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High-Dose Topotecan, Melphalan and Cyclophosphamide (TMC) with Stem Cell Support: a New Regimen for the Treatment of Multiple Myeloma

The goal of this trial was to assess the toxicity and potential efficacy of high-dose topotecan, melphalan and cyclophosphamide as a preparative regimen for patients with multiple myeloma undergoing autologous stem cell transplantation. Eighteen patients were treated, 8 for first remission consolidation, 4 with relapse sensitive disease, 3 primary refractory and 3 relapsed refractory. The median age was 56 (38 – 65) and the median number of prior regimens was 3 (1 – 8). Patients received cyclophosphamide 1 g/m2/d on days −6, −5, −4; melphalan 70 mg/m2 on days −3, −2 and topotecan 3.0 to 3.5 mg/m2/d on days −6 to −2. Peripheral blood stem cells were infused on day 0. Toxicity (Bearman Toxicity Criteria) was mostly limited to grade 1 – 2 mucositis and grade 1 diarrhea. There were no transplant-related deaths. The overall response rate at 3 months post transplantation was 89% with 17% CR, 2 of those in refractory patients. The overall response rate in refractory patients was 67%. With a median follow up of 12.3 months, 89% of patients are alive. The TMC regimen is well tolerated and produces high response rates. Further evaluation of TMC to fully assess response and survival is ongoing.