Floatz Rating
CC47/100
Confidence
Indicative
Sponsor
Fondazione EMN Italy Onlus
Modality
Small molecule
Development Phase
Phase 3
Status
Active
Evidence ledger · v0.2
Clinical Evidence
Clinical track record: trial progression, reported outcomes, safety signals, and endpoint quality.
41High confidence
Detailed axis rationale is planned and will be published soon.
| Trial | Phase | Status | N | Primary endpoint | Readout |
|---|---|---|---|---|---|
NCT06682637CT.gov Melflufen for Elderly Patients With Relapsed Myeloma | — | Withdrawn | — | — | — |
NCT04649060CT.gov Study of Melflufen (Melphalan Flufenamide) in Combination With Daratumumab in Relapsed-Refractory Multiple Myeloma | — | Terminated | — | — | — |
NCT03639610CT.gov PK of Melphalan During Treatment With Melflufen and Dexamethasone in Patients With RRMM and Impaired Renal Function | — | Terminated | — | — | — |
NCT03481556CT.gov Study of Melphalan Flufenamide (Melflufen) + Dex With Bortezomib or Daratumumab in Patients With RRMM | — | Terminated | — | — | — |
NCT03151811CT.gov A Study of Melphalan Flufenamide (Melflufen)-Dex or Pomalidomide-dex for RRMM Patients Refractory to Lenalidomide | — | Terminated | — | — | — |
NCT02963493CT.gov A Study of Melphalan Flufenamide (Melflufen) Plus Dexamethasone in Patients With Relapsed or Refractory Multiple Myeloma | — | Completed | — | — | — |
NCT01897714CT.gov Safety and Efficacy of Melflufen and Dexamethasone in Relapsed and/or Relapsed-Refractory Multiple Myeloma Patients | — | Terminated | — | — | — |
NCT04534322CT.gov Expanded Access Program for Melphalan Flufenamide (Melflufen) in Triple Class Refractory Multiple Myeloma | — | Approved For Marketing | — | — | — |
Competitive Position
Competitive setting: how crowded the indication is, class-level failures, and timing against rivals.
59High confidence
Detailed axis rationale is planned and will be published soon.
Same indication · Plasma Cell Myeloma
| Asset | Sponsor | Phase | Rating |
|---|---|---|---|
| Melphalan Flufenamide (this asset) | Fondazione EMN Italy Onlus | P3 | CC · 47 |
| Hyaluronidase Fihj | Massachusetts General Hospital | P4 | BBB |
| Filanesib | PETHEMA Foundation | P2 | BBB |
| Vincristine Sulfate | Roswell Park Cancer Institute | P3 | BBB |
| Cyclosporin A | Seoul National University Hospital | P3 | BBB |
| Anti-Human T-Lymphocyte Immunoglobulin, Rabbit | University of Birmingham | P4 | BBB |
| Epoetin Alfa | Mayo Clinic | P3 | BB |
| Arsenic Trioxide | Duke University | P2 | BB |
| Sorafenib | OHSU Knight Cancer Institute | P2 | BB |
+42 more in the Plasma Cell Myeloma cohort
Other indications for Melphalan Flufenamide
| Indication | Sponsor | Phase | Rating |
|---|---|---|---|
| Colorectal Neoplasm | — | P3 | CCC · 48 |
| Kidney Failure | — | P2 | CC · 44 |
Scientific Foundation
Strength of the underlying biology: target validation, tractability, modality fit, and how related mechanisms have fared.
NR
Planned for methodology v0.2.
Development Feasibility
How realistically the program can be executed, drawing on modality precedent, enrollment dynamics, and sponsor delivery.
NR
Planned for methodology v0.2.
Commercial Opportunity
Commercial prize: addressable population, unmet need, and the value case for the indication.
NR
Planned for methodology v0.2.
IP & Exclusivity
Exclusivity position, covering patent protection and freedom-to-operate runway.
NR
Planned for methodology v0.2.
Manufacturing & Supply
Manufacturing and supply readiness, driven by modality process and scale-up risk.
NR
Planned for methodology v0.2.
Related assets
Citation
Floatz Terminal. Melphalan Flufenamide in Plasma Cell Myeloma. Methodology v0.2. Rated under v0.2 effective July 8, 2026. Last refreshed July 8, 2026. Accessed July 14, 2026. https://terminal.floatz.ai/assets/melphalan-flufenamide-plasma-cell-myeloma
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