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

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).

Study Overview

• Status: Active, not recruiting
• Conditions: Multiple Myeloma
• Intervention / Treatment: Drug: Pomalidomide; Drug: Dexamethasone; Drug: Daratumumab; Drug: Teclistamab; Drug: Bortezomib

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 587
• Phase: Phase 3

Expanded Access

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Contacts and Locations

• Study Contact: Name: Study Contact; Phone Number: 844-434-4210; Email: Participate-In-This-Study@its.jnj.com

Study Locations

• Argentina
  • Buenos Aires, Argentina, C1118AAT
    • Hospital Aleman
  • Buenos Aires, Argentina, C1199ABB
    • Hospital Italiano de Buenos Aires
  • Cordoba, Argentina, X5016KEH
    • Hospital Privado - Centro Medico de Cordoba
• Belgium
  • Antwerpen, Belgium, 2030
    • ZNA Cadix
  • Brugge, Belgium, 8000
    • AZ St.-Jan Brugge-Oostende AV
  • Gent, Belgium, 9000
    • UZ Gent
  • Haine-saint-paul, LA Louviere, Belgium, 7100
    • Hopital de Jolimont
  • Kortrijk, Belgium, 8500
    • Az Groeninge
  • Leuven, Belgium, 3000
    • UZ Leuven
  • Roeselare, Belgium, 8800
    • Algemeen Ziekenhuis Delta
• Brazil
  • Brasilia, Brazil, 70390-140
    • Hospitais Integradaos da Gavea S/A - DF Star
  • Curitiba, Brazil, 81520-060
    • Liga Paranaense de Combate ao Cancer
  • Florianopolis, Brazil, 88034-000
    • Centro de Pesquisa e Ensino em Oncologia de Santa Catarina - CEPEN
  • Natal, Brazil, 59062 000
    • Liga Norte Riograndense Contra O Cancer
  • Porto Alegre, Brazil, 90050-170
    • Irmandade Santa Casa de Misericordia de Porto Alegre
  • Rio de Janeiro, Brazil, 22775-001
    • Instituto de Educacao, Pesquisa e Gestao em Saude Instituto Americas (COI)
  • Salvador, Brazil, 41253-190
    • Hospital Sao Rafael
  • Sao Paulo, Brazil, 01323-000
    • Hospital Paulistano
  • Sao Paulo, Brazil, 01455-010
    • Clinica Sao Germano
  • Sao Paulo, Brazil, 01323-900
    • Real e Benemerita Associacao Portuguesa de Beneficencia
  • São Paulo, Brazil, 4501000
    • Instituto D Or de Pesquisa e Ensino (IDOR)
• Canada
  • Alberta
    • Calgary, Alberta, Canada, T2N 4N2
      • Tom Baker 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, 100191
    • Peking University Third Hospital
  • Beijing, China, 100034
    • Peking University First Hospital
  • Beijing, China, 100044
    • Peking University People s 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, 510060
    • Sun Yat-sen University Cancer Center
  • Hangzhou, China, 310003
    • First affiliated Hospital of Zhejiang University
  • 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, 110022
    • 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
• Denmark
  • Aalborg, Denmark, DK-9000
    • Aalborg University Hospital
  • Aarhus N, Denmark, DK-8200
    • Aarhus University Hospital
  • Copenhagen, Denmark, 2100
    • Rigshospitalet
  • Odense, Denmark, 5000
    • Odense Universitets Hospital
  • Vejle, Denmark, DK-7100
    • Vejle Hospital
• France
  • Creteil, France, 94000
    • CHU Henri Mondor
  • LILLE Cedex, France, 59037
    • CHRU de Lille - Hopital Claude Huriez
  • Limoges, France, 87042
    • CHU de Limoges Hopital Dupuytren
  • Nantes, France, 44093
    • C.H.U. Hotel Dieu - France
  • Pierre Benite cedex, France, 69495
    • Centre hospitalier Lyon-Sud
  • Poitiers, France, 86021
    • CHU De Poitiers
  • Strasbourg, France, 67200
    • Institut de Cancerologie Strasbourg Europe ICANS
  • Toulouse cedex 9, France, 31059
    • Pôle IUC Oncopole CHU
  • Tours, France, 37044
    • CHRU Hôpital Bretonneau
• Germany
  • Dresden, Germany, 01307
    • Universitätsklinikum Carl-Gustav-Carus Dresden
  • Düsseldorf, Germany, 40225
    • Heinrich-Heine -Universitaet Duesseldorf
  • Essen, Germany, 45239
    • Evang. Krankenhaus Essen-Mitte gGmbH
  • Freiburg, Germany, 79106
    • Universitatsklinikum Freiburg
  • Hamburg, Germany, 20246
    • Universitaetsklinikum Hamburg Eppendorf
  • Hamm, Germany, 59073
    • St. Barbara-Klinik Hamm GmbH
  • Heidelberg, Germany, 69120
    • Universitaetsklinikum Heidelberg
  • Kiel, Germany, 24105
    • Universitaetsklinikum Schleswig-Holstein Campus Kiel
  • Leipzig, Germany, 04103
    • Universitaetsklinikum Leipzig
  • Tübingen, Germany, 72076
    • Universitaetsklinikum Tuebingen
• Greece
  • Athens Attica, Greece, 115 28
    • Alexandra General Hospital of Athens
  • Thessaloniki, Greece, 57010
    • G.Papanikolaou
  • Thessaloniki, Greece, 546 39
    • Anticancer Hospital of Thessaloniki Theageneio
• Italy
