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

Primary Purpose

Multiple Myeloma

Status
Terminated
Phase
Phase 2
Locations
Austria
Study Type
Interventional
Intervention
Bevacizumab
Sponsored by
Hoffmann-La Roche
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Multiple Myeloma

Eligibility Criteria

19 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Bevacizumab 5 mg/kg

Arm Description

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
Overall Survival
Overall survival was defined as the time from the first dose of study medication until death.

Full Information

First Posted
March 4, 2014
Last Updated
June 6, 2014
Sponsor
Hoffmann-La Roche
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1. Study Identification

Unique Protocol Identification Number
NCT02079519
Brief Title
A Study of Avastin (Bevacizumab) in Patients With Multiple Myeloma
Official Title
Bevacizumab as Treatment for Patients With Relapsed/Refractory Multiple Myeloma
Study Type
Interventional

2. Study Status

Record Verification Date
June 2014
Overall Recruitment Status
Terminated
Why Stopped
The study was discontinued prematurely by the sponsor due to a lack of recruitment.
Study Start Date
May 2006 (undefined)
Primary Completion Date
May 2008 (Actual)
Study Completion Date
May 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hoffmann-La Roche

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multiple Myeloma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Bevacizumab 5 mg/kg
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Bevacizumab
Other Intervention Name(s)
Avastin, RO 487-6646
Intervention Description
Bevacizumab was provided as a concentrate in vials.
Primary Outcome Measure Information:
Title
Percentage of Participants With a Complete Response or a Partial Response
Description
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.
Time Frame
Baseline to the end of the study (up to 1 year)
Secondary Outcome Measure Information:
Title
Progression-free Survival
Description
Progression-free survival was defined as the time from the first dose of study drug to disease progression or death due to progression.
Time Frame
Baseline to the end of the study (up to 1 year)
Title
Overall Survival
Description
Overall survival was defined as the time from the first dose of study medication until death.
Time Frame
Baseline to the end of the study (up to 1 year)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clinical Trials
Organizational Affiliation
Hoffmann-La Roche
Official's Role
Study Chair
Facility Information:
City
Salzburg
ZIP/Postal Code
5020
Country
Austria
City
Wien
ZIP/Postal Code
1090
Country
Austria
City
Wien
ZIP/Postal Code
1140
Country
Austria
City
Wien
ZIP/Postal Code
1160
Country
Austria

12. IPD Sharing Statement

Learn more about this trial

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

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