A Study Comparing Teclistamab Monotherapy Versus Pomalidomide, Bortezomib, Dexamethasone (PVd) or Carfilzomib, Dexamethasone (Kd) in Participants With Relapsed or Refractory Multiple Myeloma (MajesTEC-9)

A Phase 3 Randomized Study Comparing Teclistamab Monotherapy Versus Pomalidomide, Bortezomib, Dexamethasone (PVd) or Carfilzomib, Dexamethasone (Kd) in Participants With Relapsed or Refractory Multiple Myeloma Who Have Received 1 to 3 Prior Lines of Therapy, Including an Anti-CD38 Monoclonal Antibody and Lenalidomide

The purpose of this study is to compare the efficacy of teclistamab with PVd/Kd in Part 1 and to further characterize safety and efficacy of an alternative dosing for teclistamab in Part 2 in participants with relapsed or refractory multiple myeloma.

Study Overview

• Status: Active, not recruiting
• Conditions: Relapsed or Refractory Multiple Myeloma
• Intervention / Treatment: Drug: Teclistamab; Drug: Pomalidomide; Drug: Bortezomib; Drug: Dexamethasone; Drug: Carfilzomib

Detailed Description

Multiple myeloma is an incurable, malignant, plasma cell disorder. Teclistamab (JNJ-64007957) is a full-size, Immunoglobulin G (IgG) 4 proline, alanine, and alanine (PAA) bispecific antibody that targets the cluster of differentiation (CD3) receptor expressed on the surface of T cells and B cell maturation antigen (BCMA). With its dual binding sites, teclistamab is able to draw CD3 positive T cells in close proximity to BCMA positive cells, resulting in T-cell activation and subsequent lysis of BCMA positive cells. Pomalidomide is a third-generation immunomodulatory imide drug (IMiD) that exerts potent, direct tumoricidal and immune-enhancing effects and Carfilzomib is a second-generation proteasome inhibitor that inhibits proteasome which results in disruption of protein turnover and induces apoptosis. The primary hypothesis of this study is that teclistamab monotherapy (Arm A) will significantly improve progression free survival (PFS) compared with investigator's choice of PVd or Kd (Arm B) in participants with relapsed or refractory multiple myeloma who have received 1 to 3 prior lines of therapy, including an anti-CD38 monoclonal antibody and lenalidomide. The study will include a screening phase, treatment phase, and follow-up phase. Safety will be assessed by physical examinations, neurologic examinations, eastern cooperative oncology group (ECOG) performance status, clinical laboratory tests, vital signs, and AE monitoring. The overall duration of the study will be up to 9 years.

• Study Type: Interventional
• Enrollment (Actual): 614
• Phase: Phase 3

Expanded Access

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Contacts and Locations

Study Locations

• Australia
  • Blacktown, Australia, 2148
    • Blacktown Hospital
  • Fitzroy, Australia, 3065
    • St Vincents Hospital Melbourne
  • Melbourne, Australia, 3128
    • Box Hill Hospital
  • Murdoch, Australia, 6150
    • Fiona Stanley Hospital
  • Nedlands, Australia, 6009
    • Sir Charles Gairdner Hospital
• Austria
  • Salzburg, Austria, 5020
    • LKH - Universitätsklinikum der PMU Salzburg
  • Vienna, Austria, A-1090
    • Medical University Vienna MUV
• Belgium
  • Brasschaat, Belgium, 2930
    • Algemeen Ziekenhuis klina
  • Haine-St-Paul, Belgium, 7100
    • Jolimont
  • Kortrijk, Belgium, 8500
    • AZ Groeninge
  • Leuven, Belgium, 3000
    • Universitair Ziekenhuis Gasthuisberg
  • Liège, Belgium, 4000
    • CHR de la Citadelle
• Brazil
  • Brasília, Brazil, 70390-140
    • Hospitais Integradaos da Gavea S/A - DF Star
  • Caxias do Sul, Brazil, 95070 560
    • Fundacao Universidade de Caxias Do Sul
  • Curitiba, Brazil, 81520 060
    • Liga Paranaense de Combate ao Cancer
  • Joinville, Brazil, 89201-260
    • Instituto Joinvilense de Hematologia e Oncologia Ltda Centro de Hematologia e Oncologia
  • Natal, Brazil, 59062 000
    • Liga Norte Riograndense Contra O Câncer
  • Niterói, Brazil, 24020-073
    • Complexo Hospitalar de Niteroi
  • Rio de Janeiro, Brazil, 22775-001
    • Instituto de Educacao, Pesquisa e Gestao em Saude Instituto Americas (COI)
  • Salvador, Brazil, 41253-190
    • Hospital São Rafael
  • São José do Rio Preto, Brazil, 15090-000
    • Fundacao Faculdade Regional de Medicina de Sao Jose do Rio Preto Hospital de Base
  • São Paulo, Brazil, 01321-001
    • Real e Benemérita Associação Portuguesa de Beneficência
  • São Paulo, Brazil, 05652-900
    • Sociedade Beneficente Israelita Brasileira Hospital Albert Einstein
  • São Paulo, Brazil, 01323-001
    • Hospital Alemao Oswaldo Cruz
  • São Paulo, Brazil, 01509 900
    • Fundacao Antonio Prudente A C Camargo Cancer Center
  • São Paulo, Brazil, 01401 002
    • Instituto D Or de Pesquisa e Ensino IDOR
  • São Paulo, Brazil, 01308-901
    • Sociedade beneficente de senhoras Hospital Sirio Libanes
  • São Paulo, Brazil, 04537 081
    • Clínica Médica São Germano LTDA
• Canada
  • Alberta
    • Calgary, Alberta, Canada, T2N 5G2
      • Arthur J E Child Comprehensive Cancer Centre
  • New Brunswick
    • Saint John, New Brunswick, Canada, E2L 4L2
      • Saint John Regional Hospital
  • Ontario
    • Brampton, Ontario, Canada, L6R 3J7
      • Brampton Civic Hospital
    • Oshawa, Ontario, Canada, L1G2B9
      • Lakeridge Health Oshawa
  • Quebec
    • Montreal, Quebec, Canada, H1T 2M4
      • CIUSSS de l Est de l Ile de Montreal Installation Hopital Maisonneuve Rosemont
• China
  • Beijing, China, 100020
    • Beijing chaoyang hospital
  • Beijing, China, 102208
    • Beijing Jishuitan Hospital
  • Changchun, China, 130021
    • The First Bethune Hospital of Jilin University
  • Changsha, China, 410013
    • The Third Xiangya Hospital, Central South University
  • Chengdu, China, 610032
    • Sichuan Provincial Peoples Hospital
  • Chongqing, China, 400030
    • Chongqing University Cancer Hospital
  • 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
  • Harbin, China, 150000
    • Harbin Medical University Cancer Hospital
  • Nanchang, China, 330006
    • The First Affiliated Hospital of Nanchang University
  • Nanjing, China, 210008
    • Nanjing Drum Tower Hospital
  • Nanning, China, 530021
    • First Affiliated Hospital of Guangxi Medical University
  • Shanghai, China, 200434
    • Shanghai Fourth People s Hospital
  • Shenyang, China, 110055
    • Shengjing Hospital of China Medical University
  • Shenzhen, China, 518025
    • Shenzhen 2nd People's Hospital
  • Tianjin, China, 300060
    • Tianjin Medical University Cancer Institute and Hospital
  • Tianjin, China, 301617
