A Phase 3 Randomized Study Comparing Talquetamab SC in Combination With Daratumumab SC and Pomalidomide (Tal-DP) or Talquetamab SC in Combination With Daratumumab SC (Tal-D) Versus Daratumumab SC, Pomalidomide and Dexamethasone (DPd), in Participants With Relapsed or Refractory Multiple Myeloma Who Have Received at Least 1 Prior Line of Therapy

Status: Active_not_recruiting
Location: See all (210) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
SUMMARY

The purpose of the study is to compare the efficacy of talquetamab subcutaneous(ly) (SC) in combination with daratumumab SC and pomalidomide (Tal-DP) and talquetamab SC in combination with daratumumab SC (Tal-D), respectively, with daratumumab SC in combination with pomalidomide and dexamethasone (DPd).

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

• Documented multiple myeloma as defined: a) Multiple myeloma diagnosis according to the International Myeloma Working Group (IMWG) diagnostic criteria and b) Measurable disease at screening as defined by any of the following: i) Serum M-protein level greater than or equal to (\>=) 0.5 grams per deciliter (g/dL) (central laboratory); ii) Urine M-protein level \>= 200 milligram (mg) per 24 hours (central laboratory); iii) Light chain multiple myeloma without measurable M-protein in the serum or the urine: serum immunoglobulin free light chain \>= 10 milligram per deciliter (mg/dL) (central laboratory), and abnormal serum immunoglobulin kappa lambda free light chain ratio

• Relapsed or refractory disease as defined by: i) Relapsed disease is defined as an initial response to prior treatment, followed by confirmed progressive disease by IMWG criteria greater than (\>) 60 days after cessation of treatment; ii) Refractory disease is defined as less than (\<) 25 percent (%) reduction in monoclonal paraprotein (M-protein) or confirmed progressive disease by IMWG criteria during previous treatment or less than or equal to (\<=) 60 days after cessation of treatment

• Received at least 1 prior line of antimyeloma therapy including a proteasome inhibitor (PI) and lenalidomide. Participants who have received only 1 prior line of antimyeloma therapy must be considered lenalidomide-refractory (that is, have demonstrated progressive disease by IMWG criteria on or within 60 days of completion of lenalidomide-containing regimen). Participants who have received \>=2 prior lines of antimyeloma therapy must be considered lenalidomide exposed

• Documented evidence of progressive disease based on investigator's determination of response by the IMWG criteria on or after their last regimen

• Have an Eastern Cooperative Oncology Group (ECOG) performance status score of 0, 1, or 2 at screening and immediately prior to the start of administration of study treatment

