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

Who is this study for? Patients with Multiple Myeloma
What treatments are being studied? M3258
Status: Terminated
Location: See all (7) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 1
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).

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Participants having Eastern Co-operative Oncology Group (ECOG) Performance Status less than or equals to (\<=) 1

• Adequate hematological, hepatic and renal function as defined in the protocol

• Participant must have measurable disease of Multiple Myeloma (MM) and received greater than (\>) 3 prior lines of therapy for MM including a Proteasome Inhibitors (PI), an Immunomodulatory Imide Drug (IMiD) and an anti-CD38 mAb or who are refractory to at least PI agent (carfilzomib or bortezomib) and IMiD according to the International Myeloma Working Group (IMWG) criteria

• Participant must have documented evidence progressive disease as defined by the IMWG criteria either on or after their last regimen

• Other protocol defined inclusion criteria could apply

Locations
United States
Colorado
Colorado Blood Cancer Institute
Denver
Washington, D.c.
Georgetown University Medical Center- Research Parent
Washington
New Jersey
Hackensack University Medical Center
Hackensack
Tennessee
Sarah Cannon Research Institute
Nashville
Other Locations
France
Centre Hospitalier Regional Universitaire de Lille
Lille
CHU de Nantes
Nantes
CHU de Poitiers
Vauvert
Time Frame
Start Date: 2019-09-26
Completion Date: 2021-04-01
Participants
Target number of participants: 10
Treatments
Experimental: M3258 10 mg QD
Experimental: M3258 10 mg Twice per Week
Experimental: M3258 20 mg Twice per Week
Sponsors
Collaborators: Merck KGaA, Darmstadt, Germany
Leads: EMD Serono Research & Development Institute, Inc.

This content was sourced from clinicaltrials.gov