mg by mouth daily on days 1-21 of 28 day cycle Dexamethasone, 40 mg by mouth on days 1, 8, 15, and 22 of 28 day cycle Romidepsin, IV on days 1 and 15 of 28 day cycle, dose level to be determined
|
|---|---|
|
Age, Continuous
|
60.5 years
n=99 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
2 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
White
|
2 Participants
n=99 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
|
Number of Prior lines of therapy
|
2.5 Line of Prior Therapy
n=99 Participants
|
|
Beta 2 Microglobulin
|
2.15 mg/L
n=99 Participants
|
|
Lactate Dehydrogenase
|
209.5 U/L
n=99 Participants
|
PRIMARY outcome
Timeframe: During the duration of the study (from first to last dose of study drug, on average ten 28-day cycles)Population: MTD not established as study terminated while only 2 subjects enrolled. Only romidepsin dose tested was 9mg/mg2
Establish a maximum tolerated dose (MTD) of romidepsin in combination with pomalidomide and dexamethasone in patients with relapsed or refractory multiple myeloma (phase I)
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: From baseline to cycle of maximum response, which occurred on average after 2 cycles; 1 cycle = 28 daysThe efficacy (as assessed by clinical response) of the combination of pomalidomide (CC-4047®) and romidepsin as therapy for patients with relapsed or refractory multiple myeloma (MM) (phase II portion) was evaluated using the IMWG Response Criteria for disease assessment. The best response was reported. (Criteria can be found at the following link, due to length and complexity of the response criteria: http://imwg.myeloma.org/international-myeloma-working-group-imwg-uniform-response-criteria-for-multiple-myeloma/)
Outcome measures
| Measure |
ALL Patients
n=2 Participants
Pomalidomide, 4 mg by mouth daily on days 1-21 of 28 day cycle Dexamethasone, 40 mg by mouth on days 1, 8, 15, and 22 of 28 day cycle Romidepsin, IV on days 1 and 15 of 28 day cycle, dose level to be determined
|
|---|---|
|
Efficacy of Study Regimen Combination
Progression of Disease
|
1 Participants
|
|
Efficacy of Study Regimen Combination
Very Good Partial Response
|
1 Participants
|
SECONDARY outcome
Timeframe: From start of treatment, to date of disease progression (on average, ten 28-day cycles)Outcome measures
| Measure |
ALL Patients
n=2 Participants
Pomalidomide, 4 mg by mouth daily on days 1-21 of 28 day cycle Dexamethasone, 40 mg by mouth on days 1, 8, 15, and 22 of 28 day cycle Romidepsin, IV on days 1 and 15 of 28 day cycle, dose level to be determined
|
|---|---|
|
Time to Disease Progression (Progression Free Survival)
|
9.5 cycles (defined as 28 days)
Interval 1.0 to 18.0
|
Adverse Events
Pomalidomide, Romidepsin, Dexamethasone
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Pomalidomide, Romidepsin, Dexamethasone
n=2 participants at risk
Pomalidomide, 4 mg by mouth daily on days 1-21 of 28 day cycle Dexamethasone, 40 mg by mouth on days 1, 8, 15, and 22 of 28 day cycle Romidepsin, IV on days 1 and 15 of 28 day cycle, dose level to be determined Dexamethasone
Romidepsin: Romidepsin intravenously on days 1 and 15 of a 28-day cycle
pomalidomide: Pomalidomide 4mg daily by mouth on days 1-21 of a 28-day cycle
Dexamethasone: Dexamethasone 40mg by mouth on days 1, 8, 15 and 22 of a 28-day cycle
|
|---|---|
|
Psychiatric disorders
Insomnia
|
50.0%
1/2 • Number of events 4 • Adverse events were recorded from baseline until removal from study. Serious adverse events were recorded from baseline until 30 days after the last dose of study drug.
Adverse events were recorded using the CTCAE version 4.0. Serious adverse events were recorded from baseline until 30 days after the last dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea with moderate exertion
|
50.0%
1/2 • Number of events 1 • Adverse events were recorded from baseline until removal from study. Serious adverse events were recorded from baseline until 30 days after the last dose of study drug.
Adverse events were recorded using the CTCAE version 4.0. Serious adverse events were recorded from baseline until 30 days after the last dose of study drug.
|
|
General disorders
Fatigue
|
50.0%
1/2 • Number of events 1 • Adverse events were recorded from baseline until removal from study. Serious adverse events were recorded from baseline until 30 days after the last dose of study drug.
Adverse events were recorded using the CTCAE version 4.0. Serious adverse events were recorded from baseline until 30 days after the last dose of study drug.
|
|
Nervous system disorders
Peripheral Neuropathy
|
50.0%
1/2 • Number of events 1 • Adverse events were recorded from baseline until removal from study. Serious adverse events were recorded from baseline until 30 days after the last dose of study drug.
Adverse events were recorded using the CTCAE version 4.0. Serious adverse events were recorded from baseline until 30 days after the last dose of study drug.
|
|
Eye disorders
Blurred Vision
|
50.0%
1/2 • Number of events 2 • Adverse events were recorded from baseline until removal from study. Serious adverse events were recorded from baseline until 30 days after the last dose of study drug.
Adverse events were recorded using the CTCAE version 4.0. Serious adverse events were recorded from baseline until 30 days after the last dose of study drug.
|
|
Gastrointestinal disorders
Nausea - intermittent
|
50.0%
1/2 • Number of events 2 • Adverse events were recorded from baseline until removal from study. Serious adverse events were recorded from baseline until 30 days after the last dose of study drug.
Adverse events were recorded using the CTCAE version 4.0. Serious adverse events were recorded from baseline until 30 days after the last dose of study drug.
|
|
Gastrointestinal disorders
Nausea
|
50.0%
1/2 • Number of events 3 • Adverse events were recorded from baseline until removal from study. Serious adverse events were recorded from baseline until 30 days after the last dose of study drug.
Adverse events were recorded using the CTCAE version 4.0. Serious adverse events were recorded from baseline until 30 days after the last dose of study drug.
|
|
Gastrointestinal disorders
Dyspepsia - intermittent
|
50.0%
1/2 • Number of events 1 • Adverse events were recorded from baseline until removal from study. Serious adverse events were recorded from baseline until 30 days after the last dose of study drug.
Adverse events were recorded using the CTCAE version 4.0. Serious adverse events were recorded from baseline until 30 days after the last dose of study drug.
|
|
Gastrointestinal disorders
Dyspepsia
|
50.0%
1/2 • Number of events 1 • Adverse events were recorded from baseline until removal from study. Serious adverse events were recorded from baseline until 30 days after the last dose of study drug.
Adverse events were recorded using the CTCAE version 4.0. Serious adverse events were recorded from baseline until 30 days after the last dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Generalized weakness
|
50.0%
1/2 • Number of events 1 • Adverse events were recorded from baseline until removal from study. Serious adverse events were recorded from baseline until 30 days after the last dose of study drug.
Adverse events were recorded using the CTCAE version 4.0. Serious adverse events were recorded from baseline until 30 days after the last dose of study drug.
|
|
Gastrointestinal disorders
constipation
|
50.0%
1/2 • Number of events 1 • Adverse events were recorded from baseline until removal from study. Serious adverse events were recorded from baseline until 30 days after the last dose of study drug.
Adverse events were recorded using the CTCAE version 4.0. Serious adverse events were recorded from baseline until 30 days after the last dose of study drug.
|
|
Nervous system disorders
Paresthesia around mouth
|
50.0%
1/2 • Number of events 1 • Adverse events were recorded from baseline until removal from study. Serious adverse events were recorded from baseline until 30 days after the last dose of study drug.
Adverse events were recorded using the CTCAE version 4.0. Serious adverse events were recorded from baseline until 30 days after the last dose of study drug.
|
|
Nervous system disorders
Dizziness
|
50.0%
1/2 • Number of events 4 • Adverse events were recorded from baseline until removal from study. Serious adverse events were recorded from baseline until 30 days after the last dose of study drug.
Adverse events were recorded using the CTCAE version 4.0. Serious adverse events were recorded from baseline until 30 days after the last dose of study drug.
|
|
Cardiac disorders
Palpitations
|
50.0%
1/2 • Number of events 2 • Adverse events were recorded from baseline until removal from study. Serious adverse events were recorded from baseline until 30 days after the last dose of study drug.
Adverse events were recorded using the CTCAE version 4.0. Serious adverse events were recorded from baseline until 30 days after the last dose of study drug.
|
|
Infections and infestations
upper respiratory infection
|
50.0%
1/2 • Number of events 2 • Adverse events were recorded from baseline until removal from study. Serious adverse events were recorded from baseline until 30 days after the last dose of study drug.
Adverse events were recorded using the CTCAE version 4.0. Serious adverse events were recorded from baseline until 30 days after the last dose of study drug.
|
|
Nervous system disorders
tremors
|
50.0%
1/2 • Number of events 2 • Adverse events were recorded from baseline until removal from study. Serious adverse events were recorded from baseline until 30 days after the last dose of study drug.
Adverse events were recorded using the CTCAE version 4.0. Serious adverse events were recorded from baseline until 30 days after the last dose of study drug.
|
|
Psychiatric disorders
agitation
|
50.0%
1/2 • Number of events 1 • Adverse events were recorded from baseline until removal from study. Serious adverse events were recorded from baseline until 30 days after the last dose of study drug.
Adverse events were recorded using the CTCAE version 4.0. Serious adverse events were recorded from baseline until 30 days after the last dose of study drug.
|
|
Gastrointestinal disorders
bloating
|
50.0%
1/2 • Number of events 1 • Adverse events were recorded from baseline until removal from study. Serious adverse events were recorded from baseline until 30 days after the last dose of study drug.
Adverse events were recorded using the CTCAE version 4.0. Serious adverse events were recorded from baseline until 30 days after the last dose of study drug.
|
|
Gastrointestinal disorders
Stomach pain - epigastric area
|
50.0%
1/2 • Number of events 1 • Adverse events were recorded from baseline until removal from study. Serious adverse events were recorded from baseline until 30 days after the last dose of study drug.
Adverse events were recorded using the CTCAE version 4.0. Serious adverse events were recorded from baseline until 30 days after the last dose of study drug.
|
|
Infections and infestations
ear infection
|
50.0%
1/2 • Number of events 1 • Adverse events were recorded from baseline until removal from study. Serious adverse events were recorded from baseline until 30 days after the last dose of study drug.
Adverse events were recorded using the CTCAE version 4.0. Serious adverse events were recorded from baseline until 30 days after the last dose of study drug.
|
|
Gastrointestinal disorders
Diarrhea
|
50.0%
1/2 • Number of events 3 • Adverse events were recorded from baseline until removal from study. Serious adverse events were recorded from baseline until 30 days after the last dose of study drug.
Adverse events were recorded using the CTCAE version 4.0. Serious adverse events were recorded from baseline until 30 days after the last dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
50.0%
1/2 • Number of events 2 • Adverse events were recorded from baseline until removal from study. Serious adverse events were recorded from baseline until 30 days after the last dose of study drug.
Adverse events were recorded using the CTCAE version 4.0. Serious adverse events were recorded from baseline until 30 days after the last dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
nasal congestion
|
50.0%
1/2 • Number of events 4 • Adverse events were recorded from baseline until removal from study. Serious adverse events were recorded from baseline until 30 days after the last dose of study drug.
Adverse events were recorded using the CTCAE version 4.0. Serious adverse events were recorded from baseline until 30 days after the last dose of study drug.
|
|
Infections and infestations
urinary tract infection
|
50.0%
1/2 • Number of events 2 • Adverse events were recorded from baseline until removal from study. Serious adverse events were recorded from baseline until 30 days after the last dose of study drug.
Adverse events were recorded using the CTCAE version 4.0. Serious adverse events were recorded from baseline until 30 days after the last dose of study drug.
|
|
General disorders
pain - bilateral hips
|
50.0%
1/2 • Number of events 2 • Adverse events were recorded from baseline until removal from study. Serious adverse events were recorded from baseline until 30 days after the last dose of study drug.
Adverse events were recorded using the CTCAE version 4.0. Serious adverse events were recorded from baseline until 30 days after the last dose of study drug.
|
|
Hepatobiliary disorders
ALT elevation
|
50.0%
1/2 • Number of events 5 • Adverse events were recorded from baseline until removal from study. Serious adverse events were recorded from baseline until 30 days after the last dose of study drug.
Adverse events were recorded using the CTCAE version 4.0. Serious adverse events were recorded from baseline until 30 days after the last dose of study drug.
|
|
Hepatobiliary disorders
AST elevation
|
50.0%
1/2 • Number of events 2 • Adverse events were recorded from baseline until removal from study. Serious adverse events were recorded from baseline until 30 days after the last dose of study drug.
Adverse events were recorded using the CTCAE version 4.0. Serious adverse events were recorded from baseline until 30 days after the last dose of study drug.
|
|
Nervous system disorders
headache
|
50.0%
1/2 • Number of events 1 • Adverse events were recorded from baseline until removal from study. Serious adverse events were recorded from baseline until 30 days after the last dose of study drug.
Adverse events were recorded using the CTCAE version 4.0. Serious adverse events were recorded from baseline until 30 days after the last dose of study drug.
|
|
Infections and infestations
nail infection
|
50.0%
1/2 • Number of events 1 • Adverse events were recorded from baseline until removal from study. Serious adverse events were recorded from baseline until 30 days after the last dose of study drug.
Adverse events were recorded using the CTCAE version 4.0. Serious adverse events were recorded from baseline until 30 days after the last dose of study drug.
|
|
Gastrointestinal disorders
jaw pain
|
50.0%
1/2 • Number of events 1 • Adverse events were recorded from baseline until removal from study. Serious adverse events were recorded from baseline until 30 days after the last dose of study drug.
Adverse events were recorded using the CTCAE version 4.0. Serious adverse events were recorded from baseline until 30 days after the last dose of study drug.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60