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

Study Overview
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Brief Summary
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This study evaluated the efficacy and safety of Avastin (bevacizumab, 5 mg/kg intravenously every 2 weeks) in patients with multiple myeloma, relapsed/refractory after at least 2 lines of prior therapy.

Official Title
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Bevacizumab as Treatment for Patients With Relapsed/Refractory Multiple Myeloma

Conditions
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Multiple Myeloma

Intervention / Treatment
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* Drug: Bevacizumab


Participation Criteria
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Eligibility Criteria
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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. Clinically significant cardiac disease.

Ages Eligible for Study
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Minimum Age: 19 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Bevacizumab 5 mg/kg<br>Participants received bevacizumab 5 mg/kg intravenously every 2 weeks for 6 months until disease progression or termination of the study. Participants showing a continuous benefit of therapy could receive treatment for a maximum of 12 months. | Drug: Bevacizumab<br>* Bevacizumab was provided as a concentrate in vials.<br>* Other names: RO 487-6646;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Participants With a Complete Response or a Partial Response | A complete response was defined as the disappearance of the original monoclonal protein from the blood and urine on at least 2 determinations 6 weeks apart; < 5% plasma cells in the bone marrow on at least 2 determinations 6 weeks apart; if a skeletal survey is available, no increase in the size or number of lytic bone lesions; and the disappearance of soft tissue plasmacytomas for at least 6 weeks. A partial response was defined as a ≥ 50% reduction of monoclonal protein in the blood on at least 2 determinations 6 weeks apart; if present, reduction in 24-hour urinary light chain excretion by either ≥ 90% or to < 200 mg for at least 2 determinations 6 weeks apart; ≥ 50% reduction in the size of tissue plasmacytomas for at least 6 weeks; and if a skeletal survey is available, no increase in the size or number of lytic bone lesions. | Baseline to the end of the study (up to 1 year) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progression-free Survival | Progression-free survival was defined as the time from the first dose of study drug to disease progression or death due to progression. | Baseline to the end of the study (up to 1 year) | 
| Overall Survival | Overall survival was defined as the time from the first dose of study medication until death. | Baseline to the end of the study (up to 1 year) |