Primary-outcome results across pivotal trials
Per-arm reported values from Phase 2/3 and Phase 3 trials with results posted to ClinicalTrials.gov.
| Trial | Indication | Primary endpoint | Arm | Value |
|---|---|---|---|---|
| NCT02076009 | Multiple Myeloma | Progression-free Survival (PFS) From randomization to either disease progression or death whichever occurs first (up to 21 months) | Daratumumab, Lenalidomide, Low-dose Dexamethasone (DRd) | NA months |
| Lenalidomide, Low-dose Dexamethasone (Rd) | 18.43 months | |||
| NCT02136134 | Multiple Myeloma | Progression-free Survival (PFS) From the date of randomization to either progressive disease or death, whichever occurred first (approximately 1 year 4 months) | Bortezomib + Dexamethasone (Vd) | 7.16 months |
| Daratumumab + Bortezomib and Dexamethasone (DVd) | NA months | |||
| NCT02195479 | Multiple Myeloma | Progression Free Survival (PFS) From randomization (Day -3) up to 2.4 years | Daratumumab, Velcade, Melphalan and Prednisone (D-VMP) | NA Months |
| Velcade, Melphalan and Prednisone (VMP) | 18.14 Months | |||
| NCT02252172 | Multiple Myeloma | Progression-free Survival (PFS) From randomization (Day -3) to disease progression, death, subsequent anti-myeloma therapy, withdrawal of consent to study participation or clinical cut-off (CCO) whichever occurs first (up to 3.5 years) | Daratumumab + Lenalidomide + Dexamethasone (DRd) | NA Months |
| Lenalidomide + Dexamethasone (Rd) | 31.87 Months | |||
| NCT02541383 Cassiopeia | Multiple Myeloma | Post-Consolidation Stringent Complete Response (sCR) Rate At day 100 post Autologous Stem Cell Transplant (ASCT), up to 114 days post ASCT | Arm A Part 1 | 110 Participants |
| Arm B Part 1 | 157 Participants | |||
| NCT02541383 Cassiopeia | Multiple Myeloma | Progression Free Survival (PFS) Post Completion of Maintenance Therapy From the date of second randomization to either progressive disease or death which ever occurred first, with a median follow-up time of 35.4 months (cut-off for analysis was 26 months after the last rando 2 date). | Arm A Part 2 | 46.7 Months |
| Arm B Part 2 | NA Months | |||
| NCT03158688 CANDOR | Multiple Myeloma | Progression-free Survival (PFS) as Assessed by the Independent Review Committee (PA DCO Only) From randomization until the PA DCO date of 14 July 2019; the longest treatment duration as of the DCO was 102.3 weeks | Kd - Carfilzomib and Dexamethasone | 68 Participants |
| Kd - Carfilzomib and Dexamethasone | 86 Participants | |||
| KdD - Carfilzomib, Dexamethasone and Daratumumab | 202 Participants | |||
| KdD - Carfilzomib, Dexamethasone and Daratumumab | 110 Participants | |||
| NCT03180736 EMN14 | Multiple Myeloma | Comparison of Progression Free Survival Between Treatment Arms (Daratumumab /Pomalidomide /Dexamethasone vs Pomalidomide / Dexamethasone) PFS is assessed monthly from randomization until PD or death, whichever occurs first (approximately up to 3 years). PFS2 is assessed monthly from randomization until PD or death, whichever occurs first (approximately up to 5 years). | Daratumumab+Pomalidomide+Dexamethasone | 24.41 months |
| Daratumumab+Pomalidomide+Dexamethasone | 12.42 months | |||
| Pomalidomide + Dexamethasone | 6.93 months | |||
| Pomalidomide + Dexamethasone | 17.58 months | |||
| NCT03201965 | Amyloidosis | Percentage of Participants With Overall Complete Hematologic Response (CHR) Up to 2.4 years | CyBorD | 18.1 percentage of participants |
