Trial Outcomes & Findings for UARK 2006-15: A Study of Tandem Transplants With or Without Bortezomib and Thalidomide (NCT NCT00574080)
NCT ID: NCT00574080
Last Updated: 2017-11-20
Results Overview
Time from study registration until disease progression or death.
Recruitment status
TERMINATED
Study phase
PHASE3
Target enrollment
20 participants
Primary outcome timeframe
Up to 3 years 8 months
Results posted on
2017-11-20
Participant Flow
Participants are myeloma patients who have already received one or more treatment regimens and are seen at our facility
Participant milestones
| Measure |
VTD + DPACE/Melphalan
Velcade, thalidomide, and dexamethasone + Dexamethasone, CisPlatin, Adriamycin, Cyclophosphamide, and Etoposide \& Melphalan
|
DPACE/Melphalan
Dexamethasone, CisPlatin, Adriamycin, Cyclophosphamide, and Etoposide \& Melphalan
|
|---|---|---|
|
Overall Study
STARTED
|
10
|
10
|
|
Overall Study
COMPLETED
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
10
|
10
|
Reasons for withdrawal
| Measure |
VTD + DPACE/Melphalan
Velcade, thalidomide, and dexamethasone + Dexamethasone, CisPlatin, Adriamycin, Cyclophosphamide, and Etoposide \& Melphalan
|
DPACE/Melphalan
Dexamethasone, CisPlatin, Adriamycin, Cyclophosphamide, and Etoposide \& Melphalan
|
|---|---|---|
|
Overall Study
Death
|
10
|
10
|
Baseline Characteristics
UARK 2006-15: A Study of Tandem Transplants With or Without Bortezomib and Thalidomide
Baseline characteristics by cohort
| Measure |
VTD + DPACE/Melphalan
n=10 Participants
Velcade, thalidomide, and dexamethasone + Dexamethasone, CisPlatin, Adriamycin, Cyclophosphamide, and Etoposide \& Melphalan
|
DPACE/Melphalan
n=10 Participants
Dexamethasone, CisPlatin, Adriamycin, Cyclophosphamide, and Etoposide \& Melphalan
|
Total
n=20 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
|
10 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Age, Continuous
|
56.2 years
STANDARD_DEVIATION 5.01 • n=5 Participants
|
59 years
STANDARD_DEVIATION 8.67 • n=7 Participants
|
57.6 years
STANDARD_DEVIATION 7.04 • n=5 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
10 participants
n=5 Participants
|
10 participants
n=7 Participants
|
20 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Up to 3 years 8 monthsPopulation: no analysis, participants either died or were withdrawn by PI. study terminated with \<10% of target accrual enrolled.
Time from study registration until disease progression or death.
Outcome measures
Outcome data not reported
Adverse Events
VTD + DPACE/Melphalan
Serious events: 4 serious events
Other events: 0 other events
Deaths: 0 deaths
DPACE/Melphalan
Serious events: 3 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
VTD + DPACE/Melphalan
n=10 participants at risk
Velcade, thalidomide, and dexamethasone + Dexamethasone, CisPlatin, Adriamycin, Cyclophosphamide, and Etoposide \& Melphalan
|
DPACE/Melphalan
n=10 participants at risk
Dexamethasone, CisPlatin, Adriamycin, Cyclophosphamide, and Etoposide \& Melphalan
|
|---|---|---|
|
Blood and lymphatic system disorders
embolus
|
0.00%
0/10
|
10.0%
1/10 • Number of events 1
|
|
General disorders
death
|
10.0%
1/10 • Number of events 1
|
0.00%
0/10
|
|
Cardiac disorders
death
|
0.00%
0/10
|
10.0%
1/10 • Number of events 1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
death
|
0.00%
0/10
|
10.0%
1/10 • Number of events 1
|
Other adverse events
Adverse event data not reported
Additional Information
Nathan M. Petty
University of Arkansas for Medical Sciences, Myeloma Institute
Phone: 501-526-6990
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place