Multiple MyelomaPhase 2NCT01745588
Autologous Stem Cell Transplant With Pomalidomide (CC-4047®) Maintenance Versus Continuous Clarithromycin/ Pomalidomide / Dexamethasone Salvage Therapy in Relapsed or Refractory Multiple Myeloma
A Phase 2 study testing Pomalidomide, stem cell and Dexamethasone in people with Multiple Myeloma, run by Memorial Sloan Kettering Cancer Center at 10 sites in United States.
Trial summary
The purpose of this study is to see whether pomalidomide (also known as Pomalyst) reduces the number of myeloma cells in the bones, and to see what is the best way to use pomalidomide in patients with myeloma. To do this, the investigators want to compare two types of treatment using pomalidomde. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Multiple Myeloma
- What is being tested?
- Pomalidomide, stem cell and Dexamethasone
- Type of treatment
- Pill or oral medicine, Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 23 participants
- Where
- 10 sitesUnited States
- Study dates
- Dec 2012to 3 Sep 2025
- Phase
- Phase 2
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients must have histologically or cytologically confirmed relapsed multiple myeloma as defined by the International Myeloma Working Group (IMWG).
- Patients must have measurable disease as defined by the International Uniform Response Criteria, defined as any of the following:
- serum M-protein of ≥ 500mg/dL
- urine M-protein of ≥ 200mg/ 24 hours
- involved free light chain ≥ 10mg/dL provided serum free light chain ratio is abnormal
- Patients must have had a previous auto-SCT performed as part of a consolidation of an initial remission and had a remission, defined as a partial response or greater that lasted at least 12 months either on or off maintenance therapy without evidence of progression as defined by IMWG criteria.
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- Patients who are post auto-SCT as primary therapy must have received maintenance therapy with lenalidomide.
- Patients must be registered within 6 months of last dose of lenalidomide.
- Minimum of 3 months of maintenance therapy prior to disease progression.
- Age ≥ 18 years.
- Life expectancy of ≥12 weeks.
- KPS ≥ 70 or ECOG < 1 (Appendix IV)
- Patients must have adequate organ and marrow function as defined below:
- ANC ≥ 750/μL
- Platelets≥ 50,000/μL
- Total bilirubin ≤ 1.5 mg/dL
- AST(SGOT) ≤ 3 X upper limit of normal.
- ALT(SGPT) ≤ 3 X upper limit of normal.
- Cardiac Ejection Fraction ≥ 40%
- Serum Creatinine ≤ 2.0 mg/dL
- Patients must have an adequate number of CD34+ stem cells collected to allow for transplantation (defined as ≥ 2x10^6 CD34+ cells / kg body weight). If not previously collected and stored or if previous collection was inadequate, the patient must be willing to undergo stem cell mobilization and collection as per standard practice.
- Patients who participate in this study must be willing and able to tolerate prophylactic anticoagulation either with aspirin, low-molecular weight heparin (LMWH), or warfarin.
- Ability to understand and the willingness to sign a written informed consent document.
- Patient must be determined fit to undergo auto-SCT procedure by a study physician.
- Females of reproductive potential must adhere to the scheduled pregnancy testing as required in the POMALYST REMS™ program. Females of childbearing potential (FCBP)† must have a negative serum or urine pregnancy test with a sensitivity of at least 25 mIU/mL within 10 - 14 days and again within 24 hours prior to prescribing pomalidomide (prescriptions must be filled within 7 days) and 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 28 days before she starts taking pomalidomide. FCBP must also agree to ongoing pregnancy testing. Men must agree to use a latex condom during sexual contact with a FCBP even if they have had a successful vasectomy. All patients must be counseled at a minimum of every 28 days about pregnancy precautions and risks of fetal exposure.
- A female of childbearing potential is a sexually mature female who: 1) has not undergone a hysterectomy or bilateral oophorectomy; or 2) has not been naturally postmenopausal for at least 24 consecutive months (i.e.,has had menses at any time in the preceding 24 consecutive months).
- All study participants must be registered into the mandatory POMALYST REMS™ program, and be willing and able to comply with the requirements of the POMALYST REMS™ program.
- A female of childbearing potential is a sexually mature female who: 1) has not undergone a hysterectomy or bilateral oophorectomy; or 2) has not been naturally postmenopausal for at least 24 consecutive months (i.e., has had menses at any time in the preceding 24 consecutive months).
Who cannot join
- Patients who have had myeloma therapy within 14 days prior to entering the study or those who have not recovered from adverse events due to agents administered more than 2 weeks earlier. Patients may have received bisphosphonate therapy or radiation therapy as part of routine myeloma care at any time prior to study entry.
- Patients may not be receiving any other investigational agents.
- Any prior use of thalidomide or pomalidomide.
- History of allergic reactions attributed to compounds of similar chemical or biologic composition to lenalidomide (including thalidomide) clarithromycin, or melphalan.
- Known prior positivity for active HIV or infectious hepatitis, type B or C.
- Uncontrolled illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure , unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
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- Pregnant and lactating women are excluded from the study because the risks to an unborn fetus or potential risks in nursing infants are unknown.
- History of thrombosis or thromboembolic event within last 30 days prior to study entry.
- Patients with CNS involvement.
