At a glance
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A Randomized Clinical Trial of Lenalidomide (CC-5013) and Dexamethasone With and Without Autologous Peripheral Blood Stem Cell Transplant in Patients With Newly Diagnosed Multiple Myeloma
In Brief
A Phase 4 clinical trial evaluating Autologous peripheral blood stem cell transplant, Lenalidomide, and 6 other interventions for Multiple Myeloma. Completed, enrolled 60 participants across 1 site.
Detailed Summary
The study is being done to compare the combination of lenalidomide and dexamethasone followed by autologous peripheral blood stem cell transplant (PBSCT) and lenalidomide and dexamethasone without PBSCT in patients with untreated multiple myeloma. This comparison will include how the subjects respond to each study treatment combination, and what side effects are caused by each combination.
Study Details
Timeline
Interventions
Subjects deemed suitable by the principal investigator will undergo autologous peripheral blood stem cell transplantation on day 0.
Administered orally at a dose 25 mg daily on days 1-21 of each 28-day cycle.
Administered orally at a dose of 40 mg daily on days 1, 8, 15, 22 of each cycle.
Peripheral stem cell collection will be performed at marrow recovery, usually when white blood cell (WBC) is \>2500 x 109 cells/liter; platelet count is \>20 x 103/mm3.
Subjects undergoing autologous peripheral blood stem cell transplant will receive melphalan 200 mg/m2 intravenously on days -2 and -1 or only on day -2.
Subjects will receive G-CSF subcutaneously daily beginning on day 5 and until blood counts recover.
Subjects may receive up to the maximum recommended high-dose of cyclophosphamide at 4 gm/m2 intravenously.
Mesna will be provided with the cyclophosphamide.