Bevacizumab With or Without Thalidomide in Treating Patients With Relapsed or Refractory Multiple Myeloma
Multiple Myeloma and Plasma Cell Neoplasm
About this trial
This is an interventional treatment trial for Multiple Myeloma and Plasma Cell Neoplasm focused on measuring refractory multiple myeloma, stage I multiple myeloma, stage II multiple myeloma, stage III multiple myeloma
Eligibility 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 No arterial thromboembolic event within the past 6 months, including any of the following: Transient ischemic attack Cerebrovascular accident Unstable angina Myocardial infarction 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 peripheral neuropathy or CNS abnormalities ≥ grade 2 Patients with prior exposure to thalidomide and assigned to arm I may have grade 2 peripheral 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
Sites / Locations
- City of Hope Comprehensive Cancer Center
- USC/Norris Comprehensive Cancer Center and Hospital
- University of California Davis Cancer Center
- University of Chicago Cancer Research Center