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Melphalan+Prednisolon With or Without Thalidomide in Previously Untreated Elderly Patients With Multiple Myeloma

Multiple Myeloma Clinical Trial

Official title:
Phase III Trial Comparing Treatment With Melphalan+Prednisolon (MP) With Melphalan+Prednisolon+Thalidomide (MPT) for Previously Untreated Elderly Patients With Multiple Myeloma

Clinical Trial 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

Clinical Trial Description

This trial will include patients who are not candidates for transplantation and above the age of 55. Treatment cycles will include (MP)melphalan (9 mg /sq.m/day d1-4), prednisolone (60 mg/sq.m/d,d1-4) every six weeks for maximum 8 cycles. Patients will be randomised to (MPT) Thalidomide (1:1) 100 mg/day continuously. Cross-over to MPT is allowed if insufficient response is obtained in the MP arm. response will be evaluated every other cycle. At the end of 12 months of treatment patients will be followed until progress and death. Second line treatment is not defined. ;

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT00934154
Study type Interventional
Source Erkim Ilac A.S.
Contact
Status Completed
Phase Phase 3
Start date March 2006
Completion date September 2012
View Details
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