The purpose of this study is to compare the efficacy of teclistamab daratumumab (Tec-Dara) with daratumumab subcutaneously (SC) in combination with pomalidomide and dexamethasone (DPd) or daratumumab SC in combination with bortezomib and dexamethasone (DVd).
Accepts Healthy Volunteers
Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms |
No |
Study Type
An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies. |
Interventional |
Eligible Ages | 18 Years and Over |
Gender | All |
Trial ID:
This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries. |
NCT05083169 |
Phase
Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use. |
Phase 3 |
Lead Sponsor
The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data. |
Janssen Research & Development, LLC |
Principal Investigator
The person who is responsible for the scientific and technical direction of the entire clinical study. |
Janssen Research & Development, LLC Clinical Trial |
Principal Investigator Affiliation | Janssen Research & Development, LLC |
Agency Class
Category of organization(s) involved as sponsor (and collaborator) supporting the trial. |
Industry |
Overall Status | Recruiting |
Countries | Argentina, Belgium, Brazil, Canada, China, Denmark, France, Germany, Greece, Italy, Japan, Korea, Republic of, Netherlands, Poland, Russian Federation, Spain, Sweden, Taiwan, Turkey, United Kingdom, United States |
Conditions
The disease, disorder, syndrome, illness, or injury that is being studied. |
Multiple Myeloma |
Teclistamab is a novel B-cell maturation antigen (BCMA) bispecific antibody that is being evaluated to treat participants with multiple myeloma, an incurable malignant plasma cell disorder. The primary hypothesis of this study is that Tec-Dara will significantly improve progression free survival (PFS) compared with investigator's choice of DPd/DVd in participants with relapsed refractory multiple myeloma. Approximately 560 participants will be randomly assigned in a 1:1 ratio to receive either Tec-Dara (Arm A) or investigator's choice of DPd/DVd (Arm B). The study will be conducted in 3 phases: Screening Phase, Treatment Phase, and Follow-up Phase. Participants will be treated until disease progression, unacceptable toxicity, or other reasons to discontinue the study. Disease evaluation will occur every cycle. Safety will be assessed throughout the study. Efficacy will be assessed using International Myeloma Working Group (IMWG) criteria. The overall duration of the study will be approximately 5 years.
Experimental: Arm A: Teclistamab-daratumumab (Tec-Dara)
Participants will receive teclistamab and daratumumab by subcutaneous (SC) injection. Step-up doses of teclistamab will be given prior to the first full dose.
Experimental: Arm B: DPd or DVd
Participants will be randomized either to daratumumab, pomalidomide, dexamethasone (DPd) treatment to receive daratumumab SC injection; pomalidomide orally; dexamethasone orally or intravenously, or to Daratumumab, Bortezomib, Dexamethasone (DVd) treatment to receive daratumumab SC injection; bortezomib SC injection, and dexamethasone orally or intravenously.
Drug: - Daratumumab
Daratumumab will be administered SC injection.
Drug: - Pomalidomide
Pomalidomide will be administered orally.
Drug: - Dexamethasone
Dexamethasone will be administered orally or intravenously.
Drug: - Bortezomib
Bortezomib will be administered SC injection.
Drug: - Teclistamab
Teclistamab will be administered SC injection.
If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.
Status
Recruiting
Address
University of Alabama Birmingham
Birmingham, Alabama, 35294
Status
Recruiting
Address
City of Hope
Duarte, California, 91010
Status
Recruiting
Address
Stanford University Medical Center
Stanford, California, 94305-5623
Status
Recruiting
Address
Yale University
New Haven, Connecticut, 06510
Status
Recruiting
Address
Emory University - Winship Cancer Institute
Atlanta, Georgia, 30322
Status
Recruiting
Address
Tufts Medical Center
Boston, Massachusetts, 02111
Status
Recruiting
Address
Henry Ford Hospital
Detroit, Michigan, 48202
Status
Recruiting
Address
Ascension Providence Hospital
Southfield, Michigan, 48075
Status
Recruiting
Address
Cleveland Clinic
Cleveland, Ohio, 44195
Status
Recruiting
Address
West Penn Hospital
Pittsburgh, Pennsylvania, 15224
Status
Recruiting
Address
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, 15232
Status
Recruiting
Address
Medical University of South Carolina
Charleston, South Carolina, 29425-8900
Status
Recruiting
Address
Baptist Cancer Center
Memphis, Tennessee, 38120
Status
Recruiting
Address
Vanderbilt - Ingram Cancer Center
Nashville, Tennessee, 37232
Status
Recruiting
Address
University of Texas Southwestern Medical Center
Dallas, Texas, 75235
Status
Recruiting
Address
Huntsman Cancer Institute
Salt Lake City, Utah, 84112
Status
Recruiting
Address
Seattle Cancer Care Alliance
Seattle, Washington, 98109
Status
Recruiting
Address
University of Wisconsin Carbone Cancer Center
Madison, Wisconsin, 53792
Status
Active, not recruiting
Address
Hospital Aleman
Buenos Aires, , C1118AAT
Status
Active, not recruiting
Address
Hospital Italiano de Buenos Aires
Buenos Aires, , C1199ABB
Status
Active, not recruiting
Address
Hospital Privado - Centro Medico de Cordoba
Cordoba, , X5016KEH
Status
Active, not recruiting
Address
ZNA Stuivenberg
Antwerpen, , 2060
Status
Active, not recruiting
Address
AZ St.-Jan Brugge-Oostende AV
Brugge, , 8000
Status
Active, not recruiting
Address
UZ Gent
Gent, , 9000
Status
Active, not recruiting
Address
Hopital de Jolimont
Haine-saint-paul, LA Louviere, , 7100
Status
Active, not recruiting
Address
Az Groeninge
Kortrijk, , 8500
Status
Active, not recruiting
Address
UZ Leuven
Leuven, , 3000
Status
Active, not recruiting
Address
Algemeen Ziekenhuis Delta
Roeselare, , 8800
Status
Completed
Address
Hospitais Integradaos da Gavea S/A - DF Star
Brasilia, , 70390-140
Status
Active, not recruiting
Address
Liga Paranaense de Combate ao Cancer
Curitiba, , 81520-060
Status
Completed
Address
Centro de Pesquisa e Ensino em Oncologia de Santa Catarina - CEPEN
Florianopolis, , 88034-000
Status
Active, not recruiting
Address
Liga Norte Riograndense Contra O Cancer
Natal, , 59062-000
Status
Active, not recruiting
Address
Irmandade Santa Casa de Misericordia de Porto Alegre
Porto Alegre, , 90050-170
Status
Completed
Address
Instituto de Educacao, Pesquisa e Gestao em Saude Instituto Americas (COI)
Rio de Janeiro, , 22775-001
Status
Active, not recruiting
Address
Hospital Sao Rafael
Salvador, , 41253-190
Status
Active, not recruiting
Address
Hospital Paulistano
Sao Paulo, , 01323-000
Status
Active, not recruiting
Address
Clinica Sao Germano
Sao Paulo, , 01455-010
Status
Active, not recruiting
Address
Real e Benemérita Associação Portuguesa de Beneficência
São Paulo, , 01323-900
Status
Active, not recruiting
Address
Instituto D'Or de Pesquisa e Ensino (IDOR)
São Paulo, , 4501000
Status
Active, not recruiting
Address
Tom Baker Cancer Centre
Calgary, Alberta, T2N 4N2
Status
Active, not recruiting
Address
Cross Cancer Institute
Edmonton, Alberta, T6G 1Z2
Status
Active, not recruiting
Address
BC Cancer Agency - Vancouver BC
Vancouver, British Columbia, V5Z 4E6
Status
Active, not recruiting
Address
QEII Health Sciences
Halifax, Nova Scotia, B3H 2Y9
Status
Active, not recruiting
Address
Princess Margaret Cancer Centre University Health Network
Toronto, Ontario, M5G 1X6
Status
Active, not recruiting
Address
Beijing Chaoyang Hospital
Beijing, , 100020
Status
Active, not recruiting
