Melphalan+Prednisolon With or Without Thalidomide in Previously Untreated Elderly Patients With Multiple Myeloma
Status:
Completed
Trial end date:
2012-09-01
Target enrollment:
Participant gender:
Summary
This is a multi-centre Phase III randomized controlled study of patients with multiple
myeloma (MM). Eligible patients who are not candidates for transplantation will be randomized
to receive eight courses of Melphalan/Prednisolone with or without Thalidomide treatment.
Thalidomide will be initiated at the dose of 100 mg/day and maintained at 100 mg/day. The
patients will be assessed for any responses at the end of 2nd, 4th, 6th and 8th cycles of
treatment. The toxicities will be assessed at monthly intervals. Patients will be assessed
for the:
1. Incidence and grade of any toxicity
2. Level of maximum disease response
3. Time to disease progression
4. Time to death