Trial Outcomes & Findings for 2nd Autologous Stem Cell Transplant in Patients With Persistent/Recurrent (AL) Amyloidosis (NCT NCT00075608)
NCT ID: NCT00075608
Last Updated: 2017-01-27
Results Overview
Feasibility and tolerability will be evaluated based on participants completing second transplant with tolerable adverse events
TERMINATED
PHASE2
12 participants
3 months after treatment and annually
2017-01-27
Participant Flow
Participants were recruited from March 2003 through July 2008 through the transplant clinic and amyloid clinic.
Participant milestones
| Measure |
Second Transplant
Participants underwent a second treatment with high dose chemotherapy and stem cell transplant
|
|---|---|
|
Overall Study
STARTED
|
12
|
|
Overall Study
COMPLETED
|
12
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
2nd Autologous Stem Cell Transplant in Patients With Persistent/Recurrent (AL) Amyloidosis
Baseline characteristics by cohort
| Measure |
Second Transplant
n=12 Participants
Participants underwent a second treatment with high dose chemotherapy and stem cell transplant
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
12 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
|
Age, Continuous
|
54.25 years
STANDARD_DEVIATION 1 • n=5 Participants
|
|
Gender
Female
|
5 Participants
n=5 Participants
|
|
Gender
Male
|
7 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
12 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 3 months after treatment and annuallyPopulation: No data were collected or analyzed due to study termination
Feasibility and tolerability will be evaluated based on participants completing second transplant with tolerable adverse events
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: 3 months after treatment and annuallyPopulation: No data were collected or analyzed due to study termination
Response and durability of response will be based on hematologic Complete Response or Partial Response and date of relapse or death
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: 3 months after treatment and annuallyPopulation: No data were collected or analyzed due to study termination
Evaluate immune reconstitution based on time to engraftment
Outcome measures
Outcome data not reported
Adverse Events
Second Transplant
Serious adverse events
| Measure |
Second Transplant
n=12 participants at risk
Participants who received a second transplant
|
|---|---|
|
Blood and lymphatic system disorders
Sepsis
|
16.7%
2/12 • Number of events 3 • 1 year
Adverse events were assessed for up to 1 year.
|
|
Infections and infestations
febrile neutropenia
|
66.7%
8/12 • Number of events 8 • 1 year
Adverse events were assessed for up to 1 year.
|
|
Renal and urinary disorders
Acute renal failure
|
16.7%
2/12 • Number of events 2 • 1 year
Adverse events were assessed for up to 1 year.
|
|
General disorders
fatigue
|
66.7%
8/12 • Number of events 8 • 1 year
Adverse events were assessed for up to 1 year.
|
|
Gastrointestinal disorders
nausea
|
25.0%
3/12 • Number of events 3 • 1 year
Adverse events were assessed for up to 1 year.
|
|
Gastrointestinal disorders
diarrhea
|
41.7%
5/12 • Number of events 5 • 1 year
Adverse events were assessed for up to 1 year.
|
|
Cardiac disorders
hypotension
|
41.7%
5/12 • Number of events 5 • 1 year
Adverse events were assessed for up to 1 year.
|
|
Cardiac disorders
arrhythmia
|
16.7%
2/12 • Number of events 2 • 1 year
Adverse events were assessed for up to 1 year.
|
Other adverse events
| Measure |
Second Transplant
n=12 participants at risk
Participants who received a second transplant
|
|---|---|
|
Gastrointestinal disorders
nausea
|
75.0%
9/12 • Number of events 13 • 1 year
Adverse events were assessed for up to 1 year.
|
|
Gastrointestinal disorders
diarrhea
|
41.7%
5/12 • Number of events 6 • 1 year
Adverse events were assessed for up to 1 year.
|
|
Blood and lymphatic system disorders
peripheral edema
|
16.7%
2/12 • Number of events 2 • 1 year
Adverse events were assessed for up to 1 year.
|
|
Respiratory, thoracic and mediastinal disorders
dyspnea
|
25.0%
3/12 • Number of events 3 • 1 year
Adverse events were assessed for up to 1 year.
|
|
Investigations
hypocalcemia
|
16.7%
2/12 • Number of events 2 • 1 year
Adverse events were assessed for up to 1 year.
|
|
Investigations
hypoalbuminemia
|
25.0%
3/12 • Number of events 3 • 1 year
Adverse events were assessed for up to 1 year.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place