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 Blood, 15 October 2008, Vol. 112, No. 8, pp. 3107-3114.
Prepublished online as a Blood First Edition Paper on May 27, 2008; DOI 10.1182/blood-2008-04-149427.

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CLINICAL TRIALS AND OBSERVATIONS

Oral melphalan, prednisone, and thalidomide in elderly patients with multiple myeloma: updated results of a randomized controlled trial

Antonio Palumbo1, Sara Bringhen1, Anna M. Liberati2, Tommaso Caravita3, Antonietta Falcone4, Vincenzo Callea5, Marco Montanaro6, Roberto Ria7, Antonio Capaldi8, Renato Zambello9, Giulia Benevolo10, Daniele Derudas11, Fausto Dore12, Federica Cavallo1, Francesca Gay1, Patrizia Falco1, Giovannino Ciccone13, Pellegrino Musto14, Michele Cavo15, and Mario Boccadoro1

1 Divisione di Ematologia dell'Università di Torino, Azienda Ospedaliera S. Giovanni Battista, Torino; 2 Clinica Medica I, Policlinico Monteluce, Perugia; 3 Cattedra e Divisione di Ematologia, Università Tor Vergata, Ospedale S. Eugenio, Roma; 4 Unità Operativa di Ematologia Trapianto di Cellule Staminali, Casa Sollievo della Sofferenza, San Giovanni Rotondo; 5 Divisione di Ematologia, Ospedali Riuniti, Reggio di Calabria; 6 Unità Operativa Complessa di Ematologia, Ospedale Sant'Anna di Ronciglione, Ronciglione (VT); 7 Sezione Medicina Interna e Oncologia Clinica, Policlinico di Bari, Bari; 8 Divisione di Oncologia ed Ematologia, IRCCS, Candiolo; 9 Divisione di Ematologia e Immunologia Clinica Universitaria, Dipartimento Medicina Clinica e Sperimentale, Padova; 10 Ematologia, Azienda Ospedaliera S. Giovanni Battista, Torino; 11 Unità Operativa di Ematologia, Ospedale A. Businco, Cagliari; 12 Istituto di Ematologia, Università di Sassari, Sassari; 13 Servizio di Epidemiologia dei Tumori dell'Università di Torino, Azienda Ospedaliera S. Giovanni Battista, Torino, e CPO Piemonte; 14 Ematologia e Trapianto Cellule Staminali, IRCCS, Centro di Riferimento Oncologico della Basilicata, Rionero in Vulture (PZ); and 15 Istituto di Ematologia e Oncologia Medica, Policlinico S. Orsola, Bologna, Italy

The initial analysis of the oral combination melphalan, prednisone, and thalidomide (MPT) in newly diagnosed patients with myeloma showed significantly higher response rate and longer progression-free survival (PFS) than did the standard melphalan and prednisone (MP) combination and suggested a survival advantage. In this updated analysis, efficacy and safety end points were updated. Patients were randomly assigned to receive oral MPT or MP alone. Updated analysis was by intention to treat and included PFS, overall survival (OS), and survival after progression. After a median follow-up of 38.1 months, the median PFS was 21.8 months for MPT and 14.5 months for MP (P = .004). The median OS was 45.0 months for MPT and 47.6 months for MP (P = .79). In different patient subgroups, MPT improved PFS irrespective of age, serum concentrations of β2-microglobulin, or high International Staging System. Thalidomide or bortezomib administration as salvage regimens significantly improved survival after progression in the MP group (P = .002) but not in the MPT group (P = .34). These data confirm activity of MPT for PFS but failed to show any survival advantage. New agents in the management of relapsed disease could explain this finding. The study is registered at www.clinicaltrials.gov as #NCT00232934 [ClinicalTrials.gov] .


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