title: Lenalidomide-prednisone induction followed by lenalidomide-melphalan-prednisone consolidation and lenalidomide-prednisone maintenance in newly diagnosed elderly unfit myeloma patients.
abstract: This multicenter phase II trial evaluated the safety and efficacy of lenalidomide-prednisone (RP) induction, followed by lenalidomide-melphalan-prednisone (MPR) consolidation and RP maintenance in elderly unfit newly diagnosed myeloma patients. Patients received four 28-day RP induction courses (lenalidomide 25 mg/day on days 1-21 and prednisone 50 mg three times/week), followed by six 28-day MPR consolidation cycles (melphalan 2 mg, prednisone 50 mg three times/week and lenalidomide 10-15 mg/day on days 1-21), and maintenance with lenalidomide (10 mg/day on days 1-21 every 28 days) plus prednisone (25 mg three times/week). Forty-six patients were enrolled. Median age was 75 years, 59% of patients had at least one comorbidity and 35% at least two. Partial response rate was 80%, including 29% very good partial response. Median time to progression was 19.6 months, median progression-free survival was 18.4 months and 2-year overall survival was 80%. At the tolerated consolidation dose (melphalan 25 mg/month and lenalidomide 10 mg/day), the most frequent grade 3 adverse events were neutropenia (36.4%), anemia (12.1%), cutaneous reactions (18.2%) and infections (12.1%). Grade 4 neutropenia occurred in 12.1% of patients. In conclusion, RP induction followed by MPR consolidation and RP maintenance showed a manageable safety profile, and reduced the risk of severe hematological toxicity in unfit elderly myeloma patients.
authors.affiliation: Division of Transfusional Medicine and Hematology, Cirié, Italy.
authors.forename: P
authors.initials: P
authors.lastname: Falco
authors.forename: F
authors.initials: F
authors.lastname: Cavallo
authors.forename: A
authors.initials: A
authors.lastname: Larocca
authors.forename: D
authors.initials: D
authors.lastname: Rossi
authors.forename: T
authors.initials: T
authors.lastname: Guglielmelli
authors.forename: A
authors.initials: A
authors.lastname: Rocci
authors.forename: M
authors.initials: M
authors.lastname: Grasso
authors.forename: M L M
authors.initials: ML
authors.lastname: Siez
authors.forename: L
authors.initials: L
authors.lastname: De Paoli
authors.forename: S
authors.initials: S
authors.lastname: Oliva
authors.forename: S
authors.initials: S
authors.lastname: Molica
authors.forename: R
authors.initials: R
authors.lastname: Mina
authors.forename: F
authors.initials: F
authors.lastname: Gay
authors.forename: G
authors.initials: G
authors.lastname: Benevolo
authors.forename: P
authors.initials: P
authors.lastname: Musto
authors.forename: P
authors.initials: P
authors.lastname: Omedè
authors.forename: R
authors.initials: R
authors.lastname: Freilone
authors.forename: S
authors.initials: S
authors.lastname: Bringhen
authors.forename: A M
authors.initials: AM
authors.lastname: Carella
authors.forename: G
authors.initials: G
authors.lastname: Gaidano
authors.forename: M
authors.initials: M
authors.lastname: Boccadoro
authors.forename: A
authors.initials: A
authors.lastname: Palumbo
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use*; D005260:Female; D006801:Humans; D000077269:Lenalidomide; D008297:Male; D008558:Melphalan / Q000008:administration & dosage; D009101:Multiple Myeloma / Q000188:drug therapy* / Q000401:mortality / Q000473:pathology; D009367:Neoplasm Staging; D011241:Prednisone / Q000008:administration & dosage; D011379:Prognosis; D015996:Survival Rate; D013792:Thalidomide / Q000008:administration & dosage / Q000031:analogs & derivatives
chemical_list: D013792:Thalidomide; D000077269:Lenalidomide; D008558:Melphalan; D011241:Prednisone