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Een studie van Teclistamab in combinatie met Daratumumab Subcutaan (SC) (Tec-Dara) Versus Daratumumab SC, Pomalidomide en Dexamethason (DPd) of Daratumumab SC, Bortezomib en Dexamethason (DVd) bij deelnemers met gerecidiveerd of refractair multipel myeloom (MajesTEC-3)

2 november 2026 bijgewerkt door: Janssen Research & Development, LLC

Een gerandomiseerde fase 3-studie waarin Teclistamab wordt vergeleken in combinatie met Daratumumab SC (Tec-Dara) Versus Daratumumab SC, Pomalidomide en Dexamethason (DPd) of Daratumumab SC, Bortezomib en Dexamethason (DVd) bij deelnemers met gerecidiveerd of refractair multipel myeloom

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).

Studie Overzicht

Toestand

Actief, niet wervend

Conditie

Interventie / Behandeling

Studietype

Ingrijpend

Inschrijving (Werkelijk)

587

Fase

  • Fase 3

Uitgebreide toegang

Goedgekeurd te koop aan het publiek. Zie uitgebreid toegangsrecord.

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studie Locaties

  • Argentinië
      • Buenos Aires, Argentinië, C1199ABB
        • Hospital Italiano de Buenos Aires
      • CABA, Argentinië, C1118AAT
        • Hospital Aleman
      • Córdoba, Argentinië, X5016KEH
        • Hospital Privado Centro Medico de Cordoba
  • België
      • Antwerp, België, 2030
        • ZAS Cadix
      • Bruges, België, 8000
        • AZ St.-Jan Brugge-Oostende AV
      • Ghent, België, 9000
        • UZ Gent
      • Haine Saint Paul La Louviere, België, 7100
        • Hopital de Jolimont
      • Kortrijk, België, 8500
        • Az Groeninge
      • Leuven, België, 3000
        • UZ Leuven
      • Roeselare, België, 8800
        • Algemeen Ziekenhuis Delta
  • Brazilië
      • Brasília, Brazilië, 70390-140
        • Hospitais Integradaos da Gavea S/A - DF Star
      • Curitiba, Brazilië, 81520-060
        • Hospital Erasto Gaertner- Liga Paranaense de Combate ao Cancer
      • Florianópolis, Brazilië, 88034-000
        • Centro de Pesquisa e Ensino em Oncologia de Santa Catarina CEPEN
      • Natal, Brazilië, 59062 000
        • Liga Norte Riograndense Contra O Cancer
      • Porto Alegre, Brazilië, 90050-170
        • Irmandade Santa Casa de Misericordia de Porto Alegre
      • Rio de Janeiro, Brazilië, 22775 001
        • Instituto de Educacao, Pesquisa e Gestao em Saude Instituto Americas (COI)
      • Salvador, Brazilië, 41253-190
        • IDOR - Regional Bahia
      • São Paulo, Brazilië, 4501000
        • Instituto D Or de Pesquisa e Ensino IDOR
      • São Paulo, Brazilië, 01323-000
        • Hospital Paulistano
      • São Paulo, Brazilië, 01323 900
        • Real e Benemerita Associacao Portuguesa de Beneficencia
      • São Paulo, Brazilië, 04537 081
        • Clinica Medica Sao Germano LTDA
  • Canada
    • Alberta
      • Calgary, Alberta, Canada, T2N 5G2
        • Arthur J E Child Comprehensive Cancer Centre
      • Edmonton, Alberta, Canada, T6G 1Z2
        • Cross Cancer Institute
    • British Columbia
      • Vancouver, British Columbia, Canada, V5Z 4E6
        • BC Cancer Agency - Vancouver BC
    • Nova Scotia
      • Halifax, Nova Scotia, Canada, B3H 2Y9
        • QEII Health Sciences
    • Ontario
      • Toronto, Ontario, Canada, M5G 1X6
        • Princess Margaret Cancer Centre University Health Network
  • China
      • Beijing, China, 100044
        • Peking University People's Hospital
      • Beijing, China, 100191
        • Peking University Third Hospital
      • Beijing, China, 100034
        • Peking University First Hospital
      • Changchun, China, 130021
        • The First Hospital of Jilin University
      • Changshashi, China, 410013
        • The Third Xiangya Hospital of Central Sourth University
      • Chaoyang District, China, 100020
        • Beijing Chaoyang Hospital
      • Chengdu, China, 610041
        • West China Hospital Sichuan University
      • Fuzhou, China, 350001
        • Fujian Meidical University Union Hospital
      • Guangzhou, China, 511363
