Originally published as JCO Early Release 10.1200/JCO.2006.10.2509 on May 7 2007
Journal of Clinical Oncology, Vol 25, No 17 (June 10), 2007: pp. 2434-2441
© 2007 American Society of Clinical Oncology.
Prospective, Randomized Study of Single Compared With Double Autologous Stem-Cell Transplantation for Multiple Myeloma: Bologna 96 Clinical Study
Michele Cavo,
Patrizia Tosi,
Elena Zamagni,
Claudia Cellini,
Paola Tacchetti,
Francesca Patriarca,
Francesco Di Raimondo,
Ettore Volpe,
Sonia Ronconi,
Delia Cangini,
Franco Narni,
Affra Carubelli,
Luciano Masini,
Lucio Catalano,
Mauro Fiacchini,
Antonio de Vivo,
Alessandro Gozzetti,
Antonio Lazzaro,
Sante Tura,
Michele Baccarani
From the Istituto di Ematologia ed Oncologia Medica [Seràgnoli], Università di Bologna, Bologna; Clinica Ematologia, Università di Udine, Udine; Cattedra di Ematologia, Università di Catania, Catania; Servizio di Ematologia, Avellino; Sezione di Ematologia, Università di Modena, Modena; Unità Operativa di Ematologia, Cagliari; Servizio di Ematologia, Reggio Emilia; Divisione di Ematologia, Università Federico II, Napoli; Divisione di Ematologia e Trapianti, Università di Siena, Siena; and Oncologia Medica ed Ematologia, Piacenza
Address reprint requests to Michele Cavo, MD, [Seràgnoli] Institute of Hematology and Medical Oncology, via Massarenti 9, 40138, Bologna, Italy; e-mail: mcavo{at}med.unibo.it
Purpose: We performed a prospective, randomized study of single (arm A) versus double (arm B) autologous stem-cell transplantation (ASCT) for younger patients with newly diagnosed multiple myeloma (MM).
Patients and Methods: A total of 321 patients were enrolled onto the study and were randomly assigned to receive either a single course of high-dose melphalan at 200 mg/m2 (arm A) or melphalan at 200 mg/m2 followed, after 3 to 6 months, by melphalan at 120 mg/m2 and busulfan at 12 mg/kilogram (arm B).
Results: As compared with assignment to the single-transplantation group (n = 163 patients), random assignment to receive double ASCT (n = 158 patients) significantly increased the probability to attain at least a near complete response (nCR; 33% v 47%, respectively; P = .008), prolonged relapse-free survival (RFS) duration of 18 months (median, 24 v 42 months, respectively; P < .001), and significantly extended event-free survival (EFS; median, 23 v 35 months, respectively; P = .001). Administration of a second transplantation and of novel agents for treating sequential relapses in up to 50% of patients randomly assigned to receive a single ASCT likely contributed to prolong the survival duration of the whole group, whose 7-year rate (46%) was similar to that of the double-transplantation group (43%; P = .90). Transplantation-related mortality was 3% in arm A and 4% in arm B (P = .70).
Conclusion: In comparison with a single ASCT as up-front therapy for newly diagnosed MM, double ASCT effected superior CR or nCR rate, RFS, and EFS, but failed to significantly prolong overall survival. Benefits offered by double ASCT were particularly evident among patients who failed at least nCR after one autotransplantation.
published online ahead of print at www.jco.org on May 7, 2007.
Supported by Università di Bologna, Progetti di Ricerca Fondamentale Orientata (M.C.); Ministero dell'Università e Ricerca Scientifica, progetto FIRB, RBAU012E9A_001 (M.C.); and Fondazione Carisbo.
Presented in part at the 46th Annual Meeting of the American Society of Hematology, December 6-9, 2004, San Diego, CA.
Authors' disclosures of potential conflicts of interest and author contributions are found at the end of this article.
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