A Study of Teclistamab in Combination With Daratumumab Subcutaneously (SC) (Tec-Dara) Versus Daratumumab SC, Pomalidomide, and Dexamethasone (DPd) or Daratumumab SC, Bortezomib, and Dexamethasone (DVd) in Participants With Relapsed or Refractory Multiple Myeloma
MajesTEC-3
A Phase 3 Randomized Study Comparing Teclistamab in Combination With Daratumumab SC (Tec-Dara) Versus Daratumumab SC, Pomalidomide, and Dexamethasone (DPd) or Daratumumab SC, Bortezomib, and Dexamethasone (DVd) in Participants With Relapsed or Refractory Multiple Myeloma
4 other identifiers
interventional
587
21 countries
176
Brief Summary
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3 multiple-myeloma
Started Oct 2021
Typical duration for phase_3 multiple-myeloma
176 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 8, 2021
CompletedStudy Start
First participant enrolled
October 14, 2021
CompletedFirst Posted
Study publicly available on registry
October 19, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 8, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 8, 2028
April 13, 2026
April 1, 2026
7.2 years
October 8, 2021
April 9, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
Progression Free Survival (PFS)
PFS is defined as the time from the date of randomization to the date of first documented disease progression, as defined in the International Myeloma Working Group (IMWG) criteria, or death due to any cause, whichever occurs first.
Up to 5 years
Secondary Outcomes (20)
Overall Response (Partial Response [PR] or Better)
Up to 5 years
Very Good Partial Response (VGPR) or Better
Up to 5 years
Complete Response (CR) or Better
Up to 5 years
Minimal Residual Disease (MRD)-negativity
Up to 5 years
Progression Free Survival on Next-line Therapy (PFS2)
Up to 5 years
- +15 more secondary outcomes
Study Arms (2)
Arm A: Teclistamab-daratumumab (Tec-Dara)
EXPERIMENTALParticipants will receive teclistamab and daratumumab by subcutaneous (SC) injection. Step-up doses of teclistamab will be given prior to the first full dose.
Arm B: DPd or DVd
EXPERIMENTALParticipants 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.
Interventions
Daratumumab will be administered SC injection.
Teclistamab will be administered SC injection.
Eligibility Criteria
You may qualify if:
- Documented multiple myeloma as defined by the criteria: a. multiple myeloma diagnosis according to the International Myeloma Working Group (IMWG) diagnostic criteria, b. measurable disease at screening as defined by any of the following: 1) serum M-protein level greater than or equal to (\>=) 0.5 gram per deciliter (g/dL); or 2) urine M-protein level \>=200 milligrams (mg)/24 hours; or 3) serum immunoglobulin free light chain \>=10 mg/dL and abnormal serum immunoglobulin kappa lambda free light chain ratio
- Received 1 to 3 prior line(s) of antimyeloma therapy including a proteasome inhibitor (PI) and lenalidomide; a. participants who have received only 1 line of prior line of antimyeloma therapy must be lenalidomide refractory. Stable disease or progression on or within 60 days of the last dose of lenalidomide given as maintenance will meet this criterion
- Documented evidence of progressive disease based on investigator's determination of response by 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 prior to the start of administration of study treatment
- Have clinical laboratory values within the specified range
You may not qualify if:
