Bevacizumab, Lenalidomide, and Dexamethasone in Patients With Relapsed or Refractory Stage II or III Multiple Myeloma

Completed · Phase 2

Conditions studied: Multiple Myeloma in Relapse, Stage II Multiple Myeloma, Stage III Multiple Myeloma

In brief

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 facts

Study ID

NCT00410605

Run by

National Cancer Institute (NCI)

People needed

39

Starts

2006-11-01

Expected to finish

2014-06-01

Last updated by the study team

2017-09-01

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Histologically or cytologically confirmed symptomatic multiple myeloma:
• Stage II or III disease
• Relapsed or refractory disease after >= 2 courses of prior chemotherapy
• Measurable levels of monoclonal protein (M protein) > 1.0 g/dL by serum protein electrophoresis OR > 200 mg of monoclonal light chain by 24-hour urine protein electrophoresis
• Measurable bone disease, defined as >= 1 unidimensionally measurable lesion (longest diameter to be recorded) >= 20 mm with conventional techniques OR >= 10 mm with spiral CT scan (for patients with lytic bone disease)
• No known brain metastases
• ECOG performance status (PS) 0-2 OR Karnofsky PS 70-100%
• Patients with PS of 3 are eligible if it is due to pain that is likely to improve with treatment
• Life expectancy > 6 months
• No known HIV positivity
• No abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within the past 6 months
• No active infections requiring oral or intravenous antibiotics within the past week
• No proteinuria (i.e., albuminuria) > 1,000 mg/24 hours unless related to the diagnosis of multiple myeloma
• Patients with light chain (i.e., "Bence-Jones") proteinuria are still eligible if the non-light chain component of protein is < 1,000 mg/24 hours
• No serious nonhealing wound or ulcer
• No blood pressure > 150/90 mm Hg (even with medication)
• No significant traumatic injury within the past 28 days
• No clinically significant peripheral vascular disease
• No evidence of bleeding diathesis or coagulopathy
• No unstable angina or myocardial infarction within the past 6 months
• No stroke within the past 6 months
• No New York Heart Association class III or IV heart failure
• No secondary malignancy within the past 2 years except squamous cell or basal cell carcinoma of the skin or carcinoma in situ of the cervix
• Hemoglobin > 9 g/dL (may be supported by transfusion or growth factors)
• WBC >= 2,000/mm\^3

Where it is running

• University of Pittsburgh Cancer Institute — Pittsburgh, Pennsylvania, United States
• University of Wisconsin Hospital and Clinics — Madison, Wisconsin, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.