Address
Peking University First Hospital
Beijing, , 100034
Status
Active, not recruiting
Address
Peking University People's Hospital
Beijing, , 100044
Status
Completed
Address
Peking University Third Hospital
Beijing, , 100191
Status
Completed
Address
The First Hospital of Jilin University
Changchun, , 130021
Status
Active, not recruiting
Address
The Third Xiangya Hospital of Central Sourth University
Changshashi, , 410013
Status
Active, not recruiting
Address
West China Hospital, Sichuan University
Chengdu, , 610041
Status
Active, not recruiting
Address
Fujian Meidical University Union Hospital
Fuzhou, , 350001
Status
Active, not recruiting
Address
Sun Yat-Sen University Cancer Center
Guangzhou, , 510060
Status
Completed
Address
First affiliated Hospital of Zhejiang University
Hangzhou, , 310003
Status
Active, not recruiting
Address
First affiliated Hospital of Zhejiang University
Hangzhou, , 310003
Status
Active, not recruiting
Address
Zhongda Hospital,Southeast University
Nanjing, , 210009
Status
Active, not recruiting
Address
First Affiliated Hospital of Guangxi Medical University
Nanning, , 530021
Status
Active, not recruiting
Address
Shanghai Zhongshan Hospital
Shanghai, , 200032
Status
Active, not recruiting
Address
Shengjing Hospital of China Medical University
Shenyang, , 110022
Status
Active, not recruiting
Address
Peking University Shenzhen Hospital
Shenzhen, , 518036
Status
Completed
Address
Tianjin Medical University General Hospital
Tianjin, , 300011
Status
Active, not recruiting
Address
Tianjin Medical University Cancer Institute and Hospital
Tianjin, , 300060
Status
Active, not recruiting
Address
The Second Affiliated Hospital of Xi'an Jiaotong University
Xi'an, , 710004
Status
Active, not recruiting
Address
The Affiliated Hospital of Xuzhou Medical University
Xuzhou, , 221000
Status
Completed
Address
Henan Cancer Hospital
Zhengzhou, , 450008
Status
Active, not recruiting
Address
Aalborg University Hospital
Aalborg, , DK-9000
Status
Active, not recruiting
Address
Aarhus University Hospital
Aarhus N, , DK-8200
Status
Active, not recruiting
Address
Rigshospitalet
Copenhagen, , 2100
Status
Active, not recruiting
Address
Odense Universitets Hospital
Odense, , 5000
Status
Active, not recruiting
Address
Vejle Hospital
Vejle, , DK-7100
Status
Active, not recruiting
Address
CHU Henri Mondor
Creteil, , 94000
Status
Active, not recruiting
Address
CHRU de Lille - Hopital Claude Huriez
LILLE Cedex, , 59037
Status
Active, not recruiting
Address
CHU de Limoges, Hopital Dupuytren
Limoges, , 87042
Status
Active, not recruiting
Address
C.H.U. Hotel Dieu - France
Nantes, , 44093
Status
Active, not recruiting
Address
Centre hospitalier Lyon-Sud
Pierre Benite cedex, , 69495
Status
Active, not recruiting
Address
CHU De Poitiers
Poitiers, , 86021
Status
Active, not recruiting
Address
Institut de Cancerologie Strasbourg Europe (ICANS)
Strasbourg, , 67200
Status
Active, not recruiting
Address
Pôle IUC Oncopole CHU
Toulouse cedex 9, , 31059
Status
Active, not recruiting
Address
CHRU Hôpital Bretonneau
Tours, , 37044
Status
Active, not recruiting
Address
Universitätsklinikum Carl-Gustav-Carus Dresden
Dresden, , 01307
Status
Active, not recruiting
Address
Heinrich-Heine -Universitaet Duesseldorf
Düsseldorf, , 40225
Status
Completed
Address
Evang. Krankenhaus Essen-Mitte gGmbH
Essen, , 45239
Status
Active, not recruiting
Address
Universitatsklinikum Freiburg
Freiburg, , 79106
Status
Active, not recruiting
Address
Universitaetsklinikum Hamburg Eppendorf
Hamburg, , 20246
Status
Active, not recruiting
Address
St. Barbara-Klinik Hamm GmbH
Hamm, , 59073
Status
Active, not recruiting
Address
Universitaetsklinikum Heidelberg
Heidelberg, , 69120
Status
Completed
Address
Universitaetsklinikum Schleswig-Holstein Campus Kiel
Kiel, , 24105
Status
Active, not recruiting
Address
Universitaetsklinikum Leipzig
Leipzig, , 04103
Status
Active, not recruiting
Address
Universitaetsklinikum Tuebingen
Tübingen, , 72076
Status
Active, not recruiting
