New hope for hard-to-treat myeloma: teclistamab takes on standard combos

NCT ID NCT05572515

Disease control Sponsor: Janssen Research & Development, LLC Source: ClinicalTrials.gov ↗

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study compares teclistamab (a newer immunotherapy) with two standard drug combinations (PVd or Kd) in about 614 adults whose multiple myeloma has come back or stopped responding after 1 to 3 prior treatments. The main goal is to see if teclistamab helps people live longer without the cancer growing. The study also checks safety and how well a different dosing schedule works.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

614 people

The number who actually took part.

Started

Mar 2023

Expected to finish

Aug 2031

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

plasma cell myeloma Recurrence refractory plasma cell neoplasm

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Relapsed or refractory multiple myeloma

Contacts and locations

Locations

A O U Sant Orsola Malpighi

Bologna, 40138, Italy
A O Universitaria Senese Ospedale Santa Maria alle Scotte

Siena, 53100, Italy
A.O.U. Citta della Salute e della Scienza di Torino - Presidio Molinette

Turin, 10126, Italy
ASUI Santa Maria della Misericordia di Udine

Udine, 33100, Italy
Aalborg University Hospital

Aalborg, 9000, Denmark
Aarhus University Hospital

Aarhus, 8200, Denmark
Aberdeen Royal Infirmary

Aberdeen, AB25 2ZN, United Kingdom
Agios Andreas General Hospital of Patra

Pátrai, 263 35, Greece
Aichi Medical University Hospital

Nagakute, 480-1195, Japan
Akademiska Sjukhuset

Uppsala, 751 85, Sweden
Alaska Oncology and Hematology LLC

Anchorage, Alaska, 99508, United States
Alexander T. Augusta Military Medical Center

Fort Belvoir, Virginia, 22060, United States
Alexandra General Hospital of Athens

Athens Attica, 115 28, Greece
Algemeen Ziekenhuis Klina

Brasschaat, 2930, Belgium
Alta Bates Comprehensive Cancer Center

Berkeley, California, 94704, United States
Ankara Gulhane Training and Research Hospital

Ankara, 06010, Turkey (Türkiye)
Ankara University Medical Faculty

Ankara, 06620, Turkey (Türkiye)
Antalya Training And Research Hospital

Antalya, 07100, Turkey (Türkiye)
Arcispedale Santa Maria Nuova - IRCCS

Reggio Emilia, 42123, Italy
Arthur J E Child Comprehensive Cancer Centre

Calgary, Alberta, T2N 5G2, Canada
Asklepios Klinik Altona

Hamburg, 22763, Germany
Az Groeninge

Kortrijk, 8500, Belgium
Azienda Ospedaliero Universitaria Policlinico Paolo Giaccone

Palermo, 90127, Italy
Banner MD Anderson Cancer Center

Gilbert, Arizona, 85234, United States
Baylor College of Medicine

Houston, Texas, 77030, United States
BeiJing JiShuiTan Hospital

Beijing, 102208, China
Beijing Chaoyang Hospital

Beijing, 100020, China
Bhagwan Mahaveer Cancer Hospital & Research Centre

Jaipur, 302017, India
Blacktown Hospital

Blacktown, 2148, Australia
Bnai Zion Medical Center

Haifa, 31048, Israel
Boston University Medical Center

Boston, Massachusetts, 02118, United States
Box Hill Hospital

Melbourne, 3128, Australia
Brampton Civic Hospital

Brampton, Ontario, L6R 3J7, Canada
Brooke Army Medical Center

Fort Sam Houston, Texas, 78234, United States
CHR de la Citadelle

Liège, 4000, Belgium
CHU Amiens - Hopital Sud

Amiens, 80000, France
CHU Grenoble

Grenoble, 38700, France
CHU Nantes

Nantes, 44000, France
CHU de Montpellier Hopital Saint Eloi

Montpellier, 34090, France
CHU de Nancy - Hopital de Brabois

Vandœuvre-lès-Nancy, 54500, France
CIUSSS de l Est de l Ile de Montreal Installation Hopital Maisonneuve Rosemont

