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Annals of Oncology Advance Access published online on September 15, 2006
Annals of Oncology, doi:10.1093/annonc/mdl313
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© 2006 European Society for Medical Oncology
Received April 3, 2006
Revised June 5, 2006
Accepted July 24, 2006

original article

Lenalidomide and pegylated liposomal doxorubicin-based chemotherapy for relapsed or refractory multiple myeloma: safety and efficacy

R. Baz 1, E. Walker 2, M. A. Karam 1, T. K. Choueiri 1, R. A. Jawde 1, K. Bruening 2, J. Reed 1, B. Faiman 1, Y. Ellis 1, C. Brand 1, G. Srkalovic 3, S. Andresen 4, R. Knight 3, J. Zeldis 3, and M. A. Hussein 1 *

1 Cleveland Clinic Cancer Center Myeloma Research Program, Cleveland Clinic, Cleveland
2 Department of Quantitative Health Sciences, Cleveland Clinic, Cleveland
3 Hematology and Medical Oncology, Sparrow Cancer Center, Lansing, Celgene Corporation, Summit, USA
4 Department of Hematology and Medical Oncology, Cleveland Clinic, Cleveland

* To whom correspondence should be addressed.
M. A. Hussein, E-mail: mashussein{at}runbox.us


  Abstract

Background: Lenalidomide is active and well tolerated in relapsed and refractory multiple myeloma. We conducted a phase I/II trial of the combination of lenalidomide and chemotherapy to evaluate the safety and efficacy of the combination.

Methods: The 62 patients enrolled received liposomal doxorubicin 40 mg/m2 i.v. and vincristine 2 mg i.v. on day 1, dexamethasone 40 mg p.o. on days 1-4 (DVd), and lenalidomide on days 1-21 in 28-day cycles. Primary end points were maximum tolerated dose (MTD) of lenalidomide with DVd chemotherapy and overall response rate (ORR) by Southwest Oncology Group criteria of the combination.

Findings: The median age was 62 years, 70% of patients were males and 65% had refractory multiple myeloma. The MTD of lenalidomide with DVd chemotherapy was 10 mg and the dose-limiting toxicity was non-neutropenic sepsis. After 7.5 months of median follow-up, the ORR of the combination was 75%, with 29% of patients achieving a complete or near complete remission. The median progression-free survival was 12 months, while the median overall survival has not yet been reached.

Interpretation: The combination of lenalidomide and DVd chemotherapy was well tolerated and resulted in high response rates in this mostly refractory patient population. Evaluation of this combination in newly diagnosed patients is warranted.

Keywords: Multiple Myeloma; Refractory; Lenalidomide; reduced dose dexamethasone; Doxil.
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