Trial locations and contacts
10 sites in 1 country.
10 sites in 1 country
United States10 sites
Memorial Sloan Kettering Cancer Center
Basking Ridge, New Jersey
Memorial Sloan Kettering Cancer Center @ Suffolk
Commack, New York, 11725
Memorial Sloan Kettering West Harrison
Harrison, New York, 10604
Rutgers Cancer Institute of New Jersey
New Brunswick, New Jersey, 08903
North Shore LIJ
New Hyde Park, New York, 11040
Memorial Sloan Kettering Cancer Center
New York, New York, 10065
Weill Medical College of Cornell University
New York, New York
Memorial Sloan Kettering Cancer Center at Mercy Medical Center
Rockville Centre, New York, 11570
Memorial Sloan Kettering Cancer Center at Phelps Memorial Hospital Center
Sleepy Hollow, New York, 10591
SUNY Upstate Medical University
Syracuse, New York
About this study
Official title: Autologous Stem Cell Transplant With Pomalidomide (CC-4047®) Maintenance Versus Continuous Clarithromycin/ Pomalidomide / Dexamethasone Salvage Therapy in Relapsed or Refractory Multiple Myeloma: A Phase 2 Open-Label Randomized Study by Tristate Consortium
The purpose of this study is to see whether pomalidomide (also known as Pomalyst) reduces the number of myeloma cells in the bones, and to see what is the best way to use pomalidomide in patients with myeloma. To do this, the investigators want to compare two types of treatment using pomalidomde. This is a randomized trial which means that the decision as to which treatment the patient will receive will be made by a computer, much like flipping a coin.
All patients start by receiving 4 cycles of clarithromycin, pomalidomide and dexamethasone (ClaPD). After 4 cycles, half of the patients will undergo an autologous stem cell transplant followed by pomalidomide (Group 1). The other half of the patients will continue to receive ClaPD for 9 cycles to be followed by pomalidomide maintenance. (Group 2).
At the end of the study, the two groups will be compared to see if there is a difference in disease outcome.
- Conditions
- Multiple Myeloma
- Being tested
- Pomalidomide, stem cell, Dexamethasone, Clarithromycin
- Keywords
- CC-4047(Pomalidomide)Pomalyst, Clarithromycin, Biaxin, DEXAMETHASONE, (ClaPD), Stem cell, 12-138
- Medical subject headings
- Multiple Myeloma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PomalidomideDrug
stem cellProcedure or surgery
DexamethasoneDrug
ClarithromycinDrug
| Study group | Role | What they receive |
|---|---|---|
| Clarithromycin + Pomalidomide + Dexamethasone + stem cell | Experimental | All patients will receive 4 cycles of clarithromycin 500mg twice daily on days 1-28, pomalidomide 4 mg daily on days 1 through 21 and dexamethasone orally at a dose of 40 mg daily on days 1, 8, 15, and 22 of each 28-day cycle. Patients randomized to auto-SCT will proceed within 28 days after completion of the 4th cycle of ClaPD to receive melphalan 140mg/m2 or 200mg/m2 (as per institutional guidelines) followed by hematopoietic cell infusion. Receives: Drug: Pomalidomide; Procedure: stem cell; Drug: Clarithromycin |
| Clarithromycin + Pomalidomide + Dexamethasone Alone | Experimental | All patients will receive 4 cycles of clarithromycin 500mg twice daily on days 1-28 pomalidomide 4 mg daily on days 1 through 21 and dexamethasone orally at a dose of 40 mg daily on days 1, 8, 15, and 22 of each 28 day cycle. Patients assigned to ClaPD alone will receive 5 additional cycles of ClaPD. Receives: Drug: Pomalidomide; Drug: Dexamethasone; Drug: Clarithromycin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall Response Rate
Very Good PR or greater will be evaluated nine months postrandomization according to International Uniform Response Criteria. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.
Measured: at 9 months after the start of treatment
Secondary outcomes (4)
Number of Participants With Adverse Events
The frequency of subjects experiencing a specific adverse event will be tabulated overall and by each treatment course. In the by-subject analysis, a subject having the same event more than once will be counted only once. Adverse events will be summarized by worst NCI CTCAE grade. Laboratory data will be graded according to NCI CTCAE severity grade
Measured: 3 years
Overall Survival
Measured: up to 94 months
Progression Free Survival
Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions
Measured: up to 94 months
Median Overall Survival
Overall survival rate
Measured: up to 118 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Dec 2012 (estimated)
- Study startDec 2012
- Primary completion3 Sep 2025
- Study completion3 Sep 2025
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 Memorial Sloan Kettering Cancer CenterThe 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- Memorial Sloan Kettering Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- Celgene Corporation, Weill Medical College of Cornell University, North Shore University Hospital, Rutgers Cancer Institute of New Jersey, State University of New York - Upstate Medical University
- Responsible party
- Sponsor
- Investigators
- Sergio Giralt, MD, Principal investigator, Memorial Sloan Kettering Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01745588
- Sponsor's protocol ID
- 12-138
- Status last verified
- Sep 2025
- First submitted
- 6 Dec 2012
- Last updated
- 25 Sep 2026
- Results posted
- Yes, on ClinicalTrials.gov