Melphalan+Prednisolon With or Without Thalidomide in Previously Untreated Elderly Patients With Multiple Myeloma
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
Timeline
- Start
- 2006-03
- Primary completion
- 2009-09
- Completion
- 2012-09
Outcome
Mixed primary results
paper Primary endpoint was treatment response and toxicities following 4 and 8 cycles of therapy. PMID 20942865 ↗
paper there were more partial responses or better in the MPT arm than in the MP arm (57.9% vs. 37.5%; P=0.030). PMID 20942865 ↗
paper A higher rate of grade 3-4 infections was observed in the MPT arm compared with the MP arm (22.4% vs. 7.0%; P=0.033). PMID 20942865 ↗
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Thalidomide | Other / unclassified | 100 mg | — |
| Background | Melphalan | Small molecule | 2 mg | — |
| Background | Melphalan | Small molecule | 9 mg/m2 | — |
| Background | Prednisolone | Other / unclassified | 16 mg | — |
| Background | Prednisolone | Other / unclassified | 60 mg/m2 | — |