title: A randomised comparison of melphalan with prednisone or dexamethasone as induction therapy and dexamethasone or observation as maintenance therapy in multiple myeloma: NCIC CTG MY.7.
abstract: The effectiveness of melphalan plus dexamethasone (M-Dex) with melphalan plus prednisone (MP) as induction therapy and dexamethasone with observation as maintenance therapy was compared in 585 older patients with multiple myeloma. Randomization to the M-Dex arm was stopped as a result of an analysis performed which met a predetermined event-related criterion. Of 466 patients randomised to MP or M-Dex, no differences were detected in the respective median progression-free survivals (PFS) [1.8 vs. 1.9 years; Hazard Ratio (HR) = 0.88, 95% CI 0.72-1.07; P = 0.2] or overall survivals (OS) (2.5 vs. 2.7 years; HR = 0.91, 95% CI 0.74-1.11; P = 0.3). Of the initial 585 patients, 292 remained evaluable for maintenance therapy. Patients randomised to maintenance dexamethasone had a superior median PFS (2.8 years vs. 2.1 years; HR = 0.61, 95% CI 0.47-0.79; P = 0.0002). No difference in median OS was detected (4.1 years vs. 3.8 years; HR = 0.88, 95% CI 0.65-1.18; P = 0.4). The maintenance therapy results were robust when analysed by using two additional methodologies. Dexamethasone did not improve clinical outcome when combined with melphalan during induction; maintenance dexamethasone improved PFS, but this did not translate into a detectable survival advantage.
authors.affiliation: Royal Victoria Hospital, Montreal, QC, Canada.
authors.forename: Chaim
authors.initials: C
authors.lastname: Shustik
authors.forename: Andrew
authors.initials: A
authors.lastname: Belch
authors.forename: Sue
authors.initials: S
authors.lastname: Robinson
authors.forename: Sheldon H
authors.initials: SH
authors.lastname: Rubin
authors.forename: Sean P
authors.initials: SP
authors.lastname: Dolan
authors.forename: Michael J
authors.initials: MJ
authors.lastname: Kovacs
authors.forename: Kuljit S
authors.initials: KS
authors.lastname: Grewal
authors.forename: David
authors.initials: D
authors.lastname: Walde
authors.forename: Robert
authors.initials: R
authors.lastname: Barr
authors.forename: Jonathan
authors.initials: J
authors.lastname: Wilson
authors.forename: Kulwant
authors.initials: K
authors.lastname: Gill
authors.forename: Linda
authors.initials: L
authors.lastname: Vickars
authors.forename: Leona
authors.initials: L
authors.lastname: Rudinskas
authors.forename: Dolores A
authors.initials: DA
authors.lastname: Sicheri
authors.forename: Kenneth
authors.initials: K
authors.lastname: Wilson
authors.forename: Marina
authors.initials: M
authors.lastname: Djurfeldt
authors.forename: Lois E
authors.initials: LE
authors.lastname: Shepherd
authors.forename: Keyue
authors.initials: K
authors.lastname: Ding
authors.forename: Ralph M
authors.initials: RM
authors.lastname: Meyer
mesh_terms: D000284:Administration, Oral; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000008:administration & dosage*; D003907:Dexamethasone / Q000008:administration & dosage* / Q000627:therapeutic use; D004334:Drug Administration Schedule; D005260:Female; D005938:Glucocorticoids / Q000008:administration & dosage* / Q000627:therapeutic use; D006801:Humans; D008297:Male; D008558:Melphalan / Q000008:administration & dosage; D008875:Middle Aged; D009101:Multiple Myeloma / Q000188:drug therapy* / Q000401:mortality; D011241:Prednisone / Q000008:administration & dosage; D016016:Proportional Hazards Models; D012074:Remission Induction; D015996:Survival Rate; D016896:Treatment Outcome
chemical_list: D005938:Glucocorticoids; D003907:Dexamethasone; D008558:Melphalan; D011241:Prednisone