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A phase 3 trial of Melphalan flufenamide, Dexamethasone and Daratumumab in Multiple myeloma, run by Oncopeptides AB, recorded as terminated on the registry.
Study of Melflufen (Melphalan Flufenamide) in Combination With Daratumumab in Relapsed-Refractory Multiple Myeloma is a phase 3 interventional study registered as NCT04649060 by Oncopeptides AB, with 54 participants recorded, started 2020-12-21 and due to reach its primary completion in 2022-02-07. Interventions recorded: Melflufen, Dexamethasone, Daratumumab. Conditions recorded: Relapsed Multiple Myeloma, Relapsed-Refractory Multiple Myeloma.
Linked to the drug Melphalan flufenamide because the registry names it among its interventions and Multiple myeloma among its conditions. Registry record only: no result has been read by an editor.
Numbers are from the trial as recorded here; see the source links in the table below. This is orientation, not medical advice: ask your team how closely the trial population matches you.
54 enrolled.
The median PFS was not reached in Arm A. There were insufficient numbers of participants with events.; Figures from the ClinicalTrials.gov results section (first posted 2023-06-08), not from a publication · 95% CI 3.38 to NA
Source95% CI NA to NA; Figures from the ClinicalTrials.gov results section (first posted 2023-06-08), not from a publication · The median OS was not reached in Arm B and the 95% CI was not available due to insufficient numbers of participants with events.
Source95% CI 38.8 to 77.6; Figures from the ClinicalTrials.gov results section (first posted 2023-06-08), not from a publication · 95% CI 13.8 to 50.2
Source| Endpoint | Arm | n | Value | HR (95% CI) | p | Source |
|---|---|---|---|---|---|---|
| Progression Free Survival (PFS)primary | Arm A (Melflufen+Dexamethasone+Daratumumab) | 27 | The median PFS was not reached in Arm A. There were insufficient numbers of participants with events.; Figures from the ClinicalTrials.gov results section (first posted 2023-06-08), not from a publication | 0.184 (0.052 to 0.65) | 0.0032 | link |
| Arm B (Daratumumab) | 27 | 4.86 months | ||||
| Overall Survival (OS) | Arm A (Melflufen+Dexamethasone+Daratumumab) | 27 | 11.04 months | 0.47 (0.086 to 2.569) | 0.3721 | link |
| Arm B (Daratumumab) | 27 | The median OS was not reached in Arm B and the 95% CI was not available due to insufficient numbers of participants with events. | ||||
| Overall Response Rate (ORR) | Arm A (Melflufen+Dexamethasone+Daratumumab) | 27 | 59.3% | - | 0.03 | link |
| Arm B (Daratumumab) | 27 | 29.6% |
Shares Oncopeptides, Melphalan flufenamide, Dexamethasone, Relapsed or refractory multiple myeloma and the tag pipeline.
Shares Oncopeptides, Melphalan flufenamide, Dexamethasone, Relapsed or refractory multiple myeloma and the tag pipeline.
Shares Daratumumab, Dexamethasone, Relapsed or refractory multiple myeloma, Multiple myeloma and the tag pipeline.
Shares Dexamethasone, Relapsed or refractory multiple myeloma, Multiple myeloma and the tag pipeline.
Shares Relapsed or refractory multiple myeloma, Multiple myeloma and the tag pipeline.
Shares Relapsed or refractory multiple myeloma, Multiple myeloma and the tag pipeline.
Shares Relapsed or refractory multiple myeloma, Multiple myeloma and the tag pipeline.
Shares Relapsed or refractory multiple myeloma, Multiple myeloma and the tag pipeline.