Trial Outcomes & Findings for The Impact of Velcade(TM)on Antibody Secreting Cells in Sensitized Renal Allograft Candidates (NCT NCT00722722)
NCT ID: NCT00722722
Last Updated: 2016-05-09
Results Overview
Response to treatment with Bortezomib (BTZ) alone was defined as a reduction in serum Donor Specific Alloantibody (DSA) levels following treatment. DSA levels were measured prior to treatment and after treatment. A good response occurred if all DSA were reduced. A partial response when a reduction was observed in at least one DSA, but not all DSA. No response occurred when no reduction of any DSA was attained.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
18 participants
Primary outcome timeframe
6 months
Results posted on
2016-05-09
Participant Flow
Participant milestones
| Measure |
4 Dose Group
4 doses of bortezomib (1.3mg/m\^2 of body surface area)
Bortezomib: Velcade given in four-dose cycles intravenously (through a vein).
|
16 Dose Group
16 doses of bortezomib (1.3mg/m\^2 of body surface area)
Bortezomib: Velcade given in four-dose cycles intravenously (through a vein).
|
32 Dose Group
32 doses of bortezomib (1.3mg/m\^2 of body surface area)
Bortezomib: Velcade given in four-dose cycles intravenously (through a vein).
|
|---|---|---|---|
|
Overall Study
STARTED
|
3
|
5
|
10
|
|
Overall Study
COMPLETED
|
3
|
5
|
10
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
The Impact of Velcade(TM)on Antibody Secreting Cells in Sensitized Renal Allograft Candidates
Baseline characteristics by cohort
| Measure |
4 Dose Group
n=3 Participants
4 doses of bortezomib (1.3mg/m\^2 of body surface area)
Bortezomib: Velcade given in four-dose cycles intravenously (through a vein).
|
16 Dose Group
n=5 Participants
16 doses of bortezomib (1.3mg/m\^2 of body surface area)
Bortezomib: Velcade given in four-dose cycles intravenously (through a vein).
|
32 Dose Group
n=10 Participants
32 doses of bortezomib (1.3mg/m\^2 of body surface area)
Bortezomib: Velcade given in four-dose cycles intravenously (through a vein).
|
Total
n=18 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
35.3 years
STANDARD_DEVIATION 3.5 • n=99 Participants
|
40.4 years
STANDARD_DEVIATION 11.4 • n=107 Participants
|
39.5 years
STANDARD_DEVIATION 6.6 • n=206 Participants
|
39.1 years
STANDARD_DEVIATION 7.6 • n=7 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=99 Participants
|
5 Participants
n=107 Participants
|
7 Participants
n=206 Participants
|
14 Participants
n=7 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
4 Participants
n=7 Participants
|
|
Region of Enrollment
United States
|
3 participants
n=99 Participants
|
5 participants
n=107 Participants
|
10 participants
n=206 Participants
|
18 participants
n=7 Participants
|
PRIMARY outcome
Timeframe: 6 monthsPopulation: In the 32 dose group, one patient received a kidney transplant with a B-cell flow cytometric crossmatch channel shift of less than 300 after dose 20 and was transplanted with a positive crossmatch donor. This patient was then excluded from further DSA analysis.
Response to treatment with Bortezomib (BTZ) alone was defined as a reduction in serum Donor Specific Alloantibody (DSA) levels following treatment. DSA levels were measured prior to treatment and after treatment. A good response occurred if all DSA were reduced. A partial response when a reduction was observed in at least one DSA, but not all DSA. No response occurred when no reduction of any DSA was attained.
Outcome measures
| Measure |
4 Dose Group
n=3 Participants
4 doses of bortezomib (1.3mg/m\^2 of body surface area)
Bortezomib: Velcade given in four-dose cycles intravenously (through a vein).
|
16 Dose Group
n=5 Participants
16 doses of bortezomib (1.3mg/m\^2 of body surface area)
Bortezomib: Velcade given in four-dose cycles intravenously (through a vein).
|
32 Dose Group
n=9 Participants
32 doses of bortezomib (1.3mg/m\^2 of body surface area)
Bortezomib: Velcade given in four-dose cycles intravenously (through a vein).
|
|---|---|---|---|
|
Response to Bortezomib Monotherapy
Good Response
|
0 participants
|
0 participants
|
0 participants
|
|
Response to Bortezomib Monotherapy
Partial Response
|
1 participants
|
1 participants
|
6 participants
|
|
Response to Bortezomib Monotherapy
No Response
|
2 participants
|
4 participants
|
3 participants
|
Adverse Events
4 Dose Group
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
16 Dose Group
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
32 Dose Group
Serious events: 0 serious events
Other events: 10 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
4 Dose Group
n=3 participants at risk
4 doses of bortezomib (1.3mg/m\^2 of body surface area)
Bortezomib: Velcade given in four-dose cycles intravenously (through a vein).
