Multiple MyelomaPhase 1/2Romi PomaNCT01979276
Study of Pomalidomide, Dexamethasone, and Romidepsin for Rel/Ref Myeloma
A Phase 1/2 study testing Romidepsin, pomalidomide and Dexamethasone in people with Multiple Myeloma, run by Weill Medical College of Cornell University at 1 site in United States.
Trial summary
This clinical trial is for subjects with multiple myeloma that has returned after treatment (relapsed) or did not respond to prior treatment (refractory). The study is in two parts, Phase I and Phase II. Phase I will determine the maximum tolerated dose of romidepsin in combination with pomalidomide and dexamethasone. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Multiple Myeloma
- What is being tested?
- Romidepsin, pomalidomide and Dexamethasone
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2013to Oct 2016
- Phase
- Phase 1/2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- histologically confirmed multiple myeloma.
- measurable disease as defined by > 0.5 g/dL serum monoclonal protein, >0.1 g/dL serum free light chains, >0.2 g/24 hrs urinary M-protein excretion, and/or measurable plasmacytoma(s).
- relapsed or refractory multiple myeloma as defined by progression of disease either after prior therapy or lack of response to currently used therapy
- relapsed or progressive disease after at least 3 prior therapeutic treatments or regimens for multiple myeloma.
- refractory to bortezomib and lenalidomide
- >18 years at the time of signing the informed consent form.
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- life expectancy of > 3 months.
- Karnofsky performance status > 70%, or > 60% if due to bony involvement of multiple myeloma
- normal organ and marrow function as defined below:
- Absolute Neutrophil Count > 1,000 cells/mm3 for Phase I, > 750 cells/mm3 for Phase II
- Platelet Count > 75,000/mm3 for Phase I, > 50, 000/mm3 for Phase II
- AST/ Serum SGOT < 3.0 x upper limits of normal
- ALT/ Serum SGPT < 3.0 x upper limit of normal
- Serum creatinine < 2.0 mg/dL
- Serum total bilirubin < 1.5 x upper limit of normal
- Laboratory test results within these ranges:
- Serum potassium ≥ 3.8 mmol/L h. Serum magnesium >1.8 mg/dL
- Females of child bearing potential (FCBP) must have a negative serum or urine pregnancy test with a sensitivity of at least 25 mIU/mL within 10-14 days prior to start of study drug(s) and again with 24 hours of prescribing pomalidomide (prescriptions must be filled within 7 days).
- Females of child bearing potential must either commit to continued abstinence from heterosexual intercourse or begin TWO acceptable methods of birth control, one highly effective method and one additional effective method AT THE SAME TIME, at least 4 weeks before starting pomalidomide. FCBP must also agree to ongoing pregnancy testing. Men must agree to use a latex condom during sexual contact with females of child bearing potential even if they have had a successful vasectomy.
- able to take aspirin (81 or 325 mg) daily as prophylactic anticoagulation (patients intolerant to ASA may use warfarin or low molecular weight heparin).
- Ability to understand and the willingness to sign a written informed consent document.
Who cannot join
- Subjects with non-secretory Multiple Myeloma (no measurable monoclonal protein or plasmacytoma(s), free light chains, and/or M-spike in blood or urine).
- Patients with a prior history of other malignancies (except for basal cell or squamous cell carcinoma of the skin or carcinoma in situ of the cervix or breast) unless disease free for ≥ 3 years.
- Any known cardiac abnormalities such as:
- Congenital long QT syndrome
- QTc interval ≥ 480 milliseconds
- Myocardial infarction within 6 months of C1D1. Subjects with a history of myocardial infarction between 6 and 12 months prior to C1D1 who are asymptomatic and have had a negative cardiac risk assessment (treadmill stress test, nuclear medicine stress test, or stress echocardiogram) since the event may participate
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- Other significant ECG abnormalities including 2nd degree atrio-ventricular (AV) block type II, 3rd degree AV block, or bradycardia (ventricular rate less than 50 beats/min)
- Symptomatic coronary artery disease (CAD), e.g., angina Canadian Class II-IV. In any subject in whom there is doubt, the subject should have a stress imaging study and, if abnormal, angiography to define whether or not CAD is present
- An ECG recorded at screening showing evidence of cardiac ischemia (ST depression depression of ≥2 mm, measured from isoelectric line to the ST segment). If in any doubt, the patient should have a stress imaging study and, if abnormal, angiography to define whether or not CAD is present
- Congestive heart failure (CHF) that meets New York Heart Association (NYHA) Class II to IV definitions (see Appendix E) and/or ejection fraction <40% by MUGA scan or <50% by echocardiogram and/or MRI;
- A known history of sustained ventricular tachycardia (VT), ventricular fibrillation (VF), Torsade de Pointes, or cardiac arrest unless currently addressed with an automatic implantable cardioverter defibrillator (AICD);
- Hypertrophic cardiomegaly or restrictive cardiomyopathy from prior treatment or other causes;
- Uncontrolled hypertension, i.e., blood pressure (BP) of ≥160/95; patients who have a history of hypertension controlled by medication must be on a stable dose (for at least one month) and meet all other inclusion criteria; or
- Any cardiac arrhythmia requiring an anti-arrhythmic medication (excluding stable doses of beta-blockers)
- Any Known seropositivity for or active viral infection with human immunodeficiency virus (HIV), hepatitis B virus (HBV) or hepatitis C virus (HCV). Patients who are seropositive because of hepatitis B virus vaccine are eligible.
- Any active viral or bacterial infections or any coexisting medical problem that would significantly increase the risks of this treatment program.
- Any coexisting medical problem or laboratory evaluation that, in the treating physician's or principal investigator's opinion, makes the patient unsuitable to participate in this clinical trial.
- Any serious medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from signing the informed consent form.
- Pregnant or breast feeding females. (Lactating females must agree not to breast feed while taking pomalidomide.)
- Subjects with any condition, including the presence of laboratory abnormalities, which in the opinion of the Investigator places the subject at unacceptable risk if he/she were to participate in the study or confounds the ability to interpret data from the study.
- Use of any other experimental drug or therapy within 14 days of baseline.
- Subjects with a history of development of erythema nodosum, if characterized by a desquamating rash, while taking thalidomide, lenalidomide, pomalidomide or similar drugs.
- Concurrent use of other anti-cancer agents or treatment.
- Concomitant use of CYP3A4 inhibitors (See Appendix D)
- Prior therapy with romidepsin, thalidomide or pomalidomide
- Central nervous system or meningeal involvement
- Patients taking drugs leading to significant QT prolongation
- Known hypersensitivity to thalidomide or lenalidomide
Trial locations and contacts
1 site in 1 country.
United States1 site
Weill Cornell Medical College
New York, New York, 10065
About this study
Official title: A Phase I/II Study of Pomalidomide (CC-4047®), Dexamethasone and Romidepsin in Patients With Relapsed or Refractory Multiple Myeloma (Romi Poma)
This clinical trial is for subjects with multiple myeloma that has returned after treatment (relapsed) or did not respond to prior treatment (refractory). The study is in two parts, Phase I and Phase II. Phase I will determine the maximum tolerated dose of romidepsin in combination with pomalidomide and dexamethasone. The purpose of Phase II is to evaluate the effectiveness of combining romidepsin with pomalidomide and dexamethasone. The hypothesis is that overall response in a cohort of patients treated with romidepsin + pomalidomide + dexamethasone will be 60 percent.
Read the detailed description
This phase I/II study is a treatment program for patients with relapsed or refractory multiple myeloma. Up to 48 patients will be enrolled. Phase I will follow a 3+3 dose escalation design to find the maximum tolerated dose of romidepsin in combination with pomalidomide and dexamethasone.
In Phase I, subjects will receive:
- Pomalidomide 4mg daily by mouth on days 1-21 of a 28-day cycle
- Dexamethasone 40mg by mouth on days 1, 8, 15 and 22 of a 28-day cycle
- Romidepsin intravenously (9 mg/m2, 12 mg/m2, 15 mg/m2 or 18 mg/m2) on days 1 and 15 of a 28-day cycle.
