Melphalan + Prednisone Versus Melphalan + Prednisone + Thalidomide in Induction Therapy for Multiple Myeloma in Elderly Patients: Final Analysis of the Dutch Cooperative Group HOVON 49 Study

• Published in: Blood 2008-11, Vol.112 (11), p.649-649
• Main Authors: Wijermans, P., Schaafsma, M., van Norden, Y., Ammerlaan, R., Wittebol, S., Sinnige, H., Zweegman, Sonja, van Marwijk Kooi, M., Van der Griend, R., Lokhorst, H., Sonneveld, P.
• Format: Article
• Language: English
• ISSN: 0006-4971; 1528-0020
• DOI: 10.1182/blood.V112.11.649.649

Introduction: The Dutch cooperative group HOVON started a randomised phase III study in elderly patients with multiple myeloma (MM) in September 2002 comparing the standard Melphalan and Prednisone (MP) treatment with the combination Melphalan, Prednison and Thalidomide (MPT) (HOVON 49 study). Patients with previous untreated multiple myeloma > 65 years of age with a stage IB or higher were candidates for this trial. Melphalan was given in a dose of 0.25 mg/kg and prednisone 1 mg/kg for 5 days every 4 weeks. Thalidomide was given daily in a dose of 200 mg.. A maximum of 8 cycles was planned. In case of ongoing improvement of response further therapy was allowed till a plateau phase was reached. When a good response and a plateau phase was reached the patients on MPT received maintenance therapy with Thalidomide 50 mg/day until disease progression. Responses were assessed using the IMWG criteria. The primary endpoint was Event Free Survival (EFS). Progression Free Survival (PFS), Overall Survival (OS) and Response Rate (RR) were secondary endpoints. The study was powered for 420 patients. However accrual decreased significantly after the publications of 2 other trials comparing MP with MPT. Therefor the HOVON monitoring board decided to stop the trial when 344 patients had been included. Results: 344 patients from 59 centers were registered. 11 patients were not eligible and 3 patients were excluded for lack of signed informed consent or insufficient data at the time of evaluation. The 333 remaining patients, had been randomized to MP (n=168)and MPT (n=165. The arms were well matched for age, sex, stage of the disease, performance status and type of M-protein. The best response on protocol with MPT was 66% (CR 2%, VGPR 28% and PR 36%) as compared to 47% with MP (CR 2%, VGPR 8% and PR 37%), respectively (p