BENITIONSClinical Trial Intelligence

Melphalan, Prednisone, and Thalidomide or Lenalidomide in Treating Patients With Newly Diagnosed Multiple Myeloma

Phase 3 Active, not recruiting NCT00602641

ConditionMultiple Myeloma
PhasePhase 3
SponsorNational Cancer Institute (NCI)
StatusActive, not recruiting
Enrollment306 participants
InterventionsLaboratory Biomarker Analysis, Lenalidomide, Melphalan, Prednisone, Quality-of-Life Assessment
Start dateFeb 29, 2008
Completion dateJan 18, 2014
Results postedJun 29, 2015

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
Arm II (mPR-R)18.7 months
Hazard Ratio (HR)0.84 (95% CI 0.67–1.045)

Open in BENITIONS View on ClinicalTrials.gov

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