AzTrials
AzTrials

Multiple MyelomaPhase 3MajesTEC-9NCT05572515

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

A Phase 3 study testing Teclistamab, Pomalidomide and Bortezomib in people with Multiple Myeloma, run by Janssen Research & Development, LLC at 211 sites in 24 countries.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Multiple Myeloma
What is being tested?
Teclistamab, Pomalidomide and Bortezomib
Could I receive a placebo?
No, everyone receives an active treatment
How many people
614 participants
Where
211 sitesin 24 countries
Study dates
29 Mar 2023to 31 Aug 2031
Phase
Phase 3
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

211 sites in 24 countries.

211 sites in 24 countries

United States30 sites

  • Alaska Oncology and Hematology LLC

    Anchorage, Alaska, 99508

  • Rocky Mountain Cancer Centers

    Aurora, Colorado, 80218

  • Alta Bates Comprehensive Cancer Center

    Berkeley, California, 94704

  • Walter Reed National Military Medical Center

    Bethesda, Maryland, 20889

  • Boston University Medical Center

    Boston, Massachusetts, 02118

  • Cooper Health System MD Anderson Cancer Center at Cooper

    Camden, New Jersey, 08103

  • Saint Lukes Hospital Saint Lukes Cancer Specialists

    Chesterfield, Missouri, 63017

  • Durham VAMC

    Durham, North Carolina, 27705

  • University of Connecticut

    Farmington, Connecticut, 06030

  • Alexander T. Augusta Military Medical Center

    Fort Belvoir, Virginia, 22060

  • Brooke Army Medical Center

    Fort Sam Houston, Texas, 78234

  • Banner MD Anderson Cancer Center

    Gilbert, Arizona, 85234

  • Baylor College of Medicine

    Houston, Texas, 77030

  • Michael E DeBakey VA Medical Center

    Houston, Texas, 77030

  • Harris Health Smith Clinic

    Houston, Texas, 77054

  • Penn Medicine Lancaster General Health

    Lancaster, Pennsylvania, 17601

  • MemorialCare Long Beach Medical Center

    Long Beach, California, 90806

  • East Jefferson General Hospital Bone Marrow Transport Clinic

    Metairie, Louisiana, 70006

  • University of Miami Sylvester Cancer Center

    Miami, Florida, 33136

  • Tennessee Oncology

    Nashville, Tennessee, 37203

  • Herbert Irving Comprehensive Cancer Center Columbia University Medical Center

    New York, New York, 10032

  • Virginia Oncology Associates

    Norfolk, Virginia, 23502

  • University of California Irvine

    Orange, California, 92868

  • Orlando Health Cancer Institute

    Orlando, Florida, 32806

  • Utah Cancer Specialists

    Salt Lake City, Utah, 84106

  • Maryland Oncology Hematology P A

    Silver Spring, Maryland, 20904

  • NorthWest Medical Specialties, PLLC

    Tacoma, Washington, 98405

  • Mission Cancer Blood

    Waukee, Iowa, 50263

  • Cleveland Clinic Florida

    Weston, Florida, 33331

  • PIH Health Hospital

    Whittier, California, 90602

Other trials in United States

China24 sites

  • Beijing Chaoyang Hospital

    Beijing, 100020

  • BeiJing JiShuiTan Hospital

    Beijing, 102208

  • The First Bethune Hospital of Jilin University

    Changchun, 130021

  • The Third Xiangya Hospital, Central South University

    Changsha, 410013

  • Sichuan Provincial Peoples Hospital

    Chengdu, 610032

  • Chongqing University Cancer Hospital

    Chongqing, 400030

  • Fujian Meidical University Union Hospital

    Fuzhou, 350001

  • Sun Yat -Sen University Cancer Center

    Guangzhou, 511363

  • First affiliated Hospital of Zhejiang University 1

    Hangzhou, 310003

  • First affiliated Hospital of Zhejiang University

    Hangzhou, 310003

  • Harbin medical university cancer hospital

    Harbin, 150000

