A Study to Assess Change in Disease Activity and Adverse Events (AE)s in Adult Participants With Multiple Myeloma Receiving Etentamig (ABBV-383) as an Intravenous (IV) Infusion Alone or in Combination With Oral, IV, Subcutaneous Daratumumab; Lenalidomide; Dexamethasone; Carfilzomib
Launched by ABBVIE · Mar 19, 2025
Trial Information
Current as of August 19, 2025
Recruiting
Keywords
ClinConnect Summary
This clinical trial is designed to evaluate a new treatment called Etentamig (ABBV-383) for adults with multiple myeloma, a type of cancer affecting the blood's plasma cells. The study aims to determine how safe and effective this drug is when given alone or in combination with other existing treatments like daratumumab, lenalidomide, and carfilzomib. The trial will involve about 440 participants across 50 sites globally, and it will assess how the body processes the drug, as well as any side effects that may occur.
To be eligible for this trial, participants must be adults diagnosed with multiple myeloma and have an Eastern Cooperative Oncology Group (ECOG) performance score of 1 or lower, which means they are generally able to carry out daily activities with minimal assistance. Throughout the study, participants will receive intravenous infusions of Etentamig, and they will have regular check-ups that include blood tests and questionnaires to monitor their health and any side effects. It's important to note that this trial may require more visits and treatments than standard care, and participants will be closely monitored for their safety and response to the treatment.
Gender
ALL
Eligibility criteria
- Inclusion Criteria:
- • Eastern cooperative oncology group (ECOG) performance of \<= 1.
- • Confirmed diagnosis of multiple myeloma (MM) according to the International Myeloma Working Group (IMWG) diagnostic criteria with either newly diagnosed or relapsed or refractory (RR) MM, depending on the substudy.
- Exclusion Criteria:
- • Participant who has known active central nervous system involvement of MM.
- • Participant who has known active infection as outlined in the protocol.
About Abbvie
AbbVie is a global biopharmaceutical company dedicated to developing innovative therapies that address complex health challenges. Founded in 2013 as a spin-off from Abbott Laboratories, AbbVie focuses on key therapeutic areas, including immunology, oncology, neuroscience, and virology. The company is committed to advancing scientific research and delivering groundbreaking treatments that enhance patient outcomes and quality of life. With a robust pipeline and a strong emphasis on collaboration, AbbVie strives to transform the future of medicine through its commitment to clinical excellence and patient-centered approaches.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Ramat Gan, Tel Aviv, Israel
Haifa, , Israel
Jerusalem, , Israel
Petah Tikva, , Israel
Denver, Colorado, United States
West Perth, Western Australia, Australia
Patients applied
Trial Officials
ABBVIE INC.
Study Director
AbbVie
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported