Bevacizumab With or Without Thalidomide in Treating Patients With Relapsed or Refractory Multiple Myeloma

NCT00022607 | Completed Phase 2

• 5 other identifiers: CDR0000068834CCC-PHII-30CHNMC-PHII-30CHNMC-IRB-01006NCI-2712
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 4

Brief Summary

RATIONALE: 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 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 whether bevacizumab works better with or without thalidomide for multiple myeloma. PURPOSE: This randomized phase II trial is to see if bevacizumab works better with or without thalidomide in treating patients who have relapsed or refractory multiple myeloma.

Conditions

Multiple Myeloma and Plasma Cell Neoplasm

Keywords

refractory multiple myeloma; stage I multiple myeloma; stage II multiple myeloma; stage III multiple myeloma

Interventions

bevacizumab BIOLOGICAL

thalidomide DRUG

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• California Cancer Consortium: lead
• National Cancer Institute (NCI): collaborator

Study Sites (4)

City of Hope Comprehensive Cancer Center

Duarte, California, 91010-3000, United States

Location

USC/Norris Comprehensive Cancer Center and Hospital

Los Angeles, California, 90089, United States

Location

University of California Davis Cancer Center

Sacramento, California, 95817, United States

Location

University of Chicago Cancer Research Center

Chicago, Illinois, 60637-1470, United States

Location

MeSH Terms

Conditions

Multiple Myeloma; Neoplasms, Plasma Cell

Interventions

Bevacizumab; Thalidomide

Condition Hierarchy (Ancestors)

Neoplasms by Histologic Type; Neoplasms; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Paraproteinemias; Blood Protein Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemorrhagic Disorders; Lymphoproliferative Disorders; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Phthalimides; Phthalic Acids; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Piperidones; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Isoindoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Purpose: TREATMENT
• Sponsor Type: NETWORK

Study Record Dates

• First Submitted: August 10, 2001
• First Posted: January 27, 2003
• Study Start: January 1, 2002
• Study Completion: May 1, 2006
• Last Updated: June 24, 2013

Record last verified: 2004-10

Locations

US (4)