        • Sun Yat -Sen University Cancer Center
      • Hangzhou, China, 310003
        • First affiliated Hospital of Zhejiang University
      • Hangzhou, China, 310003
        • First affiliated Hospital of Zhejiang University 1
      • Nanjing, China, 210009
        • Zhongda Hospital Southeast University
      • Nanning, China, 530021
        • First Affiliated Hospital of Guangxi Medical University
      • Shanghai, China, 200032
        • Shanghai Zhongshan Hospital
      • Shenyang, China, 110136
        • Shengjing Hospital Of China Medical University
      • Shenzhen, China, 518036
        • Peking University Shenzhen Hospital
      • Tianjin, China, 300060
        • Tianjin Medical University Cancer Institute and Hospital
      • Tianjin, China, 300011
        • Tianjin Medical University General Hospital
      • Xi'an, China, 710004
        • The Second Affiliated Hospital of Xi'an Jiaotong University
      • Xuzhou, China, 221000
        • The Affiliated Hospital of Xuzhou Medical University
      • Zhengzhou, China, 450008
        • Henan Cancer Hospital
  • Denemarken
      • Aalborg, Denemarken, DK-9000
        • Aalborg University Hospital
      • Aarhus N, Denemarken, DK-8200
        • Aarhus University Hospital
      • Copenhagen, Denemarken, 2100
        • Rigshospitalet
      • Odense, Denemarken, 5000
        • Odense Universitets Hospital
      • Vejle, Denemarken, DK-7100
        • Vejle Hospital
  • Duitsland
      • Dresden, Duitsland, 01307
        • Universitaetsklinikum Carl-Gustav-Carus Dresden
      • Düsseldorf, Duitsland, 40225
        • Heinrich-Heine -Universitaet Duesseldorf
      • Essen, Duitsland, 45239
        • Evang. Krankenhaus Essen-Mitte gGmbH
      • Freiburg im Breisgau, Duitsland, 79106
        • Universitatsklinikum Freiburg
      • Hamburg, Duitsland, 20246
        • Universitaetsklinikum Hamburg Eppendorf
      • Hamm, Duitsland, 59073
        • St. Barbara-Klinik Hamm GmbH
      • Heidelberg, Duitsland, 69120
        • Universitaetsklinikum Heidelberg
      • Kiel, Duitsland, 24105
        • Universitaetsklinikum Schleswig Holstein Campus Kiel
      • Leipzig, Duitsland, 04103
        • Universitaetsklinikum Leipzig
      • Tübingen, Duitsland, 72076
        • Universitaetsklinikum Tuebingen
  • Frankrijk
      • Créteil, Frankrijk, 94000
        • CHU Henri Mondor
      • Lille, Frankrijk, 59000
        • Hopital Claude Huriez
      • Limoges, Frankrijk, 87042
        • CHU de Limoges Hopital Dupuytren
      • Lyon, Frankrijk, 69002
        • Hospices Civils de Lyon HCL
      • Nantes, Frankrijk, 44093
        • C.H.U. Hotel Dieu - France
      • Poitiers, Frankrijk, 86021
        • CHU De Poitiers
      • Strasbourg, Frankrijk, 67200
        • Hôpitaux Universitaires de Strasbourg - Hôpital de Hautepierre
      • Toulouse, Frankrijk, 31059
        • Pôle IUC Oncopole CHU
      • Tours, Frankrijk, 37044
        • CHRU Hôpital Bretonneau
  • Griekenland
      • Athens Attica, Griekenland, 115 28
        • Alexandra General Hospital of Athens
      • Thessaloniki, Griekenland, 57010
        • G.Papanikolaou
      • Thessaloniki, Griekenland, 546 39
        • Anticancer Hospital of Thessaloniki Theageneio
  • Italië
      • Bari, Italië, 70124
        • U.O. Ematologia con Trapianto- AOU Policlinico di Bari
      • Bergamo, Italië, 24127
        • ASST Papa Giovanni XXIII Bergamo
      • Bologna, Italië, 40138
        • Policlinico Sant'Orsola Malpighi
      • Florence, Italië, 50134
        • Azienda Ospedaliera Universitaria Careggi
      • Meldola, Italië, 47014
        • Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori
      • Pavia, Italië, 27100
        • IRCCS Policlinico San Matteo, Università degli studi di Pavi
      • Roma, Italië, 00161
        • Università di Roma 'La Sapienza' - Ospedale Umberto 1°
      • Turin, Italië, 10126
        • A.O.U. Citta della Salute e della Scienza di Torino - Presidio Molinette
  • Japan
      • Fukuoka, Japan, 814-0180
        • Fukuoka University Hospital
      • Gifu, Japan, 503-8502
        • Ogaki Municipal Hospital
      • Higashiibaraki-gun, Japan, 311-3193
        • National Hospital Organization Mito Medical Center
      • Isehara, Japan, 259-1193
        • Tokai University Hospital
      • Kamakura-shi, Japan, 247-8533
        • Shonan Kamakura General Hospital
      • Kashiwa, Japan, 277 8577
        • National Cancer Center Hospital East
      • Koshigaya, Japan, 343-8555
        • Dokkyo Medical University Saitama Medical Center
      • Kumamoto, Japan, 860-8556
        • Kumamoto University Hospital
      • Kurume, Japan, 830-0011
        • Kurume University Hospital
      • Matsumoto, Japan, 399-8701
        • National Hospital Organization Matsumoto Medical Center
      • Nagoya, Japan, 467 8602
        • Nagoya City University Hospital
      • Nishinomiya Shi, Japan, 663 8501
        • Hyogo Medical University Hospital
      • Okayama, Japan, 701-1192
        • National Hospital Organization Okayama Medical Center
      • Sapporo, Japan, 060-8648
        • Hokkaido University Hospital
      • Sendai, Japan, 983-8520
        • National Hospital Organization Sendai Medical Center
      • Sendai, Japan, 980 8574
        • Tohoku University Hospital
      • Shibuya-ku, Japan, 150-8935
        • Japanese Red Cross Medical Center
      • Shiwa-gun, Japan, 028-3695
        • Iwate Medical University Hospital
      • Ōtake, Japan, 739-0696
        • National Hospital Organization Hiroshima-Nishi Medical Center
  • Nederland
      • Amsterdam, Nederland, 1081 HV
        • VU Medisch Centrum
      • Groningen, Nederland, 9713 GZ
        • Universitair Medisch Centrum Groningen
      • Nieuwegein, Nederland, 3435 CM
        • Sint Antonius Ziekenhuis - Afd.Interne - INT
      • Nijmegen, Nederland, 6525GA
        • Radboudumc
      • Zwolle, Nederland, 8025 AB
        • Isala Kliniek
  • Polen
      • Gdansk, Polen, 80-214
        • Klinika Hematologii i Transplantologii, UCK
      • Katowice, Polen, 40 519
        • Pratia Onkologia Katowice
      • Kielce, Polen, 25 734
        • Swietokrzyskie Centrum Onkologii SPZOZ w Kielcach
      • Lublin, Polen, 20 090
        • Centrum Onkologii Ziemi Lubelskiej im sw Jana z Dukli
      • Warsaw, Polen, 02-781
        • Narodowy Instytut Onkologii im Marii Sklodowskiej Curie Panstwowy Instytut Badawczy
      • Wałbrzych, Polen, 58 309
        • Specjalistyczny Szpital im dra Alfreda Sokolowskiego w Walbrzychu
      • Wroclaw, Polen, 50 367
        • Uniwersytecki Szpital Kliniczny im Jana Mikulicza Radeckiego we Wroclawiu
  • Rusland
      • Moscow, Rusland, 125284
        • S.P. Botkin Moscow City Clinical Hospital
      • Moscow, Rusland, 125284
        • S.P. Botkin Moscow City Clinical Hospital 1
      • Saint Petersburg, Rusland, 191024
        • Clinical Research Institute of Hematology and Transfusiology
  • Spanje
      • Barcelona, Spanje, 08908
        • Inst. Cat. Doncologia-H Duran I Reynals
      • Barcelona, Spanje, 8035
        • Hosp Univ Vall D Hebron
      • Gijón, Spanje, 33394
        • Hosp. de Cabuenes
      • Las Palmas de Gran Canaria, Spanje, 35010
        • Hosp. Univ. de Gran Canaria Dr. Negrin
      • Madrid, Spanje, 28041
        • Hosp. Univ. 12 de Octubre
      • Madrid, Spanje, 28034
        • Hosp. Univ. Ramon Y Cajal
      • Madrid, Spanje, 28007
        • Hosp. Gral. Univ. Gregorio Maranon
      • Palma, Spanje, 7120
        • Hosp. Univ. Son Espases
      • Pamplona, Spanje, 31008
        • Clinica Univ. de Navarra
      • Pozuelo de Alarcón, Spanje, 28223
        • Hosp. Quiron Madrid Pozuelo
      • Salamanca, Spanje, 37007
        • Hosp Clinico Univ de Salamanca
      • Santander, Spanje, 39008
        • Hosp. Univ. Marques de Valdecilla
      • Santiago de Compostela, Spanje, 15706
        • Hosp. Clinico Univ. de Santiago
      • Seville, Spanje, 41013
        • Hosp. Virgen Del Rocio
      • Valencia, Spanje, 46026
        • Hosp. Univ. I Politecni La Fe
  • Taiwan
      • Taichung, Taiwan, 40447
        • China Medical University Hospital
      • Tainan, Taiwan, 704
        • National Cheng Kung University Hospital
      • Taoyuan, Taiwan, 333
        • Chang Gung Memorial Hospital
  • Turkije (Türkiye)
      • Ankara, Turkije (Türkiye), 06590
        • Ankara University Medical Faculty
      • Atakum, Turkije (Türkiye), 55280
        • Ondokuz Mayis University
      • Istanbul, Turkije (Türkiye), 34214
        • Medipol University Hospital
      • Izmir, Turkije (Türkiye), 35340
        • Dokuz Eylul University Medical Faculty
  • Verenigd Koninkrijk
      • Blackpool, Verenigd Koninkrijk, FY3 8NR
        • Blackpool Teaching Hospitals NHS Foundation Trust
      • Dundee, Verenigd Koninkrijk, DD1 9SY
        • Ninewells Hospital & Medical School
      • London, Verenigd Koninkrijk, SE5 9RS
        • Kings College Hospital
      • Oxford, Verenigd Koninkrijk, OX3 7LE
        • Oxford University Hospitals NHS Foundation Trust
      • Plymouth, Verenigd Koninkrijk, PL6 8DH
        • University Hospitals Plymouth NHS Trust
      • Sutton, Verenigd Koninkrijk, SM2 5PT
        • Royal Marsden Hospital
  • Verenigde Staten
    • Alabama
      • Birmingham, Alabama, Verenigde Staten, 35294
        • University of Alabama Birmingham
    • California
      • Duarte, California, Verenigde Staten, 91010
        • City of Hope
      • Stanford, California, Verenigde Staten, 94305-5623
        • Stanford University Medical Center
    • Connecticut
      • New Haven, Connecticut, Verenigde Staten, 06510
        • Yale University
    • Georgia
      • Atlanta, Georgia, Verenigde Staten, 30322
        • Emory University Winship Cancer Institute
    • Massachusetts
      • Boston, Massachusetts, Verenigde Staten, 02111
        • Tufts Medical Center
    • Michigan
      • Detroit, Michigan, Verenigde Staten, 48202
        • Henry Ford Hospital
      • Southfield, Michigan, Verenigde Staten, 48075
        • Henry Ford Health System
    • Ohio
      • Cleveland, Ohio, Verenigde Staten, 44195
        • Cleveland Clinic
    • Pennsylvania
      • Pittsburgh, Pennsylvania, Verenigde Staten, 15224
        • West Penn Hospital
      • Pittsburgh, Pennsylvania, Verenigde Staten, 15232
        • University of Pittsburgh Medical Center
    • South Carolina
      • Charleston, South Carolina, Verenigde Staten, 29425-8900
        • Medical University of South Carolina
    • Tennessee
      • Memphis, Tennessee, Verenigde Staten, 38120
        • Baptist Cancer Center
      • Nashville, Tennessee, Verenigde Staten, 37232
        • Vanderbilt Ingram Cancer Center
    • Texas
      • Dallas, Texas, Verenigde Staten, 75235
        • University of Texas Southwestern Medical Center
    • Utah
      • Salt Lake City, Utah, Verenigde Staten, 84112
        • Huntsman Cancer Institute
    • Washington
      • Seattle, Washington, Verenigde Staten, 98109
        • Fred Hutchinson Cancer Center
    • Wisconsin
      • Madison, Wisconsin, Verenigde Staten, 53792
        • University of Wisconsin Carbone Cancer Center
  • Zuid -Korea
      • Daegu, Zuid -Korea, 41944
        • Kyungpook National University Hospital
      • Incheon, Zuid -Korea, 21565
        • Gachon University Gil Medical Center
      • Jeollanam-do, Zuid -Korea, 58128
        • Chonnam National University Hwasun Hospital
      • Seoul, Zuid -Korea, 03080
        • Seoul National University Hospital
      • Seoul, Zuid -Korea, 03722
        • Severance Hospital Yonsei University Health System
      • Seoul, Zuid -Korea, 06351
        • Samsung Medical Center
      • Seoul, Zuid -Korea, 06591
        • The Catholic University of Korea Seoul St Marys Hospital
  • Zweden
      • Falun, Zweden, 791 82
        • Falu Lasarett
      • Gothenburg, Zweden, 413 45
        • Sahlgrenska University Hospital
      • Helsingborg, Zweden, 25187
        • Helsingborgs lasarett
      • Luleå, Zweden, 971 80
        • Sunderby Sjukhus
      • Lund, Zweden, 221 85
        • Skanes universitetssjukhus
      • Umeå, Zweden, 901 85
        • Norrlands Universitetssjukhus
      • Uppsala, Zweden, 75185
        • Akademiska Sjukhuset

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

18 jaar en ouder (Volwassen, Oudere volwassene)

Accepteert gezonde vrijwilligers

Nee

Geslachten die in aanmerking komen voor studie

Allemaal

Beschrijving

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • Contraindications or life-threatening allergies, hypersensitivity, or intolerance to any study drug or its excipients. Additional exclusion criteria pertaining to specific study drugs include:

    1. 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,
    2. 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

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Behandeling
  • Toewijzing: Gerandomiseerd
  • Interventioneel model: Parallelle opdracht
  • Masker: Geen (open label)

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Experimenteel: 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. Participants who are still receiving the treatment and benefiting from it may enter the long-term extension (LTE) and drug access (DA)-LTE Phases to continue their current treatment until end of the study.
Geneesmiddel: Daratumumab

Daratumumab will be administered SC injection.

Geneesmiddel: Teclistamab

Teclistamab will be administered SC injection.

Andere namen:
  • JNJ-64007957
Experimenteel: 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. Participants randomized to Arm B who do not cross over to Tec-Dara may continue DPd/DVd treatment during the LTE phase. Following the completion of LTE phase, participants who crossed over to Tec-Dara during the LTE may enter the DA LTE and continue to receive study treatment with Tec Dara. Any participants still receiving DPd/DVd at the end of the LTE may not cross over to Tec-Dara and will not continue into the DA-LTE.
Geneesmiddel: Daratumumab

Daratumumab will be administered SC injection.

Geneesmiddel: Pomalidomide

Pomalidomide will be administered orally.

Geneesmiddel: Dexamethasone

Dexamethasone will be administered orally or intravenously.

Geneesmiddel: Bortezomib

Bortezomib will be administered SC injection.

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Progression Free Survival (PFS)
Tijdsspanne: Up to 5 years

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

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Overall Response (Partial Response [PR] or Better)
Tijdsspanne: Up to 5 years

Overall response (PR or better) is defined as participants who have a PR or better per IMWG criteria.
Up to 5 years
Very Good Partial Response (VGPR) or Better
Tijdsspanne: Up to 5 years

VGPR or better is defined as participants who achieve a VGPR or better response per IMWG criteria.
Up to 5 years
Complete Response (CR) or Better
Tijdsspanne: Up to 5 years

CR or better is defined as participants who achieve a CR or better response per IMWG criteria.
Up to 5 years
Minimal Residual Disease (MRD)-negativity
Tijdsspanne: Up to 5 years

MRD-negativity is defined as participants who achieve MRD negativity at a threshold of 10^-5 at any timepoint after the date of randomization and before disease progression or start of subsequent antimyeloma therapy.
Up to 5 years
Progression Free Survival on Next-line Therapy (PFS2)
Tijdsspanne: Up to 5 years

PFS2 is defined as the time interval between the date of randomization and date of event, which is defined as progressive disease as assessed by investigator on the first subsequent line of antimyeloma therapy, or death from any cause, whichever occurs first.
Up to 5 years
Overall Survival (OS)
Tijdsspanne: Up to 5 years

OS is measured from the date of randomization to the date of the participant's death.
Up to 5 years
Time to Next Treatment (TTNT)
Tijdsspanne: Up to 5 years

TTNT is defined as the interval time from randomization to the start of subsequent antimyeloma treatment.
Up to 5 years
Duration of Response
Tijdsspanne: Up to 5 years

Duration of response will be calculated among responders (with a PR or better response) from the date of initial documentation of a response (PR or better) to the date of first documented evidence of progressive disease according to the IMWG response criteria, or death due to any cause, whichever occurs first.
Up to 5 years
Number of Participants with Adverse Events (AEs) by Severity
Tijdsspanne: Up to 5 years

Number of participants with AEs by Severity will be reported.
Up to 5 years
Serum Concentration of Teclistamab
Tijdsspanne: Up to 5 years

Serum samples will be analyzed to determine concentrations of teclistamab using a validated, specific, and sensitive method.
Up to 5 years
Number of Participants with Anti-drug Antibodies (ADAs) to Teclistamab and Daratumumab
Tijdsspanne: Up to 5 years

Number of participants with ADAs to teclistamab and daratumumab will be reported.
Up to 5 years
Time to Worsening of Symptoms
Tijdsspanne: Up to 5 years

Time to worsening is measured as the interval from the date of randomization to the start date of meaningful change.
Up to 5 years
Change from Baseline in Symptoms, Functioning, and Overall Health-related Quality of Life (HRQoL) as Assessed by European Organization for Research and Treatment of Cancer Quality-of-life Questionnaire Core 30 (EORTC-QLQ-C30)
Tijdsspanne: Baseline up to 5 years

The EORTC-QLQ-C30 Version 3 includes 30 items in 5 functional scales (physical, role, emotional, cognitive, and social), 1 global health status scale, 3 symptom scales (pain, fatigue, and nausea/vomiting), and 6 single symptom items (dyspnea, insomnia, appetite loss, constipation, diarrhea, and financial difficulties). The responses are reported using a verbal and numeric rating scales. The item and scale scores are transformed to a 0 to 100 scale. A high scale score represents a higher response level. Thus, a high score for a functional scale represents a high/healthy level of functioning and a high score for the global health status represents high HRQoL, but a high score for a symptom scale/item represents a high level of symptomatology/problems.
Baseline up to 5 years
Change from Baseline in Symptoms, Functioning, and Overall HRQoL as Assessed by Multiple Myeloma Symptom and Impact Questionnaire (MySIm-Q) Scale Score
Tijdsspanne: Baseline up to 5 years

