title: Expanded safety experience with lenalidomide plus dexamethasone in relapsed or refractory multiple myeloma.
abstract: Lenalidomide gained Food and Drug Administration (FDA) approval for treatment of patients with relapsed or refractory multiple myeloma (MM) in combination with dexamethasone in June 2006. In April 2005, the FDA and patient advocacy groups requested an expanded access programme to both provide lenalidomide to patients likely to benefit and obtain additional safety information. Relapsed/refractory MM patients received lenalidomide 25 mg/d (days 1-21) and dexamethasone 40 mg/d (days 1-4, 9-12, and 17-20 of cycles 1-4; days 1-4 only from cycle 5 onwards), in 4-week cycles until disease progression, study drug discontinuation, or lenalidomide approval. Of the 1438 patients enrolled, approximately 60% were male, median age was 64 years, and 61.7% had Durie-Salmon stage III disease. Median time on study was 15.4 weeks (range: 0.1-49.1) and median dose was 25 mg. The most common adverse events (AEs) were haematological (49%), gastrointestinal (59%), and fatigue (55%). The most common grade > or =3 AEs were haematological (45%), fatigue (10%), and pneumonia (7%). The most common serious AEs were pneumonia (8%), pyrexia (4%), and deep-vein thrombosis (3%). Primary cause of death was disease progression (10%). Safety data confirmed known AEs of lenalidomide plus dexamethasone therapy in patients with relapsed/refractory MM.
authors: Princess Margaret Hospital, Toronto, ON, Canada.
authors: Christine
authors: C
authors: Chen
authors: Donna E
authors: DE
authors: Reece
authors: David
authors: D
authors: Siegel
authors: Ruben
authors: R
authors: Niesvizky
authors: Ralph V
authors: RV
authors: Boccia
authors: Edward A
authors: EA
authors: Stadtmauer
authors: Rafat
authors: R
authors: Abonour
authors: Paul
authors: P
authors: Richardson
authors: Jeffrey
authors: J
authors: Matous
authors: Shaji
authors: S
authors: Kumar
authors: Nizar J
authors: NJ
authors: Bahlis
authors: Melissa
authors: M
authors: Alsina
authors: Robert
authors: R
authors: Vescio
authors: Steven E
authors: SE
authors: Coutre
authors: Dennis
authors: D
authors: Pietronigro
authors: Robert D
authors: RD
authors: Knight
authors: Jerome B
authors: JB
authors: Zeldis
authors: Vincent
authors: V
authors: Rajkumar
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use*; D003907:Dexamethasone / Q000008:administration & dosage / Q000009:adverse effects; D019008:Drug Resistance, Neoplasm; D005260:Female; D006801:Humans; D000077269:Lenalidomide; D008297:Male; D008875:Middle Aged; D009101:Multiple Myeloma / Q000188:drug therapy*; D012008:Recurrence; D013792:Thalidomide / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives; D016896:Treatment Outcome
chemical_list: D013792:Thalidomide; D003907:Dexamethasone; D000077269:Lenalidomide