Phase II will expand the number of subjects in the MTD arm of the trial until 48 subjects are enrolled. In Phase II, subjects subjects will receive:
- Pomalidomide 4mg daily by mouth on days 1-21 of a 28-day cycle
- Dexamethasone 40mg by mouth on days 1, 8, 15 and 22 of a 28-day cycle
- Romidepsin intravenously on days 1 and 15 of a 28-day cycle at the Maximum Tolerated Dose determined by Phase I
- Conditions
- Multiple Myeloma
- Being tested
- Romidepsin, pomalidomide, Dexamethasone
- Medical subject headings
- Multiple Myeloma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RomidepsinDrug
Romidepsin intravenously on days 1 and 15 of a 28-day cycle
pomalidomideDrug
Pomalidomide 4mg daily by mouth on days 1-21 of a 28-day cycle
DexamethasoneDrug
Dexamethasone 40mg by mouth on days 1, 8, 15 and 22 of a 28-day cycle
| Study group | Role | What they receive |
|---|---|---|
| Pomalidomide, Romidepsin, Dexamethasone | Experimental | 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 Receives: Drug: Romidepsin; Drug: pomalidomide; Drug: Dexamethasone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum Tolerated Dose (MTD) of Romidepsin in Combination With Pomalidomide and Dexamethasone
Establish a maximum tolerated dose (MTD) of romidepsin in combination with pomalidomide and dexamethasone in patients with relapsed or refractory multiple myeloma (phase I)
Measured: During the duration of the study (from first to last dose of study drug, on average ten 28-day cycles)
Efficacy of Study Regimen Combination
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/)
Measured: From baseline to cycle of maximum response, which occurred on average after 2 cycles; 1 cycle = 28 days
Secondary outcomes (1)
Time to Disease Progression (Progression Free Survival)
Measured: From start of treatment, to date of disease progression (on average, ten 28-day cycles)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Nov 2013 (estimated)
- Study startNov 2013
- Primary completionOct 2016
- Study completionOct 2016
Why it stopped: this study was terminated due to losing financial support, and enrollment challenges
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Multiple MyelomaStudies of the same condition, open and under way.
- More trials run by Weill Medical College of Cornell UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 4 participants (actual)
Sponsor and investigators
- Lead sponsor
- Weill Medical College of Cornell University
- Sponsor type
- University, hospital or other
- Collaborators
- Celgene Corporation
- Responsible party
- Sponsor
- Investigators
- Ruben Niesvizky, MD, Principal investigator, Weill Medical College of Cornell University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01979276
- Sponsor's protocol ID
- 1306014005
- Acronym
- Romi Poma
- Status last verified
- May 2018
- First submitted
- 25 Oct 2013
- Last updated
- 6 Jun 2018
- Results posted
- Yes, on ClinicalTrials.gov
Study at a glance
From the registry record, last updated by the sponsor on 6 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I/II Study of Pomalidomide (CC-4047®), Dexamethasone and Romidepsin in Patients With Relapsed or Refractory Multiple Myeloma (Romi Poma)
- ClinicalTrials.gov ID
- NCT01979276
- Acronym / sponsor ID
- Romi Poma / 1306014005
- Conditions
- Multiple Myeloma
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: this study was terminated due to losing financial support, and enrollment challenges
- Enrolment
- 4 participants (actual)
- Lead sponsor
- Weill Medical College of Cornell UniversityUniversity, hospital or other
- Collaborators
- Celgene Corporation
- Study start
- Nov 2013 (actual)
- Primary completion
- Oct 2016 (actual)
- Study completion
- Oct 2016 (actual)
- First posted
- 8 Nov 2013 (estimated)
- Results
- Posted 31 Jan 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This clinical trial is for subjects with multiple myeloma that has returned after treatment (relapsed) or did not respond to prior treatment (refractory). The study is in two parts, Phase I and Phase II. Phase I will determine the maximum tolerated dose of romidepsin in combination with pomalidomide and dexamethasone. The purpose of Phase II is to evaluate the effectiveness of combining romidepsin with pomalidomide and dexamethasone. The hypothesis is that overall response in a cohort of patients treated with romidepsin + pomalidomide + dexamethasone will be 60 percent.
