High -Dose Sequential Therapy and Single Autologous Transplantation for Multiple Myeloma
Drug: BCNU Melphalan
|Study Design:||Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||High -Dose Sequential Therapy and Single Autologous Transplantation for Multiple Myeloma|
- Evaluate the risk of interstitial pneumonitis with the current dosing of BCNU and melphalan [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
- Remission rate, event-free survival, overall survival and relapse [ Time Frame: 2 years ] [ Designated as safety issue: No ]
|Study Start Date:||August 2006|
|Study Completion Date:||April 2010|
|Primary Completion Date:||April 2009 (Final data collection date for primary outcome measure)|
We have performed over 200 autologous HCT for myeloma at Stanford using high-dose sequential therapy with a BCNU dose of 550 mg/m2 plus melphalan 200 mg/m2. Analysis of 196 patients treated this way demonstrates a median event-free survival of 36 months with a median overall survival of more than six years. The main toxicity of this therapy is related to BCNU-pneumonitis or interstitial pneumonitis (IP). This complication is related to the dose of BCNU and is well described in the literature(18). In our myeloma patients treated with this dose of BCNU the incidence of IP is 34%.
There have been recent studies evaluating the role of tandem autologous transplants for patients with multiple myeloma. These trials were based upon the hypothesis that performing tandem high-dose therapy regimens would lead to increased tumor cell kill, decreased tumor burden and an improvement in overall survival(9, 19). There are trials comparing single to double transplants that suggest there may be a benefit for tandem autologous transplants for event-free survival and overall survival (20-22). However, our results with high-dose sequential therapy including the dose-intense BCNU/Melphalan transplant demonstrates similar median event-free survival and overall survival when compared with the results of tandem transplant approaches.
The proposed trial will continue to use a high-dose sequential transplant approach, however, we will use a reduced dose of BCNU which we expect to be associated with a lower incidence of IP.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00349778
|United States, California|
|Stanford University School of Medicine|
|Stanford, California, United States, 94305|
|Principal Investigator:||Sally Arai||Stanford University|