Comparison · NCT05405166-deaths
Isa-IV + Pd vs Isa-SC + Pd: deaths from any cause
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: deaths from any cause. Trial comparisons, record NCT05405166-deaths. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT05405166-deaths
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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 | 0.183 | 0.141 | 0.233 | wilson | |
| Risk in group 2 | 0.19 | 0.147 | 0.242 | wilson | |
| Risk difference, group 1 minus group 2 | -0.00728 | -0.0737 | 0.0591 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 0.962 | 0.674 | 1.37 | log | |
| Odds ratio, group 1 over group 2 | 0.953 | 0.616 | 1.48 | log | |
| Number needed to treat, for one fewer death from any cause on Isa-IV + Pd than on Isa-SC + Pd | 137 | from the risk difference interval | the interval includes no difference |
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. | 49 | 268 | EG000 |
| 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. | 50 | 263 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, all-cause mortality
- Time frame
Adverse events and deaths were collected from first dose of study medication administration (Day 1) up to 30 days after the last dose of study medication, approximately 28 months. Interim results are presented up to PCD of 06-Nov-2024.
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.
For software
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