title: A randomized phase 2 study of lenalidomide therapy for patients with relapsed or relapsed and refractory multiple myeloma.
abstract: 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 myelo-suppression 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.
authors.affiliation: Dana-Farber Cancer Institute, 44 Binney St, Boston, MA 02115, USA. paul_richardson@dfci.harvard.edu
authors.forename: Paul G
authors.initials: PG
authors.lastname: Richardson
authors.forename: Emily
authors.initials: E
authors.lastname: Blood
authors.forename: Constantine S
authors.initials: CS
authors.lastname: Mitsiades
authors.forename: Sundar
authors.initials: S
authors.lastname: Jagannath
authors.forename: Steven R
authors.initials: SR
authors.lastname: Zeldenrust
authors.forename: Melissa
authors.initials: M
authors.lastname: Alsina
authors.forename: Robert L
authors.initials: RL
authors.lastname: Schlossman
authors.forename: S Vincent
authors.initials: SV
authors.lastname: Rajkumar
authors.forename: K Raman
authors.initials: KR
authors.lastname: Desikan
authors.forename: Teru
authors.initials: T
authors.lastname: Hideshima
authors.forename: Nikhil C
authors.initials: NC
authors.lastname: Munshi
authors.forename: Kathleen
authors.initials: K
authors.lastname: Kelly-Colson
authors.forename: Deborah
authors.initials: D
authors.lastname: Doss
authors.forename: Mary L
authors.initials: ML
authors.lastname: McKenney
authors.forename: Svetlana
authors.initials: S
authors.lastname: Gorelik
authors.forename: Diane
authors.initials: D
authors.lastname: Warren
authors.forename: Andrea
authors.initials: A
authors.lastname: Freeman
authors.forename: Rebecca
authors.initials: R
authors.lastname: Rich
authors.forename: Anfang
authors.initials: A
authors.lastname: Wu
authors.forename: Marta
authors.initials: M
authors.lastname: Olesnyckyj
authors.forename: Kenton
authors.initials: K
authors.lastname: Wride
authors.forename: William S
authors.initials: WS
authors.lastname: Dalton
authors.forename: Jerome
authors.initials: J
authors.lastname: Zeldis
authors.forename: Robert
authors.initials: R
authors.lastname: Knight
authors.forename: Edie
authors.initials: E
authors.lastname: Weller
authors.forename: Kenneth C
authors.initials: KC
authors.lastname: Anderson
mesh_terms: D000328:Adult; D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000008:administration & dosage / Q000627:therapeutic use; D003907:Dexamethasone / Q000008:administration & dosage; D005260:Female; D006801:Humans; D000077269:Lenalidomide; D008297:Male; D008875:Middle Aged; D009101:Multiple Myeloma / Q000150:complications / Q000188:drug therapy* / Q000401:mortality; D010523:Peripheral Nervous System Diseases / Q000139:chemically induced; D012008:Recurrence; D012074:Remission Induction / Q000379:methods; D016879:Salvage Therapy / Q000009:adverse effects / Q000379:methods*; D016019:Survival Analysis; D015996:Survival Rate; D013792:Thalidomide / Q000008:administration & dosage / Q000031:analogs & derivatives* / Q000493:pharmacokinetics / Q000633:toxicity; D020246:Venous Thrombosis / Q000139:chemically induced
chemical_list: D013792:Thalidomide; D003907:Dexamethasone; D000077269:Lenalidomide