Study Assessing Activity of Intravenous (IV) Etentamig Monotherapy Versus Standard Available Therapies in Adult Participants With Relapsed or Refractory Multiple Myeloma
Фаза 3 – широко изпитване преди одобрение
Заболявания:
Multiple Myeloma
Спонсор: AbbVie
Налично на:
БГ
Обобщение
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.
Кой може да участва
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.
Места на провеждане
22
Австралия (1)
St George Hospital /ID# 261806
Kogarah , New South Wales
Белгия (1)
Algemeen Ziekenhuis klina /ID# 260856
Brasschaat , Antwerpen
Канада (1)
University Health Network_Princess Margaret Cancer Centre /ID# 261566
Toronto , Ontario
COMPLETED
Китай (1)
Beijing Chaoyang Hospital,Capital Medical University /ID# 245533
Beijing , Beijing Municipality
Чехия (1)
Fakultni Nemocnice Brno - Jihlavska /ID# 245689
Brno , Brno-mesto
COMPLETED
Дания (1)
Odense University Hospital /ID# 260924
Odense , Region Syddanmark
Франция (1)
Ch Saint Quentin /Id# 261856
Saint-Quentin , Aisne
COMPLETED
Гърция (1)
Alexandra General Hospital /ID# 240591
Athens , Attica
Унгария (1)
Gyor-Moson-Sopron Varmegyei Petz Aladar Egyetemi Oktato Korhaz /ID# 261648
Győr , Győr-Moson-Sopron
Израел (1)
Shaare Zedek Medical Center /ID# 245681
Jerusalem , Jerusalem
Италия (1)
ASST Ovest Milanese /ID# 256813
Legnano , Milano
Япония (1)
Anjo Kosei Hospital /ID# 263434
Anjo , Aichi-ken
Полша (1)
Uniwersytecki Szpital Kliniczny We Wroclawiu /ID# 260172
Wroclaw , Lower Silesian Voivodeship
Puerto Rico (1)
Hematology And Oncology Institute /ID# 272531
Manati
South Africa (1)
Alberts Cellular Therapy /ID# 245725
Pretoria , Gauteng
Южна Корея (1)
Seoul National University Hospital /ID# 245491
Seoul , Seoul Teugbyeolsi
Испания (1)
Instituto Catalan de Oncologia (ICO) Badalona /ID# 246398
Badalona , Barcelona
Швеция (1)
Helsingborgs Lasarett /ID# 262513
Helsingborg , Skåne County
Taiwan (1)
National Taiwan University Hospital /ID# 245482
Taipei City , Taipei
Турция (1)
Dr. Abdurrahman Yurtaslan Ankara Onkoloji Egitim ve Arastirma Hastanesi /ID# 261672
Ankara
Великобритания (1)
Addenbrookes Hospital /ID# 261104
Cambridge , Cambridgeshire
САЩ (1)
University of Alabama at Birmingham - Main /ID# 261434