|
16 Dose Group
n=5 participants at risk
16 doses of bortezomib (1.3mg/m\^2 of body surface area)
Bortezomib: Velcade given in four-dose cycles intravenously (through a vein).
|
32 Dose Group
n=10 participants at risk
32 doses of bortezomib (1.3mg/m\^2 of body surface area)
Bortezomib: Velcade given in four-dose cycles intravenously (through a vein).
|
|---|---|---|---|
|
Blood and lymphatic system disorders
Anemia Grade 1
|
66.7%
2/3 • Number of events 2 • Subjects were followed for 6 months. Before each drug dose, subjects were evaluated for possible toxicities that may have occurred after the previous doses(s).
|
20.0%
1/5 • Number of events 1 • Subjects were followed for 6 months. Before each drug dose, subjects were evaluated for possible toxicities that may have occurred after the previous doses(s).
|
40.0%
4/10 • Number of events 4 • Subjects were followed for 6 months. Before each drug dose, subjects were evaluated for possible toxicities that may have occurred after the previous doses(s).
|
|
Blood and lymphatic system disorders
Anemia Grade 2
|
0.00%
0/3 • Subjects were followed for 6 months. Before each drug dose, subjects were evaluated for possible toxicities that may have occurred after the previous doses(s).
|
80.0%
4/5 • Number of events 4 • Subjects were followed for 6 months. Before each drug dose, subjects were evaluated for possible toxicities that may have occurred after the previous doses(s).
|
60.0%
6/10 • Number of events 6 • Subjects were followed for 6 months. Before each drug dose, subjects were evaluated for possible toxicities that may have occurred after the previous doses(s).
|
|
Blood and lymphatic system disorders
Thrombocytopenia Grade 1
|
33.3%
1/3 • Number of events 1 • Subjects were followed for 6 months. Before each drug dose, subjects were evaluated for possible toxicities that may have occurred after the previous doses(s).
|
60.0%
3/5 • Number of events 3 • Subjects were followed for 6 months. Before each drug dose, subjects were evaluated for possible toxicities that may have occurred after the previous doses(s).
|
70.0%
7/10 • Number of events 7 • Subjects were followed for 6 months. Before each drug dose, subjects were evaluated for possible toxicities that may have occurred after the previous doses(s).
|
|
Blood and lymphatic system disorders
Thrombocytopenia Grade 2
|
0.00%
0/3 • Subjects were followed for 6 months. Before each drug dose, subjects were evaluated for possible toxicities that may have occurred after the previous doses(s).
|
0.00%
0/5 • Subjects were followed for 6 months. Before each drug dose, subjects were evaluated for possible toxicities that may have occurred after the previous doses(s).
|
10.0%
1/10 • Number of events 1 • Subjects were followed for 6 months. Before each drug dose, subjects were evaluated for possible toxicities that may have occurred after the previous doses(s).
|
|
Blood and lymphatic system disorders
Leukopenia Grade 1
|
0.00%
0/3 • Subjects were followed for 6 months. Before each drug dose, subjects were evaluated for possible toxicities that may have occurred after the previous doses(s).
|
0.00%
0/5 • Subjects were followed for 6 months. Before each drug dose, subjects were evaluated for possible toxicities that may have occurred after the previous doses(s).
|
10.0%
1/10 • Number of events 1 • Subjects were followed for 6 months. Before each drug dose, subjects were evaluated for possible toxicities that may have occurred after the previous doses(s).
|
|
Blood and lymphatic system disorders
Leukopenia Grade 2
|
0.00%
0/3 • Subjects were followed for 6 months. Before each drug dose, subjects were evaluated for possible toxicities that may have occurred after the previous doses(s).
|
0.00%
0/5 • Subjects were followed for 6 months. Before each drug dose, subjects were evaluated for possible toxicities that may have occurred after the previous doses(s).
|
20.0%
2/10 • Number of events 2 • Subjects were followed for 6 months. Before each drug dose, subjects were evaluated for possible toxicities that may have occurred after the previous doses(s).
|
|
Gastrointestinal disorders
Nausea/Vomiting Grade 1
|
0.00%
0/3 • Subjects were followed for 6 months. Before each drug dose, subjects were evaluated for possible toxicities that may have occurred after the previous doses(s).
