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Brief Title: Autologous Stem Cell Transplant With Pomalidomide (CC-4047®) Maintenance Versus Continuous Clarithromycin/ Pomalidomide / Dexamethasone Salvage Therapy in Relapsed or Refractory Multiple Myeloma
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
Study ID: NCT01745588
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.
Detailed Description:
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Memorial Sloan Kettering Cancer Center, Basking Ridge, New Jersey, United States
Rutgers Cancer Institute of New Jersey, New Brunswick, New Jersey, United States
Memorial Sloan Kettering Cancer Center @ Suffolk, Commack, New York, United States
Memorial Sloan Kettering West Harrison, Harrison, New York, United States
North Shore LIJ, New Hyde Park, New York, United States
Memorial Sloan Kettering Cancer Center, New York, New York, 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, United States
Memorial Sloan Kettering Cancer Center at Phelps Memorial Hospital Center, Sleepy Hollow, New York, United States
SUNY Upstate Medical University, Syracuse, New York, United States
Name: Sergio Giralt, MD
Affiliation: Memorial Sloan Kettering Cancer Center
Role: PRINCIPAL_INVESTIGATOR