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: 9 months ] [ 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 ]
|Study Start Date:||December 2012|
|Estimated Study Completion Date:||December 2015|
|Estimated Primary Completion Date:||December 2015 (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 200mg/m2 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|
|Contact: Sergio Giralt, MD||212-639-6009|
|Contact: Hani Hassoun, MD||212-639-3228|
|United States, New Jersey|
|Rutgers Cancer Institute of New Jersey||Not yet recruiting|
|New Brunswick, New Jersey, United States, 08903|
|Contact: Clinical Trials Office - Cancer Institute of New Jersey 732-235-8675|
|Principal Investigator: Mecide Gharibo, MD|
|United States, New York|
|North Shore LIJ||Not yet recruiting|
|New Hyde Park, New York, United States, 11040|
|Contact: Ruthee-Lu Bayer, MD|
|Principal Investigator: Ruthee-Lu Bayer, MD|
|Memorial Sloan Kettering Cancer Center||Recruiting|
|New York, New York, United States, 10065|
|Contact: Sergio Giralt, MD 212-639-6009|
|Contact: Hani Hassoun,, MD 212-639-3228|
|Principal Investigator: Sergio Giralt, MD|
|Weill Medical College of Cornell University||Not yet recruiting|
|New York, New York, United States|
|Contact: Tomer Mark, MD|
|Principal Investigator: Tomer Mark, MD|
|SUNY Upstate Medical University||Not yet recruiting|
|Syracuse, New York, United States|
|Principal Investigator: Teresa Gentile, MD|
|Principal Investigator:||Sergio Giralt, MD||Memorial Sloan-Kettering Cancer Center|