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Assessing Treatments for Patients with Relapsed or Refractory Systemic Light Chain (AL) Amyloidosis
AL Amyloidosis - Assessing Treatments for Patients with Relapsed or Refractory Systemic Light Chain AL Amyloidosis
||Raymond Comenzo, MD
This is a phase 3, randomized, controlled, open-label, multicenter study of the oral formulation of dexamethasone plus MLN9708 (investigational study drug) compared with treatment chosen by the investigator from a prespecified list of regimens available in clinical practice. Treatment options will include: dexamethasone alone, dexamethasone plus an alkylating agent (melphalan or cyclophosphamide), or dexamethasone plus an immunomodulatory drug ([IMiD], thalidomide or lenalidomide) in patients with relapsed or refractory AL amyloidosis. The sponsor is Millennium Pharmaceuticals Inc. For any questions, please call the number listed above. Participants may also view clinicaltrials.gov for any additional information.
- Must be relapsed or refractory after 1 or 2 prior therapies
- Cardiac and/or renal involvement
- Adequate cardiac and renal functions
- Amyloidosis due to mutations of the transthyretin gene or presence of other non-AL amyloidosis.
- Female patients who are lactating, breastfeeding, or pregnant.
- Clinically overt multiple myeloma
Participants will be randomly assigned to a treatment schedule, which will be either “Arm A” or “Arm B”, but not both. Arm A participants will be given MLN9708 plus Dexamethasone. The study doctor will choose one of the treatments from below if you are assigned in Arm B: 1) Dexamethasone alone 2) Dexamethasone plus Melphalan 3) Dexamethasone plus Cyclophosphamide 4) Dexamethasone plus Thalamide 5) Dexamethasone plus Lenalidomide. You will also have physical exams, blood tests and scans as required by the study.
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