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Phase I‐ II trial of oral cyclophosphamide, prednisone and lenalidomide for the treatment of patients with relapsed and refractory multiple myeloma
Author(s) -
Reece Donna E.,
MasihKhan Esther,
Atenafu Eshetu G.,
JimenezZepeda Victor H.,
Anglin Peter,
Chen Christine,
Kukreti Vishal,
Mikhael Joseph R.,
Trudel Suzanne
Publication year - 2015
Publication title -
british journal of haematology
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.907
H-Index - 186
eISSN - 1365-2141
pISSN - 0007-1048
DOI - 10.1111/bjh.13100
Subject(s) - medicine , lenalidomide , prednisone , refractory (planetary science) , cyclophosphamide , regimen , multiple myeloma , surgery , gastroenterology , chemotherapy , physics , astrobiology
Summary 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/m 2 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.