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Dr. Waage - Melphalan-Prednisone-Thalidomide to Newly Diagnosed Patients with Multiple Myeloma: A Placebo Controlled Randomised Phase 3 Trial
Anders Waage, MD
University Hospital
Trondheim, Norway
01.08.08

"Thalidomide induces higher rate of good responses in patients, it also gives a longer time to progression in the patients, however this anti-myeloma activity does not translate into better survival, which is somewhat surprising."
Dr. Waage


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[78] Melphalan-Prednisone-Thalidomide to Newly Diagnosed Patients with Multiple Myeloma: A Placebo Controlled Randomised Phase 3 Trial. Session Type: Oral Session

Anders Waage, Peter Gimsing, Gunnar Juliusson, Ingemar Turesson, Peter Fayers Department of Hematology, St. Olavs University Hospital/NTNU, Trondheim, Norway; Department of Hematology, National Hospital, Copenhagen, Denmark; Department of Hematology, Lund University Hospital, Lund, Sweden; Department of Hematology, Malmo University, Malmo, Sweden; Public Health, University of Aberdeen, Aberdeen, United Kingdom

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.
Abstract #78 appears in Blood, Volume 110, issue 11, November 16, 2007


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