Locations
United States
Arkansas
University of Arkansas for Medical Sciences
Little Rock
Arizona
The University of Arizona Cancer Center
Tucson
Connecticut
Norwalk Hospital-oncology
Norwalk
Washington, D.c.
George Washington University
Washington D.c.
MedStar Georgetown University Hospital
Washington D.c.
Florida
Memorial Healthcare System
Hollywood
University of Miami Health System
Miami
Illinois
University Of Illinois
Chicago
Kansas
University of Kansas
Westwood
Louisiana
Ochsner Health System
New Orleans
Tulane University Hospital & Clinics
New Orleans
Massachusetts
Boston University Medical Center
Boston
Massachusetts General
Boston
University of Massachusetts Medical School
Worcester
Maryland
Johns Hopkins University
Baltimore
Michigan
University of Michigan Health System
Ann Arbor
Minnesota
University Of Minnesota
Minneapolis
Missouri
Washington University School Of Medicine
St Louis
Mississippi
University of Mississippi Medical Center
Jackson
North Carolina
University of North Carolina
Chapel Hill
Levine Cancer Institute, Carolinas HealthCare System
Charlotte
Novant Health
Charlotte
Novant Health
Winston-salem
Wake Forest Baptist Medical Center
Winston-salem
New Jersey
Rutgers Cancer Institute of New Jersey
New Brunswick
New York
NYU Langone Health
New York
SUNY Upstate Medical University
Syracuse
Ohio
University Hospitals Cleveland Medical Center
Cleveland
OhioHealth
Columbus
The Ohio State University Wexner Medical Center - James Cancer Hospital
Columbus
Pennsylvania
Thomas Jefferson University
Philadelphia
South Carolina
Medical University of South Carolina
Charleston
Tennessee
Baptist Cancer Center
Memphis
Texas
Houston Methodist Hospital
Houston
MD Anderson Cancer Center
Houston
Joe Arrington Cancer Research Treatment Center
Lubbock
Utah
Huntsman Cancer Institute
Salt Lake City
Virginia
University of Virginia
Charlottesville
Virginia Commonwealth University - Massey Cancer Center
Richmond
Washington
Fred Hutchinson Cancer Research Center
Seattle
Other Locations
Belgium
UZ Brussel
Brussels
UZA
Edegem
Virga Jessa Ziekenhuis
Hasselt
CHC MontLegia
Liège
Clinique Saint Pierre
Ottignies
UCL Mont Godinne
Yvoir
Brazil
Fundacao Pio XII
Barretos
Santa Casa de Misericordia de Belo Horizonte
Belo Horizonte
Hospitais Integradaos da Gavea S/A - DF Star
Brasília
Fundacao Universidade de Caxias do Sul
Caxias Do Sul
Liga Paranaense de Combate ao Cancer
Curitiba
Centro de Pesquisa e Ensino em Oncologia de Santa Catarina CEPEN
Florianópolis
Liga Norte Riograndense Contra O Cancer
Natal
Irmandade Santa Casa de Misericordia de Porto Alegre
Porto Alegre
Hospital Das Clinicas Da Faculdade De Medicina De RPUSP HCRP
Ribeirão Preto
Instituto de Educacao, Pesquisa e Gestao em Saude Instituto Americas (COI)
Rio De Janeiro
Hospital Sao Rafael
Salvador
Clinica Sao Germano
São Paulo
Fundacao Antonio Prudente A C Camargo Cancer Center
São Paulo
Hospital Paulistano
São Paulo
Instituto D Or de Pesquisa e Ensino IDOR
São Paulo
Real e Benemerita Associacao Portuguesa de Beneficencia
São Paulo
Sociedade Beneficente de Senhoras Hospital Sirio Libanes
São Paulo
China
Peking Union Medical College Hospital
Beijing
Peking University First Hospital
Beijing
The First Hospital of Jilin University
Changchun
The second Xiangya Hospital of Central South University
Changsha
Beijing Chaoyang Hospital
Chaoyang District
Sichuan Academy of Medical Science Sichuan Provincial People's Hospital
Chengdu
Fujian Medical University Union Hospital
Fuzhou
Guangdong Provincial People's Hospital
Guangzhou
Sun Yat Sen University Cancer Center
Guangzhou
The First Affiliated Hospital Zhejiang University College of Medicine
Hangzhou
Nanjing Drum Tower Hospital
Nanjing
Shanghai Fourth People s Hospital
