NCT03481556

Study of Melphalan Flufenamide (Melflufen) + Dex With Bortezomib or Daratumumab in Patients With RRMM

An Open-Label Phase 1/2a Study of the Safety and Efficacy of Melflufen and Dexamethasone in Combination With Either Bortezomib or Daratumumab in Patients With Relapsed or Relapsed-Refractory Multiple Myeloma

• Status: Terminated
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 56 (actual)
• Sponsor: Oncopeptides AB · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is an open-label Phase 1/2a study which will enroll patients that have relapsed or relapsed-refractory multiple myeloma to combination regimens of melflufen with currently approved agents. Patients will receive either melflufen+dexamethasone+bortezomib or melflufen+dexamethasone+daratumumab.

Conditions

• Multiple Myeloma

Interventions

Type	Name	Description
DRUG	Melphalan flufenamide (Melflufen)	Intravenous infusion
DRUG	Dexamethasone	Oral tablets
DRUG	Bortezomib	Subcutaneous administration
DRUG	Daratumumab	Intravenous infusion

Timeline

• Start date: 2018-04-12
• Primary completion: 2022-02-02
• Completion: 2022-02-02
• First posted: 2018-03-29
• Last updated: 2022-12-19
• Results posted: 2022-12-19

Locations

16 sites across 4 countries: United States, Czechia, France, Spain

Regulatory

• FDA-regulated drug study