  • The First Affiliated Hospital of NanChang University

    Nanchang, 330006

  • Nanjing Drum Tower Hospital

    Nanjing, 210008

  • First Affiliated Hospital of Guangxi Medical University

    Nanning, 530021

  • Shanghai Fourth People s Hospital

    Shanghai, 200434

  • Shengjing Hospital Of China Medical University

    Shenyang, 110055

  • Shenzhen 2nd People's Hospital

    Shenzhen, 518025

  • Tianjin Medical University Cancer Institute and Hospital

    Tianjin, 300060

  • Institute of Hematology and Blood Diseases Hospital

    Tianjin, 301617

  • The First Affiliated Hospital of Wenzhou Medical University

    Wenzhou, 325000

  • Wuhan Union Hospital

    Wuhan, 430023

  • Wuxi People s Hospital

    Wuxi, 214023

  • The Second Affiliated Hospital of Xi'an Jiaotong University

    Xi'an, 710004

  • Henan Cancer Hospital

    Zhengzhou, 450008

Other trials in China

Japan21 sites

  • Institute of Science Tokyo Hospital

    Bunkyō City, 113 8519

  • Chiba Cancer Center

    Chiba, 260-8717

  • Ogaki Municipal Hospital

    Gifu, 503-8502

  • National Hospital Organization Shibukawa Medical Center

    Gunma, 377-0280

  • Kansai Medical University Hospital

    Hirakata, 573 1191

  • Hitachi General Hospital

    Hitachi, 317-0077

  • Saitama Medical University Hospital

    Iruma-gun, 350-0495

  • Kameda Medical Center

    Kamogawa, 296-8602

  • National Cancer Center Hospital East

    Kashiwa, 277 8577

  • Kurashiki Central Hospital

    Kurashiki, 710-8602

  • Matsuyama Red Cross Hospital

    Matsuyama, 790-8524

  • Aichi Medical University Hospital

    Nagakute, 480-1195

  • JRC Nagasaki Genbaku Hospital

    Nagasaki, 852-8511

  • Niigata University Medical And Dental Hospital

    Niigata, 951 8520

  • National Hospital Organization Okayama Medical Center

    Okayama, 701-1192

  • Osaka Metropolitan University Hospital

    Osaka, 545 8586

  • Hokkaido University Hospital

    Sapporo, 060-8648

  • Juntendo University Hospital

    Tokyo, 113-0033

  • The Cancer Institute Hospital of JFCR

    Tokyo, 135 8550

  • Yamagata University Hospital

    Yamagata, 990 2331

  • Yamanashi Prefectural Central Hospital

    Yamanashi, 400-8506

Other trials in Japan

Brazil16 sites

  • Hospitais Integradaos da Gavea S/A - DF Star

    Brasília, 70390-140

  • Fundacao Universidade de Caxias do Sul

    Caxias do Sul, 95070 560

  • Hospital Erasto Gaertner- Liga Paranaense de Combate ao Cancer

    Curitiba, 81520-060

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

    Joinville, 89201-260

  • Liga Norte Riograndense Contra O Cancer

    Natal, 59062 000

  • Complexo Hospitalar de Niteroi

    Niterói, 24020-073

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

    Rio de Janeiro, 22775-001

  • IDOR - Regional Bahia

    Salvador, 41253-190

  • Funfarme Sjrp

    São José do Rio Preto, 15090-000

  • Sociedade Beneficente de Senhoras Hospital Sirio Libanes

    São Paulo, 01308-901

  • Real e Benemérita Associação Portuguesa de Beneficência

    São Paulo, 01321-001

  • Hospital Alemao Oswaldo Cruz

    São Paulo, 01323-001

  • IDOR - Regional Sao Paulo

    São Paulo, 01401 002

  • Fundacao Antonio Prudente A C Camargo Cancer Center

    São Paulo, 01509 900

  • Clinica Medica Sao Germano LTDA

    São Paulo, 04537 081

  • Sociedade Beneficente Israelita Brasileira Hospital Albert Einstein

    São Paulo, 05652-900

Other trials in Brazil

Spain13 sites

  • Hosp. Univ. Germans Trias I Pujol

    Badalona, 08916

  • Hosp. de Jerez de La Frontera

    Jerez de la Frontera, 11407

  • Institut Catala d Oncologia L Hospitalet

    L'Hospitalet de Llobregat, 08908

  • Hosp. de Leon

    León, 24008

  • Hosp. Univ. Infanta Leonor

    Madrid, 28031

  • Hosp. Univ. Ramon Y Cajal

    Madrid, 28034

  • Hosp. Univ. 12 de Octubre

    Madrid, 28041

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

    Murcia, 30008

  • Hospital Universitario Central de Asturias

    Oviedo, 33011

  • Hosp. Son Llatzer

    Palma de Mallorca, 07198

  • Hosp. Montecelo

    Pontevedra, 36071

  • Hosp. Quiron Madrid Pozuelo

    Pozuelo de Alarcón, 28223

  • Hospital Universitari i Politecnic La Fe

    Valencia, 46026

Other trials in Spain

France12 sites

  • CHU Amiens - Hopital Sud

    Amiens, 80000

  • Hôpital Côte de Nacre

    Caen, 14000

  • CHU Grenoble

    Grenoble, 38700

  • Centre Hospitalier du Mans

    Le Mans, 72037

  • Hopital Saint Vincent de Paul

    Lille, 59020

  • CHU de Montpellier Hopital Saint Eloi

    Montpellier, 34295 cede

  • CHU Nantes

    Nantes, 44000

  • Hopital Saint-Antoine

    Paris, 75012

  • Hopital de la Pitie Salpetriere

    Paris, 75013

  • Hopital Necker Enfants Malades

    Paris, 75743

  • Institut Universitaire du Cancer Toulouse Oncopole

    Toulouse, 31100

  • CHU de Nancy - Hopital de Brabois

    Vandœuvre-lès-Nancy, 54500

Other trials in France

Italy10 sites

  • A O U Sant Orsola Malpighi

    Bologna, 40138

  • Fondazione IRCCS Istituto Nazionale dei Tumori

    Milan, 20133

  • Azienda Ospedaliero Universitaria Policlinico Paolo Giaccone

    Palermo, 90127

  • Ospedale Santa Chiara AO Universitaria Pisana

    Pisa, 56126

  • Arcispedale Santa Maria Nuova - IRCCS

    Reggio Emilia, 42123

  • Campus Bio Medico di Roma

    Roma, 00128

  • A O Universitaria Senese Ospedale Santa Maria alle Scotte

    Siena, 53100

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

    Turin, 10126

  • ASUI Santa Maria della Misericordia di Udine

    Udine, 33100

  • Ospedale di Circolo e Fondazione Macchi

    Varese, 21100

Other trials in Italy

Germany9 sites

  • Medizinische Universitat Lausitz Carl Thiem

    Cottbus, 03048

  • Universitatsklinikum Carl Gustav Carus Dresden

    Dresden, 01307

  • Universitätsmedizin Greifswald

    Greifswald, 17475

  • Asklepios Klinik Altona

    Hamburg, 22763

  • Universitaetsklinikum Heidelberg

    Heidelberg, 69120

  • Universitaetsklinikum Giessen und Marburg GmbH

    Marburg, 35043

  • Universitatsklinikum Tubingen

    Tübingen, 72076

  • Universitatsklinikum Ulm

    Ulm, 89070

  • Heinrich-Braun-Klinikum gGmbH

    Zwickau, 08060

Other trials in Germany

United Kingdom9 sites

  • Aberdeen Royal Infirmary

    Aberdeen, AB25 2ZN

  • University Hospitals Birmingham NHS Foundation Trust

    Birmingham, B15 2GW

  • Colchester Hospital University NHS

    Colchester, CO4 5JL

  • The Clatterbridge Cancer Centre

    Liverpool, L7 8YA

  • Chelsea And Westminster Hospital

    London, SW10 9NH

  • St Georges Hospital

    London, SW17 0QT

  • James Cook University Hospital

    Middlesbrough, Ts4 3Bw

  • Norfolk and Norwich University Hospital

    Norwich, NR4 7UY

  • Royal Stoke University Hospital

    Staffordshire, ST4 6QG

Other trials in United Kingdom

Turkey (Türkiye)8 sites

  • Ankara Gulhane Training and Research Hospital

    Ankara, 06010

  • Dr Abdurrahman Yurtaslan Oncology Training and Research Hospital

    Ankara, 06200

  • Ankara University Medical Faculty

    Ankara, 06620

  • Liv Hospital Ankara

    Ankara, 06680

  • Antalya Training And Research Hospital

    Antalya, 07100

  • Pamukkale University Medical Faculty

    Denizli, 20070

  • Medipol Mega Universite Hastanesi

    Istanbul, 34214

  • Ondokuz Mayis University

    Samsun, 55280

Other trials in Turkey (Türkiye)

