A Randomized Clinical Trial of Lenalidomide (CC-5013) and Dexamethasone With and Without Autologous Peripheral Blood Stem Cell Transplant in Patients With Newly Diagnosed Multiple Myeloma
Study For Patients Of Multiple Myeloma Therapy Prior To Stem Cell Transplant With Or Without Lenalidomide/Dexamethasone
Sponsor: Celgene Inc.
Enrolling: Male and Female Patients
IRB Number: AAAJ2355
U.S. Govt. ID: NCT01731886
Contact: Ryan Shelton: 212-304-5480 / rs3323@columbia.edu
Additional Study Information: This research study is being done to compare the combination of lenalidomide and dexamethasone followed by autologous peripheral blood stem cell transplant (PBSCT) and lenalidomide and dexamethasone without PBSCT in subjects with untreated multiple myeloma. This comparison will include how many subjects respond to each study treatment combination, how long their responses last, whether they live longer, and what side effects are caused by each combination.Lenalidomide is an oral medicine that works within the bone marrow to stop or slow the growth of cancerous myeloma cells. Dexamethasone is a synthetic steroid with powerful anti-inflammatory effects. It can also alter your body's immune response. Lenalidomide in combination with dexamethasone is approved by the U.S. Food and Drug Administration (FDA) for people with multiple myeloma.PBSCT is a procedure that restores stem cells that have been destroyed by high doses of chemotherapy. An autologous PBSCT is one that uses stem cells that have been collected from you. Stem cells are the original cells from which all the blood cells (including white blood cells, which fight infection, red blood cells, which carry oxygen, and platelets, which help the blood to clot) develop. The use of high doses of chemotherapy to kill cancer cells in subjects, along with the use of your own stem cells through PBSCT has become a standard of care treatment for subjects diagnosed with multiple myeloma.
This study is closed
Investigator
Suzanne Lentzsch, MD
Do You Qualify?
Do you have multiple myeloma? Yes No
Are you eligible for a stem cell transplant? Yes No
Have you had chemotherapy? Yes No
Have you had radiotherapy? Yes No
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For more information, please contact:
Ryan Shelton
rs3323@columbia.edu
212-304-5480