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

NCT ID: NCT05572515

Last Updated: 2025-12-19

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: PHASE3
• Total Enrollment: 614 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-03-29
• Study Completion Date: 2031-08-31

Brief Summary

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.

Conditions

Relapsed or Refractory Multiple Myeloma

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Teclistamab

Participants will receive teclistamab monotherapy in Part 1 and an alternative dosing regimen of teclistamab in Part 2.

Group Type: EXPERIMENTAL

Teclistamab

Intervention Type: DRUG

Teclistamab will be administered subcutaneously.

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.

Group Type: EXPERIMENTAL

Pomalidomide

Intervention Type: DRUG

Pomalidomide will be administered orally.

Bortezomib

Intervention Type: DRUG

Bortezomib will be administered subcutaneously.

Dexamethasone

Intervention Type: DRUG

Dexamethasone will be administered orally in PVd and intravenously or orally in Kd.

Carfilzomib

Intervention Type: DRUG

Carfilzomib will be administered intravenously.

Interventions

Teclistamab

Teclistamab will be administered subcutaneously.

Intervention Type: DRUG

Pomalidomide

Pomalidomide will be administered orally.

Intervention Type: DRUG

Bortezomib

Bortezomib will be administered subcutaneously.

Intervention Type: DRUG

Dexamethasone

Dexamethasone will be administered orally in PVd and intravenously or orally in Kd.

Intervention Type: DRUG

Carfilzomib

Carfilzomib will be administered intravenously.

Intervention Type: DRUG

Other Intervention Names

JNJ-64007957

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Janssen Research & Development, LLC

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Janssen Research & Development, LLC Clinical Trial

