AzTrials
AzTrials

Multiple MyelomaPhase 3MajesTEC-3NCT05083169

A Study of Teclistamab in Combination With Daratumumab Subcutaneously (SC) (Tec-Dara) Versus Daratumumab SC, Pomalidomide, and Dexamethasone (DPd) or Daratumumab SC, Bortezomib, and Dexamethasone (DVd) in Participants With Relapsed or Refractory Multiple Myeloma

A Phase 3 study testing Daratumumab, Pomalidomide and Dexamethasone in people with Multiple Myeloma, run by Janssen Research & Development, LLC at 176 sites in 21 countries.

Active, not recruiting

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

Official record
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Trial summary

The purpose of this study is to compare the efficacy of teclistamab daratumumab (Tec-Dara) with daratumumab subcutaneously (SC) in combination with pomalidomide and dexamethasone (DPd) or daratumumab SC in combination with bortezomib and dexamethasone (DVd). 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?
Daratumumab, Pomalidomide and Dexamethasone
Could I receive a placebo?
No, everyone receives an active treatment
How many people
587 participants
Where
176 sitesin 21 countries
Study dates
14 Oct 2021to 15 Sep 2028
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 multiple myeloma as defined by the criteria: a. multiple myeloma diagnosis according to the International Myeloma Working Group (IMWG) diagnostic criteria, b. measurable disease at screening as defined by any of the following: 1) serum M-protein level greater than or equal to (>=) 0.5 gram per deciliter (g/dL); or 2) urine M-protein level >=200 milligrams (mg)/24 hours; or 3) serum immunoglobulin free light chain >=10 mg/dL and abnormal serum immunoglobulin kappa lambda free light chain ratio
  • Received 1 to 3 prior line(s) of antimyeloma therapy including a proteasome inhibitor (PI) and lenalidomide; a. participants who have received only 1 line of prior line of antimyeloma therapy must be lenalidomide refractory. Stable disease or progression on or within 60 days of the last dose of lenalidomide given as maintenance will meet this criterion
  • Documented evidence of progressive disease based on investigator's determination of response by IMWG criteria on or after their last regimen
  • Have an eastern cooperative oncology group (ECOG) performance status score of 0, 1, or 2 at screening and prior to the start of administration of study treatment
  • Have clinical laboratory values within the specified range

Who cannot join

  • Contraindications or life-threatening allergies, hypersensitivity, or intolerance to any study drug or its excipients. Additional exclusion criteria pertaining to specific study drugs include:
  • A participant is not eligible to receive daratumumab subcutaneous (SC) in combination with pomalidomide and dexamethasone (DPd) as control therapy if any of the following are present: 1) Contraindications or life-threatening allergies, hypersensitivity, or intolerance to pomalidomide, 2) Disease that is considered refractory to pomalidomide per IMWG,
  • A participant is not eligible to receive daratumumab SC in combination with bortezomib and dexamethasone (DVd) as control therapy if any of the following are present: 1) Contraindications or life-threatening allergies, hypersensitivity, or intolerance to bortezomib, 2) Grade 1 peripheral neuropathy with pain or Grade >= 2 peripheral neuropathy as defined by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) Version 5.0, 3) Disease that is considered refractory to bortezomib per IMWG, 4) Received a strong cytochromes P450 (CYP3A4) inducer within 5 half-lives prior to randomization
  • Received any prior B cell maturation antigen (BCMA)-directed therapy
  • Has disease that is considered refractory to an anti-cluster of differentiation 38 (CD38) monoclonal antibody per IMWG
  • Received a cumulative dose of corticosteroids equivalent to >=140 mg of prednisone within 14 days before randomization
  • Received a live, attenuated vaccine within 4 weeks before randomization
  • Plasma cell leukemia at the time of screening, Waldenström's macroglobulinemia, POEMS syndrome (polyneuropathy, organomegaly, endocrinopathy, M-protein, and skin changes), or primary amyloid light chain amyloidosis

Trial locations and contacts

176 sites in 21 countries.

