drugset / Trial / NCT00305812
Lenalidomide and Melphalan in Treating Patients With Previously Untreated Multiple Myeloma
RandomizedSingle-groupOpen-labelTreatment
Summary
RATIONALE: Lenalidomide may stop the growth of multiple myeloma by blocking blood flow to the cancer. It may also stimulate the immune system in different ways and stop cancer cells from growing. Drugs used in chemotherapy, such as melphalan, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving lenalidomide together with melphalan may kill more cancer cells. PURPOSE: This randomized phase II trial is studying the side effects and best dose of lenalidomide when given together with melphalan and to see how well they work in treating patients with multiple myeloma.
Timeline
- Start
- 2006-03-09
- Primary completion
- 2008-06-30
- Completion
- 2008-06-30
Publications
- Background White DJ, Paul N, Macdonald DA, Meyer RM, Shepherd LE. Addition of lenalidomide to melphalan in the treatment of newly diagnosed multiple myeloma: the National Cancer Institute of Canada Clinical Trials Group MY.11 trial. Curr Oncol. 2007 Apr;14(2):61-5. doi: 10.3747/co.2007.107.
- Results White DJ, Bahlis NJ, Marcellus DC, et al.: Phase II testing of lenalidomide plus melphalan for previously untreated older patients with multiple myeloma: the NCIC CTG MY.11 trial. [Abstract] Blood 112 (11): A-2767, 2008.
- Results White DJ, Kovacs MJ, Belch A, et al.: Phase II testing of lenalidomide plus melphalan for previously untreated older patients with multiple myeloma: toxicity data from the NCIC CTG MY.11 trial. [Abstract] Blood 110 (11): A-189, 2007.
- White DJ, Bahlis NJ, Marcellus DC, Belch A, Stewart AK, Chen C, Kovacs MJ, Macdonald DA, Reece DE, Reiman T, Harnett E, Meyer RM, Chapman JA, Couban S. Lenalidomide plus melphalan without prednisone for previously untreated older patients with multiple myeloma: a phase II trial. Clin Lymphoma Myeloma Leuk. 2013 Feb;13(1):19-24. doi: 10.1016/j.clml.2012.08.009. Epub 2012 Nov 7.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Lenalidomide | Other / unclassified | 10 mg | Oral |
| Subject | Lenalidomide | Other / unclassified | 15 mg | Oral |
| Subject | Lenalidomide | Other / unclassified | 20 mg | Oral |
| Subject | Melphalan | Small molecule | 4 mg/m2 | Oral |
| Subject | Melphalan | Small molecule | 5 mg/m2 | Oral |
| Subject | Melphalan | Small molecule | 6 mg/m2 | Oral |
| Subject | Melphalan | Small molecule | 9 mg/m2 | Oral |
| Background | Dexamethasone | Small molecule | — | Oral |