7 terminated, 1 approved for marketing, 1 completed, 1 withdrawn. 6 Phase 2, 3 Phase 1, 2 Phase 3.
| Phase | Trials | Status |
|---|---|---|
| Phase 2 | 6 | Terminated 4, Completed 1, Withdrawn 1 |
| Phase 1 | 3 | Terminated 3 |
| Phase 3 | 2 | Terminated 2 |
Follow melflufen: new trials by email Literature Review of melflufen trials Research Report on melflufen
Tick up to 5 trials to compare them side by side (eligibility, arms, endpoints, adverse events) in a Literature Matrix.
| Trial | Phase | Status | Sponsor | Enrollment | Start | Updated |
|---|---|---|---|---|---|---|
| Melflufen for Elderly Patients With Relapsed Myeloma Melflufen, Dexamethasone - Relapse Multiple Myeloma | Phase 2 | Withdrawn | Fondazione EMN Italy Onlus | 2025-03-26 | 2025-04-01 | |
| Study of Melflufen (Melphalan Flufenamide) in Combination With Daratumumab in Relapsed-Refractory Multiple Myeloma Melflufen, Dexamethasone, Daratumumab - Relapsed Multiple Myeloma, Relapsed-Refractory Multiple Myeloma | Phase 3 | Terminated | Oncopeptides AB | 54 | 2020-12-21 | 2023-06-08 |
| A Clinical Study of Melphalan Flufenamide (Melflufen) and Dexamethasone for Patients With Immunoglobulin Light Chain (AL) Amyloidosis Melphalan-Flufenamide (Melflufen), Dexamethasone - AL Amyloidosis | Phase 1 | Terminated | Oncopeptides AB | 6 | 2020-08-06 | 2022-03-28 |
| A PK, Safety and Tolerability Study of Peripheral and Central Infusion of Melflufen in RRMM Patients Melphalan, Dexamethasone - RRMM | Phase 2 | Terminated | Oncopeptides AB | 27 | 2020-08-04 | 2023-03-09 |
| PK of Melphalan During Treatment With Melflufen and Dexamethasone in Patients With RRMM and Impaired Renal Function Melflufen, Dexamethasone - Renal Impairment, Multiple Myeloma | Phase 2 | Terminated | Oncopeptides AB | 35 | 2018-08-28 | 2023-03-10 |
| Study of Melphalan Flufenamide (Melflufen) + Dex With Bortezomib or Daratumumab in Patients With RRMM Melphalan flufenamide (Melflufen), Dexamethasone, Bortezomib - Multiple Myeloma | Phase 1 / Phase 2 | Terminated | Oncopeptides AB | 56 | 2018-04-12 | 2022-12-19 |
| A Study of Melphalan Flufenamide (Melflufen)-Dex or Pomalidomide-dex for RRMM Patients Refractory to Lenalidomide Melflufen, Pomalidomide, Dexamethasone - Multiple Myeloma | Phase 3 | Terminated | Oncopeptides AB | 495 | 2017-06-12 | 2024-01-30 |
| A Study of Melphalan Flufenamide (Melflufen) Plus Dexamethasone in Patients With Relapsed or Refractory Multiple Myeloma Melphalan flufenamide (Melflufen), Dexamethasone - Multiple Myeloma | Phase 2 | Completed | Oncopeptides AB | 157 | 2016-12-28 | 2022-11-22 |
| Safety and Efficacy of Melflufen and Dexamethasone in Relapsed and/or Relapsed-Refractory Multiple Myeloma Patients Melflufen, Dexamethasone - Relapsed and/or Relapsed-refractory Multiple Myeloma | Phase 1 / Phase 2 | Terminated | Oncopeptides AB | 75 | 2013-07-01 | 2020-10-23 |
| Expanded Access Program for Melphalan Flufenamide (Melflufen) in Triple Class Refractory Multiple Myeloma Melphalan Flufenamide, Dexamethasone - Relapsed and/or Refractory Multiple Myeloma | Approved for marketing | Oncopeptides AB | 2021-03-18 |
Multiple Myeloma (5) · Immunoglobulin Light-chain Amyloidosis (1) · Renal Insufficiency (1)
Oncopeptides AB (9) · Fondazione EMN Italy Onlus (1)
United States (7) · Czechia (6) · Spain (5) · France (4) · Greece (4) · Italy (4) · Norway (3) · Poland (3) · Bulgaria (2) · Denmark (2) · Germany (2) · Hungary (2) · Israel (2) · Netherlands (2) · Russia (2)
Giovanni Palladini, MD (1) · Johan Harmenberg, MD (1) · Johan Harmenberg, MD, PhD (1) · Paul G Richardson, MD (1) · Pieter Sonneveld, Prof. (1)
PMID 37355418, PMID 32213344, PMID 33296242, PMID 34671975, PMID 35032434, PMID 37646657, PMID 37646660, PMID 38426292, PMID 41437395
2018 (1), 2019 (1)