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)

Status: Recruiting
Location: See all (160) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
SUMMARY

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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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.

Locations
United States
Alabama
University of Alabama at Birmingham - Main /ID# 261434
RECRUITING
Birmingham
Arizona
Mayo Clinic Hospital - Phoenix /ID# 263326
RECRUITING
Phoenix
California
Alta Bates Summit Medical Center for Research /ID# 261438
COMPLETED
Berkeley
Providence - St. Jude Medical Center /ID# 262031
RECRUITING
Fullerton
VA Loma Linda Healthcare System /ID# 261015
RECRUITING
Loma Linda
Cedars-Sinai Medical Center /ID# 261008
RECRUITING
Los Angeles
Colorado
Rocky Mountain Cancer Centers - Lone Tree /ID# 278320
RECRUITING
Lone Tree
Florida
Cancer Specialists of North Florida - Jacksonville - AC Skinner Parkway /ID# 246230
RECRUITING
Jacksonville
Mayo Clinic Hospital Jacksonville /ID# 263324
RECRUITING
Jacksonville
Georgia
Winship Cancer Institute of Emory University /ID# 262525
RECRUITING
Atlanta
Illinois
Rush University Medical Center /ID# 265690
RECRUITING
Chicago
University of Illinois Hospital and Health Sciences System /ID# 246349
RECRUITING
Chicago
Nancy W. Knowles Cancer Center /ID# 271361
RECRUITING
Elmhurst
Springfield Clinic - First /ID# 262266
RECRUITING
Springfield
Louisiana
Our Lady Of The Lake Regional Medical Center /ID# 272780
RECRUITING
Baton Rouge
Massachusetts
Beth Israel Deaconess Medical Center /ID# 271535
RECRUITING
Boston
Dana-Farber Cancer Institute /ID# 261554
RECRUITING
Boston
Maryland
Center for Cancer and Blood Disorders-American Oncology Partners of Maryland /ID# 263637
RECRUITING
Bethesda
Michigan
Regents of the University of Michigan /ID# 261577
RECRUITING
Ann Arbor
Henry Ford Hospital /ID# 262704
RECRUITING
Detroit
Karmanos Cancer Institute - Detroit /ID# 266298
RECRUITING
Detroit
Barbara Ann Karmanos Cancer Institute - McLaren Greater Lansing /ID# 259891
RECRUITING
Lansing
Minnesota
Mayo Clinic - Rochester /ID# 246228
RECRUITING
Rochester
Missouri
University of Missouri Hospital /ID# 261553
RECRUITING
Columbia
North Carolina
University of North Carolina /ID# 259854
RECRUITING
Chapel Hill
Levine Cancer Institute /ID# 246199
RECRUITING
Charlotte
Duke University Medical Center /ID# 259694
RECRUITING
Durham
New York
New York Cancer & Blood Specialists - Bay Shore /ID# 261524
RECRUITING
Bay Shore
New York Cancer & Blood Specialists - Lake Success Medical Oncology /ID# 262953
RECRUITING
New Hyde Park
New York Cancer and Blood Specialists - New York /ID# 262951
RECRUITING
New York
Eastchester Center for Cancer Care /ID# 262952
RECRUITING
The Bronx
Ohio
University Of Cincinnati Medical Center /ID# 246415
RECRUITING
Cincinnati
Cleveland Clinic Main Campus /ID# 246183
RECRUITING
Cleveland
Oregon
Oregon Medical Research Center /ID# 262335
RECRUITING
Portland
South Carolina
Medical University of South Carolina /ID# 259692
RECRUITING
Charleston
Tennessee
Baptist Memorial Hospital /ID# 270910
RECRUITING
Memphis
The West Clinic /ID# 262444
RECRUITING
Memphis
