Pamidronate versus observation in asymptomatic myeloma: final results with long-term follow-up of a randomized study.
Author(s): D'Arena G, Gobbi PG, Broglia C, Sacchi S, Quarta G, Baldini L, Iannitto E, Falcone A, Guariglia R, Pietrantuono G, Villani O, Martorelli MC, Mansueto G, Sanpaolo G, Cascavilla N, Musto P
Affiliation(s): Hematology and Stem Cell Transplantation Unit, IRCCS Casa Sollievo della Sofferenza Hospital, S. Giovanni Rotondo, Italy.
Publication date & source: 2011-05, Leuk Lymphoma., 52(5):771-5. Epub 2011 Feb 8.
Publication type: Clinical Trial, Phase III; Multicenter Study; Randomized Controlled Trial
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.