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

Multiple Myeloma Clinical Trial

Official title:

Bevacizumab as Treatment for Patients With Relapsed/Refractory Multiple Myeloma

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02079519
• Other study ID #: ML18704
• Status: Terminated
• Phase: Phase 2
• First received: March 4, 2014
• Last updated: June 6, 2014
• Start date: May 2006
• Est. completion date: May 2008

Study information

• Verified date: June 2014
• Source: Hoffmann-La Roche
• Contact: n/a
• Is FDA regulated: No
• Health authority: Austria: Bundesamt für Sicherheit im Gesundheitswesen
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 10
• Est. completion date: May 2008
• Est. primary completion date: May 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 19 Years to 75 Years

Eligibility

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.

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Multiple Myeloma
• Neoplasms, Plasma Cell

Intervention

Drug:
• Bevacizumab
Bevacizumab was provided as a concentrate in vials.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Hoffmann-La Roche

Country where clinical trial is conducted

Austria, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	No
Secondary	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)	No
Secondary	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)	No