Study of Novel Regimens in Relapsed or Refractory Multiple Myeloma

October 23, 2024 updated by: iTeos Therapeutics

Study of EOS884448 Alone, and in Combination with Iberdomide with or Without Dexamethasone, in Participants with Relapsed or Refractory Multiple Myeloma

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).

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Terminated

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
16

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Belgium
      • Antwerp, Belgium, 2020
        • ZNA Cadix
      • Brussels, Belgium, 1070
        • Institut Jules Bordet
      • Leuven, Belgium, 3000
        • Universitaire Ziekenhuizen KU Leuven
  • France
      • Amiens, France, 80054
        • CHU Amiens
      • Nantes, France, 44093
        • Centre Hospitalier Universitaire de Nantes
      • Paris, France, 75012
        • APHP Hôpital Saint-Antoine
      • Poitiers, France, 86021
        • CHU De Poitiers
      • Toulouse, France, 31059
        • CHU Toulouse
  • Spain
      • Madrid, Spain, 28040
        • Hospital Fundacion Jimenez Diaz
  • United States
    • Arizona
      • Gilbert, Arizona, United States, 85234
        • Banner MD Anderson
    • Connecticut
      • Norwich, Connecticut, United States, 06360
        • Eastern Connecticut Hematology & Oncology
    • New Jersey
      • Hackensack, New Jersey, United States, 07601
        • Hackensack University Medical Center
    • Washington
      • Seattle, Washington, United States, 98109
        • Fred Hutchinson Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Sequential Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: A: Participants will receive EOS884448
EOS884448 will be administered
Drug: EOS884448
EOS884448 will be administered in arm A,B and C
Other Names:
  • EOS-448, GSK4428859A, Belrestotug
Experimental: B: Participants will receive EOS884448 and iberdomide
EOS884448 and iberdomide will be administered
Drug: EOS884448
EOS884448 will be administered in arm A,B and C
Other Names:
  • EOS-448, GSK4428859A, Belrestotug
Drug: Iberdomide
Iberdomide will be administered in arm B and C
Other Names:
  • CC-220
Experimental: C: Participants will receive EOS884448, iberdomide and dexamethasone
EOS884448, iberdomide and dexamethasone will be administered
Drug: EOS884448
EOS884448 will be administered in arm A,B and C
Other Names:
  • EOS-448, GSK4428859A, Belrestotug
Drug: Iberdomide
Iberdomide will be administered in arm B and C
Other Names:
  • CC-220
Drug: Dexamethasone
Dexamethasone will be administered in arm C

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Number of participants with any adverse events (AEs) and serious adverse events (SAEs)
Time Frame: From first study treatment administration up to 120 days after the last dose
From first study treatment administration up to 120 days after the last dose
Number of participants with dose limiting toxicity (DLT)
Time Frame: From first study treatment administration up to 120 days after the last dose
From first study treatment administration up to 120 days after the last dose
Recommended Phase 2 dose (RP2D) of EOS884448 alone or in combinations with iberdomide with or without dexamethasone in participants with relapse/refractory multiple myeloma
Time Frame: up to 2 years
up to 2 years
Number of participants with overall response (partial or better) as determined by IMWG criteria
Time Frame: up to 2 years
up to 2 years

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
Progression-free-survival (PFS)
Time Frame: Until disease progression or death - Approximately 24 months
Until disease progression or death - Approximately 24 months
Duration of Response (DOR)
Time Frame: Until disease progression or death - Approximately 24 months
Until disease progression or death - Approximately 24 months
Time to Response (TTR)
Time Frame: Approximately 48 weeks
Approximately 48 weeks
Maximum concentration (Cmax) of EOS884448 at each dose level
Time Frame: Approximately 48 weeks
Approximately 48 weeks
Percentage of participants with anti-drug antibodies to EOS884448
Time Frame: Approximately 48 weeks
Approximately 48 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
iTeos Therapeutics

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Bristol-Myers Squibb
GlaxoSmithKline
iTeos Belgium SA

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Iteos Clinical Trials, iTeos Belgium SA

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 1, 2022

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 29, 2023

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 29, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 11, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 18, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 21, 2022

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 26, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 23, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • TIG-007

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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