Role: STUDY_DIRECTOR

Janssen Research & Development, LLC

Locations

Hosp. Univ. Ramon Y Cajal

Madrid, , Spain

Hosp. Univ. 12 de Octubre

Madrid, , Spain

Hosp. Gral. Univ. J.M. Morales Meseguer

Murcia, , Spain

Hospital Universitario Central de Asturias

Oviedo, , Spain

Hosp. Son Llatzer

Palma de Mallorca, , Spain

Hosp. Montecelo

Pontevedra, , Spain

Hosp. Quiron Madrid Pozuelo

Pozuelo de Alarcón, , Spain

Hospital Universitari i Politecnic La Fe

Valencia, , Spain

Falu Lasarett Medicinkliniken Falun

Falun, , Sweden

Helsingborgs lasarett

Helsingborg, , Sweden

Akademiska Sjukhuset

Uppsala, , Sweden

Alaska Oncology and Hematology LLC

Anchorage, Alaska, United States

Banner MD Anderson Cancer Center

Gilbert, Arizona, United States

Alta Bates Comprehensive Cancer Center

Berkeley, California, United States

MemorialCare Long Beach Medical Center

Long Beach, California, United States

University of California Irvine

Orange, California, United States

PIH Health Hospital

Whittier, California, United States

Rocky Mountain Cancer Centers

Aurora, Colorado, United States

University of Connecticut

Farmington, Connecticut, United States

University of Miami Sylvester Cancer Center

Miami, Florida, United States

Orlando Health Cancer Institute

Orlando, Florida, United States

Cleveland Clinic Florida

Weston, Florida, United States

Mission Cancer Blood

Waukee, Iowa, United States

East Jefferson General Hospital Bone Marrow Transport Clinic

Metairie, Louisiana, United States

Walter Reed National Military Medical Center

Bethesda, Maryland, United States

Maryland Oncology Hematology P A

Silver Spring, Maryland, United States

Boston University Medical Center

Boston, Massachusetts, United States

Saint Lukes Hospital Saint Lukes Cancer Specialists

Chesterfield, Missouri, United States

Cooper Health System MD Anderson Cancer Center at Cooper

Camden, New Jersey, United States

Herbert Irving Comprehensive Cancer Center Columbia University Medical Center

New York, New York, United States

Durham VAMC

Durham, North Carolina, United States

Penn Medicine Lancaster General Health

Lancaster, Pennsylvania, United States

Tennessee Oncology

Nashville, Tennessee, United States

Brooke Army Medical Center

Fort Sam Houston, Texas, United States

Baylor College of Medicine

Houston, Texas, United States

Michael E DeBakey VA Medical Center

Houston, Texas, United States

Harris Health Smith Clinic

Houston, Texas, United States

Utah Cancer Specialists

Salt Lake City, Utah, United States

Alexander T. Augusta Military Medical Center

Fort Belvoir, Virginia, United States

Virginia Oncology Associates

Norfolk, Virginia, United States

NorthWest Medical Specialties, PLLC

Tacoma, Washington, United States

Blacktown Hospital

Blacktown, , Australia

St Vincents Hospital Melbourne

Fitzroy, , Australia

Box Hill Hospital

Melbourne, , Australia

Fiona Stanley Hospital

Murdoch, , Australia

Sir Charles Gairdner Hospital

Nedlands, , Australia

LKH - Universitätsklinikum der PMU Salzburg

Salzburg, , Austria

Medical University Vienna MUV

Vienna, , Austria

Algemeen Ziekenhuis Klina

Brasschaat, , Belgium

Jolimont

Haine-St-Paul, , Belgium

Az Groeninge

Kortrijk, , Belgium

Universitair Ziekenhuis Gasthuisberg

Leuven, , Belgium

CHR de la Citadelle

Liège, , Belgium

Hospitais Integradaos da Gavea S/A - DF Star

Brasília, , Brazil

Fundacao Universidade de Caxias do Sul

Caxias do Sul, , Brazil

Liga Paranaense de Combate ao Cancer

Curitiba, , Brazil

Instituto Joinvilense de Hematologia e Oncologia Ltda Centro de Hematologia e Oncologia

Joinville, , Brazil

Liga Norte Riograndense Contra O Cancer

Natal, , Brazil

Complexo Hospitalar de Niteroi

Niterói, , Brazil

Instituto de Educacao, Pesquisa e Gestao em Saude Instituto Americas (COI)

Rio de Janeiro, , Brazil

Hospital Sao Rafael

Salvador, , Brazil

Fundacao Faculdade Regional de Medicina de Sao Jose do Rio Preto Hospital de Base

São José do Rio Preto, , Brazil

Sociedade Beneficente de Senhoras Hospital Sirio Libanes

São Paulo, , Brazil

Real e Benemérita Associação Portuguesa de Beneficência

São Paulo, , Brazil

Hospital Alemao Oswaldo Cruz

São Paulo, , Brazil

Instituto D Or de Pesquisa e Ensino IDOR

São Paulo, , Brazil

Fundacao Antonio Prudente A C Camargo Cancer Center

São Paulo, , Brazil

Clinica Medica Sao Germano LTDA

São Paulo, , Brazil

Sociedade Beneficente Israelita Brasileira Hospital Albert Einstein

São Paulo, , Brazil

Arthur J E Child Comprehensive Cancer Centre

Calgary, Alberta, Canada

Saint John Regional Hospital

Saint John, New Brunswick, Canada

Brampton Civic Hospital

Brampton, Ontario, Canada

Lakeridge Health Oshawa

Oshawa, Ontario, Canada

CIUSSS de l Est de l Ile de Montreal Installation Hopital Maisonneuve Rosemont

Montreal, Quebec, Canada

Beijing Chaoyang Hospital

Beijing, , China

BeiJing JiShuiTan Hospital

Beijing, , China

The First Bethune Hospital of Jilin University

Changchun, , China

The Third Xiangya Hospital, Central South University

Changsha, , China

Sichuan Provincial Peoples Hospital

Chengdu, , China

Chongqing University Cancer Hospital

Chongqing, , China

Fujian Meidical University Union Hospital

Fuzhou, , China

Sun Yat -Sen University Cancer Center

Guangzhou, , China

First affiliated Hospital of Zhejiang University

Hangzhou, , China

Harbin medical university cancer hospital

Harbin, , China

The First Affiliated Hospital of NanChang University

Nanchang, , China

Nanjing Drum Tower Hospital

Nanjing, , China

First Affiliated Hospital of Guangxi Medical University

Nanning, , China

Shanghai Fourth People s Hospital

Shanghai, , China

Shengjing Hospital Of China Medical University

Shenyang, , China

Shenzhen 2nd People's Hospital

Shenzhen, , China

Institute of Hematology and Blood Diseases Hospital

Tianjin, , China

Tianjin Medical University Cancer Institute and Hospital

Tianjin, , China

The First Affiliated Hospital of Wenzhou Medical University

Wenzhou, , China

Wuhan Union Hospital

Wuhan, , China

Wuxi People s Hospital

Wuxi, , China

The Second Affiliated Hospital of Xi'an Jiaotong University

Xi'an, , China

Henan Cancer Hospital

Zhengzhou, , China

Fakultni nemocnice Brno

Brno, , Czechia

Fakultni nemocnice Olomouc

Olomouc, , Czechia

Fakultni Nemocnice Ostrava

Ostrava - Poruba, , Czechia

Vseobecna fakultni nemocnice v Praze

Prague, , Czechia

Aalborg University Hospital

Aalborg, , Denmark

Aarhus University Hospital

Aarhus, , Denmark

Rigshospitalet

Copenhagen, , Denmark

Regionshospitalet Godstrup

Herning, , Denmark

Odense Universitetshospital

Odense C, , Denmark

Vejle Sygehus

Vejle, , Denmark

CHU Amiens - Hopital Sud

Amiens, , France

Hôpital Côte de Nacre

Caen, , France

CHU Grenoble

Grenoble, , France

Centre Hospitalier du Mans

Le Mans, , France

Hopital Saint Vincent de Paul

Lille, , France

CHU de Montpellier Hopital Saint Eloi

Montpellier, , France

CHU Nantes

Nantes, , France

Hopital Saint-Antoine

Paris, , France

Hopital de la Pitie Salpetriere

Paris, , France

Hopital Necker Enfants Malades

Paris, , France

Institut Universitaire du Cancer Toulouse Oncopole

Toulouse, , France

CHU de Nancy - Hopital de Brabois

Vandœuvre-lès-Nancy, , France

Medizinische Universitat Lausitz Carl Thiem

Cottbus, , Germany

Universitatsklinikum Carl Gustav Carus Dresden

Dresden, , Germany

Universitätsmedizin Greifswald

Greifswald, , Germany

Asklepios Klinik Altona

Hamburg, , Germany

Universitaetsklinikum Heidelberg

Heidelberg, , Germany

Universitaetsklinikum Giessen und Marburg GmbH

Marburg, , Germany

Universitatsklinikum Tubingen

Tübingen, , Germany

Universitatsklinikum Ulm

Ulm, , Germany

Heinrich-Braun-Klinikum gGmbH

Zwickau, , Germany

Alexandra General Hospital of Athens

Athens Attica, , Greece

Agios Andreas General Hospital of Patra

Pátrai, , Greece

G Papanikolaou Hospital of Thessaloniki

Thessaloniki, , Greece

Fortis Memorial Research Institute

Gurgaon, , India

Bhagwan Mahaveer Cancer Hospital & Research Centre

Jaipur, , India

Deenanath Mangeshkar Hospital and Research Centre

Pune, , India

Hillel Yaffe Medical Center

Hadera, , Israel

Bnai Zion Medical Center

Haifa, , Israel

Carmel Medical Center

Haifa, , Israel

Rabin Medical Center

Petah Tikva, , Israel

Sheba Medical Center

Ramat Gan, , Israel

Tel Aviv Sourasky Medical Center

Tel Aviv, , Israel

A O U Sant Orsola Malpighi

Bologna, , Italy

Fondazione IRCCS Istituto Nazionale dei Tumori

