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 — BIOLOGICAL
    Given IV
  • lenalidomide — DRUG
    Given orally
  • dexamethasone — DRUG
    Given 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 I
    Patients 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)

FacilityCityStateZIPSite coordinators
University of Pittsburgh Cancer InstitutePittsburghPennsylvania15232-
University of Wisconsin Hospital and ClinicsMadisonWisconsin53792-

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