Bevacizumab, Lenalidomide, and Dexamethasone in Patients With Relapsed or Refractory Stage II or III Multiple Myeloma
Part of paid clinical trials in Pittsburgh, Pennsylvania.
- Sponsor
- National Cancer Institute (NCI)
- Study ID
- NCT00410605
- Phase
- PHASE2
- Status
- Completed
Conditions
- Multiple Myeloma in Relapse
- Stage II Multiple Myeloma
- Stage III Multiple Myeloma
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- bevacizumab — BIOLOGICALGiven IV
- lenalidomide — DRUGGiven orally
- dexamethasone — DRUGGiven orally
Study Details
This phase II trial is studying how well giving bevacizumab together with lenalidomide and dexamethasone works in treating patients with relapsed or refractory stage II or stage III multiple myeloma. Monoclonal antibodies, such as bevacizumab, can block cancer growth in different ways. Some block the ability of cancer cells to grow and spread. Others find cancer cells and help kill them or carry cancer-killing substances to them. Bevacizumab and lenalidomide may stop the growth of multiple myeloma by blocking blood flow to the cancer. Dexamethasone may stimulate the immune system in different ways and stop cancer cells from growing. Giving bevacizumab together with lenalidomide and dexamethasone may kill more cancer cells.
Key Dates
- First listed
- Dec 13, 2006
- Start date
- Nov 30, 2006
- Status verified
- Aug 2017
- Primary completion
- Dec 31, 2011
- Completion
- Jun 30, 2014
Study Design
- Enrollment
- 39 participants (actual)
- Allocation
- NA
- Intervention model
- SINGLE_GROUP
- Primary purpose
- TREATMENT
Arms
- Experimental: Arm IPatients receive bevacizumab IV over 30-90 minutes on days 1 and 15, oral lenalidomide on days 1-21, and oral dexamethasone on days 1, 8, 15, and 22. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.
Primary Outcome Measure
Confirmed Anti-tumor Response Rate (Complete Response and Partial Response) to the Combination of Bevacizumab and Lenalidomide [ Time Frame: Up to 5 years ]
Locations (2)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| University of Pittsburgh Cancer Institute | Pittsburgh | Pennsylvania | 15232 | - |
| University of Wisconsin Hospital and Clinics | Madison | Wisconsin | 53792 | - |
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