Montreal, Quebec, H1T 2M4, Canada
Campus Bio Medico di Roma

Roma, 00128, Italy
Carmel Medical Center

Haifa, 3436212, Israel
Centre Hospitalier du Mans

Le Mans, 72037, France
Champalimaud Foundation Champalimaud Centre

Lisbon, 1400-038, Portugal
Chelsea And Westminster Hospital

London, SW10 9NH, United Kingdom
Chiba Cancer Center

Chiba, 260-8717, Japan
Chongqing University Cancer Hospital

Chongqing, 400030, China
Cleveland Clinic Florida

Weston, Florida, 33331, United States
Clinica Medica Sao Germano LTDA

São Paulo, 04537 081, Brazil
Colchester Hospital University NHS

Colchester, CO4 5JL, United Kingdom
Complexo Hospitalar de Niteroi

Niterói, 24020-073, Brazil
Cooper Health System MD Anderson Cancer Center at Cooper

Camden, New Jersey, 08103, United States
Deenanath Mangeshkar Hospital and Research Centre

Pune, 411004, India
Dr Abdurrahman Yurtaslan Oncology Training and Research Hospital

Ankara, 06200, Turkey (Türkiye)
Durham VAMC

Durham, North Carolina, 27705, United States
East Jefferson General Hospital Bone Marrow Transport Clinic

Metairie, Louisiana, 70006, United States
Fakultni Nemocnice Ostrava

Ostrava - Poruba, 708 52, Czechia
Fakultni nemocnice Brno

Brno, 625 00, Czechia
Fakultni nemocnice Olomouc

Olomouc, 779 00, Czechia
Falu Lasarett Medicinkliniken Falun

Falun, 791 82, Sweden
Fiona Stanley Hospital

Murdoch, 6150, Australia
First Affiliated Hospital of Guangxi Medical University

Nanning, 530021, China
First affiliated Hospital of Zhejiang University

Hangzhou, 310003, China
First affiliated Hospital of Zhejiang University 1

Hangzhou, 310003, China
Fondazione IRCCS Istituto Nazionale dei Tumori

Milan, 20133, Italy
Fortis Memorial Research Institute

Gurgaon, 122002, India
Fujian Meidical University Union Hospital

Fuzhou, 350001, China
Fundacao Antonio Prudente A C Camargo Cancer Center

São Paulo, 01509 900, Brazil
Fundacao Faculdade Regional de Medicina de Sao Jose do Rio Preto Hospital de Base

São José do Rio Preto, 15090-000, Brazil
Fundacao Universidade de Caxias do Sul

Caxias do Sul, 95070 560, Brazil
G Papanikolaou Hospital of Thessaloniki

Thessaloniki, 570 10, Greece
Harbin medical university cancer hospital

Harbin, 150000, China
Harris Health Smith Clinic

Houston, Texas, 77054, United States
Heinrich-Braun-Klinikum gGmbH

Zwickau, 08060, Germany
Helsingborgs lasarett

Helsingborg, 25287, Sweden
Henan Cancer Hospital

Zhengzhou, 450008, China
Herbert Irving Comprehensive Cancer Center Columbia University Medical Center

New York, New York, 10032, United States
Hillel Yaffe Medical Center

Hadera, 3810101, Israel
Hitachi General Hospital

Hitachi, 317-0077, Japan
Hokkaido University Hospital

Sapporo, 060-8648, Japan
Hopital Necker Enfants Malades

Paris, 75743, France
Hopital Saint Vincent de Paul

Lille, 59020, France
Hopital Saint-Antoine

Paris, 75012, France
Hopital de la Pitie Salpetriere

Paris, 75013, France
Hosp. Gral. Univ. J.M. Morales Meseguer

Murcia, 30008, Spain
Hosp. Montecelo

Pontevedra, 36071, Spain
Hosp. Quiron Madrid Pozuelo

Pozuelo de Alarcón, 28223, Spain
Hosp. Son Llatzer

Palma de Mallorca, 07198, Spain
Hosp. Univ. 12 de Octubre

Madrid, 28041, Spain
Hosp. Univ. Germans Trias I Pujol

Badalona, 08916, Spain
Hosp. Univ. Infanta Leonor

Madrid, 28031, Spain
Hosp. Univ. Ramon Y Cajal

Madrid, 28034, Spain
Hosp. de Jerez de La Frontera

Jerez de la Frontera, 11407, Spain
Hosp. de Leon

León, 24008, Spain
Hospitais Integradaos da Gavea S/A - DF Star

Brasília, 70390-140, Brazil
Hospital Alemao Oswaldo Cruz

São Paulo, 01323-001, Brazil
Hospital Pulau Pinang

George Town, 10450, Malaysia
Hospital Queen Elizabeth

Kota Kinabalu, 88200, Malaysia
Hospital Sao Rafael

Salvador, 41253-190, Brazil
Hospital Universitari i Politecnic La Fe

Valencia, 46026, Spain
Hospital Universitario Central de Asturias

Oviedo, 33011, Spain
Hôpital Côte de Nacre

Caen, 14000, France
Institut Catala d Oncologia L Hospitalet

L'Hospitalet de Llobregat, 08908, Spain
Institut Universitaire du Cancer Toulouse Oncopole

