title: Safety and efficacy of single-agent lenalidomide in patients with relapsed and refractory multiple myeloma.
abstract: Lenalidomide plus dexamethasone is effective for the treatment of relapsed and refractory multiple myeloma (MM); however, toxicities from dexamethasone can be dose limiting. We evaluated the efficacy and safety of lenalidomide monotherapy in patients with relapsed and refractory MM. Patients (N = 222) received lenalidomide 30 mg/day once daily (days 1-21 every 28 days) until disease progression or intolerance. Response, progression-free survival (PFS), overall survival (OS), time to progression (TTP), and safety were assessed. Overall, 67% of patients had received 3 or more prior treatment regimens. Partial response or better was reported in 26% of patients, with minimal response 18%. There was no difference between patients who had received 2 or fewer versus 3 or more prior treatment regimens (45% vs 44%, respectively). Median values for TTP, PFS, and OS were 5.2, 4.9, and 23.2 months, respectively. The most common grade 3 or 4 adverse events were neutropenia (60%), thrombocytopenia (39%), and anemia (20%), which proved manageable with dose reduction. Grade 3 or 4 febrile neutropenia occurred in 4% of patients. Lenalidomide monotherapy is active in relapsed and refractory MM with acceptable toxicities. These data support treatment with single-agent lenalidomide, as well as its use in steroid-sparing combination approaches. The study is registered at http://www.clinicaltrials.gov as NCT00065351.
authors.affiliation: Dana-Farber Cancer Institute, Harvard Medical School, 44 Binney Street, Boston, MA 02115, USA. paul_richardson@dfci.harvard.edu
authors.forename: Paul
authors.initials: P
authors.lastname: Richardson
authors.forename: Sundar
authors.initials: S
authors.lastname: Jagannath
authors.forename: Mohamad
authors.initials: M
authors.lastname: Hussein
authors.forename: James
authors.initials: J
authors.lastname: Berenson
authors.forename: Seema
authors.initials: S
authors.lastname: Singhal
authors.forename: David
authors.initials: D
authors.lastname: Irwin
authors.forename: Stephanie F
authors.initials: SF
authors.lastname: Williams
authors.forename: William
authors.initials: W
authors.lastname: Bensinger
authors.forename: Ashraf Z
authors.initials: AZ
authors.lastname: Badros
authors.forename: Robert
authors.initials: R
authors.lastname: Vescio
authors.forename: Laurie
authors.initials: L
authors.lastname: Kenvin
authors.forename: Zhinuan
authors.initials: Z
authors.lastname: Yu
authors.forename: Marta
authors.initials: M
authors.lastname: Olesnyckyj
authors.forename: Jerome
authors.initials: J
authors.lastname: Zeldis
authors.forename: Robert
authors.initials: R
authors.lastname: Knight
authors.forename: Kenneth C
authors.initials: KC
authors.lastname: Anderson
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000970:Antineoplastic Agents / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use; D018450:Disease Progression; D054796:Drug Dosage Calculations; D019008:Drug Resistance, Neoplasm / Q000187:drug effects*; D005260:Female; D006801:Humans; D000077269:Lenalidomide; D008297:Male; D008875:Middle Aged; D008954:Models, Biological; D009101:Multiple Myeloma / Q000188:drug therapy* / Q000401:mortality / Q000473:pathology; D012008:Recurrence; D016019:Survival Analysis; D013792:Thalidomide / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives* / Q000627:therapeutic use; D016896:Treatment Outcome
chemical_list: D000970:Antineoplastic Agents; D013792:Thalidomide; D000077269:Lenalidomide