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A phase 2 trial of Melphalan flufenamide and Dexamethasone in Multiple myeloma, run by Oncopeptides AB, completed.
A Study of Melphalan Flufenamide (Melflufen) Plus Dexamethasone in Patients With Relapsed or Refractory Multiple Myeloma is a phase 2 interventional study registered as NCT02963493 by Oncopeptides AB, with 157 participants recorded, started 2016-12-28 and reaching its primary completion in 2020-10-22. Interventions recorded: Melphalan flufenamide (Melflufen), Dexamethasone. Conditions recorded: 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.
157 enrolled.
Figures from the ClinicalTrials.gov results section (first posted 2022-02-01), not from a publication
Source95% CI 9.53 to 14.55; Figures from the ClinicalTrials.gov results section (first posted 2022-02-01), not from a publication · 95% CI 5.06 to 9.66 · 95% CI 7.20 to 12.29
Source95% CI 3.42 to 4.90; Figures from the ClinicalTrials.gov results section (first posted 2022-02-01), not from a publication · 95% CI 1.97 to 3.94 · 95% CI 3.09 to 4.67
Source| Endpoint | Arm | n | Value | HR (95% CI) | p | Source |
|---|---|---|---|---|---|---|
| Overall Response Rate (ORR)primary | Melphalan Flufenamide (Melflufen) + Dexamethasone: Full Analysis Set | 157 | 53 participants | - | - | link |
| Melphalan Flufenamide (Melflufen) + Dexamethasone: Patients With Extramedullary Disease | 55 | 14 participants | ||||
| Melphalan Flufenamide (Melflufen) + Dexamethasone: Patients With Triple Class Refractory Disease | 119 | 35 participants | ||||
| Overall Survival | Melphalan Flufenamide (Melflufen) + Dexamethasone: Full Analysis Set | 157 | 11.79 months | - | - | link |
| Melphalan Flufenamide (Melflufen) + Dexamethasone: Patients With Extramedullary Disease | 55 | 6.44 months | ||||
| Melphalan Flufenamide (Melflufen) + Dexamethasone: Patients With Triple Class Refractory Disease | 119 | 10.12 months | ||||
| Progression Free Survival (PFS) | Melphalan Flufenamide (Melflufen) + Dexamethasone: Full Analysis Set | 157 | 4.27 months | - | - | link |
| Melphalan Flufenamide (Melflufen) + Dexamethasone: Patients With Extramedullary Disease | 55 | 2.89 months | ||||
| Melphalan Flufenamide (Melflufen) + Dexamethasone: Patients With Triple Class Refractory Disease | 119 | 3.94 months |
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 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.
Shares Relapsed or refractory multiple myeloma, Multiple myeloma and the tag pipeline.