TriangleNCT02215967 · OUTCOME
Number of Participants With Best Response
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- COUNT_OF_PARTICIPANTS
- Unit
- Participants
- Interval / dispersion
- Not reported
- Time frame
- From start of treatment up to 84 weeks
What was measured
Best response was assessed by the International Myeloma Working Group response criteria. Partial Remission (PR) is 50% or greater reduction of serum M-protein and 90% or greater reduction in 24-h urinary M-protein. Progressive Disease (PD) is increases of greater or equal to 25% from the lowest post-treatment (nadir) value in serum M-component or urine component or percentage of bone marrow plasma cells. Definite development of new bone lesions or new plasmacytoma. Very Good Partial Remission (VGPR) is serum and urine M-protein detectable by immunofixation but not on electrophoresis. Stringent Complete Remission (sCR) is normal free light chain ratio and absence of clonal cells in bone marrow by immunohistochemistry. Complete Remission is negative immunofixation on the serum and urine. Stable Disease (SD) is not meeting criteria for CR, VGPR, PR or PD.
Analysis population: One participant in Group 9x10(6) did not get CAR T-cells and was deemed ineligible, and 3 participants in Group 9x10(6) were found to be ineligible for treatment.
Groups in this outcome
0.3 x 10^6 CAR-BCMA T-cells Infused
Dose Escalation with 5 dose levels based on the patients actual bodyweight Cyclophosphamide: 300 mg/m\^2 intravenous (IV) over 30 minutes on days -5, -4, and -3 Fludarabine: 30 mg/m\^2 intravenous (IV) over 30 minutes immediately following the cyclophosphamide on day -5, -4, and -3 Anti-B-cell maturation antigen (BCMA) chimeric antigen receptor (CAR) T cells: 0.3x10\^6- 15.0x10\^6 CAR+ T cells per kg of recipient bodyweight one time dose on day 0
1 x 10^6 CAR-BCMA T-cells Infused
Dose Escalation with 5 dose levels based on the patients actual bodyweight Cyclophosphamide: 300 mg/m\^2 intravenous (IV) over 30 minutes on days -5, -4, and -3 Fludarabine: 30 mg/m\^2 intravenous (IV) over 30 minutes immediately following the cyclophosphamide on day -5, -4, and -3 Anti-B-cell maturation antigen (BCMA) chimeric antigen receptor (CAR) T cells: 0.3x10\^6- 15.0x10\^6 CAR+ T cells per kg of recipient bodyweight one time dose on day 0
3 x 10^6 CAR-BCMA T-cells Infused
Dose Escalation with 5 dose levels based on the patients actual bodyweight Cyclophosphamide: 300 mg/m\^2 intravenous (IV) over 30 minutes on days -5, -4, and -3 Fludarabine: 30 mg/m\^2 intravenous (IV) over 30 minutes immediately following the cyclophosphamide on day -5, -4, and -3 Anti-B-cell maturation antigen (BCMA) chimeric antigen receptor (CAR) T cells: 0.3x10\^6- 15.0x10\^6 CAR+ T cells per kg of recipient bodyweight one time dose on day 0
9 x 10^6 CAR-BCMA T-cells Infused
Dose Escalation with 5 dose levels based on the patients actual bodyweight Cyclophosphamide: 300 mg/m\^2 intravenous (IV) over 30 minutes on days -5, -4, and -3 Fludarabine: 30 mg/m\^2 intravenous (IV) over 30 minutes immediately following the cyclophosphamide on day -5, -4, and -3 Anti-B-cell maturation antigen (BCMA) chimeric antigen receptor (CAR) T cells: 0.3x10\^6- 15.0x10\^6 CAR+ T cells per kg of recipient bodyweight one time dose on day 0
| Group | Source count |
|---|---|
| 0.3 x 10^6 CAR-BCMA T-cells Infused | 3 |
| 1 x 10^6 CAR-BCMA T-cells Infused | 3 |
| 3 x 10^6 CAR-BCMA T-cells Infused | 4 |
| 9 x 10^6 CAR-BCMA T-cells Infused | 16 |
Reported measurements
Partial Remission
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| 0.3 x 10^6 CAR-BCMA T-cells Infused | 1 | Not reported | Not reported | Not reported | Not reported |
| 1 x 10^6 CAR-BCMA T-cells Infused | 0 | Not reported | Not reported | Not reported | Not reported |
| 3 x 10^6 CAR-BCMA T-cells Infused | 0 | Not reported | Not reported | Not reported | Not reported |
| 9 x 10^6 CAR-BCMA T-cells Infused | 4 | Not reported | Not reported | Not reported | Not reported |
Stable Disease
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| 0.3 x 10^6 CAR-BCMA T-cells Infused | 2 | Not reported | Not reported | Not reported | Not reported |
| 1 x 10^6 CAR-BCMA T-cells Infused | 3 | Not reported | Not reported | Not reported | Not reported |
