Thalidomide to Patients With Previously Untreated Multiple Myeloma
Thalidomide to Patients With Previously Untreated Multiple Myeloma
The purpose of this study is to test the effect of thalidomide in patients with multiple
 myeloma. The patients receive either thalidomide or a placebo tablet (neither patient nor
 doctor know which of these are given) in addition to the ordinary chemotherapeutic drug
 against multiple myeloma. We will find out for how long time the patients will stay free of
 the disease and for how long time they will live, and can evaluate whether thalidomide is a
 beneficial drug against this disease.
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.
Inclusion Criteria:

 -  Patients with multiple myeloma in need of treatment

 Exclusion Criteria:

 -  Previous treatment against multiple myeloma

 -  Need of high dose chemotherapy with autologous stem cell support

 -  Women in fertile age

 -  Psychiatric disease or mental reduction leading to lack of cooperation

 -  Lack of consent

 -  Life expectancy below 3 months

 -  Active cancer of other etiology