Study of Novel Regimens in Relapsed or Refractory Multiple Myeloma

NCT ID: NCT05289492

Last Updated: 2024-10-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

TERMINATED

Clinical Phase

PHASE1

Total Enrollment

16 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-05-01

Study Completion Date

2023-11-29

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

This is a multicenter, open-label, phase I/II clinical study, to assess the safety, tolerability, antitumor activity, pharmacokinetics and pharmacodynamics of EOS884448 (also known as EOS-448 or GSK4428859A), alone or in combination with iberdomide with and without dexamethasone in participants with relapsed/refractory multiple myeloma (RRMM).

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Multiple Myeloma

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NON_RANDOMIZED

Intervention Model

SEQUENTIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

A: Participants will receive EOS884448

EOS884448 will be administered

Group Type EXPERIMENTAL

EOS884448

Intervention Type DRUG

EOS884448 will be administered in arm A,B and C

B: Participants will receive EOS884448 and iberdomide

EOS884448 and iberdomide will be administered

Group Type EXPERIMENTAL

EOS884448

Intervention Type DRUG

EOS884448 will be administered in arm A,B and C

Iberdomide

Intervention Type DRUG

Iberdomide will be administered in arm B and C

C: Participants will receive EOS884448, iberdomide and dexamethasone

EOS884448, iberdomide and dexamethasone will be administered

Group Type EXPERIMENTAL

EOS884448

Intervention Type DRUG

EOS884448 will be administered in arm A,B and C

Iberdomide

Intervention Type DRUG

Iberdomide will be administered in arm B and C

Dexamethasone

Intervention Type DRUG

Dexamethasone will be administered in arm C

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

EOS884448

EOS884448 will be administered in arm A,B and C

Intervention Type DRUG

Iberdomide

Iberdomide will be administered in arm B and C

Intervention Type DRUG

Dexamethasone

Dexamethasone will be administered in arm C

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

EOS-448, GSK4428859A, Belrestotug CC-220

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* All participants must have a documented diagnosis of relapse/refractory Multiple Myeloma and have measurable disease as defined per IMWG criteria.
* All participants must have received at least 3 prior lines of MM therapy with IMiD, PI and Anti-CD-38, and progressed on their last therapy (prior BCMA targeted therapy allowed).
* All participants must have Eastern Cooperative Oncology Group (ECOG) Performance Status of 0,1or 2.
* All participants must have adequate organ function.
* Females of childbearing potential (FCBP) or male participant must agree to follow contraception requirements.

Exclusion Criteria

* All participants with non-secretory MM
* All participants with known auto-immune disease
* All participants with history of life-threatening toxicity related to prior immune therapy.
* All participants with active graft versus host disease after allogeneic stem cell transplantation.
* All participants with active, unstable cardiovascular function.
* All participants with active infection requiring systemic therapy.
* All participants with hypersensitivity to any of the treatments.
* All participants with any active gastrointestinal dysfunction that prevents the patient from swallowing tablets or interferes with absorption of study treatment.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Bristol-Myers Squibb

INDUSTRY

Sponsor Role collaborator

GlaxoSmithKline

INDUSTRY

Sponsor Role collaborator

iTeos Belgium SA

INDUSTRY

Sponsor Role collaborator

iTeos Therapeutics

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Iteos Clinical Trials

Role: STUDY_DIRECTOR

iTeos Belgium SA

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Banner MD Anderson

Gilbert, Arizona, United States

Site Status

Eastern Connecticut Hematology & Oncology

Norwich, Connecticut, United States

Site Status

Hackensack University Medical Center

Hackensack, New Jersey, United States

Site Status

Fred Hutchinson Cancer Center

Seattle, Washington, United States

Site Status

ZNA Cadix

Antwerp, , Belgium

Site Status

Institut Jules Bordet

Brussels, , Belgium

Site Status

Universitaire Ziekenhuizen KU Leuven

Leuven, , Belgium

Site Status

CHU Amiens

Amiens, , France

Site Status

Centre Hospitalier Universitaire de Nantes

Nantes, , France

Site Status

APHP Hôpital Saint-Antoine

Paris, , France

Site Status

CHU de Poitiers

Poitiers, , France

Site Status

CHU Toulouse

Toulouse, , France

Site Status

Hospital Fundacion Jimenez Diaz

Madrid, , Spain

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States Belgium France Spain

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

TIG-007

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Ixazomib + Pomalidomide + Dexamethasone In MM
NCT04094961 ACTIVE_NOT_RECRUITING PHASE1/PHASE2