title: Pamidronate versus observation in asymptomatic myeloma: final results with long-term follow-up of a randomized study.
abstract: A prospective, multicenter, randomized trial comparing pamidronate administration (60-90 mg once a month for 1 year) versus simple observation in 177 patients with asymptomatic myeloma was performed to explore whether the administration of this drug reduces the rate of and/or the time to progression to overt, symptomatic disease. No relevant side effects were recorded in pamidronate-treated patients. With a minimum follow-up of 5 years for live patients, there were 56/89 (62.9%) progressions in the pamidronate-treated group and 55/88 (62.5%) within the controls (p = NS). Median time to progression was 46 and 48 months, respectively (p = NS). Overall survival was also similar between the two groups. Skeletal-related events at the time of progression were observed in 40/55 (72.7%) controls, but only in 22/56 (39.2%) pamidronate-treated patients (p = 0.009). In conclusion, the administration of pamidronate in asymptomatic myeloma, while reducing bone involvement at progression, did not decrease the risk of transformation and the time to progression into overt myeloma.
authors.affiliation: Hematology and Stem Cell Transplantation Unit, IRCCS Casa Sollievo della Sofferenza Hospital, S. Giovanni Rotondo, Italy.
authors.forename: Giovanni
authors.initials: G
authors.lastname: D'Arena
authors.forename: Paolo G
authors.initials: PG
authors.lastname: Gobbi
authors.forename: Chiara
authors.initials: C
authors.lastname: Broglia
authors.forename: Stefano
authors.initials: S
authors.lastname: Sacchi
authors.forename: Giovanni
authors.initials: G
authors.lastname: Quarta
authors.forename: Luca
authors.initials: L
authors.lastname: Baldini
authors.forename: Emilio
authors.initials: E
authors.lastname: Iannitto
authors.forename: Antonietta
authors.initials: A
authors.lastname: Falcone
authors.forename: Roberto
authors.initials: R
authors.lastname: Guariglia
authors.forename: Giuseppe
authors.initials: G
authors.lastname: Pietrantuono
authors.forename: Oreste
authors.initials: O
authors.lastname: Villani
authors.forename: Maria Carmen
authors.initials: MC
authors.lastname: Martorelli
authors.forename: Giovanna
authors.initials: G
authors.lastname: Mansueto
authors.forename: Grazia
authors.initials: G
authors.lastname: Sanpaolo
authors.forename: Nicola
authors.initials: N
authors.lastname: Cascavilla
authors.forename: Pellegrino
authors.initials: P
authors.lastname: Musto
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D050071:Bone Density Conservation Agents; D001847:Bone Diseases / Q000188:drug therapy / Q000517:prevention & control; D004164:Diphosphonates / Q000008:administration & dosage* / Q000627:therapeutic use; D018450:Disease Progression; D005500:Follow-Up Studies; D006801:Humans; D008875:Middle Aged; D009101:Multiple Myeloma / Q000188:drug therapy* / Q000401:mortality / Q000473:pathology; D000077268:Pamidronate; D016019:Survival Analysis; D055815:Young Adult
chemical_list: D050071:Bone Density Conservation Agents; D004164:Diphosphonates; D000077268:Pamidronate