Refractory Multiple Myeloma Clinical Trial
Official title:
Phase II Trial of Bevacizumab Combined With Lenalidomide and Dexamethasone (BEV/REV/DEX) in Relapsed or Refractory Multiple Myeloma
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.
Status | Active, not recruiting |
Enrollment | 39 |
Est. completion date | |
Est. primary completion date | December 2011 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - 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 - Absolute neutrophil count >= 1,000/mm^3 - Platelet count >= 75,000/mm^3 - Bilirubin =< 2.5 mg/dL - At least 4 weeks since prior chemotherapy or radiotherapy and recovered - More than 7 days since prior minor surgical procedures, fine-needle aspirations, or core biopsies: More than 24 hours since prior bone marrow biopsy or central veinous access placement - More than 28 days since prior major surgical procedure or open biopsy - At least 4 weeks since prior and no concurrent participation in another experimental drug study - Prior autologous peripheral blood stem cell transplantation allowed - No prior lenalidomide - Concurrent full-dose anticoagulants allowed provided all of the following criteria are met: - No active bleeding or pathological condition that carries a high risk of bleeding (e.g., tumor involving major vessels or known varices) - No thrombocytopenia requiring transfusion - Platelet count > 75,000/mm3 - INR 2-3 and stable - No concurrent major surgery - No concurrent sargramostim (GM-CSF) - No other concurrent investigational agents - No other concurrent anticancer agents or therapies - AST and ALT =< 5 times upper limit of normal - Creatinine < 2.5 mg/dL - Not pregnant or nursing - Negative pregnancy test - Fertile patients must use 2 methods of effective contraception 4 weeks before, during, and 4 weeks after completion of study treatment - No history of allergic reactions attributed to compounds of similar chemical or biological composition to lenalidomide and/or bevacizumab or other agents used in the study |
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | University of Wisconsin Hospital and Clinics | Madison | Wisconsin |
United States | University of Pittsburgh Cancer Institute | Pittsburgh | Pennsylvania |
Lead Sponsor | Collaborator |
---|---|
National Cancer Institute (NCI) |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Confirmed anti-tumor response rate (complete response and partial response) to the combination of bevacizumab and lenalidomide | Responses will be analyzed by descriptive statistics and summarized in tabular format (frequency tables). Furthermore, two-sided 95% confidence intervals for the proportions of subjects with a confirmed anti-tumor response will be computed using the method proposed by Chang, which takes into account the multiplicity problem associated with the two-stage testing procedure. The objective response rate will be estimated by using Whitehead's bias-adjustment approach. | Up to 5 years | No |
Secondary | Time to progression (TTP) | TTP will be summarized using point estimates of the median time to progression and associated 95% confidence intervals. The data will be presented graphically using Kaplan-Meier plots. Exploratory analysis, including multivariate Cox regression with demographic variables and markers of myeloma activity as covariates, may be performed. | The number of days from the day of first drug administration to the day the patient experiences an event of disease progression or death, assessed up to 5 years | No |
Secondary | Type and severity of toxicity incidents of the bevacizumab/lenalidomide combination summarized using NCI Common Toxicity Criteria | Ninety percent confidence intervals for the proportions of patients with complications (grade 3 or higher toxicities) will be constructed. | Up to 5 years | Yes |
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