Study Assessing Activity of Intravenous (IV) Etentamig Monotherapy Versus Standard Available Therapies in Adult Participants With Relapsed or Refractory Multiple Myeloma
Launched by ABBVIE · Nov 28, 2023
Trial Information
Current as of July 24, 2025
Recruiting
Keywords
ClinConnect Summary
This clinical trial is studying a new treatment called ABBV-383 for adults with relapsed or refractory multiple myeloma, which is a type of blood cancer that affects plasma cells. The trial will compare how well ABBV-383 works on its own versus standard therapies that are currently available. It aims to see if ABBV-383 can help improve symptoms in patients whose cancer has returned or hasn’t improved with previous treatments. Around 380 participants will be involved in the study across approximately 140 locations worldwide.
To join the study, participants must be adults who have had at least two previous treatments for their multiple myeloma and have measurable disease. They should also be generally healthy enough to participate, meaning they should not have serious health issues that would prevent them from completing the study. Those who join can expect to receive treatment through an IV (a method of delivering medicine directly into the bloodstream) every 28 days for about 3.5 years. They will have regular check-ups at a hospital or clinic to monitor their health and the effects of the treatment. It's important to note that being part of this trial may involve more visits and tests than the usual treatment.
Gender
ALL
Eligibility criteria
- Inclusion Criteria:
- • 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 Criteria:
- • 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.
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
Tel Aviv, Tel Aviv, Israel
Jerusalem, Yerushalayim, Israel
Haifa, , Israel
Taipei City, , Taiwan
Springfield, Illinois, United States
Bethesda, Maryland, United States
Bay Shore, New York, United States
Bronx, New York, United States
New Hyde Park, New York, United States
New York, New York, United States
Kogarah, New South Wales, Australia
Linz, Oberoesterreich, Austria
Graz, Steiermark, Austria
Beijing, Beijing, China
Le Mans Cedex 9, Sarthe, France
Avignon Cedex 9, Vaucluse, France
Orléans, , France
Athens, Attiki, Greece
Thessaloniki, , Greece
Chiba Shi, Chiba, Japan
Natori, Miyagi, Japan
Seoul, Seoul Teugbyeolsi, Korea, Republic Of
Seoul, Seoul Teugbyeolsi, Korea, Republic Of
Seoul, Seoul Teugbyeolsi, Korea, Republic Of
Ulsan, Ulsan Gwang Yeogsi, Korea, Republic Of
Seoul, , Korea, Republic Of
Lisboa, Regiao Autonoma Da Madeira, Portugal
Pretoria, Gauteng, South Africa
Orense, Ourense, Spain
Leon, , Spain
Madrid, , Spain
Salamanca, , Spain
Valencia, , Spain
Falun, , Sweden
Taichung, Keelung, Taiwan
Taipei City, Taipei, Taiwan
Taichung, , Taiwan
Athens, , Greece
Fukuyama, Hiroshima, Japan
Suita City, Osaka, Japan
Fitzroy Melbourne, Victoria, Australia
Kuilsrivier, Western Cape, South Africa
Gifu Shi, Gifu, Japan
Amagasaki, , Japan
Waratah, New South Wales, Australia
Liverpool, New South Wales, Australia
Woolloongabba, Queensland, Australia
Krems An Der Donau, Burgenland, Austria
Hangzhou, Zhejiang, China
Odense, Syddanmark, Denmark
Vejle, Syddanmark, Denmark
St Quentin Cedex, Aisne, France
Hamburg, , Germany
Athens, Attiki, Greece
Gyor, Gyor Moson Sopron, Hungary
Kyoto Shi, Kyoto, Japan
Suita Shi, Osaka, Japan
