Melflufen

DRUG5 trials

Conditions

Multiple MyelomaRelapse Multiple MyelomaRelapsed Multiple MyelomaRelapsed and/or Relapsed-refractory Multiple MyelomaRelapsed-Refractory Multiple MyelomaRenal Impairment

Phase 1

Safety and Efficacy of Melflufen and Dexamethasone in Relapsed and/or Relapsed-Refractory Multiple Myeloma Patients

TerminatedNCT01897714

Oncopeptides ABRelapsed and/or Relapsed-refractory Multiple Myeloma

Start: 2013-07-31End: 2020-03-31Updated: 2020-10-23

Phase 2

PK of Melphalan During Treatment With Melflufen and Dexamethasone in Patients With RRMM and Impaired Renal Function

TerminatedNCT03639610

Oncopeptides ABMultiple Myeloma, Renal Impairment

Start: 2018-08-28End: 2021-12-22Updated: 2023-03-10

Melflufen for Elderly Patients With Relapsed Myeloma

WithdrawnNCT06682637

Fondazione EMN Italy OnlusRelapse Multiple Myeloma

Start: 2025-03-26End: 2025-03-26Updated: 2025-04-01

Phase 3

A Study of Melphalan Flufenamide (Melflufen)-Dex or Pomalidomide-dex for RRMM Patients Refractory to Lenalidomide

TerminatedNCT03151811

Oncopeptides ABMultiple Myeloma

Start: 2017-06-12End: 2023-02-03Updated: 2024-01-30

Study of Melflufen (Melphalan Flufenamide) in Combination With Daratumumab in Relapsed-Refractory Multiple Myeloma

TerminatedNCT04649060

Oncopeptides ABRelapsed Multiple Myeloma, Relapsed-Refractory Multiple Myeloma

Start: 2020-12-21End: 2022-02-07Updated: 2023-06-08

2025-12-23

Exceptional long-term responses from OCEAN and HORIZON trials: melflufen-dexamethasone as an expansion of treatment options for relapsed/refractory multiple myeloma in the era of new immunotherapies?

2025-10-09

Long-Term Outcomes from the Phase 3 OCEAN (OP-103) Study: Melflufen and Dexamethasone (Dex) Versus Pomalidomide (Pom) and Dex in Relapsed Refractory Multiple Myeloma (RRMM)

Blood2023-11-022 citations

Developments of Multiple Myeloma Treatment During the COVID-19 Era

Oncology Times2023-10-05

Efficacy and safety of melflufen plus daratumumab and dexamethasone in relapsed/refractory multiple myeloma: results from the randomized, open-label, phase III LIGHTHOUSE study

Haematologica2023-08-309 citations

Benefit Versus Risk Assessment of Melflufen and Dexamethasone in Relapsed/Refractory Multiple Myeloma: Analyses From Longer Follow-up of the OCEAN and HORIZON Studies

Clinical Lymphoma Myeloma & Leukemia2023-05-069 citations

P34 LIGHTHOUSE (OP-108): MELFLUFEN PLUS DARATUMUMAB (DARA) AND DEXAMETHASONE (DEX) VERSUS DARA IN RELAPSED/REFRACTORY MULTIPLE MYELOMA (RRMM) REFRACTORY TO AN IMMUNOMODULATORY DRUG (IMID) AND A PROTEASOME INHIBITOR (PI) OR HAD RECEIVED ≥3 PRIOR LINES OF THERAPY INCLUDING AN IMID AND A PI

HemaSphere2023-05-011 citations

P38 PATIENT-REPORTED OUTCOMES (PRO) IN RELAPSED/REFRACTORY MULTIPLE MYELOMA (RRMM) TREATED WITH MELFLUFEN AND DEXAMETHASONE (DEX) OR POMALIDOMIDE (POM) AND DEX: ANALYSES FROM THE PHASE 3 OCEAN STUDY

HemaSphere2023-05-011 citations

Melflufen or pomalidomide plus dexamethasone for patients with multiple myeloma refractory to lenalidomide (OCEAN): a randomised, head-to-head, open-label, phase 3 study.

2022-01-1258 citations

OCEAN (OP-103): Melflufen/Dexamethasone Compared with Pomalidomide/Dexamethasone in Patients with Relapsed/Refractory Multiple Myeloma-Age Subgroup Analysis of Older Patients

Blood2021-11-052 citations

OCEAN (OP-103): Melflufen Plus Dexamethasone (Dex) Versus Pomalidomide (Pom) and Dex in Relapsed Refractory Multiple Myeloma (RRMM) - Renal Impairment (RI) Analysis

Blood2021-11-051 citations

OCEAN (OP-103): Melflufen Plus Dexamethasone (Dex) Versus Pomalidomide (Pom) and Dex in Relapsed/Refractory Multiple Myeloma (RRMM) - Impact of Prior Treatments Analysis

Blood2021-11-051 citations

OCEAN (OP-103): Melflufen/Dexamethasone (Dex) Compared with Pomalidomide (Pom)/Dex in Patients (Pts) with Relapsed/Refractory Multiple Myeloma (RRMM) - Safety and Tolerability Analyses

Blood2021-11-05

LIGHTHOUSE (OP-108): A phase 3 study of melflufen in combination with dexamethasone (dex) and daratumumab (dara) versus dara in relapsed/refractory multiple myeloma (RRMM) patients (pts).

Journal of Clinical Oncology2021-05-203 citations

Melflufen plus dexamethasone (dex) in patients (pts) with relapsed/refractory multiple myeloma (RRMM) exposed/refractory to prior alkylators: A pooled analysis of the O-12-M1 and HORIZON studies.

Journal of Clinical Oncology2021-05-201 citations

HORIZON (OP-106): An exploratory analysis of time-to-next treatment (TTNT) in patients (pts) with relapsed/refractory multiple myeloma (RRMM) who received melflufen plus dexamethasone (dex).

Journal of Clinical Oncology2020-05-205 citations

Melflufen plus dexamethasone in relapsed and refractory multiple myeloma (O-12-M1): a multicentre, international, open-label, phase 1-2 study.

2020-03-2361 citations

OCEAN: a randomized Phase III study of melflufen + dexamethasone to treat relapsed refractory multiple myeloma

Future Oncology2020-03-0636 citations

Clinical Activity of Melflufen in Patients with Triple-Class Refractory Multiple Myeloma and Poor-Risk Features in an Updated Analysis of HORIZON (OP-106), a Phase 2 Study in Patients with Relapsed/Refractory Multiple Myeloma Refractory to Pomalidomide and/or Daratumumab

Blood2019-11-1312 citations

Updated Progression-Free Survival (PFS) and Overall Survival (OS) with Melflufen and Dexamethasone in Patients with Relapsed/Refractory Multiple Myeloma (RRMM): Results from the Phase 2 Study O-12-M1

Blood2019-11-133 citations

6 more papers not shown

Melflufen

Sponsors

Conditions

Phase 1

Phase 2

Phase 3

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