Comparison · NCT04181827-sae
Arm A: Standard Therapy: PVd or DPd vs Arm B: JNJ-68284528 (Ciltacabtagene Autoleucel [Cilta-cel]): serious adverse events
Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.
2 sourcestrial-comparisons-2026-03-23-0.1.0
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ConductScience Library. Arm A: Standard Therapy: PVd or DPd vs Arm B: JNJ-68284528 (Ciltacabtagene Autoleucel [Cilta-cel]): serious adverse events. Trial comparisons, record NCT04181827-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT04181827-sae
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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 | 0.471 | 0.404 | 0.539 | wilson | |
| Risk in group 2 | 0.471 | 0.404 | 0.539 | wilson | |
| Risk difference, group 1 minus group 2 | 0 | -0.0951 | 0.0951 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 1 | 0.816 | 1.23 | log | |
| Odds ratio, group 1 over group 2 | 1 | 0.68 | 1.47 | log | |
| Number needed to harm | from the risk difference interval | the two groups' risks are equal |
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 | Arm A: Standard Therapy: PVd or DPd | Participants received either PVd or DPd as standard therapy. In pomalidomide, bortezomib and dexamethasone (PVd) treatment, participants received pomalidomide 4 milligrams (mg) orally (PO) on Days 1 to 14 in each treatment cycle; bortezomib 1.3 mg/meter square (m\^2) subcutaneous (SC) injection on Days 1, 4, 8 and 11 (Cycles 1 to 8) and on Days 1 and 8 (Cycle 9 onwards); and dexamethasone 20 mg (or 10 mg for participants aged greater than \[\>\] 75 years) PO on Days 1, 2, 4, 5, 8, 9, 11 and 12 (Cycles 1 to 8) and Days 1, 2, 8 and 9 (Cycle 9 onwards). Each treatment cycle of 21 days. In daratumumab, pomalidomide and dexamethasone (DPd) treatment, participants received daratumumab 1800 mg SC injection weekly on Days 1, 8, 15 and 22 (Cycle 1 and 2), every 2 weeks on Days 1 and 15 (Cycle 3 to 6) and every 4 weeks on Day 1 (Cycle 7 onwards); pomalidomide 4 mg PO on Days 1 to 21 (Cycle 1 onwards); dexamethasone 40 mg (or 20 mg for participants aged \>75 years) PO or intravenous(IV) weekly during Cycle 1-2 on Days 1, 8, 15, and 22 or split with 20 mg on Days 1, 2, 8, 9, 15, 16, 22, and 23. Each treatment cycle of 28 days. Participants continued to receive PVd or DPd until confirmed progressive disease (PD), death, intolerable toxicity, withdrawal of consent, or end of study, whichever occurred earlier. | 98 | 208 | EG000 |
| Group 2 | Arm B: JNJ-68284528 (Ciltacabtagene Autoleucel [Cilta-cel]) | Participants received at least one cycle of bridging therapy, that is PVd: pomalidomide 4 mg PO on Days 1 to 14, bortezomib 1.3 mg/m\^2 SC injection on Days 1, 4, 8, and 11, and dexamethasone 20 mg (or 10 mg for participants aged \>75 years) PO on Days 1, 2, 4, 5, 8, 9, 11, and 12; each treatment cycle of 21 days. DPd: daratumumab SC 1800 mg (co-formulated with rHuPH20) weekly on Days 1, 8, 15, and 22, pomalidomide 4 mg PO on Days 1 to 21, and dexamethasone PO or IV 40 mg (or 20 mg for participants aged \>75 years) weekly during Cycle 1-2 on Days 1, 8, 15, and 22 or split with 20 mg on Days 1, 2, 8, 9, 15, 16, 22, and 23. Each treatment cycle of 28 days. Additional cycles of bridging therapy was considered based on participant's clinical status and timing of availability of JNJ-68284528 (cilta-cel). Followed by bridging therapy, participants received conditioning regimen: cyclophosphamide 300 mg/m\^2 IV and fludarabine 30 mg/m\^2 IV daily, for 3 days on chimeric antigen receptor T cells (CAR-T) Day -5, -4, -3 (prior to JNJ-68284528 infusion), followed by JNJ-68284528 (cilta-cel) infusion 0.75\*10\^6 chimeric antigen receptor (CAR)-positive viable T cells per kilogram (kg) 5 to 7 days after the start of conditioning regimen. | 98 | 208 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- All-cause mortality: From randomization (Day 1) up to 3.9 years; SAEs/Other AEs: Arm A: From Cycle 1 Day 1 up to 45 months; Arm B: From Cycle 1 Day 1 up to 8 months
Source ClinicalTrials.gov
Trial
- Title
A Study Comparing JNJ-68284528, a CAR-T Therapy Directed Against B-cell Maturation Antigen (BCMA), Versus Pomalidomide, Bortezomib and Dexamethasone (PVd) or Daratumumab, Pomalidomide and Dexamethasone (DPd) in Participants With Relapsed and Lenalidomide-Refractory Multiple Myeloma
- NCT number
- NCT04181827
- Phases
- PHASE3
- Conditions
- Multiple Myeloma
- Interventions
- Cilta-cel, Pomalidomide, Bortezomib, Dexamethasone, Daratumumab
- Lead sponsor
- Janssen Research & Development, LLC
- Results first posted
- 2025-05-20
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT04181827?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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