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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 (65) 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 (that is partial response \[PR\] or better) to the last line of therapy based on investigator's determination of response by IMWG criteria

• Have discontinued concurrent use of any other anticancer treatment (including nonpalliative radiotherapy) or investigational agent

• 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
California
USC Norris Comprehensive Cancer Center
RECRUITING
Los Angeles
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
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
Kentucky
Norton Cancer Institute
RECRUITING
Louisville
North Carolina
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
Thomas Jefferson University Hospital
RECRUITING
Philadelphia
Tennessee
SCRI Oncology Partners
RECRUITING
Nashville
Texas
St. David's South Austin Medical Center
RECRUITING
Austin
Baylor University Medical Center
RECRUITING
Dallas
Utah
Huntsman Cancer Institute
RECRUITING
Salt Lake City
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
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
Germany
Marien Hospital Dusseldorf
RECRUITING
Düsseldorf
Universitatsklinikum Jena
RECRUITING
Jena
Greece
Evangelismos S A
RECRUITING
Athens
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
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
Erasmus MC
RECRUITING
Rotterdam
Haga ziekenhuis
RECRUITING
The Hague
Norway
St. Olavs Hospital
RECRUITING
Trondheim
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
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

This content was sourced from clinicaltrials.gov

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