Facilitated By

San Antonio Medical Foundation

A Randomized, Phase II Trial Evaluating the Efficacy and Safety of Lenalidomide, Bortezomib and Dexamethasone (RVD) with or Without Panobinostat in Transplant Eligible,Newly Diagnosed Multiple Myeloma.

Brooke Army Medical Center

Brooke Army Medical Center (BAMC) at Fort Sam Houston, Texas, is proud to provide safe, quality care to our military service members, their families, veterans and civilian emergency patients as the most robust and productive healthcare organization within the Military Health System (MHS).

Principal Investigator(s)
Email for information
Funded by
Henry Jackson Foundation
Research Start Date
Status
Active

<p>This is a multicenter, open-label, randomized phase II study which will enroll 112 newly diagnosed symptomatic multiple myeloma patients in a 1:1 fashion. Patients will be enrolled at approximately 20 centers in the United States.</p><p>Patients will undergo stem cell mobilization with plerixafor plus Granulocyte Colony Stimulating Factor (G-CSF), according to investigator discretion, after 4 cycles of induction therapy. Study treatment interruption for stem cell collection may not exceed 30 days. All patients will receive one additional cycle of study treatment after stem cell collection and then proceed to autologous transplant using melphalan 200mg/m2(140mg/m2 for patients > 70 years), as conditioning.</p><p>After Autologus Stem Cell Transplant( ASCT), patients still on study will initiate maintenance therapy within the 60-120 day period following ASCT, provided they have adequate blood count and clinical recovery. Patients in the RVD arm will initiate maintenance therapy with lenalidomide alone, and patients in RVD-panobinostat arm will receive lenalidomide + panobinostat maintenance. Lenalidomide will be dosed orally at 10mg/day continuously in both arms, increasing to 15mg/day after the first 84 day cycle. Panobinostat will be dosed at 10mg three times a week, every other week. Total planned duration of maintenance therapy will be 3 years.</p><p>Patients will remain on study treatment until they complete the maintenance phase, or until they experience disease progression, unacceptable toxicity, or at the discretion of the Investigator.</p>

Clinical Care
Infectious Disease
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