A phase I, open-label, dose-escalation study of amrubicin in combination with lenalidomide and weekly dexamethasone in previously treated adults with relapsed or refractory multiple myeloma
This phase 1 study investigated the safety of the anthracycline amrubicin combined with lenalidomide and dexamethasone in adults with relapsed or refractory multiple myeloma. A standard 3 + 3 design was used. Patients received intravenous amrubicin 40–80 mg/m2 on day one, lenalidomide 15 mg orally on days 1–14, and dexamethasone 40 mg orally weekly on 21 day cycles. 14 patients were enrolled, and completed a median of three cycles. The maximum tolerated dose was not reached. One patient experienced dose limiting toxicity of dizziness and diarrhea. The most frequent non-hematologic toxicity was infection (79%). Serious adverse events included cord compression and sepsis. Three patients (21%) had a partial response or better, and seven (50%) had stable disease. The median duration of response was 4.4 months, and the median progression-free survival was 3 months. Amrubicin combined with lenalidomide and dexamethasone, was safe and demonstrated clinical activity in relapsed or refractory multiple myeloma.
Clinicaltrials.gov identifier: NCT01355705
KeywordsMultiple myeloma Amrubicin Lenalidomide Relapse
ML was the principal investigator for this study; TJD, SD, BCM, SC, JG, CB, and ML contributed to patient enrollment and care; SD, and ML coordinated the research. SD, BCM, and ML contributed to acquisition, analysis, and interpretation of data. SD, EP, GK, and ML wrote the paper. All authors reviewed the manuscript and approved the final submitted version.
Compliance with ethical standards
Conflict of interest
Drs. Liedtke, Medeiros and Coutre have received research support funding from Celgene. The remaining authors declare no conflicts of interest, financial or otherwise.
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