Everolimus, Bortezomib and/or Rituximab in Patients With Relapsed/Refractory Waldenstrom's Macroglobulinemia
The purpose of this research study is to test the safety of the combination of everolimus, rituximab and bortezomib. Everolimus is a drug that works by preventing cells in your body from growing and dividing. Information from basic and other clinical research suggests that everolimus may also inhibit tumor growth in people with relapsed or refractory lymphoma. The FDA has approved everolimus for the treatment of multiple myeloma, a cancer that is closely related to Waldenstrom's Macroglobulinemia. Rituximab is approved by the FDA for the treatment of non-Hodgkin's lymphoma, which included Waldenstrom's Macroglobulinemia.
Funding Source - FDA OOPD
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||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|
- 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 [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]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.
- To assess the safety of the combination of everolimus/rituximab or everolimus/bortezomib/rituximab in the Phase II study. [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
- To assess overall response rate, duration of response, time to progression, and progression free survival in these patients in the Phase II study. [ Time Frame: 3 years ] [ Designated as safety issue: No ]
- To identify molecular regulators of response/resistance using tumor samples pre and post-treatment. [ Time Frame: 2 years ] [ Designated as safety issue: No ]
|Study Start Date:||March 2010|
|Estimated Study Completion Date:||January 2017|
|Estimated Primary Completion Date:||August 2016 (Final data collection date for primary outcome measure)|
Experimental: single arm
Combination of everolimus & rituximab with bortezomib in patients with relapsed or refractory WM
Taken orally on a daily basis
Other Name: RAD001Drug: Rituximab
Given intravenously on days 1, 8, 15 and 22 of Cycle 1 and Cycle 4 only
Other Name: RituxanDrug: Bortezomib
Given intravenously on days 1, 8 and 15 of every cycle
- 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 drug.
- 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01125293
|United States, Colorado|
|Colorado Blood Cancer Institute|
|Denver, Colorado, United States, 80218|
|United States, Massachusetts|
|Dana-Farber Cancer Institute|
|Boston, Massachusetts, United States, 02115|
|Boston, Massachusetts, United States, 01757|
|Principal Investigator:||Irene Ghobrial, MD||Dana-Farber Cancer Institute|