BENITIONSClinical Trial Intelligence

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

3상 진행 중(모집 완료) NCT00644228

대상 질환DS Stage I Multiple Myeloma, DS Stage II Multiple Myeloma, DS Stage III Multiple Myeloma
임상 단계3상
스폰서National Cancer Institute (NCI)
상태진행 중(모집 완료)
참여자 수525 명
중재(약물)Bortezomib, Dexamethasone, Laboratory Biomarker Analysis, Lenalidomide
시작일2008년 7월 28일
완료일2015년 11월 5일
결과 공개일2017년 7월 6일

요약

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)

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