  • Bari, Italy, 70124
    • U.O. Ematologia con Trapianto- AOU Policlinico di Bari
  • Bergamo, Italy, 24127
    • ASST Papa Giovanni XXIII - Bergamo
  • Bologna, Italy, 40138
    • Policlinico Sant'Orsola Malpighi
  • Firenze, Italy, 50134
    • Azienda Ospedaliera Universitaria Careggi
  • Meldola, Italy, 47014
    • Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori
  • Pavia, Italy, 27100
    • IRCCS Policlinico San Matteo, Università degli studi di Pavi
  • Roma, Italy, 00161
    • Università di Roma 'La Sapienza' - Ospedale Umberto 1°
  • Turin, Italy, 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
  • Hyôgo, Japan, 663-8501
    • The Hospital of Hyogo College of Medicine
  • 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
  • Okayama, Japan, 701-1192
    • National Hospital Organization Okayama Medical Center
  • Otake, Japan, 739-0696
    • National Hospital Organization Hiroshima-Nishi Medical Center
  • Sapporo-shi, Japan, 060-8648
    • Hokkaido University Hospital
  • Sendai, Japan, 980-8574
    • Tohoku University Hospital
  • Sendai-City, Japan, 983-8520
    • National Hospital Organization Sendai Medical Center
  • Shibuya-ku, Japan, 150-8935
    • Japanese Red Cross Medical Center
  • Shiwa-gun, Japan, 028-3695
    • Iwate Medical University Hospital
• Korea, Republic of
  • Daegu, Korea, Republic of, 41944
    • Kyungpook National University Hospital
  • Incheon, Korea, Republic of, 21565
    • Gachon University Gil Medical Center
  • Jeollanam-do, Korea, Republic of, 58128
    • Chonnam National University Hwasun Hospital
  • Seoul, Korea, Republic of, 03080
    • Seoul National University Hospital
  • Seoul, Korea, Republic of, 03722
    • Severance Hospital, Yonsei University Health System
  • Seoul, Korea, Republic of, 06351
    • Samsung Medical Center
  • Seoul, Korea, Republic of, 06591
    • The Catholic University of Korea Seoul St. Mary's Hospital
• Netherlands
  • Amsterdam, Netherlands, 1081 HV
    • VU Medisch Centrum
  • Groningen, Netherlands, 9713 GZ
    • Universitair Medisch Centrum Groningen
  • Nieuwegein, Netherlands, 3435 CM
    • Sint Antonius Ziekenhuis - Afd.Interne - INT
  • Nijmegen, Netherlands, 6525GA
    • Radboudumc
  • Zwolle, Netherlands, 8025 AB
    • Isala Kliniek
• Poland
  • Gdansk, Poland, 80-214
    • Klinika Hematologii i Transplantologii, UCK
  • Katowice, Poland, 40-519
    • Pratia Onkologia Katowice
  • Kielce, Poland, 25-734
    • Swietokrzyskie Centrum Onkologii SPZOZ w Kielcach
  • Lublin, Poland, 20-090
    • Centrum Onkologii Ziemi Lubelskiej im. sw. Jana z Dukli
  • Warszawa, Poland, 02-781
    • Narodowy Instytut Onkologii im Marii Sklodowskiej Curie Panstwowy Instytut Badawczy
  • Wałbrzych, Poland, 58-309
    • Specjalistyczny Szpital im. dra Alfreda Sokołowskiego w Wałbrzychu
  • Wroclaw, Poland, 50-367
    • Uniwersytecki Szpital Kliniczny im. Jana Mikulicza-Radeckiego we Wroclawiu
• Russian Federation
  • Moscow, Russian Federation, 125284
    • S.P. Botkin Moscow City Clinical Hospital
  • St-Petersburg, Russian Federation, 191024
    • Clinical Research Institute of Hematology and Transfusiology
• Spain
  • Barcelona, Spain, 8035
    • Hosp. Univ. Vall D Hebron
  • Barcelona, Spain, 08908
    • Inst. Cat. Doncologia-H Duran I Reynals
  • Gijón, Spain, 33394
    • Hosp. de Cabuenes
  • Las Palmas de Gran Canaria, Spain, 35010
    • Hosp. Univ. de Gran Canaria Dr. Negrin
  • Madrid, Spain, 28041
    • Hosp. Univ. 12 de Octubre
  • Madrid, Spain, 28034
    • Hosp. Univ. Ramon Y Cajal
  • Madrid, Spain, 28007
    • Hosp. Gral. Univ. Gregorio Maranon
  • Palma, Spain, 7120
    • Hosp. Univ. Son Espases
  • Pamplona, Spain, 31008
    • Clinica Univ. de Navarra
  • Pozuelo de Alarcon, Spain, 28223
    • Hosp. Quiron Madrid Pozuelo
  • Salamanca, Spain, 37007
    • Hosp. Clinico Univ. de Salamanca
  • Santander, Spain, 39008
    • Hosp. Univ. Marques de Valdecilla
  • Santiago de Compostela, Spain, 15706
    • Hosp. Clinico Univ. de Santiago
  • Sevilla, Spain, 41013
    • Hosp. Virgen Del Rocio
  • Valencia, Spain, 46026
    • Hosp. Univ. I Politecni La Fe
• Sweden
  • Falun, Sweden, 791 82
    • Falu Lasarett
  • Göteborg, Sweden, 413 45
    • Sahlgrenska University Hospital
  • Helsingborg, Sweden, 25187
    • Helsingborgs lasarett
  • Luleå, Sweden, 971 80
    • Sunderby Sjukhus
  • Lund, Sweden, 221 85
    • Skanes universitetssjukhus
  • Umea, Sweden, 901 85
    • Norrlands Universitetssjukhus
  • Uppsala, Sweden, 75185
    • Akademiska Sjukhuset
• Taiwan
  • Taichung, Taiwan, 40447
    • China Medical University Hospital
  • Tainan, Taiwan, 704
