Phase II Study of CC-5103 and Rituximab in Waldenstrom's Macroglobulinemia
- The study drug CC-5103 will be administered orally once daily for 21 days followed by 7
days of no CC-5103 (this will be one 28 day treatment cycle). This cycle will repeat
itself every 28 days as long as the patient is tolerating the medication and there is
no disease progression.
- Starting on the second week, patients will begin treatment with rituximab intravenously
once a week for 4 weeks (week 2-5). Prior to each treatment, patients will receive
medications to prevent or reduce the side effects of rituximab (benadryl, tylenol and
possible decadron). During the infusion, the patients' blood pressure and pulse will
be monitored frequently and the rate of infusion may decrease depending upon the side
effects. Blood work will also be performed each week.
- On week 12 the disease status will be evaluated. A physical exam, blood test, CT scan
and bone marrow biopsy may be repeated if necessary to fully evaluate the disease. If
the disease has gone away completely, some tests may be repeated again to confirm this.
- If the disease has gotten worse after 12 weeks, then the patient will be removed from
- If the disease is stable or getting better, the patient will continue with therapy.
During weeks 13-16 rituximab infusions will be repeated and CC-5103 will continue to be
taken daily for 21 days followed by 7 days of rest. This 28 day cycle may be repeated
until the patient has completed 48 weeks (12 months) of treatment as long as the side
effects are acceptable and the disease does not progress.
- All patients will undergo an off-study evaluation that includes a physical exam, blood
work, CT scans and bone marrow biopsy. If the patient completes 78 weeks of therapy and
the disease does not get worse, they will be evaluated every 12 weeks to determine the
status of their disease for up to 2 years.
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
To define objective response, time to progression and safety for combined CC-5103 and rituximab therapy in Waldenstrom's macroglobulinemia patients.
Steven Treon, MD, MA, PhD
Dana-Farber Cancer Insitute
United States: Institutional Review Board
|Beth Israel Deaconess Medical Center||Boston, Massachusetts 02215|
|Dana-Farber Cancer Institute||Boston, Massachusetts 02115|