Bevacizumab in Treating Patients With Relapsed or Refractory Multiple Myeloma

Phase 2

Completed

• Conditions: Multiple Myeloma and Plasma Cell Neoplasm

• Registration Number: NCT00482495
• Lead Sponsor: Mayo Clinic

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.

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.

Study Timeline

• Study Start: 2006-04
• Primary Completion: 2006-12
• Study First Submitted: 2007-06-04
• Study First Submitted QC: 2007-06-04
• Study First Posted: 2007-06-05
• Study Completion: 2009-11
• Status Verified: 2011-05
• Last Update Submitted: 2011-05-10
• Last Update Posted: 2011-05-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 42

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Confirmed hematologic response
Progression-free survival at 1 year

Secondary Outcome Measures

Name	Time	Method
Toxicity as measured by NCI CTCAE v3.0
Time to progression
Duration of response
Survival

Trial Locations

Locations (1)

Mayo Clinic; 🇺🇸 Rochester, Minnesota, United States