Denmark6 sites

  • Aalborg University Hospital

    Aalborg, 9000

  • Aarhus University Hospital

    Aarhus, 8200

  • Rigshospitalet

    Copenhagen, DK-2100

  • Regionshospitalet Godstrup

    Herning, 7400

  • Odense Universitetshospital

    Odense C, 5000

  • Vejle Sygehus

    Vejle, 7100

Other trials in Denmark

Israel6 sites

  • Hillel Yaffe Medical Center

    Hadera, 3810101

  • Bnai Zion Medical Center

    Haifa, 31048

  • Carmel Medical Center

    Haifa, 3436212

  • Rabin Medical Center

    Petah Tikva, 49100

  • Sheba Medical Center

    Ramat Gan, 52621

  • Tel Aviv Sourasky Medical Center

    Tel Aviv, 64239

Other trials in Israel

Australia5 sites

  • Blacktown Hospital

    Blacktown, 2148

  • St Vincents Hospital Melbourne

    Fitzroy, 3065

  • Box Hill Hospital

    Melbourne, 3128

  • Fiona Stanley Hospital

    Murdoch, 6150

  • Sir Charles Gairdner Hospital

    Nedlands, 6009

Other trials in Australia

Belgium5 sites

  • Algemeen Ziekenhuis Klina

    Brasschaat, 2930

  • Jolimont

    Haine-St-Paul, 7100

  • Az Groeninge

    Kortrijk, 8500

  • Universitair Ziekenhuis Gasthuisberg

    Leuven, 3000

  • CHR de la Citadelle

    Liège, 4000

Other trials in Belgium

Canada5 sites

  • Brampton Civic Hospital

    Brampton, Ontario, L6R 3J7

  • Arthur J E Child Comprehensive Cancer Centre

    Calgary, Alberta, T2N 5G2

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

    Montreal, Quebec, H1T 2M4

  • Lakeridge Health Oshawa

    Oshawa, Ontario, L1G2B9

  • Saint John Regional Hospital

    Saint John, New Brunswick, E2L 4L2

Other trials in Canada

Portugal5 sites

  • Uls Almada Seixal - Hosp. Garcia de Orta

    Almada, 2805-267

  • Uls Braga - Hosp. Braga

    Braga, 4710-243

  • Champalimaud Foundation Champalimaud Centre

    Lisbon, 1400-038

  • Instituto Portugues de Oncologia

    Porto, 4200072

  • Uls Gaia Espinho

    Vila Nova de Gaia, 4434-502

Other trials in Portugal

Czechia4 sites

  • Fakultni nemocnice Brno

    Brno, 625 00

  • Fakultni nemocnice Olomouc

    Olomouc, 779 00

  • Fakultni Nemocnice Ostrava

    Ostrava - Poruba, 708 52

  • Vseobecna fakultni nemocnice v Praze

    Prague, 128 08

Other trials in Czechia

Malaysia4 sites

  • Hospital Pulau Pinang

    George Town, 10450

  • Hospital Queen Elizabeth

    Kota Kinabalu, 88200

  • University Malaya Medical Centre

    Kuala Lumpur, 59100

  • Subang Jaya Medical Centre

    Subang Jaya, 47500

Other trials in Malaysia

Netherlands4 sites

  • Meander Medisch Centrum

    Amersfoort, 3813 TZ

  • VUMC Amsterdam

    Amsterdam, 1081 HV

  • Universitair Medisch Centrum Groningen

    Groningen, 9700 RB

  • UMC Utrecht

    Utrecht, 3584 CX

Other trials in Netherlands

Poland4 sites

  • Uniwersyteckie Centrum Kliniczne