| 3 x 10^6 CAR-BCMA T-cells Infused | 3 | Not reported | Not reported | Not reported | Not reported |
| 9 x 10^6 CAR-BCMA T-cells Infused | 2 | Not reported | Not reported | Not reported | Not reported |
Very Good Partial Remission
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| 0.3 x 10^6 CAR-BCMA T-cells Infused | 0 | Not reported | Not reported | Not reported | Not reported |
| 1 x 10^6 CAR-BCMA T-cells Infused | 0 | Not reported | Not reported | Not reported | Not reported |
| 3 x 10^6 CAR-BCMA T-cells Infused | 1 | Not reported | Not reported | Not reported | Not reported |
| 9 x 10^6 CAR-BCMA T-cells Infused | 6 | Not reported | Not reported | Not reported | Not reported |
Complete Remission
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| 0.3 x 10^6 CAR-BCMA T-cells Infused | 0 | Not reported | Not reported | Not reported | Not reported |
| 1 x 10^6 CAR-BCMA T-cells Infused | 0 | Not reported | Not reported | Not reported | Not reported |
| 3 x 10^6 CAR-BCMA T-cells Infused | 0 | Not reported | Not reported | Not reported | Not reported |
| 9 x 10^6 CAR-BCMA T-cells Infused | 1 | Not reported | Not reported | Not reported | Not reported |
Stringent Complete Remission
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| 0.3 x 10^6 CAR-BCMA T-cells Infused | 0 | Not reported | Not reported | Not reported | Not reported |
| 1 x 10^6 CAR-BCMA T-cells Infused | 0 | Not reported | Not reported | Not reported | Not reported |
| 3 x 10^6 CAR-BCMA T-cells Infused | 0 | Not reported | Not reported | Not reported | Not reported |
| 9 x 10^6 CAR-BCMA T-cells Infused | 2 | Not reported | Not reported | Not reported | Not reported |
Progressive Disease
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| 0.3 x 10^6 CAR-BCMA T-cells Infused | 0 | Not reported | Not reported | Not reported | Not reported |
| 1 x 10^6 CAR-BCMA T-cells Infused | 0 | Not reported | Not reported | Not reported | Not reported |
| 3 x 10^6 CAR-BCMA T-cells Infused | 0 | Not reported | Not reported | Not reported | Not reported |
| 9 x 10^6 CAR-BCMA T-cells Infused | 1 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 1
- group Id
- OG001
- value
- 0
- group Id
- OG002
- value
- 0
- group Id
- OG003
- value
- 4
- title
- Partial Remission
- categories
- measurements
- group Id
- OG000
- value
- 2
- group Id
- OG001
- value
- 3
- group Id
- OG002
- value
- 3
- group Id
- OG003
- value
- 2
- title
- Stable Disease
- categories
- measurements
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 0
- group Id
- OG002
- value
- 1
- group Id
- OG003
- value
- 6
- title
- Very Good Partial Remission
- categories
- measurements
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 0
- group Id
- OG002
- value
- 0
- group Id
- OG003
- value
- 1
- title
- Complete Remission
- categories
- measurements
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 0
- group Id
- OG002
- value
- 0
- group Id
- OG003
- value
- 2
- title
- Stringent Complete Remission
- categories
- measurements
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 0
- group Id
- OG002
- value
- 0
- group Id
- OG003
- value
- 1
- title
- Progressive Disease
- denoms
- counts
- group Id
- OG000
- value
- 3
- group Id
- OG001
- value
- 3
- group Id
- OG002
- value
- 4
- group Id
- OG003
- value
- 16
- units
- Participants
- description
- Best response was assessed by the International Myeloma Working Group response criteria. Partial Remission (PR) is 50% or greater reduction of serum M-protein and 90% or greater reduction in 24-h urinary M-protein. Progressive Disease (PD) is increases of greater or equal to 25% from the lowest post-treatment (nadir) value in serum M-component or urine component or percentage of bone marrow plasma cells. Definite development of new bone lesions or new plasmacytoma. Very Good Partial Remission (VGPR) is serum and urine M-protein detectable by immunofixation but not on electrophoresis. Stringent Complete Remission (sCR) is normal free light chain ratio and absence of clonal cells in bone marrow by immunohistochemistry. Complete Remission is negative immunofixation on the serum and urine. Stable Disease (SD) is not meeting criteria for CR, VGPR, PR or PD.