Shanghai
Tongji Hospital of Tongji University
Shanghai
Peking University Shenzhen Hospital
Shenzhen
First Affiliated Hospital SooChow University
Suzhou
Institute of Hematology & Blood Disease Hospital Chinese Academy of Medical Science
Tianjin
Tianjin cancer hospital
Tianjin
Tongji Hospital, Tongji Medical College of HUST
Wuhan
Henan Cancer Hospital
Zhengzhou
France
APHP - Hopital Henri Mondor
Créteil
CHU Dijon
Dijon
Centre Leon Berard
Lyon
CHU de Montpellier - Hopital Saint-Eloi
Montpellier
CHU de Nantes hotel Dieu
Nantes
CHU HOPITAL DE L'ARCHET - Hematology
Nice
CHU Hopital Saint Antoine
Paris
CHRU - Hôpital du Haut Lévêque - Centre François Magendie
Pessac
Institut Universitaire du cancer de Toulouse-Oncopole
Toulouse
Germany
Charite Campus Benjamin Franklin
Berlin
Universitaetsklinikum Koeln
Cologne
Asklepios Klinik Altona
Hamburg
Universitaetsklinikum Heidelberg
Heidelberg
Universitaetsklinikum Leipzig
Leipzig
Universitätsmedizin der Johannes Gutenberg Universität
Mainz
Universitaetsklinikum Wuerzburg
Würzburg
Greece
Alexandra General Hospital of Athens
Athens Attica
Anticancer Hospital of Thessaloniki Theageneio
Thessaloniki
G Papanikolaou Hospital of Thessaloniki
Thessalonikis
Israel
Ha'Emek Medical Center
Afula
Shamir Medical Center Assaf Harofeh
Be’er Ya‘aqov
Hillel Yaffe Medical Center
Hadera
Bnai Zion Medical Center
Haifa
Carmel Medical Center
Haifa
Rambam Medical Center
Haifa
Shaare Zedek Medical Center
Jerusalem
Galilee Medical Center
Nahariya
Beilinson medical center
Petah Tikva
Sheba Medical Center
Ramat Gan
Ziv Medical Center
Safed
Sourasky (Ichilov) Medical Center
Tel Aviv
Italy
A.O. Universitaria Ospedali Riuniti di Ancona
Ancona
Policlinico di Bari
Bari
Azienda Ospedaliera Policlinico S. Orsola-Malpighi
Bologna
Azienda Ospedaliera Spedali Civili di Brescia
Brescia
PO G.Rodolico, AOU Policlinico-Vittorio Emanuele Catania
Catania
ASST Grande Ospedale Metropolitano Niguarda
Milan
Fondazione IRCCS Istituto Nazionale dei Tumori
Milan
Azienda Ospedaliera Universitaria di Padova
Padua
Ospedale Villa Sofia-Cervello
Palermo
Fondazione IRCCS Policlinico San Matteo
Pavia
Arcispedale Santa Maria Nuova - IRCCS
Reggio Emilia
Presidio Ospedaliero Santo Spirito in Sassia
Roma
IRCCS Ospedale Casa Sollievo della Sofferenza
San Giovanni Rotondo
A.O.U. Città della Salute e della Scienza
Torino
Japan
Institute of Science Tokyo Hospital
Bunkyō City
Chiba Cancer Center
Chiba
Fukuoka University Hospital
Fukuoka
Ogaki Municipal Hospital
Gifu
Gunma University Hospital
Gunma
Kansai Medical University Hospital
Hirakata
Hyogo Medical University Hospital
Hyôgo
Japanese Red Cross Society Himeji Hospital
Hyōgo
Shonan Kamakura General Hospital
Kamakura-shi
National Cancer Center Hospital East
Kashiwa
Dokkyo Medical University Saitama Medical Center
Koshigaya
Kumamoto University Hospital
Kumamoto
Kyoto Kuramaguchi Medical Center
Kyoto
National Hospital Organization Matsumoto Medical Center
Matsumoto
Niigata Cancer Center Hospital
Niigata
National Hospital Organization Hiroshima-Nishi Medical Center
Ōtake
Hokkaido University Hospital
Sapporo
Tohoku University Hospital
Sendai
Iwate Medical University Hospital
Shiwa-gun
The University of Osaka Hospital
Suita
The Cancer Institute Hospital of JFCR
Tokyo
Netherlands
Albert Schweitzer ziekenhuis-lokatie Dordwijk
Dordrecht
Maxima Medisch Centrum
Eindhoven
Erasmus MC
Rotterdam
Poland
Szpital Specjalistyczny w Brzozowie Podkarpacki Osrodek Onkologiczny im Ks B Markiewicza
Brzozów
Uniwersyteckie Centrum Kliniczne
Gdansk
Pratia Onkologia Katowice
Katowice
Swietokrzyskie Centrum Onkologii SPZOZ w Kielcach
Kielce
Szpital Uniwersytecki w Krakowie
Krakow
Centrum Onkologii Ziemi Lubelskiej im sw Jana z Dukli
