A Phase 3, Multicenter, Randomized, Open Label Study of Etentamig Compared With Standard Available Therapies in Subjects With Relapsed or Refractory Multiple Myeloma (3L+ RRMM Monotherapy Study)
A Phase 3, Multicenter, Randomized, Open Label Study of Etentamig Compared With Standard Available Therapies in Subjects With Relapsed or Refractory Multiple Myeloma (3L+ RRMM Monotherapy Study)
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, infections, weaker bones, and kidney failure. Treatments are available, but MM can come back (relapsed) or may not get better (refractory) with treatment. This is a study to determine change in disease symptoms of etentamig compared to standard available therapies in adult participants with relapsed/refractory (R/R) MM.
Etentamig is an investigational drug being developed for the treatment of R/R MM. This study is broken into 2 Arms; Arm A and Arm B. In Arm A, participants will receive etentamig as a monotherapy. In Arm B, participants will receive the standard available therapy (SAT) identified by the Investigator during screening, in accordance with the local (or applicable) approved label, package insert, summary of product characteristics, and/or the institutional guidelines, as applicable. Around 380 adult participants with relapsed/refractory multiple myeloma will be enrolled at approximately 140 sites across the world.
In Arm A participants will receive etentamig as an infusion into the vein in 28 day cycles, during the 3.5 year study duration. In Arm B, participants will receive the SAT identified by the Investigator during screening, in accordance with the local (or applicable) approved label, package insert, summary of product characteristics, and/or the institutional guidelines, as applicable, during the 3.5 year study duration.
There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests, checking for side effects and questionnaires.
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:
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).
-- US and Puerto Rico only: Participant must have received at least 1 or more line of therapy, including exposure to a PI, an IMiD, and an anti-CD38 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:
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Birmingham, Alabama 35233, United States
Berkeley, California 94705, United States
Fullerton, California 92835, United States
Lone Tree, Colorado 80124, United States
Jacksonville, Florida 32256, United States
Atlanta, Georgia 30322, United States
Chicago, Illinois 60607, United States
Baton Rouge, Louisiana 70808, United States
Bethesda, Maryland 20817, United States
Boston, Massachusetts 02215, United States
Ann Arbor, Michigan 48109-1276, United States
Lansing, Michigan 48912, United States
Omaha, Nebraska 68130, United States
Bay Shore, New York 11706, United States
New Hyde Park, New York 11042, United States
New York, New York 10028, United States
Charlotte, North Carolina 28204, United States
Charleston, South Carolina 29425, United States
Memphis, Tennessee 38103, United States
Nashville, Tennessee 37232-0011, United States
Norfolk, Virginia 23502, United States
Richmond, Virginia 23298, United States
Woolloongabba, Queensland 4102, Australia
Clayton, Victoria 3168, Australia
Fitzroy Melbourne, Victoria 3065, Australia
Toronto, Ontario M5G 2M9, Canada
Beijing, Beijing Municipality 100020, China
Beijing, Beijing Municipality 100730, China
Wuhan, Hubei 430022, China
Suzhou, Jiangsu 215006, China
Nanchang, Jiangxi 330006, China
Shenyang, Liaoning 110001, China
Xi'an, Shaanxi 710004, China
Tianjin, Tianjin Municipality 300020, China
Tianjin, Tianjin Municipality 300052, China
Hangzhou, Zhejiang 310003, China
Hangzhou, Zhejiang 310020, China
Wenzhou, Zhejiang 325000, China
Orléans, 45067, France
Freiburg im Breisgau, Baden-Wurttemberg 79106, Germany
Berlin, 12203, Germany
Frankfurt am Main, 60389, Germany
Athens, 10676, Greece
Győr, Győr-Moson-Sopron 9024, Hungary
Turin, Piedmont 10126, Italy
Rome, Roma 00161, Italy
Yoshida-gun, Fukui 910-1104, Japan
Amagasaki, Hyōgo 660-8550, Japan
Kyoto, Kyoto 602-8566, Japan
Suita-shi, Osaka 565-0871, Japan
Kitaadachi-gun, Saitama 362-0806, Japan
Bunkyo Ku, Tokyo 113-8677, Japan
Shibuya-ku, Tokyo 150-8935, Japan
Chuo-shi, Yamanashi 409-3898, Japan
Wroclaw, Lower Silesian Voivodeship 50-556, Poland
Lublin, Lublin Voivodeship 20-081, Poland
Gdansk, Pomeranian Voivodeship 80-214, Poland
Porto, 4200-072, Portugal
Seoul, Seoul Teugbyeolsi 06591, South Korea
Ankara, 06200, Turkey (Türkiye)
Edirne, Istanbul, 22030, Turkey (Türkiye)
London, Greater London SE1 9RT, United Kingdom
Leeds, West Yorkshire LS9 7TF, United Kingdom
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