Trial Outcomes & Findings for CART-19 Post-ASCT for Multiple Myeloma (NCT NCT02794246)
NCT ID: NCT02794246
Last Updated: 2023-06-22
Results Overview
Progression free survival as defined by Partial Response (PR); Stable Disease (SD); Very Good Partial Response (VGPR), and Stringent Complete Response (sCR) to treatment. The outcome measures range from Stable disease to Stringent Complete Response (SD worst outcome; sCR best outcome
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
6 participants
Primary outcome timeframe
Follow progression-free survival (PFS) for 2-3 years post CART-19 infusion
Results posted on
2023-06-22
Participant Flow
Participant milestones
| Measure |
CART-19 Cells
single infusion of 1-5x10E8 cells CART-19 cells
|
|---|---|
|
Overall Study
STARTED
|
6
|
|
Overall Study
Treated
|
3
|
|
Overall Study
COMPLETED
|
0
|
|
Overall Study
NOT COMPLETED
|
6
|
Reasons for withdrawal
| Measure |
CART-19 Cells
single infusion of 1-5x10E8 cells CART-19 cells
|
|---|---|
|
Overall Study
Withdrawal by Subject
|
2
|
|
Overall Study
Physician Decision
|
4
|
Baseline Characteristics
CART-19 Post-ASCT for Multiple Myeloma
Baseline characteristics by cohort
| Measure |
Single Arm
n=6 Participants
CART-19 cells
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
5 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
1 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
6 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
6 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Follow progression-free survival (PFS) for 2-3 years post CART-19 infusionProgression free survival as defined by Partial Response (PR); Stable Disease (SD); Very Good Partial Response (VGPR), and Stringent Complete Response (sCR) to treatment. The outcome measures range from Stable disease to Stringent Complete Response (SD worst outcome; sCR best outcome
Outcome measures
| Measure |
Single Arm
n=6 Participants
CART-19 cells
|
|---|---|
|
Evaluate Progression Free Survival
Stable Disease
|
1 participants
|
|
Evaluate Progression Free Survival
Partial Response
|
3 participants
|
|
Evaluate Progression Free Survival
Very Good Partial Response
|
1 participants
|
|
Evaluate Progression Free Survival
Stringent Complete Response
|
1 participants
|
Adverse Events
Single Arm
Serious events: 2 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Single Arm
n=6 participants at risk
CART-19 cells
|
|---|---|
|
Infections and infestations
Upper respiratory infection
|
16.7%
1/6 • Number of events 1 • 18 months
|
|
Immune system disorders
Cytokine release syndrome
|
16.7%
1/6 • Number of events 1 • 18 months
|
Other adverse events
| Measure |
Single Arm
n=6 participants at risk
CART-19 cells
|
|---|---|
|
Blood and lymphatic system disorders
Anemia
|
16.7%
1/6 • Number of events 1 • 18 months
|
|
Cardiac disorders
Sinus tachycardia
|
16.7%
1/6 • Number of events 1 • 18 months
|
|
Immune system disorders
Cytokine release syndrome
|
16.7%
1/6 • Number of events 1 • 18 months
|
|
Investigations
Platelet count decreased
|
16.7%
1/6 • Number of events 1 • 18 months
|
|
Investigations
Neutrophil count decreased
|
16.7%
1/6 • Number of events 1 • 18 months
|
|
Investigations
White blood cell decreased
|
16.7%
1/6 • Number of events 1 • 18 months
|
|
Metabolism and nutrition disorders
Hypokalemia
|
16.7%
1/6 • Number of events 1 • 18 months
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
16.7%
1/6 • Number of events 1 • 18 months
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
16.7%
1/6 • Number of events 1 • 18 months
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
16.7%
1/6 • Number of events 1 • 18 months
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
16.7%
1/6 • Number of events 1 • 18 months
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place