Trial Outcomes & Findings for A Study of Avastin (Bevacizumab) in Patients With Multiple Myeloma (NCT NCT02079519)

NCT ID: NCT02079519

Last Updated: 2014-07-08

Results Overview

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.

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

10 participants

Primary outcome timeframe

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

Results posted on

2014-07-08

Participant Flow

Participant milestones

Participant milestones
Measure	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.
Overall Study STARTED	10
Overall Study COMPLETED	0
Overall Study NOT COMPLETED	10

Reasons for withdrawal

Reasons for withdrawal
Measure	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.
Overall Study Disease Progression	9
Overall Study Adverse Event	1

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Bevacizumab 5 mg/kg n=10 Participants 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.
Age, Continuous	68.6 years STANDARD_DEVIATION 9.9 • n=5 Participants
Sex: Female, Male Female	7 Participants n=5 Participants
Sex: Female, Male Male	3 Participants n=5 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Bevacizumab 5 mg/kg n=10 Participants 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.
Percentage of Participants With a Complete Response or a Partial Response	0.0 Percentage of participants

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome data not reported

Adverse Events

Bevacizumab 5 mg/kg

Serious events: 5 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Bevacizumab 5 mg/kg n=10 participants at risk 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.
General disorders General physical health deterioration	20.0% 2/10 Intent-to-treat population: All participants who received at least 1 dose of study drug.
General disorders Pyrexia	10.0% 1/10 Intent-to-treat population: All participants who received at least 1 dose of study drug.
Metabolism and nutrition disorders Hypercalcaemia	10.0% 1/10 Intent-to-treat population: All participants who received at least 1 dose of study drug.
Metabolism and nutrition disorders Hyperglycaemia	10.0% 1/10 Intent-to-treat population: All participants who received at least 1 dose of study drug.
Vascular disorders Haemorrhage	10.0% 1/10 Intent-to-treat population: All participants who received at least 1 dose of study drug.
Vascular disorders Hypertension	10.0% 1/10 Intent-to-treat population: All participants who received at least 1 dose of study drug.
Blood and lymphatic system disorders Febrile neutropenia	10.0% 1/10 Intent-to-treat population: All participants who received at least 1 dose of study drug.
Blood and lymphatic system disorders Thrombocytopenia	10.0% 1/10 Intent-to-treat population: All participants who received at least 1 dose of study drug.
Injury, poisoning and procedural complications Humerus fracture	10.0% 1/10 Intent-to-treat population: All participants who received at least 1 dose of study drug.
Nervous system disorders Headache	10.0% 1/10 Intent-to-treat population: All participants who received at least 1 dose of study drug.

Other adverse events

Adverse event data not reported

Additional Information

Medical Communications

Hoffmann-La Roche

Phone: 800 821-8590

Results disclosure agreements

Principal investigator is a sponsor employee The Study being conducted under this Agreement is part of the Overall Study. Investigator is free to publish in reputable journals or to present at professional conferences the results of the Study, but only after the first publication or presentation that involves the Overall Study. The Sponsor may request that Confidential Information be deleted and/or the publication be postponed in order to protect the Sponsor's intellectual property rights.
Publication restrictions are in place

Restriction type: OTHER