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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
6
Revlimid was used with dexamethasone to treat patients with multiple myeloma
Velcade was a proteasome inhibitor indicated for treatment of patients with multiple myeloma
Dexamethasone was a steroid used to treat patients with multiple myeloma.
FARYDAK® (panobinostat) capsules was a prescription medicine used, in combination with bortezomib and dexamethasone, to treat adults with a type of cancer called multiple myeloma after at least 2 other types of treatment have been tried.
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
Near Complete Response (nCR)/CR Rate of the Combination of Panobinostat With Bortezomib, Lenalidomide and Dexamethasone (P-RVD) vs RVD in Newly Diagnosed Multiple Myeloma Patients
Time frame: 84 days
Minimal Residual Disease (MRD) Negativity (mCR) After 4 Cycles of Induction by Next Gen Sequencing
MRD negativity by Clonal Sequencing (ClonoSEQTM) assay (Adaptive Biotechnologies)
Time frame: Month 3
Best Overall Response Rate (ORR) and MRD Negativity After ASCT and Maintenance
ORR (CR + PR) and MRD negativity after ASCT and maintenance
Time frame: Month 3 up to end of study, approximately 3 years.
Depth of Response by International Myeloma Working Group (IMWG) Criteria
Rate of Very Good Partial Response (VGPR), Complete Response (CR) and Stringent Complete Response (sCR)
Time frame: Day 22 up to end of study, approximately 3 years
Duration of Response
Time frame: From measurable response to the date of first documented progression or date of death from any cause, whichever came first, assessed up to 3 years.
Overall Survival
Time frame: 3 years after the last patient is enrolled to the study
Progression Free Survival
Time frame: 3 years after the last patient is enrolled to the study
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