Milan, , Italy

Azienda Ospedaliero Universitaria Policlinico Paolo Giaccone

Palermo, , Italy

Ospedale Santa Chiara AO Universitaria Pisana

Pisa, , Italy

Arcispedale Santa Maria Nuova - IRCCS

Reggio Emilia, , Italy

Campus Bio Medico di Roma

Roma, , Italy

A O Universitaria Senese Ospedale Santa Maria alle Scotte

Siena, , Italy

A.O.U. Citta della Salute e della Scienza di Torino - Presidio Molinette

Turin, , Italy

ASUI Santa Maria della Misericordia di Udine

Udine, , Italy

Ospedale di Circolo e Fondazione Macchi

Varese, , Italy

Institute of Science Tokyo Hospital

Bunkyō City, , Japan

Chiba Cancer Center

Chiba, , Japan

Ogaki Municipal Hospital

Gifu, , Japan

National Hospital Organization Shibukawa Medical Center

Gunma, , Japan

Kansai Medical University Hospital

Hirakata, , Japan

Hitachi General Hospital

Hitachi, , Japan

Saitama Medical University Hospital

Iruma-gun, , Japan

Kameda Medical Center

Kamogawa, , Japan

National Cancer Center Hospital East

Kashiwa, , Japan

Kurashiki Central Hospital

Kurashiki, , Japan

Matsuyama Red Cross Hospital

Matsuyama, , Japan

Aichi Medical University Hospital

Nagakute, , Japan

JRC Nagasaki Genbaku Hospital

Nagasaki, , Japan

Niigata University Medical And Dental Hospital

Niigata, , Japan

National Hospital Organization Okayama Medical Center

Okayama, , Japan

Osaka Metropolitan University Hospital

Osaka, , Japan

Hokkaido University Hospital

Sapporo, , Japan

Juntendo University Hospital

Tokyo, , Japan

The Cancer Institute Hospital of JFCR

Tokyo, , Japan

Yamagata University Hospital

Yamagata, , Japan

Yamanashi Prefectural Central Hospital

Yamanashi, , Japan

Hospital Pulau Pinang

George Town, , Malaysia

Hospital Queen Elizabeth

Kota Kinabalu, , Malaysia

University Malaya Medical Centre

Kuala Lumpur, , Malaysia

Subang Jaya Medical Centre

Subang Jaya, , Malaysia

Meander Medisch Centrum

Amersfoort, , Netherlands

VUMC Amsterdam

Amsterdam, , Netherlands

Universitair Medisch Centrum Groningen

Groningen, , Netherlands

UMC Utrecht

Utrecht, , Netherlands

Uniwersyteckie Centrum Kliniczne

Gdansk, , Poland

Pratia Onkologia Katowice

Katowice, , Poland

Swietokrzyskie Centrum Onkologii SPZOZ w Kielcach

Kielce, , Poland

Uniwersytecki Szpital Kliniczny Nr 1 w Lublinie

Lublin, , Poland

Uls Almada Seixal - Hosp. Garcia de Orta

Almada, , Portugal

Uls Braga - Hosp. Braga

Braga, , Portugal

Champalimaud Foundation Champalimaud Centre

Lisbon, , Portugal

Instituto Portugues de Oncologia

Porto, , Portugal

Uls Gaia Espinho

Vila Nova de Gaia, , Portugal

Hosp. Univ. Germans Trias I Pujol

Badalona, , Spain

Hosp. de Jerez de La Frontera

Jerez de la Frontera, , Spain

Institut Catala d Oncologia L Hospitalet

L'Hospitalet de Llobregat, , Spain

Hosp. de Leon

León, , Spain

Hosp. Univ. Infanta Leonor

Madrid, , Spain

Ankara Gulhane Training and Research Hospital

Ankara, , Turkey (Türkiye)

Dr Abdurrahman Yurtaslan Oncology Training and Research Hospital

Ankara, , Turkey (Türkiye)

Ankara University Medical Faculty

Ankara, , Turkey (Türkiye)

Liv Hospital Ankara

Ankara, , Turkey (Türkiye)

Antalya Training And Research Hospital

Antalya, , Turkey (Türkiye)

Ondokuz Mayis University

Atakum, , Turkey (Türkiye)

Pamukkale University Medical Faculty

Denizli, , Turkey (Türkiye)

Medipol University Hospital

Istanbul, , Turkey (Türkiye)

Aberdeen Royal Infirmary

Aberdeen, , United Kingdom

University Hospitals Birmingham NHS Foundation Trust

Birmingham, , United Kingdom

Colchester Hospital University NHS

Colchester, , United Kingdom

The Clatterbridge Cancer Centre

Liverpool, , United Kingdom

Chelsea And Westminster Hospital

London, , United Kingdom

St Georges Hospital

London, , United Kingdom

James Cook University Hospital

Middlesbrough, , United Kingdom

Norfolk and Norwich University Hospital

Norwich, , United Kingdom

Royal Stoke University Hospital

Staffordshire, , United Kingdom

Countries

United States; Australia; Austria; Belgium; Brazil; Canada; China; Czechia; Denmark; France; Germany; Greece; India; Israel; Italy; Japan; Malaysia; Netherlands; Poland; Portugal; Spain; Sweden; Turkey (Türkiye); United Kingdom

Other Identifiers

64007957MMY3006

Identifier Type: OTHER

Identifier Source: secondary_id

2022-000928-37

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

2023-503444-13-00

Identifier Type: REGISTRY

Identifier Source: secondary_id

CR109244

Identifier Type: -

Identifier Source: org_study_id