Detailed description
This phase I/II study is a treatment program for patients with relapsed or refractory multiple myeloma. Up to 48 patients will be enrolled. Phase I will follow a 3+3 dose escalation design to find the maximum tolerated dose of romidepsin in combination with pomalidomide and dexamethasone.
In Phase I, subjects will receive:
- Pomalidomide 4mg daily by mouth on days 1-21 of a 28-day cycle
- Dexamethasone 40mg by mouth on days 1, 8, 15 and 22 of a 28-day cycle
- Romidepsin intravenously (9 mg/m2, 12 mg/m2, 15 mg/m2 or 18 mg/m2) on days 1 and 15 of a 28-day cycle.
Phase II will expand the number of subjects in the MTD arm of the trial until 48 subjects are enrolled. In Phase II, subjects subjects will receive:
- Pomalidomide 4mg daily by mouth on days 1-21 of a 28-day cycle
- Dexamethasone 40mg by mouth on days 1, 8, 15 and 22 of a 28-day cycle
- Romidepsin intravenously on days 1 and 15 of a 28-day cycle at the Maximum Tolerated Dose determined by Phase I
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pomalidomide, Romidepsin, Dexamethasone | Experimental | Drug: Romidepsin, Drug: pomalidomide, Drug: DexamethasonePomalidomide, 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 |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (21 listed)
- histologically confirmed multiple myeloma.
- measurable disease as defined by > 0.5 g/dL serum monoclonal protein, >0.1 g/dL serum free light chains, >0.2 g/24 hrs urinary M-protein excretion, and/or measurable plasmacytoma(s).
- relapsed or refractory multiple myeloma as defined by progression of disease either after prior therapy or lack of response to currently used therapy
- relapsed or progressive disease after at least 3 prior therapeutic treatments or regimens for multiple myeloma.
- refractory to bortezomib and lenalidomide
Key exclusion criteria (28 listed)
- Subjects with non-secretory Multiple Myeloma (no measurable monoclonal protein or plasmacytoma(s), free light chains, and/or M-spike in blood or urine).
- Patients with a prior history of other malignancies (except for basal cell or squamous cell carcinoma of the skin or carcinoma in situ of the cervix or breast) unless disease free for ≥ 3 years.
- Any known cardiac abnormalities such as:
- Any Known seropositivity for or active viral infection with human immunodeficiency virus (HIV), hepatitis B virus (HBV) or hepatitis C virus (HCV). Patients who are seropositive because of hepatitis B virus vaccine are eligible.
- Any active viral or bacterial infections or any coexisting medical problem that would significantly increase the risks of this treatment program.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RomidepsinRomidepsin intravenously on days 1 and 15 of a 28-day cycle | Drug | Pomalidomide, Romidepsin, Dexamethasone |
| pomalidomidePomalidomide 4mg daily by mouth on days 1-21 of a 28-day cycle | Drug | Pomalidomide, Romidepsin, Dexamethasone |
| DexamethasoneDexamethasone 40mg by mouth on days 1, 8, 15 and 22 of a 28-day cycle | Drug | Pomalidomide, Romidepsin, Dexamethasone |
Primary outcome
Maximum Tolerated Dose (MTD) of Romidepsin in Combination With Pomalidomide and Dexamethasone
Time frame: 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)
Efficacy of Study Regimen Combination
Time frame: 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/)
1 secondary outcome
Time to Disease Progression (Progression Free Survival)
Time frame: From start of treatment, to date of disease progression (on average, ten 28-day cycles)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jun 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ruben Niesvizky, MD principal investigator
Weill Medical College of Cornell University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Romidepsin, pomalidomide and Dexamethasone in people with Multiple Myeloma, run by Weill Medical College of Cornell University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 21 inclusion and 28 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 6 Jun 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 31 Jan 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maximum Tolerated Dose (MTD) of Romidepsin in Combination With Pomalidomide and Dexamethasone (time frame: During the duration of the study (from first to last dose of study drug, on average ten 28-day cycles)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jun 2018; AzTrials last refreshed its copy on 7 Nov 2026.