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Home > "B" Clinical Trials Conditions > Bevacizumab With or Without Thalidomide in Treating Patients With Relapsed or Refractory Multiple Myeloma  Bevacizumab With or Without Thalidomide in Treating Patients With Relapsed or Refractory Multiple Myeloma
Bevacizumab With or Without Thalidomide in Treating Patients With Relapsed or Refractory Multiple Myeloma
For Condition: stage 3 multiple myeloma,refractory plasma cell neoplasm,stage 2 multiple myeloma,stage 1 multiple myeloma
Status: Recruiting
Sponsor(s): California Cancer Consortium , National Cancer Institute (NCI)
Synopsis: RATIONALE: Monoclonal antibodies such as bevacizumab can locate cancer cells and either kill them or deliver cancer-killing substances to them. Thalidomide may stop the growth of cancer cells by stopping blood flow to the tumor. It is not yet known if bevacizumab is more effective with or without thalidomide for multiple myeloma. PURPOSE: Randomizedphase II trial to study the effectiveness of bevacizumab with or without thalidomide in treating patients who have relapsed or refractory multiple myeloma.
Details: OBJECTIVES: - Compare the response rate and time to progression in patients with relapsed or refractory multiple myeloma treated with bevacizumab with or without thalidomide. - Compare the toxicity of these regimens in these patients. - Compare the effects of these regimens on histological and molecular biomarkers of angiogenesis, tumor invasion, and cell death in these patients. - Correlate plasma and urine vascular endothelial growth factor and basic fibroblast growth factor levels and other potential markers of angiogenesis and myeloma cell proliferation with outcome in patients treated with these regimens. - Determine the pharmacokinetics of thalidomide in these patients. - Compare the effects of these regimens on the psychological/physical well being of these patients. OUTLINE: This is a randomized, multicenter study. Patients are stratified according to prior treatment with thalidomide (yes vs no). Patients who have received no prior treatment with thalidomide are randomized to 1 of 2 treatment arms. - Arm I: Patients receive bevacizumab IV over 30-90 minutes on days 1, 15, 29, and 43. Patients also receive oral thalidomide once daily. - Arm II: Patients receive bevacizumab as in arm I. Patients who have received prior treatment with thalidomide receive bevacizumab as in arm I. Courses repeat every 56 days in the absence of disease progression or unacceptable toxicity. Patients are followed monthly for 3 months and then every 3-4 months for 3 years. PROJECTED ACCRUAL: A total of 55-103 patients (16-32 who have received prior thalidomide, 16-32 in arm I, and 23-39 in arm II) will be accrued for this study within 2.5 years.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: - Histologically confirmed progressing multiple myeloma - Stages I, II, or III - More than 25% increase in urine or plasma paraprotein levels - More than 5% malignant plasma cell involvement in bone marrow - Smoldering myeloma is eligible provided there is evidence of progressive disease requiring therapy - At least 25% increase in M protein levels or Bence Jones excretion - Hemoglobin no greater than 10.5 g/dL - Frequent infections - Hypercalcemia - Rise in serum creatinine above normal on 2 separate occasions - Nonsecretory multiple myeloma that is bidimensionally measurable by MRI or CT scan is eligible provided the disease site is new or has shown an increase in M protein levels or Bence Jones excretion is greater than 30% from baseline - No prior or concurrent CNS involvement with primary or metastatic tumor - No nonquantifiable monoclonal proteins or IgM peaks unless there is evidence of bidimensionally measurable disease by MRI or CT scan - No history of hemorrhagic tumor or hemorrhagic metastasis PATIENT CHARACTERISTICS: Age: - 18 and over Performance status: - Karnofsky 70-100% Life expectancy: - At least 3 months Hematopoietic: - See Disease Characteristics - Absolute neutrophil count 1,000/mm^3 - Platelet count 50,000/mm^3 - No hemorrhagic illness within the past 3 weeks Hepatic: - Bilirubin 1.5 mg/dL - SGOT/SGPT 2.5 times upper limit of normal (ULN) - INR 1.5 - aPTT < 1.5 times ULN Renal: - See Disease Characteristics - Creatinine 