    • Institute of Hematology and Blood Diseases Hospital
  • Wenzhou, China, 325000
    • The First Affiliated Hospital of Wenzhou Medical University
  • Wuhan, China, 430023
    • Wuhan Union Hospital
  • Wuxi, China, 214023
    • Wuxi People s Hospital
  • Xi'an, China, 710004
    • The Second Affiliated Hospital Of Xi'an Jiaotong University
  • Zhengzhou, China, 450008
    • Henan Cancer Hospital
• Czechia
  • Brno, Czechia, 625 00
    • Fakultni nemocnice Brno
  • Olomouc, Czechia, 779 00
    • Fakultni Nemocnice Olomouc
  • Ostrava - Poruba, Czechia, 708 52
    • Fakultni Nemocnice Ostrava
  • Prague, Czechia, 128 08
    • Vseobecna fakultni nemocnice v Praze
• Denmark
  • Aalborg, Denmark, 9000
    • Aalborg University Hospital
  • Aarhus, Denmark, 8200
    • Aarhus University Hospital
  • Copenhagen, Denmark, DK-2100
    • Rigshospitalet
  • Herning, Denmark, 7400
    • Regionshospitalet Godstrup
  • Odense C, Denmark, 5000
    • Odense Universitetshospital
  • Vejle, Denmark, 7100
    • Vejle Sygehus
• France
  • Amiens, France, 80000
    • CHU Amiens - Hopital Sud
  • Caen, France, 14000
    • Hôpital Côte de Nacre
  • Grenoble, France, 38700
    • CHU Grenoble
  • Le Mans, France, 72037
    • Centre Hospitalier du Mans
  • Lille, France, 59020
    • Hopital Saint Vincent de Paul
  • Montpellier, France, 34090
    • CHU de Montpellier Hopital Saint Eloi
  • Nantes, France, 44000
    • CHU Nantes
  • Paris, France, 75012
    • Hôpital Saint-Antoine
  • Paris, France, 75013
    • Hopital de La Pitie Salpetriere
  • Paris, France, 75743
    • Hopital Necker Enfants Malades
  • Toulouse, France, 31100
    • Institut Universitaire du Cancer Toulouse Oncopole
  • Vandœuvre-lès-Nancy, France, 54500
    • CHU de Nancy - Hopital de Brabois
• Germany
  • Cottbus, Germany, 03048
    • Medizinische Universität Lausitz Carl Thiem
  • Dresden, Germany, 01307
    • Universitatsklinikum Carl Gustav Carus Dresden
  • Greifswald, Germany, 17475
    • Universitätsmedizin Greifswald
  • Hamburg, Germany, 22763
    • Asklepios Klinik Altona
  • Heidelberg, Germany, 69120
    • Universitaetsklinikum Heidelberg
  • Marburg, Germany, 35043
    • Universitaetsklinikum Giessen und Marburg GmbH
  • Tübingen, Germany, 72076
    • Universitätsklinikum Tübingen
  • Ulm, Germany, 89070
    • Universitätsklinikum Ulm
  • Zwickau, Germany, 08060
    • Heinrich-Braun-Klinikum gGmbH
• Greece
  • Athens Attica, Greece, 115 28
    • Alexandra General Hospital of Athens
  • Pátrai, Greece, 263 35
    • Agios Andreas General Hospital of Patra
  • Thessaloniki, Greece, 570 10
    • G Papanikolaou Hospital of Thessaloniki
• India
  • Gūrgaon, India, 122002
    • Fortis Memorial Research Institute
  • Jaipur, India, 302017
    • Bhagwan Mahaveer Cancer Hospital & Research Centre
  • Pune, India, 411004
    • Deenanath Mangeshkar Hospital and Research Centre
• Israel
  • Hadera, Israel, 3810101
    • Hillel Yaffe Medical Center
  • Haifa, Israel, 31048
    • Bnai Zion Medical Center
  • Haifa, Israel, 3436212
    • Carmel Medical Center
  • Petah Tikva, Israel, 49100
    • Rabin Medical Center
  • Ramat Gan, Israel, 52621
    • Sheba Medical Center
  • Tel Aviv, Israel, 64239
    • Tel Aviv Sourasky Medical Center
• Italy
  • Bologna, Italy, 40138
    • A O U Sant Orsola Malpighi
  • Milan, Italy, 20133
    • Fondazione IRCCS Istituto Nazionale Dei Tumori
  • Palermo, Italy, 90127
    • Azienda Ospedaliero Universitaria Policlinico Paolo Giaccone
  • Pisa, Italy, 56126
    • Ospedale Santa Chiara AO Universitaria Pisana
  • Reggio Emilia, Italy, 42123
    • Arcispedale Santa Maria Nuova - IRCCS
  • Roma, Italy, 00128
    • Campus Bio Medico di Roma
  • Siena, Italy, 53100
    • A O Universitaria Senese Ospedale Santa Maria alle Scotte
  • Turin, Italy, 10126
    • A.O.U. Citta della Salute e della Scienza di Torino - Presidio Molinette
  • Udine, Italy, 33100
    • ASUI Santa Maria della Misericordia di Udine
  • Varese, Italy, 21100
    • Ospedale di Circolo e Fondazione Macchi
• Japan
  • Bunkyō City, Japan, 113 8519
