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

NCT02079519 | Terminated Phase 2 Results

• 1 other identifier: ML18704
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 4

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.

Conditions

Multiple Myeloma

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Progression-free Survival

  Baseline to the end of the study (up to 1 year)

• Overall Survival

  Baseline to the end of the study (up to 1 year)

Study Arms (1)

Bevacizumab 5 mg/kg

EXPERIMENTAL

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

Interventions

Bevacizumab DRUG

Bevacizumab was provided as a concentrate in vials.

Also known as: Avastin, RO 487-6646

Bevacizumab 5 mg/kg

Eligibility Criteria

• Age: 19 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hoffmann-La Roche: lead

Study Sites (4)

Unknown Facility

Salzburg, 5020, Austria

Location

Unknown Facility

Vienna, 1090, Austria

Location

Unknown Facility

Vienna, 1140, Austria

Location

Unknown Facility

Vienna, 1160, Austria

Location

MeSH Terms

Conditions

Multiple Myeloma

Interventions

Bevacizumab

Condition Hierarchy (Ancestors)

Neoplasms, Plasma Cell; Neoplasms by Histologic Type; Neoplasms; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Paraproteinemias; Blood Protein Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemorrhagic Disorders; Lymphoproliferative Disorders; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Results Point of Contact

• Title: Medical Communications
• Organization: Hoffmann-La Roche

800 821-8590

Study Officials

• Clinical Trials

  Hoffmann-La Roche

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 4, 2014
• First Posted: March 5, 2014
• Study Start: May 1, 2006
• Primary Completion: May 1, 2008
• Study Completion: May 1, 2008
• Last Updated: July 8, 2014
• Results First Posted: July 8, 2014

Record last verified: 2014-06

Locations

AU (4)