Melphalan, Prednisone, and Thalidomide or Lenalidomide in Treating Patients With Newly Diagnosed Multiple Myeloma
Phase 3
Active, not recruiting
NCT00602641
| Condition | Multiple Myeloma |
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| Phase | Phase 3 |
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| Sponsor | National Cancer Institute (NCI) |
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| Status | Active, not recruiting |
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| Enrollment | 306 participants |
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| Interventions | Laboratory Biomarker Analysis, Lenalidomide, Melphalan, Prednisone, Quality-of-Life Assessment |
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| Start date | Feb 29, 2008 |
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| Completion date | Jan 18, 2014 |
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| Results posted | Jun 29, 2015 |
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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.
Progression-Free Survival (PFS)
Assessed every 3 months for 2 years, then every 6 months for 3 years, then annually for 10 years from the date of randomization. · months
| Arm I (MPT-T) | 21.0 months |
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| Arm II (mPR-R) | 18.7 months |
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| Hazard Ratio (HR) | 0.84 (95% CI 0.67–1.045) |
Open in BENITIONS
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