Toulouse, 31100, France
Institute of Hematology and Blood Diseases Hospital

Tianjin, 301617, China
Institute of Science Tokyo Hospital

Bunkyō City, 113 8519, Japan
Instituto D Or de Pesquisa e Ensino IDOR

São Paulo, 01401 002, Brazil
Instituto Joinvilense de Hematologia e Oncologia Ltda Centro de Hematologia e Oncologia

Joinville, 89201-260, Brazil
Instituto Portugues de Oncologia

Porto, 4200072, Portugal
Instituto de Educacao, Pesquisa e Gestao em Saude Instituto Americas (COI)

Rio de Janeiro, 22775-001, Brazil
JRC Nagasaki Genbaku Hospital

Nagasaki, 852-8511, Japan
James Cook University Hospital

Middlesbrough, Ts4 3Bw, United Kingdom
Jolimont

Haine-St-Paul, 7100, Belgium
Juntendo University Hospital

Tokyo, 113-0033, Japan
Kameda Medical Center

Kamogawa, 296-8602, Japan
Kansai Medical University Hospital

Hirakata, 573 1191, Japan
Kurashiki Central Hospital

Kurashiki, 710-8602, Japan
LKH - Universitätsklinikum der PMU Salzburg

Salzburg, 5020, Austria
Lakeridge Health Oshawa

Oshawa, Ontario, L1G2B9, Canada
Liga Norte Riograndense Contra O Cancer

Natal, 59062 000, Brazil
Liga Paranaense de Combate ao Cancer

Curitiba, 81520 060, Brazil
Liv Hospital Ankara

Ankara, 06680, Turkey (Türkiye)
Maryland Oncology Hematology P A

Silver Spring, Maryland, 20904, United States
Matsuyama Red Cross Hospital

Matsuyama, 790-8524, Japan
Meander Medisch Centrum

Amersfoort, 3813 TZ, Netherlands
Medical University Vienna MUV

Vienna, A-1090, Austria
Medipol Mega Universite Hastanesi

Istanbul, 34214, Turkey (Türkiye)
Medizinische Universitat Lausitz Carl Thiem

Cottbus, 03048, Germany
MemorialCare Long Beach Medical Center

Long Beach, California, 90806, United States
Michael E DeBakey VA Medical Center

Houston, Texas, 77030, United States
Mission Cancer Blood

Waukee, Iowa, 50263, United States
Nanjing Drum Tower Hospital

Nanjing, 210008, China
National Cancer Center Hospital East

Kashiwa, 277 8577, Japan
National Hospital Organization Okayama Medical Center

Okayama, 701-1192, Japan
National Hospital Organization Shibukawa Medical Center

Gunma, 377-0280, Japan
Niigata University Medical And Dental Hospital

Niigata, 951 8520, Japan
Norfolk and Norwich University Hospital

Norwich, NR4 7UY, United Kingdom
NorthWest Medical Specialties, PLLC

Tacoma, Washington, 98405, United States
Odense Universitetshospital

Odense C, 5000, Denmark
Ogaki Municipal Hospital

Gifu, 503-8502, Japan
Ondokuz Mayis University

Samsun, 55280, Turkey (Türkiye)
Orlando Health Cancer Institute

Orlando, Florida, 32806, United States
Osaka Metropolitan University Hospital

Osaka, 545 8586, Japan
Ospedale Santa Chiara AO Universitaria Pisana

Pisa, 56126, Italy
Ospedale di Circolo e Fondazione Macchi

Varese, 21100, Italy
PIH Health Hospital

Whittier, California, 90602, United States
Pamukkale University Medical Faculty

Denizli, 20070, Turkey (Türkiye)
Penn Medicine Lancaster General Health

Lancaster, Pennsylvania, 17601, United States
Pratia Onkologia Katowice

Katowice, 40 519, Poland
Rabin Medical Center

Petah Tikva, 49100, Israel
Real e Benemérita Associação Portuguesa de Beneficência

São Paulo, 01321-001, Brazil
Regionshospitalet Godstrup

Herning, 7400, Denmark
Rigshospitalet

Copenhagen, DK-2100, Denmark
Rocky Mountain Cancer Centers

Aurora, Colorado, 80218, United States
Royal Stoke University Hospital

Staffordshire, ST4 6QG, United Kingdom
Saint John Regional Hospital

Saint John, New Brunswick, E2L 4L2, Canada
Saint Lukes Hospital Saint Lukes Cancer Specialists

