دورية أكاديمية

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.

التفاصيل البيبلوغرافية
العنوان: 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.
المؤلفون: Dinner, Shira, Dunn, Tamara J., Price, Elizabeth, Coutré, Steven E., Gotlib, Jason, Berube, Caroline, Kaufman, Gregory P., Medeiros, Bruno C., Liedtke, Michaela
المصدر: International Journal of Hematology; Sep2018, Vol. 108 Issue 3, p267-273, 7p
مصطلحات موضوعية: ANTHRACYCLINES, ANTINEOPLASTIC agents, CLINICAL trials, COMPARATIVE studies, DRUG administration, INTRAVENOUS therapy, RESEARCH methodology, MEDICAL cooperation, MULTIPLE myeloma, ORAL drug administration, RESEARCH, THALIDOMIDE, DISEASE relapse, EVALUATION research, TREATMENT effectiveness, DEXAMETHASONE
مستخلص: 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. [ABSTRACT FROM AUTHOR]
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قاعدة البيانات: Complementary Index
الوصف
تدمد:09255710
DOI:10.1007/s12185-018-2468-5