BENITIONSClinical Trial Intelligence

Lenalidomide in Treating Patients With Multiple Myeloma Undergoing Autologous Stem Cell Transplant

3상 진행 중(모집 완료) NCT00114101

대상 질환DS Stage I Multiple Myeloma, DS Stage II Multiple Myeloma, DS Stage III Multiple Myeloma, Refractory Multiple Myeloma
임상 단계3상
스폰서National Cancer Institute (NCI)
상태진행 중(모집 완료)
참여자 수460 명
중재(약물)Autologous Hematopoietic Stem Cell Transplantation, Laboratory Biomarker Analysis, Lenalidomide, Melphalan, Peripheral Blood Stem Cell Transplantation
시작일2004년 12월 15일
완료일2012년 12월 31일
결과 공개일2013년 7월 1일

요약

This randomized phase III trial studies lenalidomide to see how well it works compared to a placebo in treating patients with multiple myeloma who are undergoing autologous stem cell transplant. Giving chemotherapy before a peripheral blood stem cell transplant helps kill any cancer cells that are in the body and helps make room in the patient's bone marrow for new blood-forming cells (stem cells) to grow. After treatment, stem cells are collected from the patient's blood and stored. More chemotherapy is then given to prepare the bone marrow for the stem cell transplant. The stem cells are then returned to the patient to replace the blood-forming cells that were destroyed by the chemotherapy. Biological therapies, such as lenalidomide, may stimulate or suppress the immune system in different ways and stop cancer cells from growing. Giving lenalidomide after autologous stem cell transplant may be an effective treatment for multiple myeloma.

Time to Progression

Duration of study (up to 10years) · months

Lenalidomide Maintenance39 months
Placebo Maintenance21 months
p-value<0.001
Hazard Ratio (HR)0.36 (95% CI 0.26–0.53)

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