Phase 2 study of arsenic trioxide in patients with relapsed or refractory multiple myeloma

Document Type

Article

Department

Haematology and Oncology, East Africa

Abstract

Despite aggressive and innovative therapy, patients with multiple myeloma(MM) invariably relapse and die of their disease. New options for non-cytotoxic salvage therapy and additional therapeutic strategies are needed.Arsenic trioxide, an antitumour agent with a multifaceted mechanism ofaction, induces apoptosis in vitro in MM cell lines and freshly isolated cellsfrom MM patients and, in preliminary studies, displayed clinical activity inpatients with late-stage MM. A phase 2, multicentre, open-label study ofarsenic trioxide was conducted in 24 MM patients; eight had relapsed and16 were refractory to prior therapy. Patients received arsenic trioxide0Æ25 mg/kg/d for 5 d/week during the first 2 weeks of each 4-week cycle.Sixteen patients had grade 3 or 4 neutropenia and one required antibiotics.Reductions (25% or more) in serum M-protein levels occurred in eight of 24(33%) patients. An additional six (25%) patients had stable disease. Themedian time to response was 67Æ5 d, with a median duration of response of130 d. Arsenic trioxide therapy lowered serum creatinine levels in twopatients with high baseline values. These data indicate that arsenic trioxide isactive and reasonably well tolerated as a single-agent salvage therapy, even inpatients with late-stage, relapsed and refractory MM.

Comments

This work was published before the author joined Aga Khan University.

Publication (Name of Journal)

British Journal of Haematology

DOI

https://doi.org/10.1111/j.1365-2141.2004.04941.x

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