NCT04075721

First in Human Dose Escalation of M3258 as a Single Agent and Expansion Study of M3258 in Combination With Dexamethasone

A Phase I Open Label First in Human Dose Escalation of the Immunoproteasome Inhibitor M3258 as a Single Agent and Expansion Study of M3258 in Combination With Dexamethasone in Participants With Relapsed Refractory Multiple Myeloma

• Status: Terminated
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 10 (actual)
• Sponsor: EMD Serono Research & Development Institute, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study was to determine the safety, tolerability, pharmacokinetics, pharmacodynamics and early efficacy signs of M3258 as a single agent and co-administered with dexamethasone in participants with Relapsed Refractory Multiple Myeloma (RRMM).

Conditions

• Multiple Myeloma

Interventions

Type	Name	Description
DRUG	M3258	Participants received M3258 at a dose of 10 milligrams (mg) orally, once daily (QD) or twice per week on Day 1 and Day 4 until disease progression.
DRUG	M3258 20 mg	Participants received M3258 at a dose of 20 mg orally, twice per week on Day 1 and Day 4 until disease progression.

Timeline

• Start date: 2019-09-26
• Primary completion: 2021-04-01
• Completion: 2021-04-01
• First posted: 2019-09-03
• Last updated: 2023-03-24
• Results posted: 2023-03-24

Locations

7 sites across 2 countries: United States, France

Regulatory

• FDA-regulated drug study