Multiple Myeloma
Conditions
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.
Interventions
DRUGBevacizumab
Bevacizumab was provided as a concentrate in vials.
Sponsors
Hoffmann-La Roche
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
19 Years to 75 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
Austria
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Bevacizumab 5 mg/kg 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. | 10 |
| Total | 10 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event | 1 |
| Overall Study | Disease Progression | 9 |
Baseline characteristics
| Characteristic | Bevacizumab 5 mg/kg |
|---|---|
| Age, Continuous | 68.6 years STANDARD_DEVIATION 9.9 |
| Sex: Female, Male Female | 7 Participants |
| Sex: Female, Male Male | 3 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 10 |
| serious Total, serious adverse events | 5 / 10 |
Outcome results
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.
Time frame: Baseline to the end of the study (up to 1 year)
Population: Intent-to-treat population: All participants who received at least 1 dose of study drug.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Bevacizumab 5 mg/kg | Percentage of Participants With a Complete Response or a Partial Response | 0.0 Percentage of participants |
Secondary
Overall Survival
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)
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.
Time frame: Baseline to the end of the study (up to 1 year)