Status:
ACTIVE_NOT_RECRUITING
A Study to Assess Adverse Events and Change in Disease Activity of Intravenously (IV) Infused Etentamig (ABBV-383) in Combination With Anti-Cancer Regimens for the Treatment of Adult Participants With Relapsed/Refractory Multiple Myeloma
Lead Sponsor:
AbbVie
Conditions:
Relapsed/Refractory Multiple Myeloma
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief 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 safety and toxicity of etentamig (ABBV-...
Eligibility Criteria
Inclusion
- Eastern Cooperative Oncology Group (ECOG) performance of \<= 2.
- Must have confirmed diagnosis of Relapsed/Refractory (R/R) Multiple Myeloma (MM) with documented evidence of progression during or after the participant's last treatment regimen based on the investigator's determination of the International Myeloma Working Group (IMWG) criteria.
- Must have measurable disease as determined by central lab as outlined in the protocol.
- Must be naïve to treatment with Etentamig.
- Must have never received BCMA-targeted therapy. Participants who have received targeted therapy against non-BCMA targets will not be excluded.
- Arms A, B and C: Participant has received at least 3 prior lines of MM treatment.
- Arm E: Participant has received 1-3 prior lines of MM treatment.
Exclusion
- Received a peripheral autologous stem cell transplant (SCT) within 12 weeks, or an allogeneic SCT within 1 year of the first dose of study treatment.
- Unresolved adverse event (AE)s \>= Grade 2 (National Cancer Institute \[NCI\] Common Terminology Criteria for Adverse Events \[CTCAE\] version 5.0) from prior anticancer therapy.
- Has any of the following conditions:
- Nonsecretory Multiple Myeloma (MM).
- Active Plasma cell leukemia i.e., either 20% of peripheral white blood cells or \> 2.0 × 10\^9L circulating plasma cells by standard differential.
- Waldenstrom's macroglobulinemia.
- Light chain amyloidosis.
- Polyneuropathy, organomegaly, endocrinopathy, monoclonal protein and skin changes (POEMS) syndrome.
- Major surgery within 4 weeks prior to first dose or planned study participation.
- Acute infections within 14 days prior to first dose of study requiring therapy (antibiotic, antifungal or antiviral).
- Uncontrolled diabetes or hypertension within 14 days prior to first dose.
- Peripheral neuropathy \>= Grade 3 or \>= Grade 2 with pain within 2 weeks prior to first dose.
Key Trial Info
Start Date :
October 20 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2033
Estimated Enrollment :
283 Patients enrolled
Trial Details
Trial ID
NCT05259839
Start Date
October 20 2022
End Date
September 1 2033
Last Update
December 19 2025
Active Locations (49)
Enter a location and click search to find clinical trials sorted by distance.
1
University of Arkansas for Medical Sciences /ID# 243096
Little Rock, Arkansas, United States, 72205
2
Sylvester Comprehensive Cancer Center /ID# 243673
Miami, Florida, United States, 33136-1002
3
Moffitt Cancer Center /ID# 243437
Tampa, Florida, United States, 33612-9416
4
University of Maryland, Baltimore /ID# 243679
Baltimore, Maryland, United States, 21201