    • National Cheng Kung University Hospital
  • Taoyuan, Taiwan, 333
    • Chang Gung Memorial Hospital
• Turkey
  • Ankara, Turkey, 06590
    • Ankara University Medical Faculty
  • Atakum, Turkey, 55280
    • Ondokuz Mayis University
  • Istanbul, Turkey, 34214
    • Medipol University Hospital
  • Izmir, Turkey, 35340
    • Dokuz Eylul University Medical Faculty
• United Kingdom
  • Blackpool, United Kingdom, FY3 8NR
    • Blackpool Teaching Hospitals NHS Foundation Trust
  • Dundee, United Kingdom, DD1 9SY
    • Ninewells Hospital & Medical School
  • London, United Kingdom, SE5 9RS
    • Kings College Hospital
  • Oxford, United Kingdom, OX3 7LE
    • Oxford University Hospitals NHS Foundation Trust
  • Plymouth, United Kingdom, PL6 8DH
    • University Hospitals Plymouth NHS Trust
  • Sutton, United Kingdom, SM2 5PT
    • Royal Marsden Hospital
• United States
  • Alabama
    • Birmingham, Alabama, United States, 35294
      • University of Alabama Birmingham
  • California
    • Duarte, California, United States, 91010
      • City of Hope
    • Stanford, California, United States, 94305-5623
      • Stanford University Medical Center
  • Connecticut
    • New Haven, Connecticut, United States, 06510
      • Yale University
  • Georgia
    • Atlanta, Georgia, United States, 30322
      • Emory University - Winship Cancer Institute
  • Massachusetts
    • Boston, Massachusetts, United States, 02111
      • Tufts Medical Center
  • Michigan
    • Detroit, Michigan, United States, 48202
      • Henry Ford Hospital
    • Southfield, Michigan, United States, 48075
      • Ascension Providence Hospital
  • Ohio
    • Cleveland, Ohio, United States, 44195
      • Cleveland Clinic
  • Pennsylvania
    • Pittsburgh, Pennsylvania, United States, 15224
      • West Penn Hospital
    • Pittsburgh, Pennsylvania, United States, 15232
      • University of Pittsburgh Medical Center
  • South Carolina
    • Charleston, South Carolina, United States, 29425-8900
      • Medical University of South Carolina
  • Tennessee
    • Memphis, Tennessee, United States, 38120
      • Baptist Cancer Center
    • Nashville, Tennessee, United States, 37232
      • Vanderbilt - Ingram Cancer Center
  • Texas
    • Dallas, Texas, United States, 75235
      • University of Texas Southwestern Medical Center
  • Utah
    • Salt Lake City, Utah, United States, 84112
      • Huntsman Cancer Institute
  • Washington
    • Seattle, Washington, United States, 98109
      • Seattle Cancer Care Alliance
  • Wisconsin
    • Madison, Wisconsin, United States, 53792
      • University of Wisconsin Carbone Cancer Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.	Drug: Daratumumab; Daratumumab will be administered SC injection.; Drug: Teclistamab; Teclistamab will be administered SC injection.; Other Names: JNJ-64007957
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: Pomalidomide; Pomalidomide will be administered orally.; Drug: Dexamethasone; Dexamethasone will be administered orally or intravenously.; Drug: Daratumumab; Daratumumab will be administered SC injection.; Drug: Bortezomib; Bortezomib will be administered SC injection.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall Response (Partial Response [PR] or Better)	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	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	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	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)	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)	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)	TTNT is defined as the interval time from randomization to the start of subsequent antimyeloma treatment.	Up to 5 years
Duration of Response	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	Number of participants with AEs by Severity will be reported.	Up to 5 years
Serum Concentration of Teclistamab	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	Number of participants with ADAs to teclistamab and daratumumab will be reported.	Up to 5 years
Time to Worsening of Symptoms	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)	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	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)	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 )	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)	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)	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	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	Depth of response in participants in high-risk molecular features will be reported.	Up to 5 years

Collaborators and Investigators

• Sponsor: Janssen Research & Development, LLC
• Investigators: Study Director: Janssen Research & Development, LLC Clinical Trial, Janssen Research & Development, LLC

Study record dates

Study Major Dates

• Study Start (Actual): October 14, 2021
• Primary Completion (Estimated): August 1, 2025
• Study Completion (Estimated): December 8, 2028

Study Registration Dates

• First Submitted: October 8, 2021
• First Submitted That Met QC Criteria: October 8, 2021
• First Posted (Actual): October 19, 2021

Study Record Updates

• Last Update Posted (Estimated): April 24, 2024
• Last Update Submitted That Met QC Criteria: April 23, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Immune System Diseases; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Immunoproliferative Disorders; Hematologic Diseases; Hemorrhagic Disorders; Hemostatic Disorders; Paraproteinemias; Blood Protein Disorders; Multiple Myeloma; Neoplasms, Plasma Cell; Physiological Effects of Drugs; Autonomic Agents; Peripheral Nervous System Agents; Anti-Inflammatory Agents; Antineoplastic Agents; Immunologic Factors; Antiemetics; Gastrointestinal Agents; Glucocorticoids; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Antineoplastic Agents, Hormonal; Angiogenesis Inhibitors; Angiogenesis Modulating Agents; Growth Substances; Growth Inhibitors; Dexamethasone; Pomalidomide; Daratumumab; Bortezomib
• Other Study ID Numbers: CR109049; 2020-004742-11 (EudraCT Number); 64007957MMY3001 (Other Identifier: Janssen Research & Development, LLC); 2023-503441-55-00 (Registry Identifier: EUCT number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: 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

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No