Comparison · NCT05405166-ca34e340
Isa-IV + Pd vs Isa-SC + Pd: Number of Participants With Treatment-emergent Anti-drug Antibodies (ADA) Against Isatuximab
Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.
2 sourcestrial-comparisons-2026-03-23-0.1.0
Cite this record
ConductScience Library. Isa-IV + Pd vs Isa-SC + Pd: Number of Participants With Treatment-emergent Anti-drug Antibodies (ADA) Against Isatuximab. Trial comparisons, record NCT05405166-ca34e340. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT05405166-ca34e340
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Measures6
Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.
| Measure | Value | 95% interval, lower | 95% interval, upper | Method | Note |
|---|---|---|---|---|---|
| Risk in group 1 | 0.0906 | 0.0611 | 0.132 | wilson | |
| Risk in group 2 | 0.0431 | 0.0243 | 0.0756 | wilson | |
| Risk difference, group 1 minus group 2 | 0.0474 | 0.0036 | 0.0931 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 2.1 | 1.05 | 4.22 | log | |
| Odds ratio, group 1 over group 2 | 2.21 | 1.05 | 4.63 | log | |
| Number needed to treat, for one more participant with the outcome on Isa-IV + Pd than on Isa-SC + Pd | 21.1 | 10.7 | 278 | from the risk difference interval |
Source ClinicalTrials.gov
Groups2
Neither group, or both, names a comparator, so the groups keep ClinicalTrials.gov's order.
| Group | Title | Description | With the outcome | Analysed | ClinicalTrials.gov code |
|---|---|---|---|---|---|
| Group 1 | 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. | 23 | 254 | OG000 |
| Group 2 | 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. | 11 | 255 | OG001 |
Source ClinicalTrials.gov
Outcome
- Type
- SECONDARY
- Title
- Number of Participants With Treatment-emergent Anti-drug Antibodies (ADA) Against Isatuximab
- Description
A participant with treatment-emergent ADA was a participant with at least 1 treatment induced or treatment boosted ADA at any time during the treatment or follow-up observation period. Treatment-induced ADA was defined as ADAs developed de novo (seroconversion) following administration of the biotherapeutic (ie, formation of ADAs any time after the initial study medication administration in a participant without pre-existing ADAs). Treatment-boosted ADA was defined as pre-existing ADAs that were boosted to a higher level following administration of biotherapeutic (ie, any time after the initial study medication administration) the ADA titer was significantly higher than the baseline titer. Number of participants with treatment-emergent ADAs is presented.
- Time frame
- From first dose of study medication administration (Day 1) up to PCD (06-Nov-2024), approximately 28 months
- Population
- The ADA population included all participants from safety population with at least 1 ADA result (negative, positive or inconclusive) post-baseline.
Source ClinicalTrials.gov
Trial
- Title
- SC Versus IV Isatuximab in Combination With Pomalidomide and Dexamethasone in RRMM
- NCT number
- NCT05405166
- Phases
- PHASE3
- Conditions
- Plasma Cell Myeloma Recurrent
- Interventions
- Isatuximab IV, Isatuximab SC, Dexamethasone, Pomalidomide, Dexamethasone, Montelukast, Paracetamol / Acetaminophen, Diphenhydramine, Methylprednisolone
- Lead sponsor
- Sanofi
- Results first posted
- 2025-11-14
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT05405166?tab=results
Source ClinicalTrials.gov
Source
- Release
- trial-comparisons-2026-03-23-0.1.0
- Release manifest SHA-256
- f66225897fbf258b57ea10bdacfd0347d3cdfda93f7f5685234b7e06ea36fa57
- AACT copy
- 2026-03-23
- Tables read
- outcome_counts.parquet, outcome_measurements.parquet, outcomes.parquet, reported_event_totals.parquet, reported_events.parquet, result_groups.parquet, studies.parquet, ctgov_trial.parquet
Source ClinicalTrials.gov
Sources 2
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions. The measures are ConductScience's calculation from them.
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