TriangleNCT05405166 · OUTCOME
ORR Based on at Least 1 Chromosomal Abnormality
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
- Not reported
- Time frame
- From first dose of study medication administration (Day 1) up to DCO date (29-Aug-2025), approximately 38 months
What was measured
BM aspirate was collected for fluorescent in situ hybridization for analysis of del\[17p\], t\[4;14\], t\[14;16\]) and 1q21+. ORR was also evaluated based on IRC assessment by disease characteristics. ORR for participants with at least 1 chromosomal abnormality i.e. \[del(17p)\] or \[1q21+ and t(4;14) or t(14;16)\] is presented. Percentages are rounded off to the tenth decimal place.
Analysis population: The ITT population included all randomized population. Only participants with at least 1 chromosomal abnormality are included in the analysis.
Groups in this outcome
Isa-IV + Pd
Participants received isatuximab 10 mg/kg IV infusion QW (i.e. on Days 1, 8, 15 and 22) in Cycle 1 (28 days) and then 10 mg/kg Q2W (i.e. on Days 1 and 15) of each subsequent 28-day cycle along with pomalidomide 4 mg orally on Days 1 to 21 of each 28-day cycle and dexamethasone 40 mg (or 20 mg for participant \>=75 years) orally on Days 1, 8, 15, and 22 of each cycle until disease progression, unacceptable AEs, participant request to discontinue treatment, or any other reason, whichever came first.
Isa-SC + Pd
Participants received isatuximab 1400 mg SC injection administered via an OBDS which is an investigational device injector QW (i.e on Days 1, 8, 15 and 22) in Cycle 1 (28 days) and then 1400 mg Q2W (i.e. on Days 1 and 15) of each subsequent 28-day cycle along with pomalidomide 4 mg orally on Days 1 to 21 of each 28-day cycle and dexamethasone 40 mg (or 20 mg for participant \>=75 years) orally on Days 1, 8, 15, and 22 of each cycle until disease progression, unacceptable AEs, participant request to discontinue treatment, or any other reason, whichever came first.
| Group | Source count |
|---|---|
| Isa-IV + Pd | 53 |
| Isa-SC + Pd | 48 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Isa-IV + Pd | 62.3 | Not reported | Not reported | Not reported | Not reported |
| Isa-SC + Pd | 62.5 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 62.3
- group Id
- OG001
- value
- 62.5
- denoms
- counts
- group Id
- OG000
- value
- 53
- group Id
- OG001
- value
- 48
- units
- Participants
- description
- BM aspirate was collected for fluorescent in situ hybridization for analysis of del\[17p\], t\[4;14\], t\[14;16\]) and 1q21+. ORR was also evaluated based on IRC assessment by disease characteristics. ORR for participants with at least 1 chromosomal abnormality i.e. \[del(17p)\] or \[1q21+ and t(4;14) or t(14;16)\] is presented. Percentages are rounded off to the tenth decimal place.
- groups
- description
- Participants received isatuximab 10 mg/kg IV infusion QW (i.e. on Days 1, 8, 15 and 22) in Cycle 1 (28 days) and then 10 mg/kg Q2W (i.e. on Days 1 and 15) of each subsequent 28-day cycle along with pomalidomide 4 mg orally on Days 1 to 21 of each 28-day cycle and dexamethasone 40 mg (or 20 mg for participant \>=75 years) orally on Days 1, 8, 15, and 22 of each cycle until disease progression, unacceptable AEs, participant request to discontinue treatment, or any other reason, whichever came first.
- id
- OG000
- title
- Isa-IV + Pd
- description
- Participants received isatuximab 1400 mg SC injection administered via an OBDS which is an investigational device injector QW (i.e on Days 1, 8, 15 and 22) in Cycle 1 (28 days) and then 1400 mg Q2W (i.e. on Days 1 and 15) of each subsequent 28-day cycle along with pomalidomide 4 mg orally on Days 1 to 21 of each 28-day cycle and dexamethasone 40 mg (or 20 mg for participant \>=75 years) orally on Days 1, 8, 15, and 22 of each cycle until disease progression, unacceptable AEs, participant request to discontinue treatment, or any other reason, whichever came first.
- id
- OG001
- title
- Isa-SC + Pd
- param Type
- NUMBER
- population Description
- The ITT population included all randomized population. Only participants with at least 1 chromosomal abnormality are included in the analysis.
- reporting Status
- POSTED
- time Frame
- From first dose of study medication administration (Day 1) up to DCO date (29-Aug-2025), approximately 38 months
- title
- ORR Based on at Least 1 Chromosomal Abnormality
- type
- SECONDARY
- unit Of Measure
- percentage of participants
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice