High-Dose Sequential Therapy and Single Autologous Transplantation for Multiple Myeloma
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|ClinicalTrials.gov Identifier: NCT00349778|
Recruitment Status : Completed
First Posted : July 10, 2006
Results First Posted : December 12, 2017
Last Update Posted : December 12, 2017
|Condition or disease||Intervention/treatment||Phase|
|Multiple Myeloma||Drug: Cyclophosphamide Drug: Etoposide Drug: Melphalan Drug: Carmustine Drug: Filgrastim||Phase 2|
Analysis of 196 previously treated patients demonstrated a median event-free survival (EFS) of 36 months with a median overall survival of more than 6 years. The main toxicity of this therapy is related to carmustine-induced pneumonitis or interstitial pneumonitis (IP). This complication is related to the dose of carmustine. Institutional experience in myeloma patients using this dose of carmustine indicates an incidence of IP of34%.
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. Our results with high-dose sequential therapy including the dose-intense carmustine/melphalan transplant demonstrates similar median EFS and overall survival (OS) 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 carmustine which we expect to be associated with a lower incidence of IP.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||102 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||High-Dose Sequential Therapy and Single Autologous Transplantation for Multiple Myeloma|
|Study Start Date :||August 2006|
|Primary Completion Date :||April 2009|
|Study Completion Date :||April 2010|
Experimental: High-Dose Sequential Therapy
Cyclophosphamide + Etoposide + Melphalan + Carmustine with Filgrastim
Cyclophosphamide as a white powder in 100 mg, 200 mg and 500 mg vials, to be dissolved in ~250 mL of saline or D5W and infused IV over 2 hours
Other Names:Drug: Etoposide
100 mg etoposide as 5 mL solution in clear ampules for injection.
Other Names:Drug: Melphalan
Melphalan as single-use glass vials of freeze-dried melphalan hydrochloride (equivalent to 50 mg of melphalan), to be reconstituted in 0.9% sodium chloride solution to not greater than 0.45 mg/mL, and administered within 1 hour of constitution.
Other Names:Drug: Carmustine
Carmustine as a powder for reconstitution in 100 mg vials, to be reconstituted with 3 mL sterile dehydrated ethanol and D5W. Carmustine should be dissolved in 500 mL of 5% dextrose in water (D5W) and infused IV over 2 hours.
Other Names:Drug: Filgrastim
Filgrastim in vials of 300 µg or 480 µg at a concentration of 300 µg/mL, to be given as a daily subcutaneous injection.
- Number of Participants With Pulmonary Toxicity [ Time Frame: 2 years ]Pulmonary toxicity was assessed as the incidence of interstitial pneumonitis.
- Overall Participant Survival (OS) [ Time Frame: 5 years ]Survival status was assessed 5 years after transplant.
- Number of Participants That Relapse After Autologous Transplantation [ Time Frame: 5 years ]Relapse was measured as the number of patients who relapse after high-dose sequential therapy then autologous transplantation
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00349778
|United States, California|
|Stanford University School of Medicine|
|Stanford, California, United States, 94305|
|Principal Investigator:||Sally Arai||Stanford University|