Carfilzomib, Rituximab, and Dexamethasone (CaRD) in Waldenstrom's Macroglobulinemia
If you take part in this research study, you will receive Carfilzomib and dexamethasone as
an infusion on Days 1, 2, 8, and 9 for Cycles 1-6. You will then have a Rituximab infusion
on Days 2 and 9. Each cycles lasts 21 days. After completing Cycle 6 and if you are
eligible, there will be a 2 month break before the maintenance phase is started. During this
break, you will have a study visit with a physical exam, blood tests, and a bone marrow
biopsy. If you continue to the maintenance phase, you will receive Carfilzomib and
Dexamethasone on Days 1 and 2 and Rituximab on Day 2 of Cycles 1-8. Each cycle will continue
to last 21 days, but will take place every 2 months. Infusions will last between 2-6 hours.
During all cycles you will have a physical exam and you will be asked questions about your
general health and specific questions about any problems that you might be having and any
medications you may be taking. Blood tests will also be done at each Cycle visit, and you
will complete a questionnaire. Bone marrow and CT scan will only be repeated at physician
discretion when appropriate and in order to ensure your response to treatment.
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
To assess the overall response rate (ORR), major response rate (MRR), and Very Good Partial Response/Complete Response (VGPR/CR) rates of CaRD in symptomatic untreated on symptomatic pretreated but proteasome inhibitor and rituximab naive, WM patients.
Steven P Treon, MD, PhD
Dana-Farber Cancer Institute
United States: Food and Drug Administration
|Dana-Farber Cancer Institute||Boston, Massachusetts 02115|