Study of Intravenously (IV) Infused Etentamig in Combination With an Oral Cereblon E3 Ligase Modulatory Drug (CELMoD) Agent Assessing Adverse Events and Change in Disease Activity in Adult Participants With Relapsed or Refractory Multiple Myeloma

Study Identifier
M24-555
CT.gov Identifier
EudraCT Identifier
Not available
EUCTIS ID
2024-512146-41-00
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Study Details

Medical Condition
  • Blood Cancer - Multiple Myeloma
  • Study Drug
  • Etentamig
  • Iberdomide
  • Phase
    Phase 1
    Sex
    Female & Male
    Age
    18+ years

    Protocol Summary

    Multiple myeloma (MM) is a plasma cell disease characterized by the growth of clonal plasma cells in the bone marrow. The purpose of this study is to assess the adverse events and change in disease activity of etentamig in combination with a cereblon E3 ligase modulatory drug (CELMoD) agent in adult participants with relapsed/refractory (R/R) multiple myeloma (MM). Adverse events and change in disease state will be assessed.

    Etentamig is an investigational drug being developed for the treatment of R/R MM. Study doctors put the participants in groups called treatment arms. Multiple doses of etentamig in combination with iberdomide will be explored. Each treatment arm receives a different dose of etentamig and iberdomide to determine a tolerable dose. Approximately 135 adult participants with R/R MM will be enrolled in the study in approximately 50 sites worldwide.

    In phase 1 participants will receive escalating intravenous (IV) etentamig in combination with oral iberdomide. In phase 2 participants will receive IV etentamig at one of two doses in combination with oral iberdomide, as part of the approximately 129 month study duration.

    There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at an approved institution (hospital or clinic). The effect of the treatment will be frequently checked by medical assessments, blood tests, questionnaires and and monitoring of side effects.

    Study Locations

    Location
    Status
    Location
    Beverly Hills Cancer Center /ID# 266921
    Beverly Hills, California, United States, 90211
    Status
    Recruiting
    Location
    Colorado Blood Cancer Institute /ID# 273751
    Denver, Colorado, United States, 80218
    Status
    Recruiting
    Location
    Washington University /ID# 266972
    St Louis, Missouri, United States, 63110
    Status
    Recruiting
    Location
    Rutgers Cancer Institute of New Jersey /ID# 266833
    New Brunswick, New Jersey, United States, 08901
    Status
    Recruiting
    Location
    Memorial Sloan Kettering Cancer Center - New York - York Avenue /ID# 270282
    New York, New York, United States, 10065
    Status
    Recruiting
    Location
    University Of North Carolina Health Care - Hillsborough Campus /ID# 278230
    Hillsborough, North Carolina, United States, 27278
    Status
    Recruiting
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