University of Tennessee Health Science Center /ID# 261622
RECRUITING
Memphis
Vanderbilt University Medical Center /ID# 261621
RECRUITING
Nashville
Texas
Texas Oncology - Northeast Texas /ID# 278304
RECRUITING
Tyler
Virginia
Virginia Cancer Specialists - Fairfax /ID# 262792
RECRUITING
Fairfax
Virginia Oncology Associates - Norfolk (Lake Wright) /ID# 278314
RECRUITING
Norfolk
VCU Massey Cancer Center: Dalton Oncology Clinic /ID# 261944
RECRUITING
Richmond
Washington
Northwest Medical Specialties Tacoma /ID# 276281
RECRUITING
Tacoma
Other Locations
Australia
Monash Health - Monash Medical Centre /ID# 262158
RECRUITING
Clayton
St Vincent's Hospital Melbourne /ID# 261808
RECRUITING
Fitzroy Melbourne
St George Hospital /ID# 261806
RECRUITING
Kogarah
Liverpool Hospital /ID# 262159
RECRUITING
Liverpool
Box Hill Hospital /ID# 262784
RECRUITING
Melbourne
Calvary Mater Newcastle /ID# 261804
RECRUITING
Waratah
Princess Alexandra Hospital /ID# 261810
RECRUITING
Woolloongabba
Austria
Medizinische Universitaet Graz /ID# 261908
RECRUITING
Graz
Universitaetsklinikum Krems /ID# 261509
RECRUITING
Krems
Ordensklinikum Linz GmbH Elisabethinen /ID# 245609
RECRUITING
Linz
Klinik Ottakring /ID# 245829
RECRUITING
Vienna
Belgium
Algemeen Ziekenhuis klina /ID# 260856
RECRUITING
Brasschaat
AZ Sint-Jan Brugge /ID# 245345
RECRUITING
Bruges
Canada
University Health Network_Princess Margaret Cancer Centre /ID# 261566
RECRUITING
Toronto
China
Beijing Chaoyang Hospital,Capital Medical University /ID# 245533
RECRUITING
Beijing
Peking Union Medical College Hospital (East) - Dongdan Campus /ID# 245545
RECRUITING
Beijing
Fujian Medical University Union Hospital /ID# 245558
RECRUITING
Fuzhou
Sun Yat-Sen University Cancer Center /ID# 245542
RECRUITING
Guangzhou
Sir Run Run Shaw Hospital Zhejiang University School of Medicine /ID# 260882
RECRUITING
Hangzhou
The First Affiliated Hospital, Zhejiang University School of Medicine /ID# 260883
RECRUITING
Hangzhou
The First Affiliated Hospital of Nanchang University /ID# 245537
RECRUITING
Nanchang
Zhongda Hospital Southeast University /ID# 245563
RECRUITING
Nanjing
Shanghai Tongji Hospital /ID# 245539
RECRUITING
Shanghai
First Affiliated Hospital of China Medical University /ID# 245547
RECRUITING
Shenyang
The First Affiliated Hospital of Soochow University /ID# 245544
RECRUITING
Suzhou
Institute of Hematology and Blood Diseases Hospital /ID# 265702
RECRUITING
Tianjin
Tianjin Medical University General Hospital /ID# 260851
RECRUITING
Tianjin
The First Affiliated Hospital of Wenzhou Medical University /ID# 245550
RECRUITING
Wenzhou
Union Hospital Tongji Medical College Huazhong University of Science and Technol /ID# 245549
RECRUITING
Wuhan
Second Affiliated Hospital of Xian Jiaotong University /ID# 261255
RECRUITING
Xi'an
Henan Cancer Hospital /ID# 245536
RECRUITING
Zhengzhou
People's Hospital of Henan Province /ID# 260918
RECRUITING
Zhengzhou
Denmark
Odense University Hospital /ID# 260924
RECRUITING
Odense
Vejle Sygehus /ID# 260923
RECRUITING
Vejle
France
CH Henri Duffaut /ID# 261844
RECRUITING
Avignon
Centre Hospitalier du Mans /ID# 261852
RECRUITING
Le Mans
Centre Hospitalier Régional d'Orléans - Hôpital de la Source /ID# 261854
RECRUITING
Orléans
Ch Saint Quentin /Id# 261856
RECRUITING
Saint-quentin
Germany
Charite Universitaetsklinikum Berlin - Campus Benjamin Franklin /ID# 260689
RECRUITING
Berlin
Klinikum Chemnitz - Flemmingstraße /ID# 273108
RECRUITING
Chemnitz
Centrum fuer Haematologie und Onkologie Bethanien /ID# 271982
RECRUITING
Frankfurt Am Main
Universitaetsklinikum Freiburg /ID# 262147
RECRUITING
Freiburg Im Breisgau
Universitaetsklinikum Hamburg-Eppendorf /ID# 260651
RECRUITING
Hamburg
Staedtisches Klinikum Karlsruhe /ID# 272377
RECRUITING
Karlsruhe
Greece
Alexandra General Hospital /ID# 240591
RECRUITING
Athens
General Hospital of Athens Evaggelismos and Ophthalmiatrio of Athens Polyclinic /ID# 240596
RECRUITING
Athens
University General Hospital Attikon /ID# 240592
RECRUITING
Athens
General University Hospital of Thessaloniki AXEPA /ID# 240595
RECRUITING
Thessaloniki
Hungary
Del-pesti Centrumkorhaz Orszagos Hematologiai es Infektologiai Intezet /ID# 261646
RECRUITING
Budapest
Semmelweis Egyetem /ID# 261647
RECRUITING
Budapest
Gyor-Moson-Sopron Varmegyei Petz Aladar Egyetemi Oktato Korhaz /ID# 261648
RECRUITING
Győr
Israel
Shaare Zedek Medical Center /ID# 245681
RECRUITING
Jerusalem
Rabin Medical Center /ID# 245498
RECRUITING
Petah Tikva
The Chaim Sheba Medical Center /ID# 245497
RECRUITING
Ramat Gan
Tel Aviv Sourasky Medical Center /ID# 245495
RECRUITING
Tel Aviv
Italy
Azienda Ospedaliero Universitaria delle Marche /ID# 256812
RECRUITING
Ancona
AOU Policlinico G. Rodolico - San Marco /ID# 256814
RECRUITING
Catania
ASST Ovest Milanese /ID# 256813
RECRUITING
Legnano
Azienda Ospedaliero-Universitaria Policlinico Umberto I /ID# 256810
RECRUITING
Rome
A.O.U. CITTA' DELLA SALUTE E DELLA SCIENZA DI TORINO - Ospedale Molinette /ID# 256808
RECRUITING
Turin
Japan
Hyogo Prefectural Amagasaki General Medical Center /ID# 265696
RECRUITING
Amagasaki
Anjo Kosei Hospital /ID# 263434
RECRUITING
Anjo
Tokyo Metropolitan Komagome Hospital /ID# 277567
RECRUITING
Bunkyo Ku
Chiba University Hospital /ID# 262006
RECRUITING
Chiba
University of Yamanashi Hospital /ID# 262912
RECRUITING
Chuo-shi
Kyushu University Hospital /ID# 264704
RECRUITING
Fukuoka
Chugoku Central Hospital /ID# 263431
RECRUITING
Fukuyama
Gifu Municipal Hospital /ID# 263321
RECRUITING
Gifu
Saitama Prefectural Cancer Center /ID# 262586
RECRUITING
Kitaadachi-gun
University Hospital Kyoto Prefectural University of Medicine /ID# 262585
RECRUITING
Kyoto
Gunma University Hospital /ID# 262580
RECRUITING
Maebashi
Nagoya City University Hospital /ID# 263320
RECRUITING
Nagoya
Naha City Hospital /ID# 263972
RECRUITING
Naha
Miyagi Cancer Center /ID# 265094
RECRUITING
Natori-shi
Japanese Red Cross Medical Center /ID# 261717
RECRUITING
Shibuya-ku
The University of Osaka Hospital /ID# 263974
RECRUITING
Suita-shi
University of Fukui Hospital /ID# 264222
RECRUITING
Yoshida-gun
Poland
Uniwersyteckie Centrum Kliniczne /ID# 260169
RECRUITING
Gdansk
Uniwersytecki Szpital Kliniczny Nr 1 w Lublinie /ID# 260168
RECRUITING
Lublin
Uniwersytecki Szpital Kliniczny We Wrocławiu /ID# 260172
RECRUITING
Wroclaw
Portugal
Fundacao Champalimaud /ID# 246258
RECRUITING
Lisbon
Unidade Local de Saude de Santa Maria, EPE /ID# 246255
RECRUITING
Lisbon
Instituto Portugues de Oncologia do Porto Francisco Gentil, EPE /ID# 246257
RECRUITING
Porto
Puerto Rico
Hematology And Oncology Institute /ID# 272531
RECRUITING
Manatí
Auxilio Mutuo Cancer Center /ID# 272565
RECRUITING
San Juan
Republic of Korea
Samsung Medical Center /ID# 245492
RECRUITING
Seoul
Seoul National University Hospital /ID# 245491
RECRUITING
Seoul
The Catholic University of Korea, Seoul St. Marys Hospital /ID# 245493
RECRUITING
Seoul
Yonsei University Health System Severance Hospital /ID# 245489
RECRUITING
Seoul
Ulsan University Hospital /ID# 245490
RECRUITING
Ulsan
South Africa
Constantiaberg Haematology /ID# 261320
RECRUITING
Cape Town
Haemalife Inc. /ID# 245724
RECRUITING
Kuils River
Alberts Cellular Therapy /ID# 245725
RECRUITING
Pretoria
Spain
Instituto Catalan de Oncologia (ICO) Badalona /ID# 246398
RECRUITING
Badalona
Hospital de Leon /ID# 261624
RECRUITING
León
Hospital General Universitario Gregorio Maranon /ID# 246401
RECRUITING
Madrid
Complejo Hospitalario Universitario Ourense /ID# 246400
RECRUITING
Ourense
Hospital Universitario de Salamanca /ID# 262218
RECRUITING
Salamanca
Hospital Universitario y Politecnico La Fe /ID# 261625
RECRUITING
Valencia
Sweden
Falu Lasarett /ID# 262231
RECRUITING
Falun
Helsingborgs Lasarett /ID# 262513
RECRUITING
Helsingborg
Uddevalla sjukhus /ID# 262034
RECRUITING
Uddevalla
Taiwan
China Medical University Hospital /ID# 245483
RECRUITING
Taichung
Taichung Veterans General Hospital /ID# 261142
RECRUITING
Taichung
National Taiwan University Hospital /ID# 245482
RECRUITING
Taipei City
Turkey
Dr. Abdurrahman Yurtaslan Ankara Onkoloji Egitim ve Arastirma Hastanesi /ID# 261672
RECRUITING
Ankara
Antalya Egitim Ve Arastirma Hastanesi /ID# 261674
RECRUITING
Antalya
Trakya University Medical Facu /ID# 261673
RECRUITING
Edirne, Istanbul
Istanbul Florence Nightingale Hospital /ID# 271543
RECRUITING
Şişli
United Kingdom
Addenbrookes Hospital /ID# 261104
RECRUITING
Cambridge
Western General Hospital - NHS Lothian /ID# 261106
RECRUITING
Edinburgh
Leeds Teaching Hospitals NHS Trust /ID# 261101
RECRUITING
Leeds
Dup_Guys and St Thomas NHS Foundation Trust - Guy's Hospital /ID# 262488
RECRUITING
London
The Royal Marsden NHS Foundation Trust /ID# 262470
RECRUITING
London
The Christie Hospital /ID# 261102
RECRUITING
Manchester
Nottingham City Hospital /ID# 261105
RECRUITING
Nottingham
Contact Information
Primary
ABBVIE CALL CENTER
abbvieclinicaltrials@abbvie.com
844-663-3742
Time Frame
Start Date: 2024-05-19
Estimated Completion Date: 2027-12
Participants
Target number of participants: 380
Treatments
Experimental: Standard Available Therapy (SAT)
Participants will receive SAT, in accordance with the local (or applicable) approved label, package insert, summary of product characteristics, and/or the institutional guidelines, as applicable. SAT choices are carfilzomib + dexamethasone (Kd), elotuzumab + pomalidomide + dexamethasone (EloPd), selinexor + bortezomib + dexamethasone (SVd).
Experimental: Etentamig
Participants will receive etentamig as a monotherapy.
Related Therapeutic Areas
Sponsors
Leads: AbbVie

This content was sourced from clinicaltrials.gov