RECRUITING

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 Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Phase 1/2 Study of Etentamig in Combination With a CELMoD Agent for the Treatment of Patients With Relapsed/Refractory Multiple Myeloma

Quick Facts

Study Start:2025-08-07
Study Completion:2037-01
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06896916

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.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Eastern Cooperative Oncology Group (ECOG) performance of 0 to 1.
  2. * Must have confirmed diagnosis of Relapsed/Refractory Multiple Myeloma (RRMM) after the participant's last treatment, as outlined in the protocol.
  3. * All participants must have measurable diseases per central laboratory as outlined in protocol
  1. * Has received prior etentamig treatment.
  2. * Prior exposure to BCMA-targeted therapy as noted in the protocol.
  3. * Has received prior cereblon E3 ligase modulatory drug (CELMoD) (iberdomide or mezigdomide).

Contacts and Locations

Study Contact

ABBVIE CALL CENTER
CONTACT
844-663-3742
abbvieclinicaltrials@abbvie.com

Principal Investigator

TeneoOne Inc
STUDY_DIRECTOR
TeneoOne Inc.

Study Locations (Sites)

Colorado Blood Cancer Institute /ID# 273751
Denver, Colorado, 80218
United States

Collaborators and Investigators

Sponsor: TeneoOne Inc.

  • TeneoOne Inc, STUDY_DIRECTOR, TeneoOne Inc.

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 Registration Dates

Study Start Date2025-08-07
Study Completion Date2037-01

Study Record Updates

Study Start Date2025-08-07
Study Completion Date2037-01

Terms related to this study

Keywords Provided by Researchers

  • Multiple Myeloma
  • Cereblon E3 Ligase Modulatory Drug
  • CELMoD
  • Iberdomide
  • Etentamig
  • ABBV-383

Additional Relevant MeSH Terms

  • Multiple Myeloma