    Gdansk, 80 214

  • Pratia Onkologia Katowice

    Katowice, 40 519

  • Swietokrzyskie Centrum Onkologii SPZOZ w Kielcach

    Kielce, 25 734

  • Uniwersytecki Szpital Kliniczny Nr 1 w Lublinie

    Lublin, 20-081

Other trials in Poland

Greece3 sites

  • Alexandra General Hospital of Athens

    Athens Attica, 115 28

  • Agios Andreas General Hospital of Patra

    Pátrai, 263 35

  • G Papanikolaou Hospital of Thessaloniki

    Thessaloniki, 570 10

Other trials in Greece

India3 sites

  • Fortis Memorial Research Institute

    Gūrgaon, 122002

  • Bhagwan Mahaveer Cancer Hospital & Research Centre

    Jaipur, 302017

  • Deenanath Mangeshkar Hospital and Research Centre

    Pune, 411004

Other trials in India

Sweden3 sites

  • Falu Lasarett Medicinkliniken Falun

    Falun, 791 82

  • Helsingborgs lasarett

    Helsingborg, 25287

  • Akademiska Sjukhuset

    Uppsala, 751 85

Other trials in Sweden

Austria2 sites

  • LKH - Universitätsklinikum der PMU Salzburg

    Salzburg, 5020

  • Medical University Vienna MUV

    Vienna, A-1090

Other trials in Austria

About this study

Official title: 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.

Being tested
Teclistamab, Pomalidomide, Bortezomib, Dexamethasone, Carfilzomib
Medical subject headings
Multiple Myeloma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • TeclistamabDrug

    Also called JNJ-64007957

    Teclistamab will be administered subcutaneously.

  • PomalidomideDrug

    Pomalidomide will be administered orally.

  • BortezomibDrug

    Bortezomib will be administered subcutaneously.

  • DexamethasoneDrug

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

  • CarfilzomibDrug

    Carfilzomib will be administered intravenously.

Study groups in NCT05572515
Study groupRoleWhat they receive
TeclistamabExperimentalParticipants will receive teclistamab monotherapy in Part 1 and an alternative dosing regimen of teclistamab in Part 2. Participants who are still receiving the treatment and benefiting from it may enter the long-term extension (LTE) and drug access (DA)-LTE Phases to continue their current treatment until end of the study.
Receives: Drug: Teclistamab
Pomalidomide, Bortezomib and Dexamethasone (PVd) or Carfilzomib and Dexamethasone (Kd)ExperimentalParticipants will receive either PVd or Kd based on principal investigator's choice during Part 1 of the study. Participants who are still receiving the treatment and benefiting from it may enter the LTE and DA-LTE Phases to continue their current treatment until end of the study.
Receives: Drug: Pomalidomide; Drug: Bortezomib; Drug: Dexamethasone; Drug: Carfilzomib

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Up to 9 years

  2. 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.

