NCT02079519 · REGISTRY CONDITION SEARCH

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

Found through the registry condition index, not selected as a treatment recommendation. This discovery collection was restricted to studies with posted results.

Phase: PHASE2
Status at capture: TERMINATED
Registry last update: 2014-07-08

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.

Open the original ClinicalTrials.gov record → · Download preserved record

What did the study report?

Outcomes, safety and baseline populations are separate source sections. Quality-of-life measures appear under their original outcome titles.

flow

Participant flow

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baseline

Baseline characteristics

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outcome · POSTED

Percentage of Participants With a Complete Response or a Partial Response

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outcome · NOT POSTED

Progression-free Survival

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outcome · NOT POSTED

Overall Survival

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adverse events

Adverse events

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more info

Limitations, agreements, and source contact

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Who could take part

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.
healthy Volunteers: false
maximum Age: 75 Years
minimum Age: 19 Years
sex: ALL
std Ages: ADULT
OLDER_ADULT

Treatment arms and interventions

arm Groups

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 Names
Drug: Bevacizumab
label
Bevacizumab 5 mg/kg
type
EXPERIMENTAL

interventions

arm Group Labels
Bevacizumab 5 mg/kg
description
Bevacizumab was provided as a concentrate in vials.
name
Bevacizumab
other Names
Avastin
RO 487-6646
type
DRUG

Study design

allocation

intervention Model

SINGLE_GROUP

masking Info

masking: NONE

primary Purpose

TREATMENT

Enrollment

count: 10
type: ACTUAL

Registered outcome plans (not posted results)

primary Outcomes

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.
measure
Percentage of Participants With a Complete Response or a Partial Response
time Frame
Baseline to the end of the study (up to 1 year)

secondary Outcomes

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

Full 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.

Source references

Source notices and limitations

Discovery and provenance

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ctgov-registry-1336d216cbd1bbff780dac70
edge id
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requested nct id
NCT02079519
primary nct id
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source kind
ctgov_condition_query
source url
https://clinicaltrials.gov/api/v2/studies?query.cond=Plasma+Cell+Neoplasms&filter.advanced=AREA%5BHasResults%5Dtrue&pageSize=1000&format=json&countTotal=true
source record id
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payload
clinical indication matching status
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end exclusive
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id
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link basis
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nct id
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occurrences
context exact
NCT02079519
end
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exact text
NCT02079519
start
0
offset unit
unicode_code_points
query cond
Plasma Cell Neoplasms
query disease state id
ds-plasma-cell-neoplasms
source file
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source file sha256
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source json pointer
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source kind
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source record id
Source null
source string basis
parsed_JSON_string_unmodified
source string sha256
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source url
https://clinicaltrials.gov/api/v2/studies?query.cond=Plasma+Cell+Neoplasms&filter.advanced=AREA%5BHasResults%5Dtrue&pageSize=1000&format=json&countTotal=true

Preserved source evidence · Not medical advice