Trial Outcomes & Findings for Trial of ID-Specific Donor Vaccinated Lymphocyte Infusion for Patients With Myeloma Relapsing or Failing to Achieve a Complete Remission After an Allogenic Transplant (NCT NCT01174082)
NCT ID: NCT01174082
Last Updated: 2018-06-01
Results Overview
PR defined as 50% reduction disease including serum monoclonal paraprotein and CR defined as absence of original monoclonal paraprotein in serum and urine.
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
2 participants
Primary outcome timeframe
DLI up to 5 years post DLI
Results posted on
2018-06-01
Participant Flow
Participant milestones
| Measure |
Recipient
Vaccine + DLI
|
Donor
Vaccine
|
|---|---|---|
|
Overall Study
STARTED
|
1
|
1
|
|
Overall Study
COMPLETED
|
1
|
1
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Trial of ID-Specific Donor Vaccinated Lymphocyte Infusion for Patients With Myeloma Relapsing or Failing to Achieve a Complete Remission After an Allogenic Transplant
Baseline characteristics by cohort
| Measure |
Recipient
n=1 Participants
Vaccine + DLI
|
Donor
n=1 Participants
Vaccine
|
Total
n=2 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
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
1 participants
n=5 Participants
|
1 participants
n=7 Participants
|
2 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: DLI up to 5 years post DLIPopulation: The donor participant was to supply the cell product to manufacturer the vaccine. The donor has no disease and therefore cannot be analyzed for a response.
PR defined as 50% reduction disease including serum monoclonal paraprotein and CR defined as absence of original monoclonal paraprotein in serum and urine.
Outcome measures
| Measure |
Recipient
n=1 Participants
Vaccine + DLI
|
Donor
Vaccine
|
|---|---|---|
|
The Rate of Partial Response(PR) and Complete Response(CR) in Patients Receiving DLI From an ID-specific Vaccinated Donor
|
1 Participants
|
0 Participants
|
Adverse Events
Recipient
Serious events: 0 serious events
Other events: 1 other events
Deaths: 1 deaths
Donor
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Recipient
n=1 participants at risk
KLH vaccine + DLI
|
Donor
n=1 participants at risk
KLH vaccine
|
|---|---|---|
|
Gastrointestinal disorders
Diarrhea
|
100.0%
1/1 • Up to 5 years post start of treatment
|
0.00%
0/1 • Up to 5 years post start of treatment
|
|
Infections and infestations
Infection
|
100.0%
1/1 • Up to 5 years post start of treatment
|
0.00%
0/1 • Up to 5 years post start of treatment
|
|
Gastrointestinal disorders
Abd cramping
|
100.0%
1/1 • Up to 5 years post start of treatment
|
0.00%
0/1 • Up to 5 years post start of treatment
|
|
Nervous system disorders
Insomnia
|
100.0%
1/1 • Up to 5 years post start of treatment
|
0.00%
0/1 • Up to 5 years post start of treatment
|
|
Nervous system disorders
Dizziness
|
100.0%
1/1 • Up to 5 years post start of treatment
|
0.00%
0/1 • Up to 5 years post start of treatment
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
100.0%
1/1 • Up to 5 years post start of treatment
|
0.00%
0/1 • Up to 5 years post start of treatment
|
|
General disorders
Fatigue
|
100.0%
1/1 • Up to 5 years post start of treatment
|
0.00%
0/1 • Up to 5 years post start of treatment
|
|
Blood and lymphatic system disorders
Decreased Platelet
|
100.0%
1/1 • Up to 5 years post start of treatment
|
0.00%
0/1 • Up to 5 years post start of treatment
|
|
Skin and subcutaneous tissue disorders
Skin Rash
|
100.0%
1/1 • Up to 5 years post start of treatment
|
0.00%
0/1 • Up to 5 years post start of treatment
|
|
Respiratory, thoracic and mediastinal disorders
Hemoptysis
|
100.0%
1/1 • Up to 5 years post start of treatment
|
0.00%
0/1 • Up to 5 years post start of treatment
|
|
General disorders
Fever
|
100.0%
1/1 • Up to 5 years post start of treatment
|
100.0%
1/1 • Up to 5 years post start of treatment
|
|
General disorders
Chills
|
0.00%
0/1 • Up to 5 years post start of treatment
|
100.0%
1/1 • Up to 5 years post start of treatment
|
|
Musculoskeletal and connective tissue disorders
Bone Pain
|
0.00%
0/1 • Up to 5 years post start of treatment
|
100.0%
1/1 • Up to 5 years post start of treatment
|
|
Nervous system disorders
Headache
|
100.0%
1/1 • Up to 5 years post start of treatment
|
0.00%
0/1 • Up to 5 years post start of treatment
|
|
Ear and labyrinth disorders
Hearing Loss
|
100.0%
1/1 • Up to 5 years post start of treatment
|
0.00%
0/1 • Up to 5 years post start of treatment
|
|
Blood and lymphatic system disorders
Pancytopenia
|
0.00%
0/1 • Up to 5 years post start of treatment
|
100.0%
1/1 • Up to 5 years post start of treatment
|
|
Nervous system disorders
Neuropathy
|
100.0%
1/1 • Up to 5 years post start of treatment
|
0.00%
0/1 • Up to 5 years post start of treatment
|
Additional Information
Qazilbash,Muzaffar,M.D. / Stem Cell Transplantation
UT MD Anderson Cancer Center
Phone: 713-792-7734
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place