Address
Alexandra General Hospital of Athens
Athens Attica, , 115 28
Status
Active, not recruiting
Address
Anticancer Hospital of Thessaloniki 'Theageneio'
Thessaloniki, , 546 39
Status
Active, not recruiting
Address
G.Papanikolaou
Thessaloniki, , 57010
Status
Active, not recruiting
Address
U.O. Ematologia con Trapianto- AOU Policlinico di Bari
Bari, , 70124
Status
Active, not recruiting
Address
ASST Papa Giovanni XXIII - Bergamo
Bergamo, , 24127
Status
Active, not recruiting
Address
Policlinico Sant'Orsola Malpighi
Bologna, , 40138
Status
Completed
Address
Azienda Ospedaliera Universitaria Careggi
Firenze, , 50134
Status
Active, not recruiting
Address
Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori
Meldola, , 47014
Status
Completed
Address
IRCCS Policlinico San Matteo, Università degli studi di Pavi
Pavia, , 27100
Status
Completed
Address
Università di Roma 'La Sapienza' - Ospedale Umberto 1°
Roma, , 00161
Status
Active, not recruiting
Address
A.O.U. Citta della Salute e della Scienza di Torino - Presidio Molinette
Turin, , 10126
Status
Active, not recruiting
Address
Fukuoka University Hospital
Fukuoka, , 814-0180
Status
Active, not recruiting
Address
Ogaki Municipal Hospital
Gifu, , 503-8502
Status
Active, not recruiting
Address
National Hospital Organization Mito Medical Center
Higashiibaraki-gun, , 311-3193
Status
Active, not recruiting
Address
The Hospital of Hyogo College of Medicine
Hyôgo, , 663-8501
Status
Active, not recruiting
Address
Tokai University Hospital
Isehara, , 259-1193
Status
Completed
Address
Shonan Kamakura General Hospital
Kamakura-shi, , 247-8533
Status
Active, not recruiting
Address
National Cancer Center Hospital East
Kashiwa, , 277-8577
Status
Active, not recruiting
Address
Dokkyo Medical University Saitama Medical Center
Koshigaya, , 343-8555
Status
Active, not recruiting
Address
Kumamoto University Hospital
Kumamoto, , 860-8556
Status
Active, not recruiting
Address
Kurume University Hospital
Kurume, , 830-0011
Status
Active, not recruiting
Address
National Hospital Organization Matsumoto Medical Center
Matsumoto, , 399-8701
Status
Active, not recruiting
Address
Nagoya City University Hospital
Nagoya, , 467-8602
Status
Active, not recruiting
Address
National Hospital Organization Okayama Medical Center
Okayama, , 701-1192
Status
Active, not recruiting
Address
National Hospital Organization Hiroshima-Nishi Medical Center
Otake, , 739-0696
Status
Active, not recruiting
Address
Hokkaido University Hospital
Sapporo-shi, , 060-8648
Status
Active, not recruiting
Address
National Hospital Organization Sendai Medical Center
Sendai-City, , 983-8520
Status
Completed
Address
Tohoku University Hospital
Sendai, , 980-8574
Status
Active, not recruiting
Address
Japanese Red Cross Medical Center
Shibuya-ku, , 150-8935
Status
Active, not recruiting
Address
Iwate Medical University Hospital
Shiwa-gun, , 028-3695
Status
Active, not recruiting
Address
Kyungpook National University Hospital
Daegu, , 41944
Status
Active, not recruiting
Address
Gachon University Gil Medical Center
Incheon, , 21565
Status
Active, not recruiting
Address
Chonnam National University Hwasun Hospital
Jeollanam-do, , 58128
Status
Active, not recruiting
Address
Seoul National University Hospital
Seoul, , 03080
Status
Active, not recruiting
Address
Severance Hospital, Yonsei University Health System
Seoul, , 03722
Status
Active, not recruiting
Address
Samsung Medical Center
Seoul, , 06351
Status
Active, not recruiting
Address
The Catholic University of Korea Seoul St. Mary's Hospital
Seoul, , 06591
Status
Active, not recruiting
Address
VU Medisch Centrum
Amsterdam, , 1081 HV
Status
Active, not recruiting
Address
Universitair Medisch Centrum Groningen
Groningen, , 9713 GZ
Status
Active, not recruiting
Address
Sint Antonius Ziekenhuis - Afd.Interne - INT
Nieuwegein, , 3435 CM
Status
Active, not recruiting
Address
Radboudumc
Nijmegen, , 6525GA
Status
Active, not recruiting
Address
Isala Kliniek
Zwolle, , 8025 AB
Status
Active, not recruiting
