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

Phase 2

Terminated

• Conditions: Multiple Myeloma
• Interventions: Drug: Bevacizumab

• Registration Number: NCT02079519
• Lead Sponsor: Hoffmann-La Roche

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2006-05
• Primary Completion: 2008-05
• Study Completion: 2008-05
• Study First Submitted: 2014-03-04
• Study First Submitted QC: 2014-03-04
• Study First Posted: 2014-03-05
• Status Verified: 2014-06
• Results First Submitted: 2014-06-06
• Results First Submitted QC: 2014-06-06
• Last Update Submitted: 2014-06-06
• Results First Posted: 2014-07-08
• Last Update Posted: 2014-07-08

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 10

Inclusion Criteria

• Adult patients, 19-75 years of age
• Multiple myeloma.
• Progressive disease after at least 2 lines of prior therapy.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Bevacizumab 5 mg/kg	Bevacizumab	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.

Primary Outcome Measures

Name	Time	Method
Percentage of Participants With a Complete Response or a Partial Response	Baseline to the end of the study (up to 1 year)	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.

Secondary Outcome Measures

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