    • Institute of Science Tokyo Hospital
  • Chiba, Japan, 260-8717
    • Chiba Cancer Center
  • Gifu, Japan, 503-8502
    • Ogaki Municipal Hospital
  • Gunma, Japan, 377-0280
    • National Hospital Organization Shibukawa Medical Center
  • Hirakata, Japan, 573 1191
    • Kansai Medical University Hospital
  • Hitachi, Japan, 317-0077
    • Hitachi General Hospital
  • Iruma-gun, Japan, 350-0495
    • Saitama Medical University Hospital
  • Kamogawa, Japan, 296-8602
    • Kameda Medical Center
  • Kashiwa, Japan, 277 8577
    • National Cancer Center Hospital East
  • Kurashiki, Japan, 710-8602
    • Kurashiki Central Hospital
  • Matsuyama, Japan, 790-8524
    • Matsuyama Red Cross Hospital
  • Nagakute, Japan, 480-1195
    • Aichi Medical University Hospital
  • Nagasaki, Japan, 852-8511
    • JRC Nagasaki Genbaku Hospital
  • Niigata, Japan, 951 8520
    • Niigata University Medical and Dental Hospital
  • Okayama, Japan, 701-1192
    • National Hospital Organization Okayama Medical Center
  • Osaka, Japan, 545 8586
    • Osaka Metropolitan University Hospital
  • Sapporo, Japan, 060-8648
    • Hokkaido University Hospital
  • Tokyo, Japan, 113-0033
    • Juntendo University Hospital
  • Tokyo, Japan, 135 8550
    • The Cancer Institute Hospital of JFCR
  • Yamagata, Japan, 990 2331
    • Yamagata University Hospital
  • Yamanashi, Japan, 400-8506
    • Yamanashi Prefectural Central Hospital
• Malaysia
  • George Town, Malaysia, 10450
    • Hospital Pulau Pinang
  • Kota Kinabalu, Malaysia, 88200
    • Hospital Queen Elizabeth
  • Kuala Lumpur, Malaysia, 59100
    • University Malaya Medical Centre
  • Subang Jaya, Malaysia, 47500
    • Subang Jaya Medical Centre
• Netherlands
  • Amersfoort, Netherlands, 3813 TZ
    • Meander Medisch Centrum
  • Amsterdam, Netherlands, 1081 HV
    • VUMC Amsterdam
  • Groningen, Netherlands, 9700 RB
    • Universitair Medisch Centrum Groningen
  • Utrecht, Netherlands, 3584 CX
    • UMC Utrecht
• Poland
  • Gdansk, Poland, 80 214
    • Uniwersyteckie Centrum Kliniczne
  • Katowice, Poland, 40 519
    • Pratia Onkologia Katowice
  • Kielce, Poland, 25 734
    • Swietokrzyskie Centrum Onkologii SPZOZ w Kielcach
  • Lublin, Poland, 20-081
    • Uniwersytecki Szpital Kliniczny Nr 1 w Lublinie
• Portugal
  • Almada, Portugal, 2805-267
    • Uls Almada Seixal - Hosp. Garcia de Orta
  • Braga, Portugal, 4710-243
    • Uls Braga - Hosp. Braga
  • Lisbon, Portugal, 1400-038
    • Champalimaud Foundation Champalimaud Centre
  • Porto, Portugal, 4200072
    • Instituto Portugues de Oncologia
  • Vila Nova de Gaia, Portugal, 4434-502
    • Uls Gaia Espinho
• Spain
  • Badalona, Spain, 08916
    • Hosp. Univ. Germans Trias I Pujol
  • Jerez de la Frontera, Spain, 11407
    • Hosp. de Jerez de La Frontera
  • L'Hospitalet de Llobregat, Spain, 08908
    • Institut Catala d Oncologia L Hospitalet
  • León, Spain, 24008
    • Hosp. de Leon
  • Madrid, Spain, 28041
    • Hosp. Univ. 12 de Octubre
  • Madrid, Spain, 28034
    • Hosp. Univ. Ramon Y Cajal
  • Madrid, Spain, 28031
    • Hosp. Univ. Infanta Leonor
  • Murcia, Spain, 30008
    • Hosp. Gral. Univ. J.M. Morales Meseguer
  • Oviedo, Spain, 33011
    • Hospital Universitario Central de Asturias
  • Palma de Mallorca, Spain, 07198
    • Hosp. Son Llatzer
  • Pontevedra, Spain, 36071
    • Hosp. Montecelo
  • Pozuelo de Alarcón, Spain, 28223
    • Hosp. Quiron Madrid Pozuelo
  • Valencia, Spain, 46026
    • Hospital Universitari i Politecnic La Fe
• Sweden
  • Falun, Sweden, 791 82
    • Falu Lasarett Medicinkliniken Falun
  • Helsingborg, Sweden, 25287
    • Helsingborgs Lasarett
  • Uppsala, Sweden, 751 85
    • Akademiska Sjukhuset
• Turkey (Türkiye)
  • Ankara, Turkey (Türkiye), 06200
    • Dr Abdurrahman Yurtaslan Oncology Training and Research Hospital
  • Ankara, Turkey (Türkiye), 06680
    • Liv Hospital Ankara
  • Ankara, Turkey (Türkiye), 06620
    • Ankara University Medical Faculty
  • Ankara, Turkey (Türkiye), 06010
    • Ankara Gulhane Training and Research Hospital
