NCT04649060

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

A Randomized, Controlled, Open-Label Phase 3 Study of Melflufen in Combination With Daratumumab Compared With Daratumumab in Patients With Relapsed or Relapsed-Refractory Multiple Myeloma

• Status: Terminated
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 54 (actual)
• Sponsor: Oncopeptides AB · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This was a randomized, controlled, open-label, Phase 3 multicenter study which enrolled patients with Relapsed-Refractory Multiple Myeloma (RRMM) who were either double refractory to an Immunomodulatory Drug (IMiD) and a Proteasome Inhibitor (PI) (regardless of the number of prior lines of therapy), or had received at least 3 prior lines of therapy including an IMiD and a PI. Patients received treatment with melflufen+dexamethasone+daratumumab or daratumumab until documented progressive disease, unacceptable toxicity, or patient/treating physician decision. Patients in the daratumumab treatment arm had the option to receive treatment with melflufen+dexamethasone+daratumumab after confirmed progressive disease.

Conditions

• Relapsed Multiple Myeloma
• Relapsed-Refractory Multiple Myeloma

Interventions

Type	Name	Description
DRUG	Melflufen	Powder for solution for i.v. infusion
DRUG	Dexamethasone	Oral tablets
DRUG	Daratumumab	Solution for s.c. injection

Timeline

• Start date: 2020-12-21
• Primary completion: 2022-02-07
• Completion: 2022-02-07
• First posted: 2020-12-02
• Last updated: 2023-06-08
• Results posted: 2023-06-08

Locations

26 sites across 11 countries: Bulgaria, Czechia, Georgia, Germany, Greece, Norway, Poland, Russia, Serbia, Spain, Ukraine

Regulatory

• FDA-regulated drug study