Phase I Study of Pomalidomide, Dexamethasone and Rituximab (PDR) in Relapsed or Refractory Waldenstrom's Macroglobulinemia
- Participants will be given a study drug-dosing calendar for each treatment cycle. Each
treatment cycle lasts 28 days during which time participants will take Pomalidomide
orally once a day. Dexamethasone and rituximab will be administered intravenously on
weeks 1, 2, 3, 4 and on weeks 12, 13, 14, 15.
- Since we are looking for the highest dose of Pomalidomide in combination with
dexamethasone and rituximab which can be administered safely without severe or
unmanageable side effects, not everyone who participates will receive the same dose of
the study drug. The dose participants will get will depend on the number of
participants who have been enrolled in the study and how well they have tolerated their
- As long as there is no evidence that the participant's Waldenstrom's Macroglobulinemia
has progressed, they can continue to receive Pomalidomide for up to 52 weeks.
Participants will be asked to return to the clinic for follow-up tests at least every
three months for four years.
Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Safety Profile, Tolerability and Maximum Tolerated Dose
To determine the safety profile, tolerability, and MTD of pomalidomide administered orally in patients with Waldenstrom's Macroglobulinemia in combination with dexamethasone and rituximab
Steven P. Treon, MD
Dana-Farber Cancer Institute
United States: Food and Drug Administration
|Dana-Farber Cancer Institute||Boston, Massachusetts 02115|