TriangleNCT03548207 · OUTCOME
Phase 1b and Phase 2: Time to First Response
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- MEDIAN
- Unit
- Months
- Interval / dispersion
- Full Range
- Time frame
- Pre dose (Day 1) up to 45.2 months
What was measured
Time to first response was defined as the time between date of the initial infusion of JNJ-68284528 and the first efficacy evaluation that the participant met all criteria for PR or better. IMWG criteria for PR: \>=50% reduction of serum M-protein and reduction in 24-hour urinary M-protein by \>=90% or \<200 mg per 24 hours, If the serum and urine M-protein are not measurable, a decrease of \>=50% in the difference between involved and uninvolved FLC levels is required in place of the M-protein criteria, If serum and urine M-protein are not measurable, and serum free light assay is also not measurable, \>=50% reduction in bone marrow PCs is required in place of M-protein, provided baseline bone marrow plasma cell percentage was \>=30%. In addition to the above criteria, if present at baseline, a \>=50% reduction in the size of soft tissue plasmacytomas is also required.
Analysis population: Analysis population included responders in mITT analysis set. mITT analysis set included all participants who received a JNJ-68284528 infusion at the targeted RP2D dose level.
Groups in this outcome
Phase 1b (US Population)
Participants received a conditioning regimen of cyclophosphamide 300 milligrams per meter square (mg/m\^2) intravenous (IV) infusion and fludarabine 30 mg/m\^2 as IV infusion daily for 3 days from Day -5 to Day -3. On Day 1, participants received target dose of JNJ-68284528 0.75\*10\^6 chimeric antigen receptor T (CAR-T) cells per kilogram (cells/kg) (range: 0.5-1.0\*10\^6 CAR-positive viable cells/kg) as IV infusion.
Phase 2 (US Population)
Participants received a conditioning regimen of cyclophosphamide 300 mg/m\^2 IV infusion and fludarabine 30 mg/m\^2 IV infusion daily for 3 days from Day -5 to Day -3. On Day 1, participants received recommended phase 2 dose (RP2D) dose of JNJ-68284528 0.75\*10\^6 CAR positive viable T cells/kg as IV infusion.
Phase 2 (Japan Population)
Participants received a conditioning regimen of cyclophosphamide 300 mg/m\^2 IV infusion and fludarabine 30 mg/m\^2 IV infusion daily for 3 days from Day -5 to Day -3. On Day 1, participants received RP2D dose of JNJ-68284528 0.75\*10\^6 CAR positive viable T cells/kg as IV infusion.
| Group | Source count |
|---|---|
| Phase 1b (US Population) | 29 |
| Phase 2 (US Population) | 66 |
| Phase 2 (Japan Population) | 8 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Phase 1b (US Population) | 0.95 | Not reported | 0.9 | 2.8 | Not reported |
| Phase 2 (US Population) | 0.95 | Not reported | 0.9 | 10.7 | Not reported |
| Phase 2 (Japan Population) | 0.92 | Not reported | 0.9 | 1.8 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 0.9
- upper Limit
- 2.8
- value
- 0.95
- group Id
- OG001
- lower Limit
- 0.9
- upper Limit
- 10.7
- value
- 0.95
- group Id
- OG002
- lower Limit
- 0.9
- upper Limit
- 1.8
- value
- 0.92
- denoms
- counts
- group Id
- OG000
- value
- 29
- group Id
- OG001
- value
- 66
- group Id
- OG002
- value
- 8
- units
- Participants
- description
- Time to first response was defined as the time between date of the initial infusion of JNJ-68284528 and the first efficacy evaluation that the participant met all criteria for PR or better. IMWG criteria for PR: \>=50% reduction of serum M-protein and reduction in 24-hour urinary M-protein by \>=90% or \<200 mg per 24 hours, If the serum and urine M-protein are not measurable, a decrease of \>=50% in the difference between involved and uninvolved FLC levels is required in place of the M-protein criteria, If serum and urine M-protein are not measurable, and serum free light assay is also not measurable, \>=50% reduction in bone marrow PCs is required in place of M-protein, provided baseline bone marrow plasma cell percentage was \>=30%. In addition to the above criteria, if present at baseline, a \>=50% reduction in the size of soft tissue plasmacytomas is also required.
- dispersion Type
- Full Range
- groups
- description
- Participants received a conditioning regimen of cyclophosphamide 300 milligrams per meter square (mg/m\^2) intravenous (IV) infusion and fludarabine 30 mg/m\^2 as IV infusion daily for 3 days from Day -5 to Day -3. On Day 1, participants received target dose of JNJ-68284528 0.75\*10\^6 chimeric antigen receptor T (CAR-T) cells per kilogram (cells/kg) (range: 0.5-1.0\*10\^6 CAR-positive viable cells/kg) as IV infusion.
- id
- OG000
- title
- Phase 1b (US Population)
- description
- Participants received a conditioning regimen of cyclophosphamide 300 mg/m\^2 IV infusion and fludarabine 30 mg/m\^2 IV infusion daily for 3 days from Day -5 to Day -3. On Day 1, participants received recommended phase 2 dose (RP2D) dose of JNJ-68284528 0.75\*10\^6 CAR positive viable T cells/kg as IV infusion.
- id
- OG001
- title
- Phase 2 (US Population)
- description
- Participants received a conditioning regimen of cyclophosphamide 300 mg/m\^2 IV infusion and fludarabine 30 mg/m\^2 IV infusion daily for 3 days from Day -5 to Day -3. On Day 1, participants received RP2D dose of JNJ-68284528 0.75\*10\^6 CAR positive viable T cells/kg as IV infusion.
- id
- OG002
- title
- Phase 2 (Japan Population)
- param Type
- MEDIAN
- population Description
- Analysis population included responders in mITT analysis set. mITT analysis set included all participants who received a JNJ-68284528 infusion at the targeted RP2D dose level.
- reporting Status
- POSTED
- time Frame
- Pre dose (Day 1) up to 45.2 months
- title
- Phase 1b and Phase 2: Time to First Response
- type
- SECONDARY
- unit Of Measure
- Months
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Preserved source evidence · Not medical advice