A Phase II Study of Pomalidomide plus Autologous Stem Cell Transplantation versus Pomalidomide/Dexamethasone in Patients with Multiple Myeloma

Protocol
12-138
Full Title
Autologous Stem Cell Transplant with Pomalidomide (CC-4047®) Maintenance versus Continuous Clarithromiycin/Pomalidomide/Dexamethasone Salvage Therapy in Relapsed or Refractory Multiple Myeloma: A Phase 2 Open-Label Randomized Study by Tristate Consortium
Phase
II
Disease Status
Relapsed/Refractory
Purpose

Pomalidomide is the latest drug to be approved by the FDA for relapsed multiple myeloma. It is chemically related to thalidomide and lenalidomide, both also approved previously for treating multiple myeloma. Laboratory studies have shown that pomalidomide may be more effective than thalidomide in killing myeloma cells.

In this study, researchers are comparing two therapeutic approaches, both of which use pomalidomide, to see which one is more effective for treating multiple myeloma that persists or has returned despite prior therapy that included a first autologous stem cell transplant. The goal of this study is to determine whether treatment with a second autologous stem cell transplant is needed when patients are treated with pomalidomide. All patients will initially receive four cycles of pomalidomide and dexamethasone (a commonly used drug in myeloma treatment). Patients will then be randomly assigned to undergo autologous stem cell transplantation (ASCT) OR continue to receive pomalidomide/dexamethasone “salvage therapy” for a total of two years.

ASCT is a treatment in which some of a patient’s stem cells are removed before chemotherapy, then returned to the patient to help re-establish the patient’s immune system after chemotherapy.

Eligibility

To be eligible for this study, patients must meet several criteria, including but not limited to the following:

  • Patients must have multiple myeloma that has returned despite prior treatment that included ASCT, and they must have achieved a remission that lasted at least one year.
  • Patents must have also had lenalidomide given as maintenance treatment after the first ASCT; no more than 6 months must have passed since the last dose of lenalidomide and entry into the study.
  • At least 2 weeks must have passed since receipt of other treatments for myeloma and entry into the study. Patients may not have had prior therapy with thalidomide or pomalidomide.
  • Patients must be physically well enough that they are fully ambulatory, capable of all self care, and are capable of all but physically strenuous activities. As an example, patients must be well enough that they would be able to carry out office work or light housework.
  • This study is open to patients aged 18 and older.

For more information about this study and to inquire about eligibility, please contact Dr. Sergio Giralt at 212-639-6009.

Disease(s)
Hematology: Multiple Myeloma
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