title: A phase 2 trial of lenalidomide, bortezomib, and dexamethasone in patients with relapsed and relapsed/refractory myeloma.
abstract: In this prospective, multicenter, phase 2 study, 64 patients with relapsed or relapsed and refractory multiple myeloma (MM) received up to 8 21-day cycles of bortezomib 1.0 mg/m(2) (days 1, 4, 8, and 11), lenalidomide 15 mg/day (days 1-14), and dexamethasone 40/20 mg/day (cycles 1-4) and 20/10 mg/day (cycles 5-8) (days of/after bortezomib dosing). Responding patients could receive maintenance therapy. Median age was 65 years; 66% were male, 58% had relapsed and 42% had relapsed and refractory MM, and 53%, 75%, and 6% had received prior bortezomib, thalidomide, and lenalidomide, respectively. Forty-eight of 64 patients (75%; 90% confidence interval, 65-84) were alive without progressive disease at 6 months (primary end point). The rate of partial response or better was 64%; median duration of response was 8.7 months. Median progression-free and overall survivals were 9.5 and 30 months, respectively (median follow-up: 44 months). Common treatment-related toxicities included sensory neuropathy (53%), fatigue (50%), and neutropenia (42%); common grade 3/4 treatment-related toxicities included neutropenia (30%), thrombocytopenia (22%), and lymphopenia (11%). Grade 3 motor neuropathy was reported in 2 patients. Lenalidomide-bortezomib-dexamethasone appears effective and tolerable in patients with relapsed or relapsed and refractory MM, demonstrating substantial activity among patients with diverse prior therapies and adverse prognostic characteristics. This trial is registered with www.clinicaltrials.gov as #NCT00378209.
authors.affiliation: Department of Medical Oncology, Dana-Farber Cancer Institute, Boston, MA;
authors.forename: Paul G
authors.initials: PG
authors.lastname: Richardson
authors.forename: Wanling
authors.initials: W
authors.lastname: Xie
authors.forename: Sundar
authors.initials: S
authors.lastname: Jagannath
authors.forename: Andrzej
authors.initials: A
authors.lastname: Jakubowiak
authors.forename: Sagar
authors.initials: S
authors.lastname: Lonial
authors.forename: Noopur S
authors.initials: NS
authors.lastname: Raje
authors.forename: Melissa
authors.initials: M
authors.lastname: Alsina
authors.forename: Irene M
authors.initials: IM
authors.lastname: Ghobrial
authors.forename: Robert L
authors.initials: RL
authors.lastname: Schlossman
authors.forename: Nikhil C
authors.initials: NC
authors.lastname: Munshi
authors.forename: Amitabha
authors.initials: A
authors.lastname: Mazumder
authors.forename: David H
authors.initials: DH
authors.lastname: Vesole
authors.forename: Jonathan L
authors.initials: JL
authors.lastname: Kaufman
authors.forename: Kathleen
authors.initials: K
authors.lastname: Colson
authors.forename: Mary
authors.initials: M
authors.lastname: McKenney
authors.forename: Laura E
authors.initials: LE
authors.lastname: Lunde
authors.forename: John
authors.initials: J
authors.lastname: Feather
authors.forename: Michelle E
authors.initials: ME
authors.lastname: Maglio
authors.forename: Diane
authors.initials: D
authors.lastname: Warren
authors.forename: Dixil
authors.initials: D
authors.lastname: Francis
authors.forename: Teru
authors.initials: T
authors.lastname: Hideshima
authors.forename: Robert
authors.initials: R
authors.lastname: Knight
authors.forename: Dixie-Lee
authors.initials: DL
authors.lastname: Esseltine
authors.forename: Constantine S
authors.initials: CS
authors.lastname: Mitsiades
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; D000369:Aged, 80 and over; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects / Q000627:therapeutic use*; D001897:Boronic Acids / Q000008:administration & dosage; D000069286:Bortezomib; D003907:Dexamethasone / Q000008:administration & dosage; D005260:Female; D006801:Humans; D000077269:Lenalidomide; D008297:Male; D008875:Middle Aged; D009101:Multiple Myeloma / Q000188:drug therapy* / Q000401:mortality / Q000473:pathology*; D009367:Neoplasm Staging; D011719:Pyrazines / Q000008:administration & dosage; D012008:Recurrence; D013792:Thalidomide / Q000008:administration & dosage / Q000031:analogs & derivatives; D016896:Treatment Outcome
chemical_list: D001897:Boronic Acids; D011719:Pyrazines; D013792:Thalidomide; D000069286:Bortezomib; D003907:Dexamethasone; D000077269:Lenalidomide