|
60.0%
3/5 • Number of events 3 • Subjects were followed for 6 months. Before each drug dose, subjects were evaluated for possible toxicities that may have occurred after the previous doses(s).
|
50.0%
5/10 • Number of events 5 • Subjects were followed for 6 months. Before each drug dose, subjects were evaluated for possible toxicities that may have occurred after the previous doses(s).
|
|
Gastrointestinal disorders
Diarrhea Grade 1
|
33.3%
1/3 • Number of events 1 • Subjects were followed for 6 months. Before each drug dose, subjects were evaluated for possible toxicities that may have occurred after the previous doses(s).
|
20.0%
1/5 • Number of events 1 • Subjects were followed for 6 months. Before each drug dose, subjects were evaluated for possible toxicities that may have occurred after the previous doses(s).
|
40.0%
4/10 • Number of events 4 • Subjects were followed for 6 months. Before each drug dose, subjects were evaluated for possible toxicities that may have occurred after the previous doses(s).
|
|
Gastrointestinal disorders
Diarrhea Grade 2
|
0.00%
0/3 • Subjects were followed for 6 months. Before each drug dose, subjects were evaluated for possible toxicities that may have occurred after the previous doses(s).
|
20.0%
1/5 • Number of events 1 • Subjects were followed for 6 months. Before each drug dose, subjects were evaluated for possible toxicities that may have occurred after the previous doses(s).
|
20.0%
2/10 • Number of events 2 • Subjects were followed for 6 months. Before each drug dose, subjects were evaluated for possible toxicities that may have occurred after the previous doses(s).
|
|
General disorders
Flu-like symptoms Grade 1
|
0.00%
0/3 • Subjects were followed for 6 months. Before each drug dose, subjects were evaluated for possible toxicities that may have occurred after the previous doses(s).
|
40.0%
2/5 • Number of events 2 • Subjects were followed for 6 months. Before each drug dose, subjects were evaluated for possible toxicities that may have occurred after the previous doses(s).
|
60.0%
6/10 • Number of events 6 • Subjects were followed for 6 months. Before each drug dose, subjects were evaluated for possible toxicities that may have occurred after the previous doses(s).
|
|
Musculoskeletal and connective tissue disorders
Myalgias Grade 1
|
0.00%
0/3 • Subjects were followed for 6 months. Before each drug dose, subjects were evaluated for possible toxicities that may have occurred after the previous doses(s).
|
40.0%
2/5 • Number of events 2 • Subjects were followed for 6 months. Before each drug dose, subjects were evaluated for possible toxicities that may have occurred after the previous doses(s).
|
70.0%
7/10 • Number of events 7 • Subjects were followed for 6 months. Before each drug dose, subjects were evaluated for possible toxicities that may have occurred after the previous doses(s).
|
|
General disorders
Chills Grade 1
|
0.00%
0/3 • Subjects were followed for 6 months. Before each drug dose, subjects were evaluated for possible toxicities that may have occurred after the previous doses(s).
|
0.00%
0/5 • Subjects were followed for 6 months. Before each drug dose, subjects were evaluated for possible toxicities that may have occurred after the previous doses(s).
|
50.0%
5/10 • Number of events 5 • Subjects were followed for 6 months. Before each drug dose, subjects were evaluated for possible toxicities that may have occurred after the previous doses(s).
|
|
General disorders
Fatigue Grade 1
|
0.00%
0/3 • Subjects were followed for 6 months. Before each drug dose, subjects were evaluated for possible toxicities that may have occurred after the previous doses(s).
|
0.00%
0/5 • Subjects were followed for 6 months. Before each drug dose, subjects were evaluated for possible toxicities that may have occurred after the previous doses(s).
|
30.0%
3/10 • Number of events 3 • Subjects were followed for 6 months. Before each drug dose, subjects were evaluated for possible toxicities that may have occurred after the previous doses(s).
|
|
General disorders
Fatigue Grade 2
|
0.00%
0/3 • Subjects were followed for 6 months. Before each drug dose, subjects were evaluated for possible toxicities that may have occurred after the previous doses(s).
|
0.00%
0/5 • Subjects were followed for 6 months. Before each drug dose, subjects were evaluated for possible toxicities that may have occurred after the previous doses(s).
|
10.0%
1/10 • Number of events 1 • Subjects were followed for 6 months. Before each drug dose, subjects were evaluated for possible toxicities that may have occurred after the previous doses(s).
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place