| Daratumumab Plus CyBorD | 53.3 percentage of participants | |||
| NCT03301220 | Smoldering Multiple Myeloma | Progression-Free Survival (PFS) as Assessed by the Independent Review Committee (IRC) From randomization (Day -5) up to 77 months | Arm A: Active Monitoring (ACTM) | 41.46 Months |
| Arm B: Daratumumab SC | NA Months | |||
| NCT03357952 | Multiple Myeloma | Number of Participants With Dose Limiting Toxicity in Safety run-in Phase (Part 1) Cycle 1 (28 days) | Part 1: Daratumumab + JNJ-63723283 | 0 Participants |
| NCT03357952 | Multiple Myeloma | Number of Participants With Treatment Emergent Adverse Events (TEAE) in Safety run-in Phase (Part 1) Up to 2 years | Part 1: Daratumumab + JNJ-63723283 | 9 Participants |
| NCT03652064 | Multiple Myeloma | Final Progression-Free Survival (PFS) Analysis : Overall Minimal Residual Disease (MRD) Negative Rate From randomization (Day 1) up to 64.8 months | Arm A: Bortezomib-lenalidomide-dexamethasone (VRd) | 39.4 Percentage of participants |
| Arm B: Daratumumab-bortezomib-lenalidomide-dexamethasone (D-VRd) | 60.9 Percentage of participants | |||
| NCT03652064 | Multiple Myeloma | Primary Analysis: Overall Minimal Residual Disease (MRD) Negative Rate From randomization (Day 1) up to 27.9 months | Arm A: Bortezomib-lenalidomide-dexamethasone (VRd) | 35.4 Percentage of participants |
| Arm B: Daratumumab-bortezomib-lenalidomide-dexamethasone (D-VRd) | 53.3 Percentage of participants | |||
| NCT03710603 Perseus | Multiple Myeloma | Progression Free Survival (PFS) From the date of randomization to either progressive disease or death whichever occurred first, up to a maximum follow-up time of 54.41 months. | Daratumumab + VRd (D-VRd) | 50 Participants |
| Velcade Lenalidomide Dexamethasone (VRd) | 103 Participants | |||
| NCT03901963 AURIGA | Multiple Myeloma | Percentage of Participants Who Had Minimal Residual Disease (MRD) Conversion From Baseline to 12 Months After Start of Maintenance Treatment as Determined by Next Generation Sequencing (NGS) From randomization up to 12 months | Daratumumab + Lenalidomide | 50.5 percentage of participants |
| Lenalidomide | 18.8 percentage of participants | |||
| NCT04181827 CARTITUDE-4 | Multiple Myeloma | Progression Free Survival (PFS) From randomization (Day 1) to either progressive disease or death, whichever occurred first (up to 3.9 years) | Arm A: Standard Therapy: PVd or DPd | 11.79 months |
| Arm B: JNJ-68284528 (Ciltacabtagene Autoleucel [Cilta-cel]) | NA months | |||
| NCT04246047 DREAMM 7 | Multiple Myeloma | Progression-free Survival (PFS) Up to approximately 41 months | Belantamab Mafodotin + Bortezomib (Bor) + Dexamethasone (Dex) | 36.6 Months |
| Daratumumab + Bor + Dex | 13.4 Months | |||
| NCT04649060 LIGHTHOUSE | Multiple Myeloma | Progression Free Survival (PFS) From the date of randomization until the end of study (approximately 12 months). | Arm A (Melflufen+Dexamethasone+Daratumumab) | NA months |
| Arm B (Daratumumab) | 4.86 months | |||
| NCT06868654 DREAMM 7 | Multiple Myeloma | Progression-free Survival (PFS) Up to approximately 32 months | Belantamab Mafodotin + Bortezomib (Bor) + Dexamethasone (Dex) | NA Months |
| Daratumumab + Bor + Dex | 8.4 Months | |||
| NCT06868667 DREAMM 7 | Multiple Myeloma | Progression-free Survival (PFS) Up to approximately 32 months | Belantamab Mafodotin + Bortezomib (Bor) + Dexamethasone (Dex) | NA Months |
| Daratumumab + Bor + Dex | 11.1 Months |