A randomized phase 2 study of lenalidomide therapy for patients with relapsed or relapsed and refractory multiple myeloma

Paul G. Richardson, Emily Blood, Constantine S. Mitsiades, Sundar Jagannath, Steven R. Zeldenrust, Melissa Alsina, Robert L. Schlossman, S. Vincent Rajkumar, K. Raman Desikan, Teru Hideshima, Nikhil C. Munshi, Kathleen Kelly-Colson, Deborah Doss, Mary L. McKenney, Svetlana Gorelik, Diane Warren, Andrea Freeman, Rebecca Rich, Anfang Wu, Marta OlesnyckyjKenton Wride, William S. Dalton, Jerome Zeldis, Robert Knight, Edie Weller, Kenneth C. Anderson

Research output: Contribution to journalArticlepeer-review

438 Scopus citations


This multicenter, open-label, randomized phase 2 study evaluated 2 dose regimens of lenalidomide for relapsed, refractory myeloma. Seventy patients were randomized to receive either 30 mg once-daily or 15 mg twice-daily oral lenalidomide for 21 days of every 28-day cycle. Patients with progressive or stable disease after 2 cycles received dexamethasone. Analysis of the first 70 patients showed increased grade 3/4 myelosuppression in patients receiving 15 mg twice daily (41% versus 13%, P = .03). An additional 32 patients received 30 mg once daily. Responses were evaluated according to European Group for Blood and Marrow Transplantation (EBMT) criteria. Overall response rate (complete, partial, or minor) to lenalidomide alone was 25% (24% for once-daily and 29% for twice-daily lenalidomide). Median overall survival in 30-mg once-daily and twice-daily groups was 28 and 27 months, respectively. Median progression-free survival was 7.7 months on once-daily versus 3.9 months on twice-daily lenalidomide (P = .2). Dexamethasone was added in 68 patients and 29% responded. Time to first occurrence of clinically significant grade 3/4 myelosuppression was shorter in the twice-daily group (1.8 vs 5.5 months, P = .05). Significant peripheral neuropathy and deep vein thrombosis each occurred in only 3%. Lenalidomide is active and well tolerated in relapsed, refractory myeloma, with the 30-mg once-daily regimen providing the basis for future studies as monotherapy and with dexamethasone.

Original languageEnglish (US)
Pages (from-to)3458-3464
Number of pages7
Issue number10
StatePublished - Nov 15 2006

ASJC Scopus subject areas

  • Biochemistry
  • Immunology
  • Hematology
  • Cell Biology


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