Lublin
Szpital Kliniczny MSWiA z Warminsko Mazurskim Centrum Onkologii w Olsztynie Oddzial Hematologii
Olsztyn
Uniwersytecki Szpital Kliniczny Nr 1 PUM im prof Tadeusza Sokolowskiego w Szczecinie
Szczecin
Wojewodzki Szpital Zespolony im L Rydygiera w Toruniu
Torun
Narodowy Instytut Onkologii im Marii Sklodowskiej Curie Panstwowy Instytut Badawczy
Warsaw
Uniwersytecki Szpital Kliniczny im Jana Mikulicza Radeckiego we Wroclawiu
Wroclaw
Republic of Korea
Dong-A University Hospital
Busan
National Cancer Center
Gyeonggi-do
Gachon University Gil Medical Center
Incheon
Chonnam National University Hwasun Hospital
Jeollanam-do
Jeonbuk National University Hospital
Jeonju
Asan Medical Center
Seoul
Samsung Medical Center
Seoul
Seoul National University Hospital
Seoul
Severance Hospital Yonsei University Health System
Seoul
The Catholic University of Korea Seoul St Marys Hospital
Seoul
Spain
Hosp. Univ. Germans Trias I Pujol
Badalona
Hosp Clinic de Barcelona
Barcelona
Hosp Univ Vall D Hebron
Barcelona
Hosp. de La Santa Creu I Sant Pau
Barcelona
Hosp. Univ. Virgen de La Arrixaca
El Palmar
Hosp. de Jerez de La Frontera
Jerez De La Frontera
Hosp. de Leon
León
Hosp Univ Hm Sanchinarro
Madrid
Hosp. Univ. 12 de Octubre
Madrid
Hosp. Univ. de La Princesa
Madrid
Hosp. Univ. Ramon Y Cajal
Madrid
Hosp Virgen de La Victoria
Málaga
Clinica Univ. de Navarra
Pamplona
Hosp Clinico Univ de Salamanca
Salamanca
Hosp. Univ. de Canarias
San Cristóbal De La Laguna
Hosp. Univ. Dr. Peset
Valencia
Taiwan
Kaohsiung Chang Gung Memorial Hospital
Kaohsiung City
Kaohsiung Medical University Chung Ho Memorial Hospital
Kaohsiung City
China Medical University Hospital
Taichung
National Cheng Kung University Hospital
Tainan
National Taiwan University Hospital
Taipei
Turkey
Ankara University Medical Faculty
Ankara
Dr. Abdurrahman Yurtaslan Oncology Training and Research Hospital, Hematology Unit
Ankara
Liv Hospital Ankara
Ankara
Antalya Training And Research Hospital
Antalya
Medipol Mega University Hospital
Istabul
Istanbul University Cerrahpasa Medical Faculty
Istanbul
Istanbul University Istanbul Medical Faculty
Istanbul
Dokuz Eylul University Medical Faculty
Izmir
Ondokuz Mayis University
Samsun
United Kingdom
Blackpool Victoria Hospital
Blackpool
Ninewells Hospital & Medical School
Dundee
Hammersmith Hospital
London
Newcastle Freeman Hospital
Newcastle Upon Tyne
Nottingham City Hospital
Nottingham
University Hospitals Plymouth NHS Trust
Plymouth
Royal Marsden Hospital
Sutton
New Cross Hospital
Wolverhampton
Time Frame
Start Date: 2022-10-13
Completion Date: 2029-06-30
Participants
Target number of participants: 864
Treatments
Experimental: Arm A: Talquetamab Subcutaneous (SC) in Combination With Daratumumab SC and Pomalidomide (Tal-DP)
Participants will receive talquetamab and daratumumab as SC injections; pomalidomide will be self-administered as a single dose orally; dexamethasone may be given orally or intravenously as a pretreatment medication and study drug.
Experimental: Arm B: Daratumumab in Combination With Pomalidomide and Dexamethasone (DPd)
Participants will receive daratumumab as SC injection; pomalidomide will be self-administered as a single dose orally; dexamethasone may be given orally or intravenously as a pretreatment medication and study drug.
Experimental: Arm C: Talquetamab SC in Combination With Daratumumab SC (Tal-D)
Participants will receive talquetamab and daratumumab as SC injection; dexamethasone may be given orally or intravenously as a pretreatment medication and study drug.
Related Therapeutic Areas
Sponsors
Leads: Janssen Research & Development, LLC

This content was sourced from clinicaltrials.gov

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