Trial Outcomes & Findings for Hemostatic Effects of VELCADE®* Treatment in Multiple Myeloma Patients (NCT NCT01720043)
NCT ID: NCT01720043
Last Updated: 2017-09-05
Results Overview
Effect of VELCADE at 1.0-1.3 mg/m2 dose on platelet aggregation at 24 and 48 hour post-infusion in patients with multiple myeloma. The following components of platelet aggregation were evaluated at varying levels: Collagen, Adenine di-Phosphate (ADP), Arachidonic acid, and Ristocetin.
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
8 participants
Primary outcome timeframe
48 hours
Results posted on
2017-09-05
Participant Flow
Participant milestones
| Measure |
All Participants
Velcade: Single dose of Velcade (1.0-1.3 mg/m2 dose)
|
|---|---|
|
Overall Study
STARTED
|
8
|
|
Overall Study
COMPLETED
|
7
|
|
Overall Study
NOT COMPLETED
|
1
|
Reasons for withdrawal
| Measure |
All Participants
Velcade: Single dose of Velcade (1.0-1.3 mg/m2 dose)
|
|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
Baseline Characteristics
Hemostatic Effects of VELCADE®* Treatment in Multiple Myeloma Patients
Baseline characteristics by cohort
| Measure |
All Participants
n=8 Participants
All participants enrolled
Velcade: Single dose of Velcade (1.0-1.3 mg/m2 dose)
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
7 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
1 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
8 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
8 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 48 hoursPopulation: One patient withdrew before receiving the 24 hour dose, leaving 7 patients evaluable for response.
Effect of VELCADE at 1.0-1.3 mg/m2 dose on platelet aggregation at 24 and 48 hour post-infusion in patients with multiple myeloma. The following components of platelet aggregation were evaluated at varying levels: Collagen, Adenine di-Phosphate (ADP), Arachidonic acid, and Ristocetin.
Outcome measures
| Measure |
All Participants
n=7 Participants
All participants enrolled
Velcade: Single dose of Velcade (1.0-1.3 mg/m2 dose)
|
|---|---|
|
Efficacy of Velcade
Collagen 2.g.ml, 24 hrs
|
-4.429 percentage
Standard Deviation 7.390
|
|
Efficacy of Velcade
ADP.10.M, 24 hrs
|
-4.571 percentage
Standard Deviation 6.949
|
|
Efficacy of Velcade
ADP.3.M, 48 hrs
|
1.571 percentage
Standard Deviation 13.587
|
|
Efficacy of Velcade
Arach.Acid.0.5.mg.mL, 48 hrs
|
-2.286 percentage
Standard Deviation 11.368
|
|
Efficacy of Velcade
Ristocetin.1.5.mg.mL, 48 hrs
|
.0143 percentage
Standard Deviation 9.353
|
|
Efficacy of Velcade
Collagen 5.g.ml, 24 hrs
|
-4.143 percentage
Standard Deviation 7.244
|
|
Efficacy of Velcade
ADP.5.M, 24 hrs
|
-6.429 percentage
Standard Deviation 7.591
|
|
Efficacy of Velcade
ADP.3.M, 24 hrs
|
-7.571 percentage
Standard Deviation 16.400
|
|
Efficacy of Velcade
Arach.Acid.0.5.mg.ml, 24 hrs
|
-11.143 percentage
Standard Deviation 15.507
|
|
Efficacy of Velcade
Ristocetin1.5.mg.ml, 24 hrs
|
-1.429 percentage
Standard Deviation 7.345
|
|
Efficacy of Velcade
Ristocetin.0.5.mg.ml, 24 hrs
|
-2.429 percentage
Standard Deviation 6.803
|
|
Efficacy of Velcade
Collagen.5.g.mL, 48 hrs
|
-2.429 percentage
Standard Deviation 10.130
|
|
Efficacy of Velcade
Collagen.2.g.mL, 48 hrs
|
-0.857 percentage
Standard Deviation 10.605
|
|
Efficacy of Velcade
ADP.10.M, 48 hrs
|
-3.429 percentage
Standard Deviation 7.044
|
|
Efficacy of Velcade
ADP.5.M, 48 hrs
|
-3.571 percentage
Standard Deviation 10.845
|
|
Efficacy of Velcade
Ristocetin.0.5.mg.mL, 48 hrs
|
-2.000 percentage
Standard Deviation 4.041
|
Adverse Events
All Participants
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
All Participants
n=8 participants at risk
All participants enrolled
Velcade: Single dose of Velcade (1.0-1.3 mg/m2 dose)
|
|---|---|
|
General disorders
Pain
|
12.5%
1/8 • Number of events 1
|
|
Vascular disorders
DVT
|
12.5%
1/8 • Number of events 1
|
|
General disorders
Fatigue
|
12.5%
1/8 • Number of events 1
|
|
Psychiatric disorders
Insomnia
|
12.5%
1/8 • Number of events 1
|
|
Nervous system disorders
Neuropathy
|
12.5%
1/8 • Number of events 1
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place