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
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 |
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 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 |