Trial Outcomes & Findings for DTPACE Followed by Tandem Transplant With Melphalan (MEL) 200 Versus MEL/Dexamethasone/Thalidomide (DT) Platinol/Adriamycin/Etoposide (PACE) Hybrid and DTPACE Consolidation (NCT NCT00083915)
NCT ID: NCT00083915
Last Updated: 2017-11-20
Results Overview
Compare a new regimen of chemotherapy called DT PACE-Melphalan (new experimental therapy) is better than transplant with Melphalan alone (standard therapy)
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
97 participants
Primary outcome timeframe
3 years depending on start date
Results posted on
2017-11-20
Participant Flow
Participant milestones
| Measure |
High Dose Melphalan
|
Mel-DT PACE
|
|---|---|---|
|
Overall Study
STARTED
|
52
|
45
|
|
Overall Study
COMPLETED
|
2
|
8
|
|
Overall Study
NOT COMPLETED
|
50
|
37
|
Reasons for withdrawal
| Measure |
High Dose Melphalan
|
Mel-DT PACE
|
|---|---|---|
|
Overall Study
Death
|
6
|
3
|
|
Overall Study
Physician Decision
|
11
|
6
|
|
Overall Study
Withdrawal by Subject
|
8
|
3
|
|
Overall Study
disease progression
|
18
|
23
|
|
Overall Study
Failure to collect
|
3
|
0
|
|
Overall Study
No response
|
3
|
1
|
|
Overall Study
Insurance issues
|
1
|
1
|
Baseline Characteristics
DTPACE Followed by Tandem Transplant With Melphalan (MEL) 200 Versus MEL/Dexamethasone/Thalidomide (DT) Platinol/Adriamycin/Etoposide (PACE) Hybrid and DTPACE Consolidation
Baseline characteristics by cohort
| Measure |
High Dose Melphalan
n=52 Participants
|
Mel-DT PACE
n=45 Participants
|
Total
n=97 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
|
27 Participants
n=5 Participants
|
24 Participants
n=7 Participants
|
51 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
25 Participants
n=5 Participants
|
21 Participants
n=7 Participants
|
46 Participants
n=5 Participants
|
|
Age, Continuous
|
64.83 years
STANDARD_DEVIATION 8.77 • n=5 Participants
|
65.5 years
STANDARD_DEVIATION 8.36 • n=7 Participants
|
65.14 years
STANDARD_DEVIATION 8.55 • n=5 Participants
|
|
Sex: Female, Male
Female
|
22 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
41 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
30 Participants
n=5 Participants
|
26 Participants
n=7 Participants
|
56 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 3 years depending on start datePopulation: only 2 participants in high dose (HD) melphalan group completed the study and only 8 from the Mel-DT Pace group completed the study. No analysis done.
Compare a new regimen of chemotherapy called DT PACE-Melphalan (new experimental therapy) is better than transplant with Melphalan alone (standard therapy)
Outcome measures
Outcome data not reported
Adverse Events
High Dose Melphalan
Serious events: 6 serious events
Other events: 27 other events
Deaths: 0 deaths
Mel-DT PACE
Serious events: 3 serious events
Other events: 24 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
High Dose Melphalan
n=52 participants at risk
|
Mel-DT PACE
n=45 participants at risk
|
|---|---|---|
|
General disorders
death
|
11.5%
6/52 • Number of events 6
|
6.7%
3/45 • Number of events 3
|
Other adverse events
| Measure |
High Dose Melphalan
n=52 participants at risk
|
Mel-DT PACE
n=45 participants at risk
|
|---|---|---|
|
General disorders
neutropenic fever
|
9.6%
5/52 • Number of events 5
|
8.9%
4/45 • Number of events 5
|
|
Blood and lymphatic system disorders
DVT
|
7.7%
4/52 • Number of events 7
|
8.9%
4/45 • Number of events 5
|
|
Blood and lymphatic system disorders
Diverticulitis
|
3.8%
2/52 • Number of events 2
|
2.2%
1/45 • Number of events 1
|
|
Infections and infestations
CVL infection
|
1.9%
1/52 • Number of events 1
|
2.2%
1/45 • Number of events 1
|
|
Gastrointestinal disorders
nausea, vomiting, diarrhea & fever
|
9.6%
5/52 • Number of events 7
|
8.9%
4/45 • Number of events 5
|
|
General disorders
pneumonia
|
5.8%
3/52 • Number of events 3
|
4.4%
2/45 • Number of events 2
|
|
General disorders
headcache, rhinitis
|
0.00%
0/52
|
2.2%
1/45 • Number of events 1
|
|
Blood and lymphatic system disorders
supraventricular tachycardia
|
0.00%
0/52
|
2.2%
1/45 • Number of events 1
|
|
Gastrointestinal disorders
difficile colitis
|
1.9%
1/52 • Number of events 1
|
0.00%
0/45
|
|
General disorders
hematoma
|
1.9%
1/52 • Number of events 1
|
2.2%
1/45 • Number of events 1
|
|
General disorders
fracture
|
1.9%
1/52 • Number of events 1
|
2.2%
1/45 • Number of events 1
|
|
General disorders
edema
|
0.00%
0/52
|
2.2%
1/45 • Number of events 1
|
|
Vascular disorders
stroke
|
0.00%
0/52
|
2.2%
1/45 • Number of events 1
|
|
Blood and lymphatic system disorders
hemorrhagic colitis
|
1.9%
1/52 • Number of events 1
|
0.00%
0/45
|
|
General disorders
dehydration
|
0.00%
0/52
|
2.2%
1/45 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
drug rash
|
1.9%
1/52 • Number of events 1
|
0.00%
0/45
|
|
Cardiac disorders
chest pain
|
1.9%
1/52 • Number of events 1
|
0.00%
0/45
|
|
Renal and urinary disorders
bladder cancer
|
1.9%
1/52 • Number of events 1
|
0.00%
0/45
|
|
Respiratory, thoracic and mediastinal disorders
plasma cells in lungs
|
0.00%
0/52
|
2.2%
1/45 • Number of events 1
|
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