Melphalan, Prednisone, and Thalidomide or Lenalidomide in Treating Patients With Newly Diagnosed Multiple Myeloma
Summary
This randomized phase III trial studies melphalan and prednisone with thalidomide to see how well it works compared to melphalan and prednisone together with lenalidomide in treating patients with newly diagnosed multiple myeloma. Drugs used in chemotherapy, such as melphalan and prednisone, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Thalidomide and lenalidomide may stop the growth of multiple myeloma by blocking blood flow to the cancer. It is not yet known whether melphalan and prednisone are more effective when given together with thalidomide or lenalidomide in treating multiple myeloma.
Timeline
- Start
- 2008-02-29
- Primary completion
- 2014-01-18
- Completion
- 2027-02-20
Outcome
Missed primary endpoint
paper Median PFS was 21 months on MPT-T and 18.7 months on mPR-R (HR, 0.84; 95% confidence interval, 0.64-1.09). PMID 26157076 ↗
registry Hazard Ratio (HR) 0.84 (90% CI 0.67 to 1.045) NCT00602641 ↗
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Lenalidomide | Other / unclassified | — | Oral |
| Comparator | Thalidomide | Other / unclassified | — | Oral |
| Background | Melphalan | Small molecule | — | Oral |
| Background | Prednisone | Other / unclassified | — | Oral |