At a glance
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High-Dose Sequential Therapy and Single Autologous Transplantation for Multiple Myeloma
In Brief
A Phase 2 clinical trial evaluating Cyclophosphamide, Etoposide, and 3 other interventions for Multiple Myeloma. Completed, enrolled 102 participants across 1 site.
Detailed 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.
Study Details
Timeline
Interventions
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
100 mg etoposide as 5 mL solution in clear ampules for injection.
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.
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.
Filgrastim in vials of 300 µg or 480 µg at a concentration of 300 µg/mL, to be given as a daily subcutaneous injection.