2 mg/dL - Creatinine clearance 40 mL/min - Calcium 12 mg/dL - No nephrotic syndrome Cardiovascular: - No active coronary artery disease - No New York Heart Association class II-IV congestive heart failure - No grade II or greater peripheral vascular disease (i.e, ischemic rest pain, non-healing ulcer, or tissue loss) - No uncontrolled hypertension - No history of deep venous thrombosis - No vascular illness within the past 3 weeks Pulmonary: - No history of pulmonary embolus Other: - No other prior malignancy unless the patient has been in complete remission for at least 2 years - No grade 2 or greater peripheral neuropathy or CNS abnormalities - No seizure disorder - No serious non-healing wound, ulcer, or bone fracture - No trauma within the past 3 weeks - No significant inflammatory illness within the past 3 weeks - No known hypersensitivity to Chinese hamster ovary cell products - No known hypersensitivity to other recombinant human or humanized antibodies and/or positive human antimurine antibodies/human antichimeric antibodies - No other significant medical, psychological, or social problem that would preclude study participation - Not pregnant or nursing - Negative pregnancy test - Fertile patients must use effective contraception for at least 2 weeks before and during study participation PRIOR CONCURRENT THERAPY: Biologic therapy: - See Chemotherapy - Prior nonmyeloablative transplantation allowed provided the following are true: - Patient is not receiving concurrent immunosuppressive therapy - Patient has no signs of graft-versus-host disease - Concurrent epoetin alfa allowed if started at least 4 weeks prior to study entry Chemotherapy: - No more than 5 prior chemotherapy regimens - Thalidomide, steroids, and interferon are not considered part of prior regimens - Mobilization with chemotherapy followed by either single or tandem autologous transplantation is counted as 1 prior regimen - Mobilization with chemotherapy followed by autologous and subsequent nonmyeloablative HLA-matched sibling allogeneic transplantation is counted as 1 prior regimen - At least 3 weeks since prior chemotherapy - No concurrent chemotherapy Endocrine therapy: - See Chemotherapy - At least 2 weeks since prior steroids - No concurrent steroids Radiotherapy: - At least 3 weeks since prior radiotherapy - No concurrent radiotherapy Surgery: - At least 3 weeks since prior surgery, including biopsy of a visceral organ Other: - At least 10 days since prior anticoagulants, including aspirin - At least 2 days since prior nonsteroidal anti-inflammatory agents - Concurrent bisphosphonates allowed
Total Enrollment:
Location and Contact Information:
Overall Study Official:
GeorgeSomlo, Study Chair, Beckman Research Institute
University of California Davis Cancer Center *Recruiting*
Sacramento, California, 95817
United States
Recruiting Joseph Tuscano 916-734-3771
University of Chicago Cancer Research Center *Recruiting*
Chicago, Illinois, 60637-1470
United States
Recruiting Todd Zimmerman 773-702-4159
City of Hope Comprehensive Cancer Center *Recruiting*
Duarte, California, 91010-3000
United States
Recruiting George Somlo 626-359-8111
USC/Norris Comprehensive Cancer Center and Hospital *Recruiting*
Los Angeles, California, 90089
United States
Recruiting Ann Mohrbacher 323-865-3924
Additional Information:
Study ID Numbers: CDR0000068834; CCC-PHII-30,CHNMC-PHII-30,NCI-2712,CHNMC-IRB-01006
Study Start Date:
Record last reviewed: December 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00022607
Other Stage 3 Multiple Myeloma Studies:
1. Antineoplaston Therapy in Treating Patients With Multiple Myeloma
2. Antibiotic Therapy in Preventing Early Infection in Patients With Multiple Myeloma Who Are Receiving Chemotherapy
3. Phase II Study of R115777 in Patients With Relapsed or Refractory Multiple Myeloma
4. R115777 in Treating Patients With Relapsed or Refractory Multiple Myeloma
5. High-Dose Melphalan Followed by Peripheral Stem Cell Transplantation in Treating Patients With Amyloidosis
Related Studies:
Other stage 3 multiple myeloma Clinical Trials
Other California Clinical Trials
Other Los Angeles Clinical Trials
Bevacizumab With or Without Thalidomide in Treating Patients With Relapsed or Refractory Multiple Myeloma
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