  • Antalya, Turkey (Türkiye), 07100
    • Antalya Training And Research Hospital
  • Denizli, Turkey (Türkiye), 20070
    • Pamukkale University Medical Faculty
  • Istanbul, Turkey (Türkiye), 34214
    • Medipol Mega Universite Hastanesi
  • Samsun, Turkey (Türkiye), 55280
    • Ondokuz Mayis University
• United Kingdom
  • Aberdeen, United Kingdom, AB25 2ZN
    • Aberdeen Royal Infirmary
  • Birmingham, United Kingdom, B15 2GW
    • University Hospitals Birmingham NHS Foundation Trust
  • Colchester, United Kingdom, CO4 5JL
    • Colchester Hospital University NHS
  • Liverpool, United Kingdom, L7 8YA
    • The Clatterbridge Cancer Centre
  • London, United Kingdom, SW10 9NH
    • Chelsea and Westminster Hospital
  • London, United Kingdom, SW17 0QT
    • St Georges Hospital
  • Middlesbrough, United Kingdom, TS4 3BW
    • James Cook University Hospital
  • Norwich, United Kingdom, NR4 7UY
    • Norfolk and Norwich University Hospital
  • Staffordshire, United Kingdom, ST4 6QG
    • Royal Stoke University Hospital
• United States
  • Alaska
    • Anchorage, Alaska, United States, 99508
      • Alaska Oncology and Hematology LLC
  • Arizona
    • Gilbert, Arizona, United States, 85234
      • Banner MD Anderson Cancer Center
  • California
    • Berkeley, California, United States, 94704
      • Alta Bates Comprehensive Cancer Center
    • Long Beach, California, United States, 90806
      • MemorialCare Long Beach Medical Center
    • Orange, California, United States, 92868
      • University of California Irvine
    • Whittier, California, United States, 90602
      • PIH Health Hospital
  • Colorado
    • Aurora, Colorado, United States, 80218
      • Rocky Mountain Cancer Centers
  • Connecticut
    • Farmington, Connecticut, United States, 06030
      • University of Connecticut
  • Florida
    • Miami, Florida, United States, 33136
      • University of Miami Sylvester Cancer Center
    • Orlando, Florida, United States, 32806
      • Orlando Health Cancer Institute
    • Weston, Florida, United States, 33331
      • Cleveland Clinic Florida
  • Iowa
    • Waukee, Iowa, United States, 50263
      • Mission Cancer Blood
  • Louisiana
    • Metairie, Louisiana, United States, 70006
      • East Jefferson General Hospital Bone Marrow Transport Clinic
  • Maryland
    • Bethesda, Maryland, United States, 20889
      • Walter Reed National Military Medical Center
    • Silver Spring, Maryland, United States, 20904
      • Maryland Oncology Hematology P A
  • Massachusetts
    • Boston, Massachusetts, United States, 02118
      • Boston University Medical Center
  • Missouri
    • Chesterfield, Missouri, United States, 63017
      • Saint Lukes Hospital Saint Lukes Cancer Specialists
  • New Jersey
    • Camden, New Jersey, United States, 08103
      • Cooper Health System MD Anderson Cancer Center at Cooper
  • New York
    • New York, New York, United States, 10032
      • Herbert Irving Comprehensive Cancer Center Columbia University Medical Center
  • North Carolina
    • Durham, North Carolina, United States, 27705
      • Durham VAMC
  • Pennsylvania
    • Lancaster, Pennsylvania, United States, 17601
      • Penn Medicine Lancaster General Health
  • Tennessee
    • Nashville, Tennessee, United States, 37203
      • Tennessee Oncology
  • Texas
    • Fort Sam Houston, Texas, United States, 78234
      • Brooke Army Medical Center
    • Houston, Texas, United States, 77030
      • Baylor College of Medicine
    • Houston, Texas, United States, 77030
      • Michael E DeBakey VA Medical Center
    • Houston, Texas, United States, 77054
      • Harris Health Smith Clinic
  • Utah
    • Salt Lake City, Utah, United States, 84106
      • Utah Cancer Specialists
  • Virginia
    • Fort Belvoir, Virginia, United States, 22060
      • Alexander T. Augusta Military Medical Center
    • Norfolk, Virginia, United States, 23502
      • Virginia Oncology Associates
  • Washington
    • Tacoma, Washington, United States, 98405
      • Northwest Medical Specialties, PLLC

