Bevacizumab in Treating Patients With Relapsed or Refractory Multiple Myeloma

This study has been completed.
Sponsor:
Collaborator:
Information provided by:
Mayo Clinic
ClinicalTrials.gov Identifier:
NCT00482495
First received: June 4, 2007
Last updated: May 10, 2011
Last verified: May 2011
  Purpose

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.


Condition Intervention Phase
Multiple Myeloma and Plasma Cell Neoplasm
Biological: bevacizumab
Genetic: gene expression analysis
Genetic: protein expression analysis
Other: laboratory biomarker analysis
Phase 2

Study Type: Interventional
Study Design: Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase II Trial of Bevacizumab in Patients With Relapsed or Refractory Multiple Myeloma

Resource links provided by NLM:


Further study details as provided by Mayo Clinic:

Primary Outcome Measures:
  • Confirmed hematologic response [ Designated as safety issue: No ]
  • Progression-free survival at 1 year [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Toxicity as measured by NCI CTCAE v3.0 [ Designated as safety issue: Yes ]
  • Time to progression [ Designated as safety issue: No ]
  • Duration of response [ Designated as safety issue: No ]
  • Survival [ Designated as safety issue: No ]

Estimated Enrollment: 42
Study Start Date: April 2006
Study Completion Date: November 2009
Primary Completion Date: December 2006 (Final data collection date for primary outcome measure)
Detailed Description:

OBJECTIVES:

Primary

  • Determine the hematologic response rate in patients with relapsed or refractory multiple myeloma treated with bevacizumab.
  • Determine the proportion of patients who are progression free and have not failed treatment after 1 year.

Secondary

  • Determine the toxicity of this drug in these patient.
  • Determine the time to disease progression in patients receiving this drug.
  • Determine the overall survival and survival at 1 year in patients receiving this drug.

OUTLINE: This is an open-label study.

Patients receive bevacizumab IV on day 1. Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity.

Blood samples are obtained for correlative studies at baseline, after course 2, and at 12 weeks. Samples are analyzed for interleukin-6, Flt-1, and VEGF levels.

After completion of study therapy, patients are followed every 3-6 months for up to 3 years.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00482495

Locations
United States, Minnesota
Mayo Clinic
Rochester, Minnesota, United States, 55940
Sponsors and Collaborators
Mayo Clinic
Investigators
Study Chair: Suzanne Hayman, MD Mayo Clinic
  More Information

Additional Information:
No publications provided

Responsible Party: Suzanne R. Hayman, M.D., Mayo Clinic
ClinicalTrials.gov Identifier: NCT00482495     History of Changes
Other Study ID Numbers: CDR0000546757, P30CA015083, MC0584, 05-004261
Study First Received: June 4, 2007
Last Updated: May 10, 2011
Health Authority: United States: Food and Drug Administration

Keywords provided by Mayo Clinic:
refractory multiple myeloma
stage I multiple myeloma
stage II multiple myeloma
stage III multiple myeloma

Additional relevant MeSH terms:
Multiple Myeloma
Neoplasms, Plasma Cell
Plasmacytoma
Blood Protein Disorders
Cardiovascular Diseases
Hematologic Diseases
Hemorrhagic Disorders
Hemostatic Disorders
Immune System Diseases
Immunoproliferative Disorders
Lymphoproliferative Disorders
Neoplasms
Neoplasms by Histologic Type
Paraproteinemias
Vascular Diseases
Bevacizumab
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Antineoplastic Agents
Growth Inhibitors
Growth Substances
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on October 23, 2014