- A participant is not eligible to receive daratumumab subcutaneous (SC) in combination with pomalidomide and dexamethasone (DPd) as control therapy if any of the following are present: 1) Contraindications or life-threatening allergies, hypersensitivity, or intolerance to pomalidomide, 2) Disease that is considered refractory to pomalidomide per IMWG,
- A participant is not eligible to receive daratumumab SC in combination with bortezomib and dexamethasone (DVd) as control therapy if any of the following are present: 1) Contraindications or life-threatening allergies, hypersensitivity, or intolerance to bortezomib, 2) Grade 1 peripheral neuropathy with pain or Grade \>= 2 peripheral neuropathy as defined by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) Version 5.0, 3) Disease that is considered refractory to bortezomib per IMWG, 4) Received a strong cytochromes P450 (CYP3A4) inducer within 5 half-lives prior to randomization
- Received any prior B cell maturation antigen (BCMA)-directed therapy
- Has disease that is considered refractory to an anti-cluster of differentiation 38 (CD38) monoclonal antibody per IMWG
- Received a cumulative dose of corticosteroids equivalent to \>=140 mg of prednisone within 14 days before randomization
- Received a live, attenuated vaccine within 4 weeks before randomization
- Plasma cell leukemia at the time of screening, Waldenström's macroglobulinemia, POEMS syndrome (polyneuropathy, organomegaly, endocrinopathy, M-protein, and skin changes), or primary amyloid light chain amyloidosis
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (176)
University of Alabama Birmingham
Birmingham, Alabama, 35294, United States
City of Hope
Duarte, California, 91010, United States
Stanford University Medical Center
Stanford, California, 94305-5623, United States
Yale University
New Haven, Connecticut, 06510, United States
Emory University Winship Cancer Institute
Atlanta, Georgia, 30322, United States
Tufts Medical Center
Boston, Massachusetts, 02111, United States
Henry Ford Hospital
Detroit, Michigan, 48202, United States
Henry Ford Health System
Southfield, Michigan, 48075, United States
Cleveland Clinic
Cleveland, Ohio, 44195, United States
West Penn Hospital
Pittsburgh, Pennsylvania, 15224, United States
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, 15232, United States
Medical University of South Carolina
Charleston, South Carolina, 29425-8900, United States
Baptist Cancer Center
Memphis, Tennessee, 38120, United States
Vanderbilt Ingram Cancer Center
Nashville, Tennessee, 37232, United States
University of Texas Southwestern Medical Center
Dallas, Texas, 75235, United States
Huntsman Cancer Institute
Salt Lake City, Utah, 84112, United States
Fred Hutchinson Cancer Center
Seattle, Washington, 98109, United States
University of Wisconsin Carbone Cancer Center
Madison, Wisconsin, 53792, United States
Hospital Aleman
Buenos Aires, C1118AAT, Argentina
Hospital Italiano de Buenos Aires
Buenos Aires, C1199ABB, Argentina
Hospital Privado Centro Medico de Cordoba
Córdoba, X5016KEH, Argentina
ZAS Cadix
Antwerp, 2030, Belgium
AZ St.-Jan Brugge-Oostende AV
Bruges, 8000, Belgium
UZ Gent
Ghent, 9000, Belgium
Hopital de Jolimont
Haine Saint Paul La Louviere, 7100, Belgium
Az Groeninge
Kortrijk, 8500, Belgium
UZ Leuven
Leuven, 3000, Belgium
Algemeen Ziekenhuis Delta
Roeselare, 8800, Belgium
Hospitais Integradaos da Gavea S/A - DF Star
Brasília, 70390-140, Brazil
Liga Paranaense de Combate ao Cancer
Curitiba, 81520 060, Brazil
Centro de Pesquisa e Ensino em Oncologia de Santa Catarina CEPEN
Florianópolis, 88034-000, Brazil