Participation Criteria

Eligibility Criteria

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

Description

Inclusion Criteria:

• Documented diagnosis of multiple myeloma as defined by the criteria below: (a)Multiple myeloma diagnosis according to 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 grams per deciliter (g/dL) (central laboratory); or (2) Urine M-protein level >=200 milligrams (mg)/24 hours (central laboratory); or (3) Serum immunoglobulin free light chain >=10 milligrams per deciliter (mg/dL) (central laboratory) and abnormal serum immunoglobulin kappa lambda free light chain ratio
• Received 1 to 3 prior lines of antimyeloma therapy including a minimum of 2 consecutive cycles of an anti- cluster of differentiation 38 (CD38) monoclonal antibody at the approved dosing regimen in any prior line and 2 consecutive cycles of lenalidomide in any prior line
• Documented evidence of progressive disease or failure to achieve a response to last line of therapy based on investigator's determination of response by International myeloma working group (IMWG) criteria
• Have an Eastern Cooperative Oncology Group (ECOG) performance status score of 0 to 2
• A female participant must agree not to be pregnant, breast-feeding, or plan to become pregnant while enrolled in this study or within 6 months after the last dose of study treatment
• Must be willing and able to adhere to the lifestyle restrictions specified in this protocol

Exclusion Criteria:

