Efficacy and safety of melphalan, arsenic trioxide and ascorbic acid combination therapy in patients with relapsed or refractory multiple myeloma: A prospective, multicentre, phase II, single-arm study

James R. Berenson, Ralph Boccia, David Siegel, Marek Bozdech, Alberto Bessudo, Edward Stadtmauer, J. Talisman Pomeroy, Ronald Steis, Marshall Flam, Jose Lutzky, Syed Jilani, Joseph Volk, Siu Fun Wong, Robert Moss, Ravi Patel, Delina Ferretti, Kit Russell, Robert Louie, Howard S. Yeh, Regina A. Swift

Research output: Contribution to journalArticlepeer-review

66 Scopus citations

Abstract

We assessed the safety and efficacy of melphalan, arsenic trioxide (ATO) and ascorbic acid (AA) (MAC) combination therapy for patients with multiple myeloma (MM) who failed more than two different prior regimens. Patients received melphalan (0.1 mg/kg p.o.), ATO (0.25 mg/kg i.v.) and AA (1 g i.v) on days 1-4 of week 1, ATO and AA twice weekly during weeks 2-5 and no treatment during week 6 of cycle 1; during cycles 2-6, the schedule remained the same except ATO and AA were given twice weekly in week 1. Objective responses occurred in 31 of 65 (48%) patients, including two complete, 15 partial and 14 minor responses. Median progression-free survival and overall survival were 7 and 19 months respectively. Twenty-two patients had elevated serum creatinine levels (SCr) at baseline, and 18 of 22 (82%) showed decreased SCr levels during treatment. Specific grade 3/4 haematological (3%) or cardiac adverse events occurred infrequently. Frequent grade 3/4 non-haematological adverse events included fever/chills (15%), pain (8%) and fatigue (6%). This steroid-free regimen was effective and well tolerated in this heavily pretreated group. These results indicate that the MAC regimen is a new therapeutic option for patients with relapsed or refractory MM.

Original languageEnglish (US)
Pages (from-to)174-183
Number of pages10
JournalBritish Journal of Haematology
Volume135
Issue number2
DOIs
StatePublished - Oct 2006
Externally publishedYes

Keywords

  • Arsenic trioxide
  • Ascorbic acid
  • Melphalan
  • Multiple myeloma
  • Phase II trial

ASJC Scopus subject areas

  • Hematology

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