A Phase 3 Study With Randomization to Melphalan/Prednisone/Thalidomide Versus Melphalan/Prednisone/Placebo to Patients With Previously Untreated Multiple Myeloma
Thalidomide has recently emerged as an effective treatment for patients with myeloma
refractory to conventional chemotherapy. So far only limited experience is available on
thalidomide for newly diagnosed myeloma. Therefore the Nordic Myeloma Study Group decided to
perform a trial comparing traditional melphalan-prednisone therapy with melphalan-prednisone
+ thalidomide/placebo. The study design is a multicentre double-blind randomised
placebo-controlled trial. Mainly patients >65 years of age will be included since patients
<65 years will be treated with high dose chemotherapy with autologous stem cell support. The
primary end-point is overall survival. Secondary end-points are quality of life, response
rate, time to response, response duration and toxicity.
Interventional
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
overall survival
october 2007
No
Anders Waage, MD
Study Chair
Department of Haematology, St. Olavs hospital/NTNU, N-7006 Trondheim
Norway: Norwegian Medicines Agency
NMSG #12
NCT00218855
January 2002
April 2007
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