    Measured: Up to 9 years

Secondary outcomes (19)

  1. 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.

    Measured: Up to 9 years

  2. 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.

    Measured: Up to 9 years

  3. 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.

    Measured: Up to 9 years

  4. 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.

    Measured: Up to 9 years

  5. Part 1: Time to Next Treatment (TTNT)

    TTNT is defined as the time from randomization to the start of subsequent antimyeloma treatment.

    Measured: Up to 9 years

  6. 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.

    Measured: Up to 9 years

  7. 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.

    Measured: Up to 9 years

  8. Part 1 and 2: Number of Participants with Adverse Events (AEs) by Severity

    Number of participants with AEs by Severity will be reported.

    Measured: Up to 9 years

  9. Part 1 and 2: Number of Participants with Serious Adverse Events (SAEs) by Severity

    Number of participants with SAEs by Severity will be reported.

    Measured: Up to 9 years

  10. 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.

    Measured: Up to 9 years

  11. Part 1 and 2: Serum Concentrations of Teclistamab

    Serum concentrations of teclistamab will be reported.

    Measured: Up to 9 years

  12. Part 1 and 2: Number of Participants with Anti-drug Antibodies (ADAs) to Teclistamab

    Number of participants with ADAs to teclistamab will be reported.

    Measured: Up to 9 years

  13. 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.

    Measured: Baseline up to 9 years

  14. 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.

    Measured: Baseline up to 9 years

  15. 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.

    Measured: Baseline up to 9 years

  16. 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).

    Measured: Baseline up to 9 years

  17. 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.

    Measured: Up to 9 years

  18. 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.

    Measured: Up to 9 years

  19. 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.

    Measured: Up to 9 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Oct 2022
  2. Study start29 Mar 2023
  3. Primary completion13 Oct 2025
  4. Study completion31 Aug 2031 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
614 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05572515
Sponsor's protocol ID
CR109244
Other IDs
64007957MMY3006, 2022-000928-37, 2023-503444-13-00, 2023
Acronym
MajesTEC-9
Status last verified
Nov 2026
First submitted
5 Oct 2022
Last updated
4 Nov 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: The data sharing policy of Johnson \& Johnson Innovative Medicine is available at www.innovativemedicine.jnj.com/our-innovation/clinical-trials/transparency. As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu
Expanded access
Available

Publications

  • Touzeau C, Mina R, Quach H, Hungria V, Bhutani D, Chen W, Kumar S, Chaulagain C, Dimopoulos MA, Bahlis NJ, Maral S, van de Donk NWCJ, Schmidt Filho J, Saja K, Teipel R, Ando M, Roeloffzen W, Annibali O, Augustson B, Botta C, Delforge M, Bourgeois E, Buda G, Hus M, Perrot A, Preis M, Beksac M, Pour L, Farmer S, Nunes M, Oriol A, Melchardt T, Hu Y, Flogegard M, Wang D, Pei L, Wroblewski S, Aries IM, Quijano Carde NA, Perova T, de Jager T, Yeh TM, Vanquickelberghe V, Shah P, Chastain K, Kobos R, Carson R, Landgren O; MajesTEC-9 Trial Investigators. Teclistamab in Multiple Myeloma with One to Three Previous Lines of Therapy. N Engl J Med. 2026 Jul 30;395(5):440-453. doi: 10.1056/NEJMoa2603870. Epub 2026 May 29.

    PubMed 42212933

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Teclistamab, Pomalidomide and Bortezomib in people with Multiple Myeloma, run by Janssen Research & Development, LLC at 211 sites in 24 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 4 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 211 sites in United States, China, Japan, Brazil, Spain and 19 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Part 1: Progression-free Survival (PFS) (time frame: Up to 9 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05572515, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Nov 2026.

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