Previously untreated patients with multiple myeloma were included in this double-blind randomised trial. Patients not eligible for high dose treatment in Norway, Sweden and Denmark were recruited. The study started in 2002 and accrual of patients stopped 1st of May 2007. Date of analysis was 1st of June 2007. The treatment was randomized between melphalan/prednisone/thalidomide and melphalan/prednisone/placebo. Starting dose of thalidomide was 200 mg escalating to 400 mg. There was no recommendation for prophylaxis for venous thromboembolism. Endpoints were overall survival, event free survival, response, time to progression and quality of life. Interim analysis for safety was performed in 2004 by an independent commitee. Altogether 362 patients with mean age 75 (49–92) years were included, 55% males. The incidence of venous thromboembolism in the blinded treatment arms was 7%. The study will be unblinded and results will be available September 2007.

Topics:
melphalan, multiple myeloma, prednisone, randomization, thalidomide, venous thromboembolism, surrogate endpoints, reaction time, denmark, norway

Author notes

Disclosure:Membership Information: Anders Waage is member of the Nordic Advisory Board for Pharmion.

2007, The American Society of Hematology
2007
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