The MySIm-Q is a disease-specific PRO assessment complementary to the EORTC-QLQ-C30. It includes 17 items resulting in a symptom subscale and an impact subscale. The recall period is the "past 7 days", and responses are reported on a 5-point verbal rating scale.
Baseline up to 5 years
Change from Baseline in Symptoms, Functioning, and Overall HRQoL as Assessed by Patient-reported Outcomes Measurement Information System Short Form v2.0 - Physical Function 8c (PROMIS PF 8c)
Tijdsspanne: Baseline up to 5 years

The PROMIS-SD is used to assess self-reported perceptions of sleep quality, sleep depth and restoration associated with sleep. The 8-item short form will be used in this study, in which responses are scored 1 to 5 for each item. Higher overall score indicates more sleep disturbance.
Baseline up to 5 years
Change from Baseline in Symptoms, Functioning, and Overall HRQoL as Assessed by Patient-reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE )
Tijdsspanne: Baseline up to 6 months

The National Cancer Institute's (NCI's) PRO-CTCAE is an item library of common adverse events experienced by people with cancer that are appropriate for self-reporting of treatment tolerability. Each symptom selected for inclusion can be rated by up to 3 attributes characterizing the presence/frequency, severity, and/or interference of the AEs. It ranges from 0 to 4 with higher scores indicating higher frequency or greater severity/impact.
Baseline up to 6 months
Change from Baseline in Symptoms, Functioning, and Overall HRQoL as Assessed by EuroQol Five Dimension Questionnaire 5-Level (EQ-5D-5L)
Tijdsspanne: Baseline up to 5 years

The EQ-5D-5L is a generic measure of health status. The EQ-5D-5L is a 5-item questionnaire that assesses 5 domains including mobility, self-care, usual activities, pain/discomfort, and anxiety/depression plus a visual analog scale rating "health today" with anchors ranging from 0 (worst imaginable health state) to 100 (best imaginable health state).
Baseline up to 5 years
Change from Baseline in Symptoms, Functioning, and Overall HRQoL as Assessed by Patient Global Impression - Severity (PGI-S)
Tijdsspanne: Baseline up to 5 years

The PGIS contains 2 questions on how the participant would currently rate severity of symptoms and impacts with a 7-day recall period. The response options are presented as a 5-point verbal rating scale from 1="none" to 5="very severe."
Baseline up to 5 years
PFS in Participants with High-risk Molecular Features
Tijdsspanne: Up to 5 years

PFS in participants with high-risk molecular features will be reported.
Up to 5 years
Depth of Response in Participants in High-risk Molecular Features
Tijdsspanne: Up to 5 years

Depth of response in participants in high-risk molecular features will be reported.
Up to 5 years

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

Janssen Research & Development, LLC

Onderzoekers

  • Studie directeur: Janssen Research & Development, LLC Clinical Trial, Janssen Research & Development, LLC

Publicaties en nuttige links

De persoon die verantwoordelijk is voor het invoeren van informatie over het onderzoek stelt deze publicaties vrijwillig ter beschikking. Dit kan gaan over alles wat met het onderzoek te maken heeft.

Algemene publicaties

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Werkelijk)

14 oktober 2021

Primaire voltooiing (Werkelijk)

1 augustus 2025

Studie voltooiing (Geschat)

15 september 2028

Studieregistratiedata

Eerst ingediend

8 oktober 2021

Eerst ingediend dat voldeed aan de QC-criteria

8 oktober 2021

Eerst geplaatst (Werkelijk)

19 oktober 2021

Updates van studierecords

Laatste update geplaatst (Werkelijk)

3 november 2026

Laatste update ingediend die voldeed aan QC-criteria

2 november 2026

Laatst geverifieerd

1 november 2026

Meer informatie

Termen gerelateerd aan deze studie

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • CR109049
  • 2020-004742-11 (EudraCT-nummer)
  • 64007957MMY3001 (Andere identificatie: Janssen Research & Development, LLC)
  • 2023-503441-55-00 (Register-ID: EUCT number)
  • 2023 (Subsidie/contract van de Amerikaanse NIH)

Plan Individuele Deelnemersgegevens (IPD)

Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?

JA

Beschrijving IPD-plan

The data sharing policy of Johnson & Johnson Innovative Medicine is available at innovativemedicine.jnj.com/our-innovation/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

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Ja

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .

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