Phase I/II Study of Combination Everolimus (RAD001), and Rituximab (Rituxan), OR Everolimus, Bortezomib (Velcade, PS-341), and Rituximab in Patients With Relapsed and/or Relapsed/Refractory Waldenstrom's Macroglobulinemia
- Since we are looking for the highest dose of a combination of study drugs that can be
administered safely without severe or unmanageable side effects in participants that
have Waldenstrom's Macroglobulinemia, not everyone who participates in this research
study will receive the same combination of study drugs or the same dose of the study
- In this research study every 4 week (28 day) period is called a cycle. While on study,
participants will receive up to 6 cycles of combination treatment followed by
everolimus alone for up to 2 years.
- Participants will take everolimus by mouth everyday, and will receive rituximab
intravenously on days 1, 8, 15 and 22 on Cycle 1 and Cycle 4 only. If the participant
receives bortezomib, it will be given intravenously on days 1, 8 and 15 of every cycle.
- After the third cycle, tests will be done to see how the disease is responding to the
study treatment. If the disease stays the same, or is helped, the participant will
continue to get the combination of study treatment for another 3 cycles.
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Phase I/II Study of Combination Everolimus (RAD001), and Rituximab (Rituxan), OR Everolimus, Bortezomib (Velcade, PS-341), and Rituximab in Patients with Relapsed and/or Relapsed/Refractory Waldenstrom's Macroglobulinemia
To determine the safety and maximum tolerated dose (MTD) of the combination of everolimus/rituximab or everolimus/bortezomib/rituximab and to assess the depth of response to the combination of everolimus/bortezomib/rituximab.
Irene Ghobrial, MD
Dana-Farber Cancer Institute
United States: Food and Drug Administration
|Dana-Farber Cancer Institute||Boston, Massachusetts 02115|
|Colorado Blood Cancer Institute||Denver, Colorado 80218|
|Milford Hospital||Milford, Massachusetts 01757|