Autologous Stem Cell Transplant With Pomalidomide (CC-4047®) Maintenance Versus Continuous Clarithromycin/ Pomalidomide / Dexamethasone Salvage Therapy in Relapsed or Refractory Multiple Myeloma
1 other identifier
interventional
23
1 country
10
Brief 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. 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_2 multiple-myeloma
Started Dec 2012
Longer than P75 for phase_2 multiple-myeloma
10 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2012
CompletedFirst Submitted
Initial submission to the registry
December 6, 2012
CompletedFirst Posted
Study publicly available on registry
December 10, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 3, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
September 3, 2025
CompletedSeptember 11, 2025
September 1, 2025
12.8 years
December 6, 2012
September 4, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
overall response rate
Very Good PR or greater will be evaluated nine months postrandomization according to International Uniform Response Criteria.
at 9 months after the start of treatment
Secondary Outcomes (4)
safety analyses
3 years
overall survival
1 year
progression free survival
1 year
Determine the rates of ≥ Grade 3 toxicities
1 year
Study Arms (2)
Clarithromycin + Pomalidomide + Dexamethasone + stem cell
EXPERIMENTALAll 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.
Clarithromycin + Pomalidomide + Dexamethasone Alone
EXPERIMENTALAll 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.
Interventions
Eligibility Criteria
You may qualify if:
- 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.
- 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
- +13 more criteria
You may not qualify if:
- 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.
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Memorial Sloan Kettering Cancer Centerlead
- Celgene Corporationcollaborator
- Weill Medical College of Cornell Universitycollaborator
- North Shore University Hospitalcollaborator
- Rutgers Cancer Institute of New Jerseycollaborator
- State University of New York - Upstate Medical Universitycollaborator
Study Sites (10)
Memorial Sloan Kettering Cancer Center
Basking Ridge, New Jersey, United States
Rutgers Cancer Institute of New Jersey
New Brunswick, New Jersey, 08903, United States
Memorial Sloan Kettering Cancer Center @ Suffolk
Commack, New York, 11725, United States
Memorial Sloan Kettering West Harrison
Harrison, New York, 10604, United States
North Shore LIJ
New Hyde Park, New York, 11040, United States
Memorial Sloan Kettering Cancer Center
New York, New York, 10065, United States
Weill Medical College of Cornell University
New York, New York, United States
Memorial Sloan Kettering Cancer Center at Mercy Medical Center
Rockville Centre, New York, 11570, United States
Memorial Sloan Kettering Cancer Center at Phelps Memorial Hospital Center
Sleepy Hollow, New York, 10591, United States
SUNY Upstate Medical University
Syracuse, New York, United States
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Sergio Giralt, MD
Memorial Sloan Kettering Cancer Center
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 6, 2012
First Posted
December 10, 2012
Study Start
December 1, 2012
Primary Completion
September 3, 2025
Study Completion
September 3, 2025
Last Updated
September 11, 2025
Record last verified: 2025-09