- groups
- description
- Dose Escalation with 5 dose levels based on the patients actual bodyweight Cyclophosphamide: 300 mg/m\^2 intravenous (IV) over 30 minutes on days -5, -4, and -3 Fludarabine: 30 mg/m\^2 intravenous (IV) over 30 minutes immediately following the cyclophosphamide on day -5, -4, and -3 Anti-B-cell maturation antigen (BCMA) chimeric antigen receptor (CAR) T cells: 0.3x10\^6- 15.0x10\^6 CAR+ T cells per kg of recipient bodyweight one time dose on day 0
- id
- OG000
- title
- 0.3 x 10^6 CAR-BCMA T-cells Infused
- description
- Dose Escalation with 5 dose levels based on the patients actual bodyweight Cyclophosphamide: 300 mg/m\^2 intravenous (IV) over 30 minutes on days -5, -4, and -3 Fludarabine: 30 mg/m\^2 intravenous (IV) over 30 minutes immediately following the cyclophosphamide on day -5, -4, and -3 Anti-B-cell maturation antigen (BCMA) chimeric antigen receptor (CAR) T cells: 0.3x10\^6- 15.0x10\^6 CAR+ T cells per kg of recipient bodyweight one time dose on day 0
- id
- OG001
- title
- 1 x 10^6 CAR-BCMA T-cells Infused
- description
- Dose Escalation with 5 dose levels based on the patients actual bodyweight Cyclophosphamide: 300 mg/m\^2 intravenous (IV) over 30 minutes on days -5, -4, and -3 Fludarabine: 30 mg/m\^2 intravenous (IV) over 30 minutes immediately following the cyclophosphamide on day -5, -4, and -3 Anti-B-cell maturation antigen (BCMA) chimeric antigen receptor (CAR) T cells: 0.3x10\^6- 15.0x10\^6 CAR+ T cells per kg of recipient bodyweight one time dose on day 0
- id
- OG002
- title
- 3 x 10^6 CAR-BCMA T-cells Infused
- description
- Dose Escalation with 5 dose levels based on the patients actual bodyweight Cyclophosphamide: 300 mg/m\^2 intravenous (IV) over 30 minutes on days -5, -4, and -3 Fludarabine: 30 mg/m\^2 intravenous (IV) over 30 minutes immediately following the cyclophosphamide on day -5, -4, and -3 Anti-B-cell maturation antigen (BCMA) chimeric antigen receptor (CAR) T cells: 0.3x10\^6- 15.0x10\^6 CAR+ T cells per kg of recipient bodyweight one time dose on day 0
- id
- OG003
- title
- 9 x 10^6 CAR-BCMA T-cells Infused
- param Type
- COUNT_OF_PARTICIPANTS
- population Description
- One participant in Group 9x10(6) did not get CAR T-cells and was deemed ineligible, and 3 participants in Group 9x10(6) were found to be ineligible for treatment.
- reporting Status
- POSTED
- time Frame
- From start of treatment up to 84 weeks
- title
- Number of Participants With Best Response
- type
- SECONDARY
- unit Of Measure
- Participants
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice