Phase II Study of V-BEAM Conditioning Regimen Prior to Second Autologous Stem Cell Transplantation
BEAM regimen (BCNU, etoposide, cytarabine, and melphalan) is the most commonly used conditioning regimen for relapsed/refractory lymphoma patients needing autologous stem cell transplantation. Since these components are all effective in myeloma and bortezomib has shown promising results in the transplant setting, here the investigators propose a phase II study to investigate the combination of bortezomib and BEAM as a new conditioning regimen for patients who relapse or progress after the first autologous transplantation and for whom a second autologous transplant is considered.
Procedure: Stem cell infusion
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Phase II Study of V-BEAM (Bortezomib, Carmustine, Etoposide, Cytarabine, and Melphalan) as Conditioning Regimen Prior to Second Autologous Stem Cell Transplantation for Multiple Myeloma|
- Complete response rate (complete response + stringent complete response) at Day +100 as defined by the International Myeloma Working Group (IMWG) criteria [ Time Frame: Day +100 ] [ Designated as safety issue: No ]
- Progression-free survival (PFS) [ Time Frame: 3 months following Day +100 visit ] [ Designated as safety issue: No ]Every 3 months
- Overall response rate (ORR) [ Time Frame: 3 months following Day +100 visit ] [ Designated as safety issue: No ]ORR includes Minimal Response (MR) + Partial Response (PR) + Very Good Partial Response (VGPR) + Near Complete Response (nCR) + Stringent Complete Response (sCR) + Complete Response (CR)
- Percentage of patients achieving at least very good partial response rate (VGPR+nCR+sCR+CR) [ Time Frame: Day +100 ] [ Designated as safety issue: No ]
- Toxicity of V-BEAM [ Time Frame: 30 days after end of treatment / Day +100 ] [ Designated as safety issue: Yes ]Patients are evaluated from first receiving study treatment until a 30-day follow-up after the conclusion of treatment for adverse events not resulting in death. Adverse events resulting in death will be evaluated through Day +100.
- Time to neutrophil engraftment after V-BEAM. [ Time Frame: Day +100 ] [ Designated as safety issue: Yes ]Time to neutrophil engraftment is defined as duration between Day 0 to the first day of ANC > 0.5x109/L post transplant when it is sustained for more than three consecutive days.
- Overall survival (OS) [ Time Frame: 3 months following Day +100 visit ] [ Designated as safety issue: No ]
- Treatment related mortality (TRM) of V-BEAM [ Time Frame: Day +100 ] [ Designated as safety issue: Yes ]
- Time to platelet engraftment after V-BEAM. [ Time Frame: Day +100 ] [ Designated as safety issue: Yes ]Time to platelet engraftment is defined as the duration between Day 0 to the first day of platelet count sustained at > 20x109/L without transfusion. The median time to neutrophil and platelet engraftment will be reported.
|Study Start Date:||September 2012|
|Estimated Study Completion Date:||December 2013|
|Primary Completion Date:||August 2013 (Final data collection date for primary outcome measure)|
Experimental: V-BEAM + Stem Cell Infusion
Bortezomib IV or SC (1.3mg/m2) on Days -6, -3, +1 and +4 Carmustine IV (300mg/m2) on Day -7 Etoposide IV twice daily (100 mg/m2) on Days -6, -5, -4, and -3 Cytarabine IV twice daily (100 mg/m2) on Days -6, -5, -4, and -3 Melphalan IV (140 mg/m2) on Day-2 Stem cell infusion on Day 0
Other Name: VelcadeDrug: Carmustine
Other Name: BCNU, BiCNU®Drug: Etoposide
Other Name: Vepesid, VP-16Drug: Cytarabine
Other Name: Ara-C, Cytosar-U, 1-β-Arabinofuranosylcytosine, Arabinosylcytosine, Cytosine arabinosideDrug: Melphalan
Other Name: Alkeran®, L-PAMProcedure: Stem cell infusion
|United States, Missouri|
|Washington University School of Medicine|
|St. Louis, Missouri, United States, 63122|
|Principal Investigator:||Ravi Vij, M.D.||Washington University School of Medicine|