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Multiple Myeloma and Plasma Cell NeoplasmPhase 2NCT00482495

Bevacizumab in Treating Patients With Relapsed or Refractory Multiple Myeloma

A Phase 2 study testing bevacizumab, gene expression analysis and protein expression analysis in people with Multiple Myeloma and Plasma Cell Neoplasm, run by Mayo Clinic at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
bevacizumab, gene expression analysis and protein expression analysis
How many people
42 participants
Where
1 siteUnited States
Study dates
Apr 2006to Nov 2009
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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

Trial locations and contacts

1 site in 1 country.

United States1 site
  • Mayo Clinic

    Rochester, Minnesota, 55940

Other trials in United States

About this study

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

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.

Being tested
bevacizumab, gene expression analysis, protein expression analysis, laboratory biomarker analysis
Keywords
refractory multiple myeloma, stage I multiple myeloma, stage II multiple myeloma, stage III multiple myeloma
Medical subject headings
Multiple Myeloma, Neoplasms, Plasma Cell

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Confirmed hematologic response

  2. Progression-free survival at 1 year

Secondary outcomes (4)
  1. Toxicity as measured by NCI CTCAE v3.0

  2. Time to progression

  3. Duration of response

  4. Survival

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Jun 2007 (estimated)
  2. Study startApr 2006
  3. Primary completionDec 2006
  4. Study completionNov 2009

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Masking
None (open label)
Enrolment
42 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00482495
Sponsor's protocol ID
CDR0000546757
Other IDs
P30CA015083, MC0584, 05-004261
Status last verified
May 2011
First submitted
4 Jun 2007
Last updated
11 May 2011
Results posted
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing bevacizumab, gene expression analysis and protein expression analysis in people with Multiple Myeloma and Plasma Cell Neoplasm, run by Mayo Clinic at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 11 May 2011. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Confirmed hematologic response. The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 May 2011; AzTrials last refreshed its copy on 6 Nov 2026.

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