BENITIONSClinical Trial Intelligence

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

Фаза 3 Идёт, набор закрыт NCT00114101

ЗаболеваниеDS Stage I Multiple Myeloma, DS Stage II Multiple Myeloma, DS Stage III Multiple Myeloma, Refractory Multiple Myeloma
ФазаФаза 3
СпонсорNational Cancer Institute (NCI)
СтатусИдёт, набор закрыт
Участники460 участн.
ВмешательствоAutologous Hematopoietic Stem Cell Transplantation, Laboratory Biomarker Analysis, Lenalidomide, Melphalan, Peripheral Blood Stem Cell Transplantation
Дата начала15.12.2004
Дата завершения31.12.2012
Публикация результатов1.07.2013

Кратко

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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