• Received any prior B cell maturation antigen (BCMA)-directed therapy
• A participant is not eligible to receive PVd as control therapy if any of the following are present: (1) Received prior pomalidomide therapy, (2) Does not meet criteria for bortezomib retreatment (3) Contraindications or life-threatening allergies, hypersensitivity, or intolerance to pomalidomide or bortezomib, (4) Grade 1 peripheral neuropathy with pain or Grade greater than or equal to (>=) 2 peripheral neuropathy as defined by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) Version 5.0, (5) Received a strong cytochrome P (CYP) 3A4 inducer within 5 half-lives prior to randomization; A participant is not eligible to receive Kd as control therapy if any of the following are present:(1) Received prior carfilzomib therapy, (2) Uncontrolled hypertension, defined as an average systolic blood pressure greater than (>)159 millimeters of mercury (mmHg) or diastolic blood pressure >99 mmHg despite optimal treatment (3) Grade 2 peripheral neuropathy with pain or Grade >=3 peripheral neuropathy as defined by NCI-CTCAE Version 5.0, (4) Contraindications or life-threatening allergies, hypersensitivity, or intolerance to carfilzomib (intolerance defined as prior therapy discontinued due to any adverse event [AE] related to carfilzomib)
• Received a maximum cumulative dose of corticosteroids of >=140 mg of prednisone or equivalent within 14 days prior to randomization
• Received a live, attenuated vaccine within 4 weeks before randomization
• Central nervous system (CNS) involvement or clinical signs of meningeal involvement of multiple myeloma
• Plasma cell leukemia at the time of screening, Waldenstrom's macroglobulinemia, polyneuropathy, organomegaly, endocrinopathy, M-protein (POEMS) syndrome 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: Teclistamab; Participants will receive teclistamab monotherapy in Part 1 and an alternative dosing regimen of teclistamab in Part 2.	Drug: Teclistamab; Teclistamab will be administered subcutaneously.; Other Names: JNJ-64007957
Experimental: Pomalidomide, Bortezomib and Dexamethasone (PVd) or Carfilzomib and Dexamethasone (Kd); Participants will receive either PVd or Kd based on principal investigator's choice during Part 1 of the study.	Drug: Pomalidomide; Pomalidomide will be administered orally.; Drug: Bortezomib; Bortezomib will be administered subcutaneously.; Drug: Dexamethasone; Dexamethasone will be administered orally in PVd and intravenously or orally in Kd.; Drug: Carfilzomib; Carfilzomib will be administered intravenously.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Part 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) 2016 response criteria, or death due to any cause, whichever occurs first.	Up to 9 years
Part 2: Number of Participants Reporting Cytokine Release Syndrome (CRS) Cases by Severity	Severity for CRS will be graded as follows: Grade 1: Fever (Temperature greater than or equal to [>=] 38°C); Grade 2: Fever (Temperature >=38°C) with either: hypotension and/or hypoxia requiring low-flow nasal cannula or blow-by; Grade 3: Fever (Temperature >=38°C) with either: hypotension and/or hypoxia requiring high-flow nasal cannula, facemask, nonrebreather mask, or Venturi mask; Grade 4: Fever (Temperature >=38°C) with either: hypotension requiring multiple vasopressors (excluding vasopressin), and/or hypoxia requiring positive pressure and Grade 5: Death.	Up to 9 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Part 1 and 2: Overall Response (Partial Response [PR] or Better)	Overall response (PR or better) is defined as participants who have a PR or better prior to subsequent antimyeloma therapy in accordance with the IMWG 2016 criteria.	Up to 9 years
Part 1 and 2: Very Good Partial Response (VGPR) or Better Response	VGPR or better (Stringent Complete Response [sCR]+Complete Response [CR]+VGPR) is defined as participants who achieve a VGPR or better response prior to subsequent antimyeloma therapy in accordance with the IMWG 2016 criteria.	Up to 9 years
Part 1 and 2: Complete Response (CR) or Better Response	CR or better response is defined as participants who achieve a CR or better response prior to subsequent antimyeloma therapy in accordance with the IMWG 2016 criteria.	Up to 9 years
Part 1: Duration of Response (DOR)	DOR is defined as the time interval between 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 2016 response criteria or death due to any cause, whichever occurs first.	Up to 9 years
Part 1: Time to Next Treatment (TTNT)	TTNT is defined as the time from randomization to the start of subsequent antimyeloma treatment.	Up to 9 years
Part 1: 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 9 years
Part 1: Overall Survival (OS)	OS is defined as the time from the date of randomization to the date of the participant's death due to any cause.	Up to 9 years
Part 1 and 2: Number of Participants with Adverse Events (AEs) by Severity	Number of participants with AEs by Severity will be reported.	Up to 9 years
Part 1 and 2: Number of Participants with Serious Adverse Events (SAEs) by Severity	Number of participants with SAEs by Severity will be reported.	Up to 9 years
Part 1 and 2: Number of Participants with Abnormal Laboratory Results	Number of participants with abnormal laboratory results (such as hematology and chemistry) will be reported.	Up to 9 years
Part 1 and 2: Serum Concentrations of Teclistamab	Serum concentrations of teclistamab will be reported.	Up to 9 years
Part 1 and 2: Number of Participants with Anti-drug Antibodies (ADAs) to Teclistamab	Number of participants with ADAs to teclistamab will be reported.	Up to 9 years
Part 1: 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)	Change from baseline in symptoms, functioning, and overall HRQoL assessed by EORTC QLQ-C30 score version 3 will be reported. The EORTC- QLQ-C30 Version 3 includes 30 items that make up 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 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 9 years
Part 1: Change from Baseline in Symptoms, Functioning, and Overall HRQoL as Assessed by Multiple Myeloma Symptom and Impact Questionnaire (MySIm-Q) Scale Score	Change from baseline in symptoms, functioning, and overall HRQoL assessed by MySIm-Q will be reported. 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 9 years
Part 1: 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)	Change from baseline in symptoms, functioning, and overall HRQoL assessed by PRO-CTCAE will be reported. 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 9 years
Part 1: Change from Baseline in Symptoms, Functioning, and Overall HRQoL as Assessed by EuroQol Five Dimension Questionnaire 5-Level (EQ-5D-5L)	Change from baseline in symptoms, functioning, and overall HRQoL assessed by EQ-5D-5L will be reported. 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 9 years
Part 1: Time to Worsening in Symptoms, Functioning, and Overall HRQoL	Time to worsening in symptoms, functioning, and overall HRQoL will be measured as the interval from the date of randomization to the start date of meaningful change.	Up to 9 years
Part 1: PFS in Participants in High-risk Molecular Features	PFS in participants in high-risk molecular features will be reported. PFS is defined as the time from the date of randomization to the date of first documented disease progression, as defined in the IMWG 2016 response criteria, or death due to any cause, whichever occurs first.	Up to 9 years
Part 1: 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 9 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): March 29, 2023
• Primary Completion (Actual): October 13, 2025
• Study Completion (Estimated): August 31, 2031