176 sites in 21 countries

China21 sites

  • Peking University First Hospital

    Beijing, 100034

  • Peking University People's Hospital

    Beijing, 100044

  • Peking University Third Hospital

    Beijing, 100191

  • The First Hospital of Jilin University

    Changchun, 130021

  • The Third Xiangya Hospital of Central Sourth University

    Changshashi, 410013

  • Beijing Chaoyang Hospital

    Chaoyang District, 100020

  • West China Hospital Sichuan University

    Chengdu, 610041

  • 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

  • Zhongda Hospital Southeast University

    Nanjing, 210009

  • First Affiliated Hospital of Guangxi Medical University

    Nanning, 530021

  • Shanghai Zhongshan Hospital

    Shanghai, 200032

  • Shengjing Hospital Of China Medical University

    Shenyang, 110136

  • Peking University Shenzhen Hospital

    Shenzhen, 518036

  • Tianjin Medical University General Hospital

    Tianjin, 300011

  • Tianjin Medical University Cancer Institute and Hospital

    Tianjin, 300060

  • The Second Affiliated Hospital of Xi'an Jiaotong University

    Xi'an, 710004

  • The Affiliated Hospital of Xuzhou Medical University

    Xuzhou, 221000

  • Henan Cancer Hospital

    Zhengzhou, 450008

Other trials in China

Japan19 sites

  • Fukuoka University Hospital

    Fukuoka, 814-0180

  • Ogaki Municipal Hospital

    Gifu, 503-8502

  • National Hospital Organization Mito Medical Center

    Higashiibaraki-gun, 311-3193

  • Tokai University Hospital

    Isehara, 259-1193

  • Shonan Kamakura General Hospital

    Kamakura-shi, 247-8533

  • National Cancer Center Hospital East

    Kashiwa, 277 8577

  • Dokkyo Medical University Saitama Medical Center

    Koshigaya, 343-8555

  • Kumamoto University Hospital

    Kumamoto, 860-8556

  • Kurume University Hospital

    Kurume, 830-0011

  • National Hospital Organization Matsumoto Medical Center

    Matsumoto, 399-8701

  • Nagoya City University Hospital

    Nagoya, 467 8602

  • Hyogo Medical University Hospital

    Nishinomiya Shi, 663 8501

  • National Hospital Organization Okayama Medical Center

    Okayama, 701-1192

  • National Hospital Organization Hiroshima-Nishi Medical Center

    Ōtake, 739-0696

  • Hokkaido University Hospital

    Sapporo, 060-8648

  • Tohoku University Hospital

    Sendai, 980 8574

  • National Hospital Organization Sendai Medical Center

    Sendai, 983-8520

  • Japanese Red Cross Medical Center

    Shibuya-ku, 150-8935

  • Iwate Medical University Hospital

    Shiwa-gun, 028-3695

Other trials in Japan

United States18 sites

  • Emory University Winship Cancer Institute

    Atlanta, Georgia, 30322

  • University of Alabama Birmingham

    Birmingham, Alabama, 35294

  • Tufts Medical Center

    Boston, Massachusetts, 02111

  • Medical University of South Carolina

    Charleston, South Carolina, 29425-8900

  • Cleveland Clinic

    Cleveland, Ohio, 44195

  • University of Texas Southwestern Medical Center

    Dallas, Texas, 75235

  • Henry Ford Hospital

    Detroit, Michigan, 48202

  • City of Hope

    Duarte, California, 91010

  • University of Wisconsin Carbone Cancer Center

    Madison, Wisconsin, 53792

  • Baptist Cancer Center

    Memphis, Tennessee, 38120

  • Vanderbilt Ingram Cancer Center

    Nashville, Tennessee, 37232

  • Yale University

    New Haven, Connecticut, 06510

  • West Penn Hospital

    Pittsburgh, Pennsylvania, 15224

  • University of Pittsburgh Medical Center

    Pittsburgh, Pennsylvania, 15232

  • Huntsman Cancer Institute

    Salt Lake City, Utah, 84112

  • Fred Hutchinson Cancer Center

    Seattle, Washington, 98109

  • Henry Ford Health System

    Southfield, Michigan, 48075

  • Stanford University Medical Center

    Stanford, California, 94305-5623

Other trials in United States

Spain15 sites

  • Inst. Cat. Doncologia-H Duran I Reynals

    Barcelona, 08908

  • Hosp Univ Vall D Hebron

    Barcelona, 8035

  • Hosp. de Cabuenes

    Gijón, 33394

  • Hosp. Univ. de Gran Canaria Dr. Negrin

    Las Palmas de Gran Canaria, 35010

