A Phase 3, Randomized, Controlled, Open-Label, Multicenter, Safety and Efficacy Study of Dexamethasone Plus MLN9708 or Physicians Choice of Treatment Administered to Patients With Relapsed or Refractory Systemic Light Chain (AL) Amyloidosis
Study For Previously Treated Patients Of Light-Chain Amyloidosis Using study drugs Dexamethasone and MLN9708
Sponsor: Millenium Pharmaceuticals Inc.
Enrolling: Male and Female Patients
IRB Number: AAAM1254
U.S. Govt. ID: NCT01659658
Contact: Ryan Shelton: 212-304-5480 / rs3323@columbia.edu
Additional Study Information: The purpose of this study is to find out if MLN9708 plus dexamethasone improves against systemic light chain amyloidosis better than the physicians choice chemotherapy treatment. Physicians choice chemotherapy treatment is a treatment regimen that is commonly used to treat amyloidosis patients. The study will also determine if MLN9708 plus dexamethasone can lessen the chance that the amyloidosis will cause the heart and/or kidneys to begin to work poorly, cause patients to need care in the hospital or result in death.Patients will be randomly assigned (like flipping a coin) to a treatment schedule, which will be either Group A or Group B, but not both. If patients are assigned to Group A, they will be given MLN9708 plus Dexamethasone. If patients are assigned to Group B, their physician will choose a treatment that they feel is best suited for the patient's disease.
This study is closed
Suzanne Lentzsch, MD
Do You Qualify?
Do you have amyloidosis? Yes No
Have you been treated previously for amyloidosis? Yes No
Do you have multiple myeloma? Yes No
You may be eligible for this study

Place Holder

For more information, please contact:
Ryan Shelton