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CompletedNCT00482495Updated May 11, 2011

Bevacizumab in Treating Patients With Relapsed or Refractory Multiple Myeloma

A Phase 2 interventional study of bevacizumab and gene expression analysis in Multiple Myeloma and Plasma Cell Neoplasm, sponsored by Mayo Clinic. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2011-05-11.

Sponsored by Mayo Clinic · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
42
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Multiple Myeloma and Plasma Cell Neoplasm

Keywords

  • refractory multiple myeloma
  • stage I multiple myeloma
  • stage II multiple myeloma
  • stage III multiple myeloma
03

In context

Multiple Myeloma

3,632 studies on the registry are indexed under Multiple Myeloma; 745 are open to participants now.

This study's planned enrollment of 42 is close to the median of 41 across 2,907 interventional studies indexed under Multiple Myeloma.

Browse Multiple Myeloma studies →

Lead sponsor

Mayo Clinic is the lead sponsor of 3,218 studies on the registry; 670 are open to participants now.

Of its 445 completed or terminated interventional studies of FDA-regulated products, 313 (70%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Eligibility 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
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Masking
None (open label)
Enrollment
42 participants (estimated)

Interventions

  • Biologicalbevacizumab
  • Geneticgene expression analysis
  • Geneticprotein expression analysis
  • Otherlaboratory biomarker analysis
06

What researchers measure

Primary outcomes

  1. Confirmed hematologic response

  2. Progression-free survival at 1 year

Secondary outcomes

  1. Toxicity as measured by NCI CTCAE v3.0

  2. Time to progression

  3. Duration of response

  4. Survival

07

Study locations

1 site
  • Mayo Clinic
    Rochester, Minnesota 55940, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 11, 2011, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00482495
Lead sponsor
Mayo Clinic
Collaborators
National Cancer Institute (NCI)
First posted
Jun 5, 2007
Start date
Apr 2006
Primary completion
Dec 2006
Completion
Nov 2009
Last update
May 11, 2011

Study contacts

Suzanne Hayman, MD
study chair · Mayo Clinic
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in May 2011. You cannot join it, but the record below documents what was studied.

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