ClinConnect ClinConnect Logo
Search / Trial NCT06158841

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 22, 2025

Recruiting

Keywords

Cervino Multiple Myeloma Etentamig Carfilzomib Pomalidomide Elotuzumab Selinexor Bortezomib Dexamethasone

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.

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

0 patients applied

Trial Officials

ABBVIE INC.

Study Director

AbbVie

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported