Bevacizumab With or Without Thalidomide in Treating Patients With Relapsed or Refractory Multiple Myeloma

Multiple Myeloma and Plasma Cell Neoplasm Clinical Trial

Official title: Phase II Randomized Trial of Bevacizumab Versus Bevacizumab and Thalidomide for Relapsed/Refractory Multiple Myeloma

Status Completed

Clinical 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 deliver cancer-killing substances to them. Thalidomide may stop the growth of cancer cells by stopping blood flow to the tumor. It is not yet known whether bevacizumab works better with or without thalidomide for multiple myeloma.

PURPOSE: This randomized phase II trial is to see if bevacizumab works better with or without thalidomide in treating patients who have relapsed or refractory multiple myeloma.

Clinical Trial Description

OBJECTIVES:

• Compare the response rate and time to progression in patients with relapsed or refractory multiple myeloma treated with bevacizumab with or without thalidomide.

• Compare the toxicity of these regimens in these patients.

• Compare the effects of these regimens on histological and molecular biomarkers of angiogenesis, tumor invasion, and cell death in these patients.

• Correlate plasma and urine vascular endothelial growth factor and basic fibroblast growth factor levels and other potential markers of angiogenesis and myeloma cell proliferation with outcome in patients treated with these regimens.

• Determine the pharmacokinetics of thalidomide in these patients.

• Compare the effects of these regimens on the psychological/physical well being of these patients.

OUTLINE: This is a randomized, multicenter study. Patients are stratified according to prior treatment with thalidomide (yes vs no).

Patients who have received no prior treatment with thalidomide are randomized to 1 of 2 treatment arms.

• Arm I: Patients receive bevacizumab IV over 30-90 minutes on days 1, 15, 29, and 43. Patients also receive oral thalidomide once daily.

• Arm II: Patients receive bevacizumab as in arm I. Patients who have received prior treatment with thalidomide receive bevacizumab as in arm I.

Courses repeat every 56 days in the absence of disease progression or unacceptable toxicity.

Patients are followed monthly for 3 months and then every 3-4 months for 3 years.

PROJECTED ACCRUAL: A total of 55-103 patients (16-32 who have received prior thalidomide, 16-32 in arm I, and 23-39 in arm II) will be accrued for this study within 2.5 years. ;

Study Design

Allocation: Randomized, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Multiple Myeloma
• Multiple Myeloma and Plasma Cell Neoplasm
• Neoplasms, Plasma Cell
• Plasmacytoma

• NCT number: NCT00022607
• Study type: Interventional
• Source: National Cancer Institute (NCI)
• Status: Completed
• Phase: Phase 2
• Start date: January 2002
• Completion date: May 2006