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Study of Novel Regimens in Relapsed or Refractory Multiple Myeloma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05289492
Recruitment Status : Recruiting
First Posted : March 21, 2022
Last Update Posted : June 21, 2022
Sponsor:
Collaborators:
Bristol-Myers Squibb
GlaxoSmithKline
iTeos Therapeutics
Information provided by (Responsible Party):
iTeos Therapeutics ( iTeos Belgium SA )

Study Description
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Brief Summary:
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).

Condition or disease Intervention/treatment Phase
Multiple Myeloma Drug: EOS884448 Drug: Iberdomide Drug: Dexamethasone Phase 1 Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 162 participants
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Study of EOS884448 Alone, and in Combination With Iberdomide With or Without Dexamethasone, in Participants With Relapsed or Refractory Multiple Myeloma
Actual Study Start Date : May 1, 2022
Estimated Primary Completion Date : February 1, 2024
Estimated Study Completion Date : December 31, 2025

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Multiple Myeloma

Arms and Interventions
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Arm Intervention/treatment
Experimental: A: Participants will receive EOS884448
EOS884448 will be administered
 Drug: EOS884448
EOS884448 will be administered in arm A,B and C
Other Name: EOS-448, GSK4428859A
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 Name: EOS-448, GSK4428859A

Drug: Iberdomide
Iberdomide will be administered in arm B and C
Other Name: 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 Name: EOS-448, GSK4428859A

Drug: Iberdomide
Iberdomide will be administered in arm B and C
Other Name: CC-220

Drug: Dexamethasone
Dexamethasone will be administered in arm C


Outcome Measures
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Primary Outcome Measures :
  1. 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 ]
  2. Number of participants with dose limiting toxicity (DLT) [ Time Frame: From first study treatment administration up to 120 days after the last dose ]
  3. 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 ]
  4. Number of participants with overall response (partial or better) as determined by IMWG criteria [ Time Frame: up to 2 years ]

Secondary Outcome Measures :
  1. Progression-free-survival (PFS) [ Time Frame: Until disease progression or death - Approximately 24 months ]
  2. Duration of Response (DOR) [ Time Frame: Until disease progression or death - Approximately 24 months ]
  3. Time to Response (TTR) [ Time Frame: Approximately 48 weeks ]
  4. Maximum concentration (Cmax) of EOS884448 at each dose level [ Time Frame: Approximately 48 weeks ]
  5. Percentage of participants with anti-drug antibodies to EOS884448 [ Time Frame: Approximately 48 weeks ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05289492


Contacts
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Contact: iTeos Belgium SA +3271919933 clinical_info@iteostherapeutics.com

Locations
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United States, New Jersey
Hackensack University Medical Center Recruiting
Hackensack, New Jersey, United States, 07601
Contact: David S. Siegel, MD, PhD         
Belgium
Institut Jules Bordet Recruiting
Brussels, Belgium, 1070
Contact: Nathalie Meuleman, MD, PhD         
Universitaire Ziekenhuizen KU Leuven Recruiting
Leuven, Belgium, 3000
Contact: Michel Delforge, MD, Pr.         
France
Centre Hospitalier Universitaire de Nantes Recruiting
Nantes, France, 44093
Contact: Philippe Moreau, MD, Pr.         
Sponsors and Collaborators
iTeos Belgium SA
Bristol-Myers Squibb
GlaxoSmithKline
iTeos Therapeutics
Investigators
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Study Director: Iteos Clinical Trials iTeos Belgium SA
More Information
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Responsible Party: iTeos Belgium SA
ClinicalTrials.gov Identifier: NCT05289492    
Other Study ID Numbers: TIG-007
First Posted: March 21, 2022    Key Record Dates
Last Update Posted: June 21, 2022
Last Verified: June 2022

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by iTeos Therapeutics ( iTeos Belgium SA ):
Multiple Myeloma
EOS884448
GSK4428859A
TIGIT
Anti-TIGIT
 iberdomide
CELMoD
CC-220
EOS-448
Additional relevant MeSH terms:
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Multiple Myeloma
Neoplasms, Plasma Cell
Neoplasms by Histologic Type
Neoplasms
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Paraproteinemias
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Lymphoproliferative Disorders
Immunoproliferative Disorders
 Immune System Diseases
Dexamethasone
Anti-Inflammatory Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents