A Phase 3 Randomized Study Comparing JNJ-79635322 and an Anti-BCMAxCD3 Bispecific Antibody in Participants With Relapsed or Refractory Multiple Myeloma Who Have Received at Least 3 Prior Lines of Therapy Including a PI, an IMiD, and an Anti CD38 Antibody
Status: Recruiting
Location: See all (144) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
SUMMARY
The purpose of this study is to evaluate how well JNJ-79635322 works when compared with an anti-B-cell maturation antigen (BCMA)xCD3 bispecific antibody.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• Documented diagnosis of multiple myeloma (MM) as defined by the criteria below:
‣ MM diagnosis according to the international myeloma working group (IMWG) diagnostic criteria
⁃ Measurable disease at screening as assessed by central laboratory
• Received at least 3 prior lines of antimyeloma therapy including a proteasome inhibitor (PI), an immunomodulatory drug (IMiD), and an anti-cluster of differentiation (CD)38 antibody
• Documented evidence of progressive disease (PD) or failure to achieve a response to the last line of therapy based on investigator's determination of response by IMWG criteria
• Toxicity related to previous anticancer therapy must have resolved to Grade 1 or better
• Have an eastern cooperative oncology group (ECOG) performance status of 0 to 2 at screening and immediately before the start of study treatment administration
Locations
United States
Arkansas
UAMS
RECRUITING
Little Rock
Arizona
Mayo Clinic Phoenix
RECRUITING
Phoenix
California
City of Hope Duarte
RECRUITING
Duarte
City of Hope Orange County Lennar Foundation Cancer Center
RECRUITING
Irvine
USC Norris Comprehensive Cancer Center
RECRUITING
Los Angeles
University of California San Francisco
RECRUITING
San Francisco
Colorado
Colorado Blood Cancer Institute
RECRUITING
Denver
Connecticut
University of Connecticut Health Center
RECRUITING
Farmington
Yale Cancer Center
RECRUITING
New Haven
Florida
Florida Cancer Specialists & Research Institute
RECRUITING
Fort Myers
Mayo Clinic Jacksonville
RECRUITING
Jacksonville
Moffit Cancer center
RECRUITING
Tampa
Georgia
Emory University
RECRUITING
Atlanta
Iowa
University of Iowa Hospital and Clinics
RECRUITING
Iowa City
Mission Cancer Blood
RECRUITING
Waukee
Illinois
City of Hope Chicago
RECRUITING
Zion
Kansas
University of Kansas Cancer Center
RECRUITING
Kansas City
Kentucky
Norton Cancer Institute
RECRUITING
Louisville
Maryland
University of Maryland School of Medicine
RECRUITING
Baltimore
Minnesota
Mayo Clinic Rochester
RECRUITING
Rochester
North Carolina
University of North Carolina
RECRUITING
Chapel Hill
Durham VAMC
RECRUITING
Durham
New York
Mount Sinai Brooklyn
RECRUITING
Brooklyn
NYU Winthrop
RECRUITING
Mineola
Icahn School of Medicine at Mount Sinai
RECRUITING
New York
Laura and Isaac Perlmutter Cancer Center NYU ACC
RECRUITING
New York
Memorial Sloan Kettering Cancer Center
RECRUITING
New York
Mount Sinai Chelsea
RECRUITING
New York
Oregon
Oregon Health And Science University
RECRUITING
Portland
Pennsylvania
Fox Chase Cancer Center
RECRUITING
Philadelphia
Thomas Jefferson University Hospital
RECRUITING
Philadelphia
Tennessee
SCRI Oncology Partners
RECRUITING
Nashville
Vanderbilt University Medical Center
RECRUITING
Nashville
Texas
St. David's South Austin Medical Center
