Trial Information

Summary: A Study of Avastin (Bevacizumab) in Patients With Multiple Myeloma

Status: Recruiting

Protocol Number: ML18704

Sponsor: Roche PA

Company Division: Pharmaceutical

Official Scientific Title: An open-label study of the effect of Avastin on overall response in patients with relapsed/refractory multiple myeloma

Brief Summary: This study will evaluate the efficacy and safety of Avastin (5mg/kg iv, every 2 weeks) in patients with multiple myeloma, relapsed/refractory after at least 2 lines of prior therapy. The anticipated time on study treatment is 3 months-1 year, and the target sample size is <100 individuals. Target sample size is 18.

Study Phase: II

Study Design / Study Details:

• Purpose: Treatment
• Allocation: Non-Randomized
• Masking: Open Label
• Control: Uncontrolled
• Assignment: Single Group
• Endpoints: Safety/Efficacy

Study Type:

Condition: Multiple Myeloma

Intervention Type: Drug

Intervention Name: bevacizumab[Avastin]

Primary Outcome: 1. Overall response (complete and partial response)

Key Secondary Outcomes: 1. Efficacy: progression free and overall survival. Safety: SAEs, and specific AEs (gastrointestinal perforation, wound healing complications, bleeding, hypertension, proteinuria); laboratory parameter.

Inclusion Criteria:

Exclusion Criteria:

Gender: Males or Females

Age Limits: Min: 19 years of age Years Max: 75 years of age Years

Accepts Healthy Volunteers: No

Anticipated Start Date: May, 2006

Trial Registration Date: 03/10/2006

Date Last Updated: 09/19/2008

Link To Trial Results

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Trial listings updated: October 6, 2008 at 2:48:28 PM