Trial information
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 type: Interventional; Treatment; Non-Randomized; Open Label; Uncontrolled; Single Group; Safety/Efficacy study
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:
- adult patients, 19-75 years of age;
- multiple myeloma;
- progressive disease after at least 2 lines of prior therapy.
Exclusion criteria:
- non-secretory myeloma;
- history of malignancy, other than squamous cell cancer, basal cell cancer, or cancer in situ of the cervix within the last 5 years;
- major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to study treatment start;
- clincally significant cardiac diease.
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: 8/19/2008
Link to trial result
This trial is being conducted at the following locations:
Austria
