A Trial Evaluating Efficacy & Safety of RVD +/- Panobinostat in Transplant Eligible, Newly Diagnosed Multiple Myeloma (NDMM)
Stopped early · Phase 2
Conditions studied: Multiple Myeloma
In brief
This was a multicenter, open-label, randomized phase II study which were to enroll 112 newly diagnosed symptomatic multiple myeloma patients in a 1:1 fashion. Patients were to enroll at approximately 20 centers in the United States. Patients were to 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 were not to exceed 30 days. All patients were to 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. After Autologus Stem Cell Transplant( ASCT), patients still on study were to 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 were to initiate maintenance therapy with lenalidomide alone, and patients in RVD-panobinostat arm were to receive lenalidomide + panobinostat maintenance. Lenalidomide were to be dosed orally at 10mg/day continuously in both arms, increasing to 15mg/day after the first 84 day cycle. Panobinostat were to be dosed at 10mg three times a week, every other week. Total planned duration of maintenance therapy were to be 3 years. Patients were to 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.
Key facts
- Study ID
- NCT02720510
- Run by
- Novartis Pharmaceuticals
- People needed
- 6
- Starts
- 2016-06-14
- Expected to finish
- 2017-05-22
- Last updated by the study team
- 2018-07-24
Who can join
Age: 18 and older, up to 74. Sex: any. Healthy volunteers: not accepted.
Where it is running
- David Geffen School of Medicine at UCLA UCLA — Los Angeles, California, United States
- Memorial West Cancer Center Memorial Cancer Institute — Pembroke Pines, Florida, United States
- Northside Hospital Central Research Dept. — Atlanta, Georgia, United States
- Oncology Hematology West Nebraska Cancer Specialists dbaNebraska Cancer Specialists — Omaha, Nebraska, United States
- Brooke Army Medical Center Hematology/Oncology — San Antonio, Texas, United States
Full record on ClinicalTrials.gov
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