Waldenstrom's Macroglobulinemia Clinical Trial
Official title:
Carfilzomib, Rituximab, and Dexamethasone (CaRD) in Waldenstrom's Macroglobulinemia
Carfilzomib is a drug that has shown anti-tumor activity by inhibiting the proteasome within
the cell, which is responsible for degrading or breaking down a wide variety of proteins.
Carfilzomib has not been approved by the FDA.
Rituximab and dexamethasone are often used to treat Waldenstrom's Macroglobulinemia (WM),
alone or in combination with other drugs. Combinations with rituximab, dexamethasone and
proteasome inhibitors, like carfilzomib, show high levels of activity in WM patients.
In this research study, the investigators are testing the safety and efficacy of Carfilzomib
when used along with Rituximab and Dexamethasone as a possible treatment for 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.
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