Status:
RECRUITING
Study Assessing Activity of Intravenous (IV) Etentamig Monotherapy Versus Standard Available Therapies in Adult Participants With Relapsed or Refractory Multiple Myeloma
Lead Sponsor:
AbbVie
Conditions:
Multiple Myeloma
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
Multiple myeloma (MM) is a cancer of the blood's plasma cells. The cancer is typically found in the bones and bone marrow (the spongy tissue inside of the bones) and can cause bone pain, fractures, in...
Eligibility Criteria
Inclusion
- Eastern Cooperative Oncology Group (ECOG) performance of \<= 2.
- Diagnosis of relapsed/refractory (R/R) multiple myeloma (MM) during or after the participant's last treatment as stated in the protocol.
- Must have measurable disease with at least 1 of the following assessed within 28 days of enrollment:
- Serum M-protein \>= 0.5 g/dL (\>= 5 g/L).
- Urine M-protein \>= 200 mg/24 hours.
- In participants without measurable serum or urine M protein, serum free light chain (FLC) \>= 100 mg/L (10 mg/dL) (involved light chain)and an abnormal serum kappa lambda ratio.
- Must have received at least 2 or more lines of therapy, including a proteasome inhibitor (PI), an immunomodulatory imide (IMiD), and an anti-CD38 monoclonal antibody (mAb).
- Must be eligible to receive the Investigator's choice standard available therapy (SAT) based on approved prescribing information, previous MM treatment history, and institutional guidelines.
Exclusion
- Clinically significant (per Investigator's judgment) drug or alcohol abuse within the last 6 months.
- Clinically significant conditions such as but not limited to the following: neurologic, psychiatric, endocrine, metabolic, immunologic, cardiovascular, pulmonary, or hepatic disease within the last 6 months that would adversely affect the participant's participation in the study.
- Central nervous system involvement of MM.
- Has received B-cell maturation antigen (BCMA)-targeted therapy.
Key Trial Info
Start Date :
May 19 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2027
Estimated Enrollment :
380 Patients enrolled
Trial Details
Trial ID
NCT06158841
Start Date
May 19 2024
End Date
December 1 2027
Last Update
December 24 2025
Active Locations (164)
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1
University of Alabama at Birmingham - Main /ID# 261434
Birmingham, Alabama, United States, 35233
2
Mayo Clinic Hospital - Phoenix /ID# 263326
Phoenix, Arizona, United States, 85054
3
Alta Bates Summit Medical Center for Research /ID# 261438
Berkeley, California, United States, 94705
4
Providence - St. Jude Medical Center /ID# 262031
Fullerton, California, United States, 92835