BENITIONSClinical Trial Intelligence

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

3期 进行中(已停止招募) NCT00114101

适应症DS Stage I Multiple Myeloma, DS Stage II Multiple Myeloma, DS Stage III Multiple Myeloma, Refractory Multiple Myeloma
分期3期
申办方National Cancer Institute (NCI)
状态进行中(已停止招募)
受试者人数460 人
干预(药物)Autologous Hematopoietic Stem Cell Transplantation, Laboratory Biomarker Analysis, Lenalidomide, Melphalan, Peripheral Blood Stem Cell Transplantation
开始日期2004年12月15日
完成日期2012年12月31日
结果公布日2013年7月1日

摘要

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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本页整理自 ClinicalTrials.gov 的公开数据,不构成医疗建议,也不构成投资建议。请务必咨询专业医师。