Liga Norte Riograndense Contra O Cancer
Natal, 59062 000, Brazil
Irmandade Santa Casa de Misericordia de Porto Alegre
Porto Alegre, 90050-170, Brazil
Instituto de Educacao, Pesquisa e Gestao em Saude Instituto Americas (COI)
Rio de Janeiro, 22775 001, Brazil
Hospital Sao Rafael
Salvador, 41253-190, Brazil
Real e Benemerita Associacao Portuguesa de Beneficencia
São Paulo, 01323 900, Brazil
Hospital Paulistano
São Paulo, 01323-000, Brazil
Clinica Medica Sao Germano S/S LTDA
São Paulo, 01455 010, Brazil
Instituto D Or de Pesquisa e Ensino IDOR
São Paulo, 4501000, Brazil
Arthur J E Child Comprehensive Cancer Centre
Calgary, Alberta, T2N 5G2, Canada
Cross Cancer Institute
Edmonton, Alberta, T6G 1Z2, Canada
BC Cancer Agency - Vancouver BC
Vancouver, British Columbia, V5Z 4E6, Canada
QEII Health Sciences
Halifax, Nova Scotia, B3H 2Y9, Canada
Princess Margaret Cancer Centre University Health Network
Toronto, Ontario, M5G 1X6, Canada
Peking University First Hospital
Beijing, 100034, China
Peking University People's Hospital
Beijing, 100044, China
Peking University Third Hospital
Beijing, 100191, China
The First Hospital of Jilin University
Changchun, 130021, China
The Third Xiangya Hospital of Central Sourth University
Changshashi, 410013, China
Beijing Chaoyang Hospital
Chaoyang District, 100020, China
West China Hospital Sichuan University
Chengdu, 610041, China
Fujian Meidical University Union Hospital
Fuzhou, 350001, China
Sun Yat -Sen University Cancer Center
Guangzhou, 511363, China
First affiliated Hospital of Zhejiang University 1
Hangzhou, 310003, China
First affiliated Hospital of Zhejiang University
Hangzhou, 310003, China
Zhongda Hospital Southeast University
Nanjing, 210009, China
First Affiliated Hospital of Guangxi Medical University
Nanning, 530021, China
Shanghai Zhongshan Hospital
Shanghai, 200032, China
Shengjing Hospital Of China Medical University
Shenyang, 110136, China
Peking University Shenzhen Hospital
Shenzhen, 518036, China
Tianjin Medical University General Hospital
Tianjin, 300011, China
Tianjin Medical University Cancer Institute and Hospital
Tianjin, 300060, China
The Second Affiliated Hospital of Xi'an Jiaotong University
Xi'an, 710004, China
The Affiliated Hospital of Xuzhou Medical University
Xuzhou, 221000, China
Henan Cancer Hospital
Zhengzhou, 450008, China
Aalborg University Hospital
Aalborg, DK-9000, Denmark
Aarhus University Hospital
Aarhus N, DK-8200, Denmark
Rigshospitalet
Copenhagen, 2100, Denmark
Odense Universitets Hospital
Odense, 5000, Denmark
Vejle Hospital
Vejle, DK-7100, Denmark
CHU Henri Mondor
Créteil, 94000, France
Hopital Claude Huriez
Lille, 59000, France
CHU de Limoges Hopital Dupuytren
Limoges, 87042, France
Hospices Civils de Lyon HCL
Lyon, 69002, France
C.H.U. Hotel Dieu - France
Nantes, 44093, France
CHU De Poitiers
Poitiers, 86021, France
Hôpitaux Universitaires de Strasbourg - Hôpital de Hautepierre
Strasbourg, 67200, France
Pôle IUC Oncopole CHU
Toulouse, 31059, France
CHRU Hôpital Bretonneau
Tours, 37044, France
Universitätsklinikum Carl-Gustav-Carus Dresden
Dresden, 01307, Germany
Heinrich-Heine -Universitaet Duesseldorf
Düsseldorf, 40225, Germany
Evang. Krankenhaus Essen-Mitte gGmbH
Essen, 45239, Germany
Universitatsklinikum Freiburg
Freiburg im Breisgau, 79106, Germany
Universitaetsklinikum Hamburg Eppendorf
Hamburg, 20246, Germany
St. Barbara-Klinik Hamm GmbH
Hamm, 59073, Germany
Universitaetsklinikum Heidelberg
Heidelberg, 69120, Germany
Universitaetsklinikum Schleswig Holstein Campus Kiel
Kiel, 24105, Germany
Universitaetsklinikum Leipzig
Leipzig, 04103, Germany
Universitaetsklinikum Tuebingen
Tübingen, 72076, Germany
Alexandra General Hospital of Athens
Athens Attica, 115 28, Greece
Anticancer Hospital of Thessaloniki Theageneio
Thessaloniki, 546 39, Greece
G.Papanikolaou
Thessaloniki, 57010, Greece
U.O. Ematologia con Trapianto- AOU Policlinico di Bari
Bari, 70124, Italy
ASST Papa Giovanni XXIII Bergamo
Bergamo, 24127, Italy
Policlinico Sant'Orsola Malpighi
Bologna, 40138, Italy
Azienda Ospedaliera Universitaria Careggi
Florence, 50134, Italy
Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori
Meldola, 47014, Italy
IRCCS Policlinico San Matteo, Università degli studi di Pavi
Pavia, 27100, Italy
Università di Roma 'La Sapienza' - Ospedale Umberto 1°
Roma, 00161, Italy
A.O.U. Citta della Salute e della Scienza di Torino - Presidio Molinette
Turin, 10126, Italy
Fukuoka University Hospital
Fukuoka, 814-0180, Japan
Ogaki Municipal Hospital
Gifu, 503-8502, Japan
National Hospital Organization Mito Medical Center
Higashiibaraki-gun, 311-3193, Japan
Tokai University Hospital
Isehara, 259-1193, Japan
Shonan Kamakura General Hospital
Kamakura-shi, 247-8533, Japan
National Cancer Center Hospital East
Kashiwa, 277 8577, Japan
Dokkyo Medical University Saitama Medical Center
Koshigaya, 343-8555, Japan
Kumamoto University Hospital
Kumamoto, 860-8556, Japan
Kurume University Hospital
Kurume, 830-0011, Japan
National Hospital Organization Matsumoto Medical Center
Matsumoto, 399-8701, Japan
Nagoya City University Hospital
Nagoya, 467 8602, Japan
Hyogo Medical University Hospital
Nishinomiya Shi, 663 8501, Japan
National Hospital Organization Okayama Medical Center
Okayama, 701-1192, Japan
National Hospital Organization Hiroshima-Nishi Medical Center
Ōtake, 739-0696, Japan
Hokkaido University Hospital
Sapporo, 060-8648, Japan
Tohoku University Hospital
Sendai, 980 8574, Japan
National Hospital Organization Sendai Medical Center
Sendai, 983-8520, Japan
Japanese Red Cross Medical Center
Shibuya-ku, 150-8935, Japan
Iwate Medical University Hospital
Shiwa-gun, 028-3695, Japan
VU Medisch Centrum
Amsterdam, 1081 HV, Netherlands
Universitair Medisch Centrum Groningen
Groningen, 9713 GZ, Netherlands
Sint Antonius Ziekenhuis - Afd.Interne - INT
Nieuwegein, 3435 CM, Netherlands
Radboudumc
Nijmegen, 6525GA, Netherlands
Isala Kliniek
Zwolle, 8025 AB, Netherlands
Klinika Hematologii i Transplantologii, UCK
Gdansk, 80-214, Poland
Pratia Onkologia Katowice
Katowice, 40 519, Poland
Swietokrzyskie Centrum Onkologii SPZOZ w Kielcach
Kielce, 25 734, Poland
Centrum Onkologii Ziemi Lubelskiej im sw Jana z Dukli
Lublin, 20 090, Poland
Narodowy Instytut Onkologii im Marii Sklodowskiej Curie Panstwowy Instytut Badawczy
Warsaw, 02-781, Poland
Specjalistyczny Szpital im dra Alfreda Sokolowskiego w Walbrzychu
Wałbrzych, 58 309, Poland
Uniwersytecki Szpital Kliniczny im Jana Mikulicza Radeckiego we Wroclawiu
Wroclaw, 50 367, Poland
S.P. Botkin Moscow City Clinical Hospital 1
Moscow, 125284, Russia
S.P. Botkin Moscow City Clinical Hospital
Moscow, 125284, Russia
Clinical Research Institute of Hematology and Transfusiology
Saint Petersburg, 191024, Russia
Kyungpook National University Hospital
Daegu, 41944, South Korea
Gachon University Gil Medical Center
Incheon, 21565, South Korea
Chonnam National University Hwasun Hospital
Jeollanam-do, 58128, South Korea
Seoul National University Hospital
Seoul, 03080, South Korea
Severance Hospital Yonsei University Health System
Seoul, 03722, South Korea
Samsung Medical Center
Seoul, 06351, South Korea
The Catholic University of Korea Seoul St Marys Hospital
Seoul, 06591, South Korea
Inst. Cat. Doncologia-H Duran I Reynals
Barcelona, 08908, Spain
Hosp Univ Vall D Hebron
Barcelona, 8035, Spain
Hosp. de Cabuenes
Gijón, 33394, Spain
Hosp. Univ. de Gran Canaria Dr. Negrin
Las Palmas de Gran Canaria, 35010, Spain
Hosp. Gral. Univ. Gregorio Maranon
Madrid, 28007, Spain
Hosp. Univ. Ramon Y Cajal
Madrid, 28034, Spain
Hosp. Univ. 12 de Octubre
Madrid, 28041, Spain
Hosp. Univ. Son Espases
Palma, 7120, Spain
Clinica Univ. de Navarra
Pamplona, 31008, Spain
Hosp. Quiron Madrid Pozuelo
Pozuelo de Alarcón, 28223, Spain
Hosp Clinico Univ de Salamanca
Salamanca, 37007, Spain
Hosp. Univ. Marques de Valdecilla
Santander, 39008, Spain
Hosp. Clinico Univ. de Santiago
Santiago de Compostela, 15706, Spain
Hosp. Virgen Del Rocio
Seville, 41013, Spain
Hosp. Univ. I Politecni La Fe
Valencia, 46026, Spain
Falu Lasarett
Falun, 791 82, Sweden
Sahlgrenska University Hospital
Gothenburg, 413 45, Sweden
Helsingborgs lasarett
Helsingborg, 25187, Sweden
Sunderby Sjukhus
Luleå, 971 80, Sweden
Skanes universitetssjukhus
Lund, 221 85, Sweden
Norrlands Universitetssjukhus
Umeå, 901 85, Sweden
Akademiska Sjukhuset
Uppsala, 75185, Sweden
China Medical University Hospital
Taichung, 40447, Taiwan
National Cheng Kung University Hospital
Tainan, 704, Taiwan
Chang Gung Memorial Hospital
Taoyuan District, 333, Taiwan
Ankara University Medical Faculty
Ankara, 06590, Turkey (Türkiye)
Ondokuz Mayis University
Atakum, 55280, Turkey (Türkiye)
Medipol University Hospital
Istanbul, 34214, Turkey (Türkiye)
Dokuz Eylul University Medical Faculty
Izmir, 35340, Turkey (Türkiye)
Blackpool Teaching Hospitals NHS Foundation Trust
Blackpool, FY3 8NR, United Kingdom
Ninewells Hospital & Medical School
Dundee, DD1 9SY, United Kingdom
Kings College Hospital
London, SE5 9RS, United Kingdom
Oxford University Hospitals NHS Foundation Trust
Oxford, OX3 7LE, United Kingdom
University Hospitals Plymouth NHS Trust
Plymouth, PL6 8DH, United Kingdom
Royal Marsden Hospital
Sutton, SM2 5PT, United Kingdom
Related Publications (1)
Costa LJ, Bahlis NJ, Perrot A, Nooka AK, Lu J, Pawlyn C, Mina R, Caeiro G, Kentos A, Hungria V, Reece D, Niu T, Mylin AK, Hansen CT, Teipel R, Besemer B, Dimopoulos MA, Zamagni E, Yoshihara S, Kim K, Min CK, Geerts P, Van Leeuwen-Segarceanu E, Tyczynska A, Reguera JL, Johansson M, Hansson M, Turgut M, Grey M, Sidana S, Rodriguez-Otero P, Martinez-Lopez J, Hashmi H, Carson R, Kobos R, Sun W, Lantz K, Seifert A, Briseno-Toomey D, O'Rourke L, Rubin M, Vieyra D, Kang L, Mateos MV; MajesTEC-3 Trial Investigators. Teclistamab plus Daratumumab in Relapsed or Refractory Multiple Myeloma. N Engl J Med. 2026 Feb 19;394(8):739-752. doi: 10.1056/NEJMoa2514663. Epub 2025 Dec 9.
PMID: 41363801DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Janssen Research & Development, LLC Clinical Trial
Janssen Research & Development, LLC
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
- Expanded Access
- Yes
Study Record Dates
First Submitted
October 8, 2021
First Posted
October 19, 2021
Study Start
October 14, 2021
Primary Completion (Estimated)
December 8, 2028
Study Completion (Estimated)
December 8, 2028
Last Updated
April 13, 2026
Record last verified: 2026-04
Data Sharing
- IPD Sharing
- Will share
The data sharing policy of the Janssen Pharmaceutical Companies of Johnson and Johnson is available at www.janssen.com/clinical-trials/transparency. As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) project site at yoda.yale.edu