Multiple Myeloma Clinical Trial
Official title:
High-Dose Sequential Therapy and Single Autologous Transplantation for Multiple Myeloma
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.
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.
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