Lublin, Lubelskie, Poland
Lisboa, , Portugal
Cape Town, Western Cape, South Africa
Lisbon, Lisboa, Portugal
Brasschaat, Limburg, Belgium
Tianjin, Tianjin, China
Uddevalla, Vastra Gotalands Lan, Sweden
Wuhan, Hubei, China
Maebashi Shi, Gunma, Japan
Fullerton, California, United States
Melbourne, Victoria, Australia
Brugge, , Belgium
Budapest, , Hungary
Catania, , Italy
Naha, Okinawa, Japan
Porto, , Portugal
Helsingborg, Sodermanlands Lan, Sweden
Jacksonville, Florida, United States
Krems An Der Donau, Niederoesterreich, Austria
Brasschaat, Antwerpen, Belgium
Helsingborg, Skane Lan, Sweden
Taichung, , Taiwan
Berkeley, California, United States
Badalona, Barcelona, Spain
Chicago, Illinois, United States
Legnano, Milano, Italy
Fairfax, Virginia, United States
Clayton, Victoria, Australia
Nagoya, Aichi, Japan
Anjo, Aichi, Japan
Fukuoka Shi, Fukuoka, Japan
Hangzhou, Zhejiang, China
Los Angeles, California, United States
Ann Arbor, Michigan, United States
Detroit, Michigan, United States
Detroit, Michigan, United States
Chapel Hill, North Carolina, United States
Charlotte, North Carolina, United States
Cincinnati, Ohio, United States
Cleveland, Ohio, United States
Clayton, Victoria, Australia
Vienna, Wien, Austria
Beijing, Beijing, China
Fuzhou, Fujian, China
Guangzhou, Guangdong, China
Zhengzhou, Henan, China
Zhengzhou, Henan, China
Nanjing, Jiangsu, China
Suzhou, Jiangsu, China
Nanchang, Jiangxi, China
Shenyang, Liaoning, China
Shanghai, Shanghai, China
Tianjin, Tianjin, China
Wenzhou, Zhejiang, China
Brno, Brno Mesto, Czechia
Hradec Králové, Hradec Kralove, Czechia
Ostrava, Ostrava Mesto, Czechia
Praha, , Czechia
Freiburg, Baden Wuerttemberg, Germany
Berlin, , Germany
Budapest, , Hungary
Petah Tikva, , Israel
Rome, Roma, Italy
Ancona, , Italy
Yoshida Gun, Fukui, Japan
Gifu Shi, Gifu, Japan
Kitaadachi Gun, Saitama, Japan
Shibuya Ku, Tokyo, Japan
Wroclaw, Dolnoslaskie, Poland
Gdansk, Pomorskie, Poland
Edirne, Istanbul, , Turkey
London, Greater London, United Kingdom
Manchester, , United Kingdom
Cambridge, Cambridgeshire, United Kingdom
Lansing, Michigan, United States
Atlanta, Georgia, United States
Antalya, , Turkey
Columbia, Missouri, United States
Charleston, South Carolina, United States
Richmond, Virginia, United States
şişli, , Turkey
Birmingham, Alabama, United States
Suita Shi, Osaka, Japan
Ankara, , Turkey
Toronto, Ontario, Canada
Nottingham, Nottinghamshire, United Kingdom
Jacksonville, Florida, United States
Atlanta, Georgia, United States
Durham, North Carolina, United States
Amagasaki, Hyogo, Japan
Memphis, Tennessee, United States
Boston, Massachusetts, United States
Wroclaw, Dolnoslaskie, Poland
Memphis, Tennessee, United States
Phoenix, Arizona, United States
Phoenix, Arizona, United States
Jacksonville, Florida, United States
Rochester, Minnesota, United States
Torino, Piemonte, Italy
Edinburgh, , United Kingdom
Boston, Massachusetts, United States
Nashville, Tennessee, United States
Xi'an, Shaanxi, China
Karlsruhe, Baden Wuerttemberg, Germany
Manati, , Puerto Rico
Edinburgh, , United Kingdom
London, Greater London, United Kingdom
Leeds, West Yorkshire, United Kingdom
London, , United Kingdom
Elmhurst, Illinois, United States
San Juan, , Puerto Rico
Frankfurt Am Main, , Germany
Edinburgh, , United Kingdom
Patients applied
Trial Officials
ABBVIE INC.
Study Director
AbbVie
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported