Trial · NCT01979276
Study of Pomalidomide, Dexamethasone, and Romidepsin for Rel/Ref Myeloma
NCT01979276, Phase 1, Phase 2, Terminated, Weill Medical College of Cornell University; results first posted 2018-01-31
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Study of Pomalidomide, Dexamethasone, and Romidepsin for Rel/Ref Myeloma. Trials, record NCT01979276. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01979276
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Study of Pomalidomide, Dexamethasone, and Romidepsin for Rel/Ref Myeloma
- NCT number
- NCT01979276
- Status
- Terminated
- Phases
- Phase 1, Phase 2
- Enrollment
- 4 participants, actual
- Lead sponsor
- Weill Medical College of Cornell University
- Conditions
- Multiple Myeloma
- Interventions
- Romidepsin, pomalidomide, Dexamethasone
- First posted
- 2013-11-08
- Last updated
- 2018-06-06
- Results first posted
- 2018-01-31
Source ClinicalTrials.gov
Registered outcomes3
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Maximum Tolerated Dose (MTD) of Romidepsin in Combination With Pomalidomide and Dexamethasone | During the duration of the study (from first to last dose of study drug, on average ten 28-day cycles) | Establish a maximum tolerated dose (MTD) of romidepsin in combination with pomalidomide and dexamethasone in patients with relapsed or refractory multiple myeloma (phase I) |
| Primary | Efficacy of Study Regimen Combination | From baseline to cycle of maximum response, which occurred on average after 2 cycles; 1 cycle = 28 days | The 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/) |
| Secondary | Time to Disease Progression (Progression Free Survival) | From start of treatment, to date of disease progression (on average, ten 28-day cycles) |
Source ClinicalTrials.gov
Outcomes3
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Maximum Tolerated Dose (MTD) of Romidepsin in Combination With Pomalidomide and Dexamethasone | During the duration of the study (from first to last dose of study drug, on average ten 28-day cycles) | MTD not established as study terminated while only 2 subjects enrolled. Only romidepsin dose tested was 9mg/mg2 | ||
| PRIMARY | Efficacy of Study Regimen Combination | From baseline to cycle of maximum response, which occurred on average after 2 cycles; 1 cycle = 28 days | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Time to Disease Progression (Progression Free Survival) | From start of treatment, to date of disease progression (on average, ten 28-day cycles) | cycles (defined as 28 days) | MEAN |
Source ClinicalTrials.gov
Results by group3
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Efficacy of Study Regimen Combination | ALL Patients | Progression of Disease | 1 | Participants | |
| Efficacy of Study Regimen Combination | ALL Patients | Very Good Partial Response | 1 | Participants | |
| Time to Disease Progression (Progression Free Survival) | ALL Patients | 9.5 | Full Range 1 to 18 | cycles (defined as 28 days) |
Source ClinicalTrials.gov
Participant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | ALL Patients | 2 | |
| Overall Study | COMPLETED | ALL Patients | 2 | |
| Overall Study | NOT COMPLETED | ALL Patients | 0 |
Source ClinicalTrials.gov
Adverse events30
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Insomnia | Psychiatric disorders | Pomalidomide, Romidepsin, Dexamethasone | 1 | 2 | 4 |
| other | Dyspnea with moderate exertion | Respiratory, thoracic and mediastinal disorders | Pomalidomide, Romidepsin, Dexamethasone | 1 | 2 | 1 |
| other | Fatigue | General disorders | Pomalidomide, Romidepsin, Dexamethasone | 1 | 2 | 1 |
| other | Peripheral Neuropathy | Nervous system disorders | Pomalidomide, Romidepsin, Dexamethasone | 1 | 2 | 1 |
| other | Blurred Vision | Eye disorders | Pomalidomide, Romidepsin, Dexamethasone | 1 | 2 | 2 |
| other | Nausea - intermittent | Gastrointestinal disorders | Pomalidomide, Romidepsin, Dexamethasone | 1 | 2 | 2 |
| other | Nausea | Gastrointestinal disorders | Pomalidomide, Romidepsin, Dexamethasone | 1 | 2 | 3 |
| other | Dyspepsia - intermittent | Gastrointestinal disorders | Pomalidomide, Romidepsin, Dexamethasone | 1 | 2 | 1 |
| other | Dyspepsia | Gastrointestinal disorders | Pomalidomide, Romidepsin, Dexamethasone | 1 | 2 | 1 |
| other | Generalized weakness | Musculoskeletal and connective tissue disorders | Pomalidomide, Romidepsin, Dexamethasone | 1 | 2 | 1 |
1 to 10 of 30Source ClinicalTrials.gov
See all 30 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Pomalidomide, Romidepsin, Dexamethasone | 0 | 2 |
| Total, other adverse events | Pomalidomide, Romidepsin, Dexamethasone | 2 | 2 |
| Total, serious adverse events | Pomalidomide, Romidepsin, Dexamethasone | 0 | 2 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT01979276
GET https://conductscience.org/api/trials/v1/NCT01979276/events?page=2