International Journal of Hematology

DOI: 10.1007/s12185-018-2468-5 Pages: 267-273

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

1. Northwestern University Feinberg School of Medicine, Department of Medicine, Division of Hematology/Oncology

2. Stanford University School of Medicine, Department of Medicine, Division of Hematology

Correspondence to:
Michaela Liedtke
Tel: 650 498-6000
Email: mliedtke@stanford.edu

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Abstract

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

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