Chesterfield, Missouri, 63017, United States
Saitama Medical University Hospital

Iruma-gun, 350-0495, Japan
Shanghai Fourth People s Hospital

Shanghai, 200434, China
Sheba Medical Center

Ramat Gan, 52621, Israel
Shengjing Hospital Of China Medical University

Shenyang, 110055, China
Shenzhen 2nd People's Hospital

Shenzhen, 518025, China
Sichuan Provincial Peoples Hospital

Chengdu, 610032, China
Sir Charles Gairdner Hospital

Nedlands, 6009, Australia
Sociedade Beneficente Israelita Brasileira Hospital Albert Einstein

São Paulo, 05652-900, Brazil
Sociedade Beneficente de Senhoras Hospital Sirio Libanes

São Paulo, 01308-901, Brazil
St Georges Hospital

London, SW17 0QT, United Kingdom
St Vincents Hospital Melbourne

Fitzroy, 3065, Australia
Subang Jaya Medical Centre

Subang Jaya, 47500, Malaysia
Sun Yat -Sen University Cancer Center

Guangzhou, 511363, China
Swietokrzyskie Centrum Onkologii SPZOZ w Kielcach

Kielce, 25 734, Poland
Tel Aviv Sourasky Medical Center

Tel Aviv, 64239, Israel
Tennessee Oncology

Nashville, Tennessee, 37203, United States
The Cancer Institute Hospital of JFCR

Tokyo, 135 8550, Japan
The Clatterbridge Cancer Centre

Liverpool, L7 8YA, United Kingdom
The First Affiliated Hospital of NanChang University

Nanchang, 330006, China
The First Affiliated Hospital of Wenzhou Medical University

Wenzhou, 325000, China
The First Bethune Hospital of Jilin University

Changchun, 130021, China
The Second Affiliated Hospital of Xi'an Jiaotong University

Xi'an, 710004, China
The Third Xiangya Hospital, Central South University

Changsha, 410013, China
Tianjin Medical University Cancer Institute and Hospital

Tianjin, 300060, China
UMC Utrecht

Utrecht, 3584 CX, Netherlands
Uls Almada Seixal - Hosp. Garcia de Orta

Almada, 2805-267, Portugal
Uls Braga - Hosp. Braga

Braga, 4710-243, Portugal
Uls Gaia Espinho

Vila Nova de Gaia, 4434-502, Portugal
Universitaetsklinikum Giessen und Marburg GmbH

Marburg, 35043, Germany
Universitaetsklinikum Heidelberg

Heidelberg, 69120, Germany
Universitair Medisch Centrum Groningen

Groningen, 9700 RB, Netherlands
Universitair Ziekenhuis Gasthuisberg

Leuven, 3000, Belgium
Universitatsklinikum Carl Gustav Carus Dresden

Dresden, 01307, Germany
Universitatsklinikum Tubingen

Tübingen, 72076, Germany
Universitatsklinikum Ulm

Ulm, 89070, Germany
University Hospitals Birmingham NHS Foundation Trust

Birmingham, B15 2GW, United Kingdom
University Malaya Medical Centre

Kuala Lumpur, 59100, Malaysia
University of California Irvine

Orange, California, 92868, United States
University of Connecticut

Farmington, Connecticut, 06030, United States
University of Miami Sylvester Cancer Center

Miami, Florida, 33136, United States
Universitätsmedizin Greifswald

Greifswald, 17475, Germany
Uniwersytecki Szpital Kliniczny Nr 1 w Lublinie

Lublin, 20-081, Poland
Uniwersyteckie Centrum Kliniczne

Gdansk, 80 214, Poland
Utah Cancer Specialists

Salt Lake City, Utah, 84106, United States
VUMC Amsterdam

Amsterdam, 1081 HV, Netherlands
Vejle Sygehus

Vejle, 7100, Denmark
Virginia Oncology Associates

Norfolk, Virginia, 23502, United States
Vseobecna fakultni nemocnice v Praze

Prague, 128 08, Czechia
Walter Reed National Military Medical Center

Bethesda, Maryland, 20889, United States
Wuhan Union Hospital

Wuhan, 430023, China
Wuxi People s Hospital

Wuxi, 214023, China
Yamagata University Hospital

Yamagata, 990 2331, Japan
Yamanashi Prefectural Central Hospital

Yamanashi, 400-8506, Japan

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