Address
Klinika Hematologii i Transplantologii, UCK
Gdansk, , 80-214
Status
Active, not recruiting
Address
Pratia Onkologia Katowice
Katowice, , 40-519
Status
Active, not recruiting
Address
Swietokrzyskie Centrum Onkologii SPZOZ w Kielcach
Kielce, , 25-734
Status
Active, not recruiting
Address
Centrum Onkologii Ziemi Lubelskiej im. św. Jana z Dukli
Lublin, , 20-090
Status
Active, not recruiting
Address
Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - Panstwowy Instytut Badawczy
Warszawa, , 02-781
Status
Active, not recruiting
Address
Specjalistyczny Szpital im. dra Alfreda Sokołowskiego w Wałbrzychu
Wałbrzych, , 58-309
Status
Active, not recruiting
Address
Uniwersytecki Szpital Kliniczny im. Jana Mikulicza-Radeckiego we Wroclawiu
Wroclaw, , 50-367
Status
Completed
Address
S.P. Botkin Moscow City Clinical Hospital
Moscow, , 125284
Status
Terminated
Address
S.P. Botkin Moscow City Clinical Hospital
Moscow, , 125284
Status
Completed
Address
Clinical Research Institute of Hematology and Transfusiology
St-Petersburg, , 191024
Status
Active, not recruiting
Address
Inst. Cat. Doncologia-H Duran I Reynals
Barcelona, , 08908
Status
Active, not recruiting
Address
Hosp. Univ. Vall D Hebron
Barcelona, , 8035
Status
Active, not recruiting
Address
Hosp. de Cabuenes
Gijón, , 33394
Status
Active, not recruiting
Address
Hosp. Univ. de Gran Canaria Dr. Negrin
Las Palmas de Gran Canaria, , 35010
Status
Active, not recruiting
Address
Hosp. Gral. Univ. Gregorio Maranon
Madrid, , 28007
Status
Active, not recruiting
Address
Hosp. Univ. Ramon Y Cajal
Madrid, , 28034
Status
Active, not recruiting
Address
Hosp. Univ. 12 de Octubre
Madrid, , 28041
Status
Active, not recruiting
Address
Hosp. Univ. Son Espases
Palma, , 7120
Status
Active, not recruiting
Address
Clinica Univ. de Navarra
Pamplona, , 31008
Status
Active, not recruiting
Address
Hosp. Quiron Madrid Pozuelo
Pozuelo de Alarcon, , 28223
Status
Active, not recruiting
Address
Hosp. Clinico Univ. de Salamanca
Salamanca, , 37007
Status
Active, not recruiting
Address
Hosp. Univ. Marques de Valdecilla
Santander, , 39008
Status
Active, not recruiting
Address
Hosp. Clinico Univ. de Santiago
Santiago de Compostela, , 15706
Status
Active, not recruiting
Address
Hosp. Virgen Del Rocio
Sevilla, , 41013
Status
Active, not recruiting
Address
Hosp. Univ. I Politecni La Fe
Valencia, , 46026
Status
Active, not recruiting
Address
Falu Lasarett
Falun, , 791 82
Status
Active, not recruiting
Address
Sahlgrenska University Hospital
Göteborg, , 413 45
Status
Active, not recruiting
Address
Helsingborgs lasarett
Helsingborg, , 25187
Status
Active, not recruiting
Address
Sunderby Sjukhus
Luleå, , 971 80
Status
Active, not recruiting
Address
Skanes universitetssjukhus
Lund, , 221 85
Status
Active, not recruiting
Address
Norrlands Universitetssjukhus
Umea, , 901 85
Status
Active, not recruiting
Address
Akademiska Sjukhuset
Uppsala, , 75185
Status
Completed
Address
China Medical University Hospital
Taichung, , 40447
Status
Active, not recruiting
Address
National Cheng Kung University Hospital
Tainan, , 704
Status
Active, not recruiting
Address
Chang Gung Memorial Hospital
Taoyuan, , 333
Status
Completed
Address
Ankara University Medical Faculty
Ankara, , 06590
Status
Active, not recruiting
Address
Ondokuz Mayis University
Atakum, , 55280
Status
Completed
Address
Medipol University Hospital
Istanbul, , 34214
Status
Completed
Address
Dokuz Eylul University Medical Faculty
Izmir, , 35340
Status
Active, not recruiting
Address
Blackpool Teaching Hospitals NHS Foundation Trust
Blackpool, , FY3 8NR
Status
Active, not recruiting
Address
Ninewells Hospital & Medical School
Dundee, , DD1 9SY
Status
Active, not recruiting
Address
Kings College Hospital
London, , SE5 9RS
Status
Completed
Address
Oxford University Hospitals NHS Foundation Trust
Oxford, , OX3 7LE
Status
Active, not recruiting
Address
University Hospitals Plymouth NHS Trust
Plymouth, , PL6 8DH
Status
Active, not recruiting
Address
Royal Marsden Hospital
Sutton, , SM2 5PT