TriangleNCT03548207 · OUTCOME
Phase 2: Overall Response Rate (ORR)
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- NUMBER
- Unit
- Percentage of participants
- Interval / dispersion
- 95% Confidence Interval
- Time frame
- Day 1 up to 45.2 months
What was measured
ORR was defined as the percentage of participants who achieved partial response (PR) or better according to international myeloma working group (IMWG) criteria. IMWG criteria for PR: greater than or equal to (\>=) 50 percent (%) reduction of serum M-protein and reduction in 24-hour urinary M-protein by \>=90% or to less than (\<) 200 milligrams (mg) per 24 hours. If the serum and urine M-protein were not measurable, a decrease of \>=50% in the difference between involved and uninvolved free light chain (FLC) levels was required in place of the M-protein criteria. If serum and urine M-protein were not measurable, and serum free light assay was also not measurable, \>=50% reduction in bone marrow plasma cells (PCs) was required in place of M-protein, provided baseline bone marrow PC percentage was \>=30%. In addition to the above criteria, if present at baseline, a \>=50% reduction in the size of soft tissue plasmacytomas was also required.
Analysis population: Modified intent-to-treat (mITT) analysis set included all participants who received a JNJ-68284528 infusion at the targeted recommended phase 2 dose (RP2D) dose level. Here, N (number of participants analyzed) signifies participants who were evaluable for this outcome measure.
Groups in this outcome
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 2 (US Population) | 68 |
| Phase 2 (Japan Population) | 8 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Phase 2 (US Population) | 97.1 | Not reported | 89.8 | 99.6 | Not reported |
| Phase 2 (Japan Population) | 100.0 | Not reported | 66.4 | 100.0 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 89.8
- upper Limit
- 99.6
- value
- 97.1
- group Id
- OG001
- lower Limit
- 66.4
- upper Limit
- 100.0
- value
- 100.0
- denoms
- counts
- group Id
- OG000
- value
- 68
- group Id
- OG001
- value
- 8
- units
- Participants
- description
- ORR was defined as the percentage of participants who achieved partial response (PR) or better according to international myeloma working group (IMWG) criteria. IMWG criteria for PR: greater than or equal to (\>=) 50 percent (%) reduction of serum M-protein and reduction in 24-hour urinary M-protein by \>=90% or to less than (\<) 200 milligrams (mg) per 24 hours. If the serum and urine M-protein were not measurable, a decrease of \>=50% in the difference between involved and uninvolved free light chain (FLC) levels was required in place of the M-protein criteria. If serum and urine M-protein were not measurable, and serum free light assay was also not measurable, \>=50% reduction in bone marrow plasma cells (PCs) was required in place of M-protein, provided baseline bone marrow PC percentage was \>=30%. In addition to the above criteria, if present at baseline, a \>=50% reduction in the size of soft tissue plasmacytomas was also required.
- dispersion Type
- 95% Confidence Interval
- groups
- 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
- OG000
- 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
- OG001
- title
- Phase 2 (Japan Population)
- param Type
- NUMBER
- population Description
- Modified intent-to-treat (mITT) analysis set included all participants who received a JNJ-68284528 infusion at the targeted recommended phase 2 dose (RP2D) dose level. Here, N (number of participants analyzed) signifies participants who were evaluable for this outcome measure.
- reporting Status
- POSTED
- time Frame
- Day 1 up to 45.2 months
- title
- Phase 2: Overall Response Rate (ORR)
- type
- PRIMARY
- unit Of Measure
- Percentage of participants
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice