High-Dose Sequential Therapy and Single Autologous Transplantation for Multiple Myeloma

Phase 2

Completed

• Conditions: Multiple Myeloma
• Interventions: Drug: Cyclophosphamide; Drug: Etoposide; Drug: Melphalan; Drug: Carmustine; Drug: Filgrastim

• Registration Number: NCT00349778
• Lead Sponsor: Stanford University

Brief Summary

This study uses a sequence of high-dose chemotherapy drugs and a stem cell transplant to treat multiple myeloma. The study is being performed to evaluate the efficacy and side effects of treatment. Specifically, the study is designed to reduce the risk of interstitial pneumonitis.

Detailed Description

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 Timeline

• Study First Submitted: 2006-07-05
• Study First Submitted QC: 2006-07-05
• Study First Posted: 2006-07-10
• Study Start: 2006-08
• Primary Completion: 2009-04
• Study Completion: 2010-04
• Results First Submitted: 2017-04-26
• Status Verified: 2017-11
• Results First Submitted QC: 2017-11-08
• Last Update Submitted: 2017-11-08
• Results First Posted: 2017-12-12
• Last Update Posted: 2017-12-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 102

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
High-Dose Sequential Therapy	Melphalan	Cyclophosphamide + Etoposide + Melphalan + Carmustine with Filgrastim
High-Dose Sequential Therapy	Filgrastim	Cyclophosphamide + Etoposide + Melphalan + Carmustine with Filgrastim
High-Dose Sequential Therapy	Cyclophosphamide	Cyclophosphamide + Etoposide + Melphalan + Carmustine with Filgrastim
High-Dose Sequential Therapy	Etoposide	Cyclophosphamide + Etoposide + Melphalan + Carmustine with Filgrastim
High-Dose Sequential Therapy	Carmustine	Cyclophosphamide + Etoposide + Melphalan + Carmustine with Filgrastim

Primary Outcome Measures

Name	Time	Method
Number of Participants With Pulmonary Toxicity	2 years	Pulmonary toxicity was assessed as the incidence of interstitial pneumonitis.

Secondary Outcome Measures

Name	Time	Method
Overall Participant Survival (OS)	5 years	Survival status was assessed 5 years after transplant.
Number of Participants That Relapse After Autologous Transplantation	5 years	Relapse was measured as the number of patients who relapse after high-dose sequential therapy then autologous transplantation

Trial Locations

Locations (1)

Stanford University School of Medicine; 🇺🇸 Stanford, California, United States