Autologous Stem Cell Transplant With Pomalidomide (CC-4047®) Maintenance Versus Continuous Clarithromycin/ Pomalidomide / Dexamethasone Salvage Therapy in Relapsed or Refractory Multiple Myeloma
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.
Procedure: stem cell
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|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|
- overall response rate [ Time Frame: at 9 months after the start of treatment ] [ Designated as safety issue: No ]Very Good PR or greater will be evaluated nine months postrandomization according to International Uniform Response Criteria.
- safety analyses [ Time Frame: 3 years ] [ Designated as safety issue: No ]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
- overall survival [ Time Frame: 1 year ] [ Designated as safety issue: No ]
- progression free survival [ Time Frame: 1 year ] [ Designated as safety issue: No ]
- Determine the rates of ≥ Grade 3 toxicities [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]according to the Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0 as specified in section 10.0.
|Study Start Date:||December 2012|
|Estimated Study Completion Date:||December 2017|
|Estimated Primary Completion Date:||December 2017 (Final data collection date for primary outcome measure)|
Experimental: Clarithromycin + Pomalidomide + Dexamethasone + stem cell
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.
|Drug: Pomalidomide Procedure: stem cell Drug: Clarithromycin|
Experimental: Clarithromycin + Pomalidomide + Dexamethasone Alone
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.
|Drug: Pomalidomide Drug: Dexamethasone Drug: Clarithromycin|
Please refer to this study by its ClinicalTrials.gov identifier: NCT01745588
|United States, New Jersey|
|Memoral Sloan Kettering Cancer Center|
|Basking Ridge, New Jersey, United States|
|Rutgers Cancer Institute of New Jersey|
|New Brunswick, New Jersey, United States, 08903|
|United States, New York|
|Memorial Sloan Kettering Cancer Center @ Suffolk|
|Commack, New York, United States, 11725|
|North Shore LIJ|
|New Hyde Park, New York, United States, 11040|
|Memorial Sloan Kettering Cancer Center|
|New York, New York, United States, 10065|
|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, United States, 11570|
|Memorial Sloan Kettering Cancer Center at Phelps Memorial Hospital Center|
|Sleepy Hollow, New York, United States, 10591|
|SUNY Upstate Medical University|
|Syracuse, New York, United States|
|Memorial Sloan Kettering West Harrison|
|West Harrison, New York, United States, 10604|
|Principal Investigator:||Sergio Giralt, MD||Memorial Sloan Kettering Cancer Center|