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

Stanford University

Status and phase

Completed

Phase 2

Conditions

Multiple Myeloma

Treatments

Drug: Carmustine

Drug: Cyclophosphamide

Drug: Etoposide

Drug: Filgrastim

Drug: Melphalan

Study type

Interventional

Funder types

Other

Identifiers

NCT00349778

IRB-05704

BMT183 (Other Identifier)

97115 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment

102 patients

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

INCLUSION CRITERIA

Stage II to III multiple myeloma, or progression after initial treatment of Stage I disease; early or relapsed
Age 18 to 75 years.
Pathology reviewed and the diagnosis confirmed at Stanford University Medical Center.
Patients with amyloidosis may be eligible for this trial, with approval by the Principle Investigator.
Patients must have a Karnofsky performance status > 70%.
Aspartate aminotransferase (AST) must be < 2 x upper limit of normal (ULN)
Alanine aminotransferase (ALT) must be < 2 x ULN
Total bilirubin < 2 mg/dL.
Serum creatinine < 2.0 or 24-hour creatinine clearance ≥ 60 mL/min.
Patients must be HIV-negative.
Patients must provide signed, informed consent.

EXCLUSION CRITERIA

Severe psychological or medical illness
Prior autologous hematopoietic cell transplantation
Pregnant
Lactating women
Smoldering multiple myeloma,
Monoclonal gammopathy of unknown significance or primary amyloidosis will be excluded from this study