A regimen of escalating doses of thalidomide, in combination with bortezomib and high-dose melphalan (mel/vel/thal), was evaluated as a conditioning regimen for autologous stem cell transplantation (ASCT) in multiple myeloma (MM) patients with a prior transplant who had relapsed or achieved less than a complete remission following a prior ASCT. Thalidomide was dose escalated starting from 600 mg to 1000 mg on days −5 to −1 in a 3 × 3 design, bortezomib was administered at 1.6 mg/m2 intravenously on days −4 and −1 and melphalan 200 mg/m2 was administered on day −2. No dose-limiting toxicity was seen in the phase I portion of the trial. An additional 20 patients were enrolled at the maximum tolerated dose of thalidomide of 1000 mg daily. The overall response rate was 69% with 38% complete remission. Median PFS and OS were 9.3 and 65.4 months, respectively, with a median follow-up of 17.8 months. The most common grade 3–4 adverse events (AEs) were neutropenic fever (58.6%), mucositis (6.9%), and diarrhea (6.9%). Serious AEs included somnolence (13.8%) and tumor lysis syndrome (3.4%). The addition of high-dose thalidomide to bortezomib and melphalan as conditioning for salvage ASCT was well tolerated and was an effective conditioning regimen.
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Conflict of interest
NB—Speaker’s bureau for Celgene, Takeda, Amgen, and Janssen; Advisory Board for Takeda, Celgene, and Amgen; Research funding from Merck and Bristol Meyers Squibb; DHV—Speaker’s bureau for Takeda, Amgen, Celgene, and Janssen; JR—Speaker’s bureau for Celgene, Takeda, Janssen, Amgen, Sanofi, and BMS; DSS—Speaker’s bureau for Celgene, Takeda, and Amgen; Advisory Board and Consulting for Takeda, Celgene, Amgen, and Janssen. The other authors declare that they have no conflict of interests.
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