Phase I-II trial of oral cyclophosphamide, prednisone and lenalidomide for the treatment of patients with relapsed and refractory multiple myeloma

Donna E. Reece, Esther Masih-Khan, Eshetu G. Atenafu, Victor H. Jimenez-Zepeda, Peter Anglin, Christine Chen, Vishal Kukreti, Joseph R Mikhael, Suzanne Trudel

Research output: Contribution to journalArticle

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Abstract

This single institution, open label Phase I-II dose escalation trial evaluated the safety and efficacy of the combination of lenalidomide (Revlimid®), cyclophosphamide and prednisone (CPR) in patients with relapsed/refractory multiple myeloma. The maximal administered dose of CPR consisted of cyclophosphamide 300 mg/m2 on day 1, 8, and 15, lenalidomide 25 mg on d 1-21 and prednisone 100 mg every other day in a 28-d cycle. Between November 2007 and June 2009, 32 patients were entered in cohorts of three at three dose levels. The median age was 64 years, 59% were male, with a median two prior regimens. Responding patients could stay on treatment until progression. The full-dose CPR regimen produced no dose-limiting toxicity and was delivered for a median of 16 months (3·5-65 months) with acceptable safety and tolerance. The overall response rate (≥ partial response) was 94% at a median follow up of 28 months. The median progression-free survival was 16·1 months [95% confidence interval (CI); 10·9-22·5 months], while the median overall survival was 27·6 months (95% CI; 16·8-36·6 months). Only the beta-2 microglobulin level at protocol entry correlated with a better survival (P = 0·047). These observations compare favourably with other 2- and 3- drug combinations for relapsed/refractory myeloma, and suggest that CPR should be evaluated further in the setting of relapsed/refractory disease, or in newly diagnosed patients.

Original languageEnglish (US)
Pages (from-to)46-54
Number of pages9
JournalBritish Journal of Haematology
Volume168
Issue number1
DOIs
StatePublished - Jan 1 2015

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Prednisone
Multiple Myeloma
Cyclophosphamide
Confidence Intervals
Therapeutics
Safety
beta 2-Microglobulin
Survival
Drug Combinations
Disease-Free Survival
lenalidomide

Keywords

  • Cyclophosphamide
  • Lenalidomide
  • Prednisone
  • Refractory multiple myeloma
  • Relapsed

ASJC Scopus subject areas

  • Hematology
  • Medicine(all)

Cite this

Phase I-II trial of oral cyclophosphamide, prednisone and lenalidomide for the treatment of patients with relapsed and refractory multiple myeloma. / Reece, Donna E.; Masih-Khan, Esther; Atenafu, Eshetu G.; Jimenez-Zepeda, Victor H.; Anglin, Peter; Chen, Christine; Kukreti, Vishal; Mikhael, Joseph R; Trudel, Suzanne.

In: British Journal of Haematology, Vol. 168, No. 1, 01.01.2015, p. 46-54.

Research output: Contribution to journalArticle

Reece, DE, Masih-Khan, E, Atenafu, EG, Jimenez-Zepeda, VH, Anglin, P, Chen, C, Kukreti, V, Mikhael, JR & Trudel, S 2015, 'Phase I-II trial of oral cyclophosphamide, prednisone and lenalidomide for the treatment of patients with relapsed and refractory multiple myeloma', British Journal of Haematology, vol. 168, no. 1, pp. 46-54. https://doi.org/10.1111/bjh.13100
Reece, Donna E. ; Masih-Khan, Esther ; Atenafu, Eshetu G. ; Jimenez-Zepeda, Victor H. ; Anglin, Peter ; Chen, Christine ; Kukreti, Vishal ; Mikhael, Joseph R ; Trudel, Suzanne. / Phase I-II trial of oral cyclophosphamide, prednisone and lenalidomide for the treatment of patients with relapsed and refractory multiple myeloma. In: British Journal of Haematology. 2015 ; Vol. 168, No. 1. pp. 46-54.
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