RECRUITING
Austin
Baylor University Medical Center
RECRUITING
Dallas
UT Southwestern Medical Center
RECRUITING
Dallas
Texas Transplant Institute
RECRUITING
San Antonio
Utah
Huntsman Cancer Institute
RECRUITING
Salt Lake City
Wisconsin
Medical College Of Wisconsin
RECRUITING
Milwaukee
Other Locations
Australia
Box Hill Hospital
RECRUITING
Box Hill
Mater Misericordiae Ltd
RECRUITING
Brisbane
Monash Medical Centre
RECRUITING
Clayton
St Vincents Hospital Melbourne
RECRUITING
Fitzroy
The Alfred Hospital
RECRUITING
Melbourne
Fiona Stanley Hospital
RECRUITING
Murdoch
Sir Charles Gairdner Hospital
RECRUITING
Nedlands
Gold Coast University Hospital
RECRUITING
Southport
Brazil
Hospital das Clinicas da Universidade Estadual de Campinas UNICAMP
RECRUITING
Campinas
Fundacao Universidade de Caxias do Sul
RECRUITING
Caxias Do Sul
Hospital Erasto Gaertner- Liga Paranaense de Combate ao Cancer
RECRUITING
Curitiba
Grupo ELORA Centro de Pesquisa e Ensino em Saude de Santa Catarina
RECRUITING
Florianópolis
Instituto de Educacao, Pesquisa e Gestao em Saude Instituto Americas (COI)
RECRUITING
Rio De Janeiro
IDOR - Regional Bahia
RECRUITING
Salvador
Funfarme Sjrp
RECRUITING
São José Do Rio Preto
Clinica Medica Sao Germano LTDA
RECRUITING
São Paulo
Fundacao Antonio Prudente A C Camargo Cancer Center
RECRUITING
São Paulo
IDOR - Regional Sao Paulo
RECRUITING
São Paulo
Sociedade Beneficente Israelita Brasileira Hospital Albert Einstein
RECRUITING
São Paulo
Canada
Arthur J E Child Comprehensive Cancer Centre
RECRUITING
Calgary
Queen Elizabeth II Health Sciences Centre
RECRUITING
Halifax
Juravinski Cancer Centre
RECRUITING
Hamilton
London Health Sciences Centre
RECRUITING
London
CIUSSS de l Est de l Ile de Montreal Installation Hopital Maisonneuve Rosemont
RECRUITING
Montreal
University Health Network UHN Princess Margaret Cancer Centre
RECRUITING
Toronto
British Columbia Cancer Agency
RECRUITING
Vancouver
China
Peking University First Hospital
RECRUITING
Beijing
Peking University People's Hospital
RECRUITING
Beijing
Sichuan Provincial Peoples Hospital
RECRUITING
Chengdu
Sun Yat Sen University Cancer Center
RECRUITING
Guangzhou
First affiliated Hospital of Zhejiang University
RECRUITING
Hangzhou
Nanjing Drum Tower Hospital
RECRUITING
Nanjing
The First Affiliated Hospital of Guangxi Medical University
RECRUITING
Nanning
Shanghai Fourth People s Hospital
RECRUITING
Shanghai
The First Affiliated Hospital of Wenzhou Medical University
RECRUITING
Wenzhou
The Second Affiliated Hospital of Xi'an Jiaotong University
RECRUITING
Xi'an
France
CHRU de Lille Hopital Claude Huriez
RECRUITING
Lille
Hospices Civils de Lyon HCL
RECRUITING
Lyon
Hotel Dieu CHU de Nantes
RECRUITING
Nantes
APHP
RECRUITING
Paris
Hopital Saint Louis APHP
RECRUITING
Paris
CHU de Bordeaux - Hospital Haut-Leveque
RECRUITING
Pessac
CHU De Poitiers
RECRUITING
Poitiers
CHU Toulouse
RECRUITING
Toulouse
CHRU de Tours
RECRUITING
Tours
Germany
Marien Hospital Dusseldorf
RECRUITING
Düsseldorf
Universitaetsklinikum Heidelberg
RECRUITING
Heidelberg
Universitatsklinikum Jena
RECRUITING
Jena
Universitaetsklinikum Wuerzburg
RECRUITING
Würzburg
Greece
Alexandra General Hospital of Athens
RECRUITING
Athens
Evangelismos S A
RECRUITING
Athens
Geniko Nosokomeio Thessalonikis George Papanikolaou
RECRUITING
Thessaloniki
Theageneio Cancer Hospital
RECRUITING
Thessaloniki
Israel
Soroka Medical Center
RECRUITING
Beersheba
Bnai Zion Medical Center
RECRUITING
Haifa
Carmel Medical Center
RECRUITING
Haifa
Rambam Medical Center
RECRUITING
Haifa
Shaare Zedek MC
RECRUITING
Jerusalem
Sheba Medical Center
RECRUITING
Ramat Gan
Baruch Padeh MC
RECRUITING
Ramat Poriya
Assuta MC
RECRUITING
Tel Aviv
Italy
A.O.U. SS. Antonio e Biagio e Cesare Arrigo
RECRUITING
Alessandria
Spedali Civili di Brescia
RECRUITING
Brescia
Fondazione IRCCS Ca Granda Ospedale Policlinico Di Milano
RECRUITING
Milan
Ospedale Santa Chiara AO Universitaria Pisana
RECRUITING
Pisa
Arcispedale Santa Maria Nuova - IRCCS
RECRUITING
Reggio Emilia
Campus Bio Medico di Roma
RECRUITING
Roma
Fondazione Policlinico Universitario A Gemelli IRCCS
RECRUITING
Roma
Humanitas Hospital
RECRUITING
Rozzano
Casa Sollievo Della Sofferenza IRCCS
RECRUITING
San Giovanni Rotondo
U.O. Ematologia Ospedale San Bortolo
RECRUITING
Vicenza
Japan
Tokyo Metropolitan Cancer and Infectious Diseases Center Komagome Hospital
RECRUITING
Bunkyō City
Chiba Cancer Center
RECRUITING
Chiba
Shonan Kamakura General Hospital
RECRUITING
Kamakura-shi
Kameda Medical Center
RECRUITING
Kamogawa
Yamanashi Prefectural Central Hospital
RECRUITING
Kofu
The Jikei University Hospital
RECRUITING
Minato
Japanese Red Cross Medical Center
RECRUITING
Shibuya City
Kanagawa Cancer Center
RECRUITING
Yokohama
Netherlands
VU Medisch Centrum
RECRUITING
Amsterdam
Universitair Medisch Centrum Groningen
RECRUITING
Groningen
St. Antonius Ziekenhuis Nieuwegein
RECRUITING
Nieuwegein
Radboud Umcn
RECRUITING
Nijmegen
Erasmus MC
RECRUITING
Rotterdam
Haga ziekenhuis
RECRUITING
The Hague
Norway
Akershus Universitetssykehus
RECRUITING
Lorenskog
Oslo University Hospital HF Ulleval sykehus
RECRUITING
Oslo
Stavanger University Hospital Ullandhaug
RECRUITING
Stavanger
St. Olavs Hospital
RECRUITING
Trondheim
Spain
Hosp. Univ. Germans Trias I Pujol
RECRUITING
Badalona
H. Vall D'Hebron
RECRUITING
Barcelona
Hosp. Clinic de Barcelona
RECRUITING
Barcelona
Hosp. Univ. Virgen de Las Nieves
RECRUITING
Granada
Hosp. Univ. 12 de Octubre
RECRUITING
Madrid
Hosp. Quiron Madrid Pozuelo
RECRUITING
Pozuelo De Alarcón
Hosp Clinico Univ de Salamanca
RECRUITING
Salamanca
Hosp de Galdakao
RECRUITING
Usansolo
Hosp. Univ. I Politecni La Fe
RECRUITING
Valencia
United Kingdom
Kent and Canterbury Hospital
RECRUITING
Canterbury
Cardiff and Vale UHB - University Hospital of Wales
RECRUITING
Cardiff
Ninewells Hospital & Medical School
RECRUITING
Dundee
University College London Hospitals
RECRUITING
London
Nottingham City Hospital
RECRUITING
Nottingham
Queen Alexandra Hospital
RECRUITING
Portsmouth
Royal Marsden Hospital
RECRUITING
Sutton
Contact Information
Primary
Study Contact
Participate-In-This-Study1@its.jnj.com
844-434-4210
Time Frame
Start Date: 2026-02-04
Estimated Completion Date: 2031-09-30
Participants
Target number of participants: 400
Treatments
Experimental: JNJ-79635322
Participants will receive subcutaneous (SC) dose of JNJ-79635322 until progressive disease (PD) or intolerable toxicity.
Active_comparator: Anti BCMAxCD3 Bispecific Antibody
Participants will receive teclistamab (an Anti BCMAxCD3 bispecific anitbody) as a SC injection until PD or intolerable toxicity.
Related Therapeutic Areas
Sponsors
Leads: Janssen Research & Development, LLC