Bevacizumab in Treating Patients With Relapsed or Refractory Multiple Myeloma

NCT00482495 | Completed Phase 2

• 4 other identifiers: CDR0000546757P30CA015083MC058405-004261
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

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 carry cancer-killing substances to them. Bevacizumab may also stop the growth of multiple myeloma by blocking blood flow to the cancer. PURPOSE: This phase II trial is studying how well bevacizumab works in treating patients with 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

Outcome Measures

Primary Outcomes (2)

• Confirmed hematologic response

• Progression-free survival at 1 year

Secondary Outcomes (4)

• Toxicity as measured by NCI CTCAE v3.0

• Time to progression

• Duration of response

• Survival

Interventions

bevacizumab BIOLOGICAL

gene expression analysis GENETIC

protein expression analysis GENETIC

laboratory biomarker analysis OTHER

Eligibility Criteria

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

DISEASE CHARACTERISTICS: * Diagnosis of relapsed or refractory multiple myeloma * Measurable or evaluable disease as defined by ≥ 1 of the following: * Serum monoclonal protein ≥ 1.0 g by protein electrophoresis * Monoclonal protein ≥ 200 mg by 24-hour urine electrophoresis * Serum immunoglobulin free light chain ≥ 10 mg/dL AND abnormal serum immunoglobulin kappa to lambda free light chain ratio * Monoclonal bone marrow plasmacytosis ≥ 30% (evaluable disease) * No concurrent amyloidosis PATIENT CHARACTERISTICS: * ECOG performance status (PS) 0 or 1 * ECOG PS 2 based on immobility from myeloma bone disease alone allowed at the discretion of treating physician * Creatinine ≤ 2.0 mg/dL * ANC ≥ 1,000/mm³ * Platelet count ≥ 75,000/mm³ * Hemoglobin ≥ 8.0 g/dL * Proteinuria ≤ 1 g/dL by 24-hour urine collection (excluding monoclonal protein) * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception during and for 4 weeks after completion of study treatment * No bleeding diathesis * No hypertension (defined as BP \> 150/100 mm Hg) * No active bleeding, healing or nonhealing wound, ulcer, or bone fracture (excluding fractures secondary to myeloma) * No active ulcerative disease including, but not limited to, any of the following: * Peptic ulcer disease * Ulcerative esophagitis * Ulcerative colitis * Crohn's disease * LVEF ≥ 50% by 2-dimensional ECHO or MUGA scan * No NYHA class III or IV heart disease * No other active malignancy except for nonmelanoma skin cancer or in situ cervical or breast cancer * No active infection * No other comorbidity that would interfere with study compliance * No transient ischemic attack, cerebrovascular accident, or myocardial infarction within the past year * No abdominal fistula, gastrointestinal perforation, or intraabdominal abscess within the past 6 months * No significant traumatic injury within the past 28 days PRIOR CONCURRENT THERAPY: * See Disease Characteristics * No more than 2 prior antimyeloma treatment courses, except for bisphosphonates * No standard or experimental drug therapy, other than ongoing bisphosphonate treatment and/or epoetin alfa, within the past 28 days * No experimental non-drug therapy within the past 28 days * Palliative radiation therapy within the past 28 days allowed provided ≤ 3 sites of bone disease was irradiated * No prior bevacizumab or other experimental antiangiogenic agents other than thalidomide or lenalidomide * No minor surgical procedures, fine-needle aspiration, or core biopsies within the past 7 days * No major surgical procedure or open biopsy within the past 28 days * No concurrent corticosteroids * Chronic steroids ≤ 20 mg/day (prednisone equivalent) for disorders other than myeloma (i.e., adrenal insufficiency, rheumatoid arthritis) allowed * No other concurrent investigational therapy * No other concurrent systemic antineoplastic therapy including, but not limited to, the following: * Cytotoxic chemotherapy * Immunotherapy * Hormonal therapy * Monoclonal antibody therapy * Concurrent bisphosphonates allowed

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

Sponsors & Collaborators

• Mayo Clinic: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Mayo Clinic

Rochester, Minnesota, 55940, United States

Location

MeSH Terms

Conditions

Multiple Myeloma; Neoplasms, Plasma Cell

Interventions

Bevacizumab; Gene Expression Profiling

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; Genetic Techniques; Investigative Techniques

Study Officials

• Suzanne Hayman, MD

  Mayo Clinic

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Masking: NONE
• Purpose: TREATMENT
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: June 4, 2007
• First Posted: June 5, 2007
• Study Start: April 1, 2006
• Primary Completion: December 1, 2006
• Study Completion: November 1, 2009
• Last Updated: May 11, 2011

Record last verified: 2011-05

Locations

US (1)