Study Registration Dates

• First Submitted: October 5, 2022
• First Submitted That Met QC Criteria: October 5, 2022
• First Posted (Actual): October 7, 2022

Study Record Updates

• Last Update Posted (Actual): April 13, 2026
• Last Update Submitted That Met QC Criteria: April 10, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Pathologic Processes; Neoplasms; Disease Attributes; Immune System Diseases; Neoplasms by Histologic Type; Hematologic Diseases; Lymphoproliferative Disorders; Immunoproliferative Disorders; Neoplasms, Plasma Cell; Hemostatic Disorders; Paraproteinemias; Blood Protein Disorders; Hemorrhagic Disorders; Pathological Conditions, Signs and Symptoms; Hemic and Lymphatic Diseases; Recurrence; Multiple Myeloma; Organic Chemicals; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Polycyclic Compounds; Inorganic Chemicals; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Steroids, Fluorinated; Pregnadienetriols; Boronic Acids; Acids, Noncarboxylic; Acids; Boron Compounds; Pyrazines; Bortezomib; Dexamethasone; carfilzomib; pomalidomide
• Other Study ID Numbers: CR109244; 64007957MMY3006 (Other Identifier: Janssen Research & Development, LLC); 2022-000928-37 (EudraCT Number); 2023-503444-13-00 (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 & 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