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A Phase II Trial of Bevacizumab in Patients With Relapsed or Refractory Multiple Myeloma

Phase 2
18 Years
Not Enrolling
Multiple Myeloma and Plasma Cell Neoplasm

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Trial Information

A Phase II Trial of Bevacizumab in Patients With Relapsed or Refractory Multiple Myeloma



- 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.


- 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.

Inclusion Criteria


- 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


- 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


- 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

Type of Study:


Study Design:

Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Confirmed hematologic response

Safety Issue:


Principal Investigator

Suzanne Hayman, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Mayo Clinic


United States: Food and Drug Administration

Study ID:




Start Date:

April 2006

Completion Date:

November 2009

Related Keywords:

  • Multiple Myeloma and Plasma Cell Neoplasm
  • refractory multiple myeloma
  • stage I multiple myeloma
  • stage II multiple myeloma
  • stage III multiple myeloma
  • Neoplasms
  • Multiple Myeloma
  • Neoplasms, Plasma Cell
  • Plasmacytoma



Mayo ClinicRochester, Minnesota  55905