BENITIONSClinical Trial Intelligence

Lenalidomide and Dexamethasone With or Without Bortezomib in Treating Patients With Previously Untreated Multiple Myeloma

Phase 3 Active, not recruiting NCT00644228

ConditionDS Stage I Multiple Myeloma, DS Stage II Multiple Myeloma, DS Stage III Multiple Myeloma
PhasePhase 3
SponsorNational Cancer Institute (NCI)
StatusActive, not recruiting
Enrollment525 participants
InterventionsBortezomib, Dexamethasone, Laboratory Biomarker Analysis, Lenalidomide
Start dateJul 28, 2008
Completion dateNov 5, 2015
Results postedJul 6, 2017

Summary

This randomized phase III trial studies lenalidomide, dexamethasone, and bortezomib to see how well it works compared to dexamethasone and lenalidomide alone in treating patients with previously untreated multiple myeloma. Biological therapies, such as lenalidomide, may stimulate the immune system in different ways and stop cancer cells from growing. Drugs used in chemotherapy, such as dexamethasone, 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. Bortezomib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth or by blocking blood flow to the cancer. It is not yet known whether lenalidomide and dexamethasone is more effective with or without bortezomib in treating multiple myeloma.

Progression-free Survival

From date of registration to date of first documentation of progression or symptomatic deterioration, or death due to any cause, assessed up to 6 years · Months

Arm I (Dexamethasone and Lenalidomide)30 Months
Arm II (Dexamethasone, Lenalidomide, Bortezomib)43 Months
p-value0.0018
Hazard Ratio (HR)0.712 (95% CI 0.560–0.906)

Open in BENITIONS View on ClinicalTrials.gov

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