Trial Outcomes & Findings for Preemptive Strike With Bortezomib in Multiple Myeloma Patients (NCT NCT00657553)

Results Overview

The number of patients on Bortezomib that have maintained event-free survival, compared to the patients on observation was not analyzed due to low attrition rates. Event-free survival is a measure of the proportion of people who remain free of a particular complication of disease (called an event) after treatment that is designed to prevent or delay that particular complication.

Recruitment status

TERMINATED

Study phase

PHASE3

Target enrollment

10 participants

Primary outcome timeframe

three years

Results posted on

2017-11-20

Participant Flow

Participant milestones

Participant milestones
Measure	Treatment Arm Bortezomib will be administered as 12 monthly courses of 1.0 mg/m2 on days 1, 4, 8, and 11 and repeated every 28 days, followed by cycles administered every other month in year 2, and then every 3 months in year 3	Observation Arm Patients will be observed for progress over the course of three years.
Overall Study STARTED	5	5
Overall Study COMPLETED	0	0
Overall Study NOT COMPLETED	5	5

Reasons for withdrawal

Reasons for withdrawal
Measure	Treatment Arm Bortezomib will be administered as 12 monthly courses of 1.0 mg/m2 on days 1, 4, 8, and 11 and repeated every 28 days, followed by cycles administered every other month in year 2, and then every 3 months in year 3	Observation Arm Patients will be observed for progress over the course of three years.
Overall Study low accrual, no analysis run	5	5

Baseline Characteristics

Preemptive Strike With Bortezomib in Multiple Myeloma Patients

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Treatment Arm n=5 Participants Bortezomib will be administered as 12 monthly courses of 1.0 mg/m2 on days 1, 4, 8, and 11 and repeated every 28 days, followed by cycles administered every other month in year 2, and then every 3 months in year 3	Observation Arm n=5 Participants Patients will be observed for progress over the course of three years.	Total n=10 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	2 Participants n=5 Participants	2 Participants n=7 Participants	4 Participants n=5 Participants
Age, Categorical >=65 years	3 Participants n=5 Participants	3 Participants n=7 Participants	6 Participants n=5 Participants
Age, Continuous	61.6 years STANDARD_DEVIATION 7.89 • n=5 Participants	64.4 years STANDARD_DEVIATION 7 • n=7 Participants	63 years STANDARD_DEVIATION 7.3 • n=5 Participants
Sex: Female, Male Female	2 Participants n=5 Participants	3 Participants n=7 Participants	5 Participants n=5 Participants
Sex: Female, Male Male	3 Participants n=5 Participants	2 Participants n=7 Participants	5 Participants n=5 Participants

PRIMARY outcome

Timeframe: three years

The number of patients on Bortezomib that have maintained event-free survival, compared to the patients on observation was not analyzed due to low attrition rates. Event-free survival is a measure of the proportion of people who remain free of a particular complication of disease (called an event) after treatment that is designed to prevent or delay that particular complication.

Outcome measures

Outcome data not reported

Adverse Events

Treatment Arm

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Observation Arm

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Nathan M. Petty

University of Arkansas for Medical Sciences, Myeloma Institute

Phone: 501-569-6990

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place