  • Hosp. Gral. Univ. Gregorio Maranon

    Madrid, 28007

  • Hosp. Univ. Ramon Y Cajal

    Madrid, 28034

  • Hosp. Univ. 12 de Octubre

    Madrid, 28041

  • Hosp. Univ. Son Espases

    Palma, 7120

  • Clinica Univ. de Navarra

    Pamplona, 31008

  • Hosp. Quiron Madrid Pozuelo

    Pozuelo de Alarcón, 28223

  • Hosp Clinico Univ de Salamanca

    Salamanca, 37007

  • Hosp. Univ. Marques de Valdecilla

    Santander, 39008

  • Hosp. Clinico Univ. de Santiago

    Santiago de Compostela, 15706

  • Hosp. Virgen Del Rocio

    Seville, 41013

  • Hosp. Univ. I Politecni La Fe

    Valencia, 46026

Other trials in Spain

Brazil11 sites

  • Hospitais Integradaos da Gavea S/A - DF Star

    Brasília, 70390-140

  • Hospital Erasto Gaertner- Liga Paranaense de Combate ao Cancer

    Curitiba, 81520-060

  • Centro de Pesquisa e Ensino em Oncologia de Santa Catarina CEPEN

    Florianópolis, 88034-000

  • Liga Norte Riograndense Contra O Cancer

    Natal, 59062 000

  • Irmandade Santa Casa de Misericordia de Porto Alegre

    Porto Alegre, 90050-170

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

    Rio de Janeiro, 22775 001

  • IDOR - Regional Bahia

    Salvador, 41253-190

  • Real e Benemerita Associacao Portuguesa de Beneficencia

    São Paulo, 01323 900

  • Hospital Paulistano

    São Paulo, 01323-000

  • Clinica Medica Sao Germano LTDA

    São Paulo, 04537 081

  • Instituto D Or de Pesquisa e Ensino IDOR

    São Paulo, 4501000

Other trials in Brazil

Germany10 sites

  • Universitaetsklinikum Carl-Gustav-Carus Dresden

    Dresden, 01307

  • Heinrich-Heine -Universitaet Duesseldorf

    Düsseldorf, 40225

  • Evang. Krankenhaus Essen-Mitte gGmbH

    Essen, 45239

  • Universitatsklinikum Freiburg

    Freiburg im Breisgau, 79106

  • Universitaetsklinikum Hamburg Eppendorf

    Hamburg, 20246

  • St. Barbara-Klinik Hamm GmbH

    Hamm, 59073

  • Universitaetsklinikum Heidelberg

    Heidelberg, 69120

  • Universitaetsklinikum Schleswig Holstein Campus Kiel

    Kiel, 24105

  • Universitaetsklinikum Leipzig

    Leipzig, 04103

  • Universitaetsklinikum Tuebingen

    Tübingen, 72076

Other trials in Germany

France9 sites

  • CHU Henri Mondor

    Créteil, 94000

  • Hopital Claude Huriez

    Lille, 59000

  • CHU de Limoges Hopital Dupuytren

    Limoges, 87042

  • Hospices Civils de Lyon HCL

    Lyon, 69002

  • C.H.U. Hotel Dieu - France

    Nantes, 44093

  • CHU De Poitiers

    Poitiers, 86021

  • Hôpitaux Universitaires de Strasbourg - Hôpital de Hautepierre

    Strasbourg, 67200

  • Pôle IUC Oncopole CHU

    Toulouse, 31059

  • CHRU Hôpital Bretonneau

    Tours, 37044

Other trials in France

Italy8 sites

  • U.O. Ematologia con Trapianto- AOU Policlinico di Bari

    Bari, 70124

  • ASST Papa Giovanni XXIII Bergamo

    Bergamo, 24127

  • Policlinico Sant'Orsola Malpighi

    Bologna, 40138

  • Azienda Ospedaliera Universitaria Careggi

    Florence, 50134

  • Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori

    Meldola, 47014

  • IRCCS Policlinico San Matteo, Università degli studi di Pavi

    Pavia, 27100

  • Università di Roma 'La Sapienza' - Ospedale Umberto 1°

    Roma, 00161

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

    Turin, 10126

Other trials in Italy

Belgium7 sites

  • ZAS Cadix

    Antwerp, 2030

  • AZ St.-Jan Brugge-Oostende AV

    Bruges, 8000

  • UZ Gent

    Ghent, 9000

  • Hopital de Jolimont

    Haine Saint Paul La Louviere, 7100

  • Az Groeninge

    Kortrijk, 8500

  • UZ Leuven

    Leuven, 3000

  • Algemeen Ziekenhuis Delta

    Roeselare, 8800

Other trials in Belgium

Poland7 sites

  • Klinika Hematologii i Transplantologii, UCK

    Gdansk, 80-214

  • Pratia Onkologia Katowice

    Katowice, 40 519

  • Swietokrzyskie Centrum Onkologii SPZOZ w Kielcach

    Kielce, 25 734

  • Centrum Onkologii Ziemi Lubelskiej im sw Jana z Dukli

    Lublin, 20 090

  • Specjalistyczny Szpital im dra Alfreda Sokolowskiego w Walbrzychu

    Wałbrzych, 58 309

  • Narodowy Instytut Onkologii im Marii Sklodowskiej Curie Panstwowy Instytut Badawczy

    Warsaw, 02-781

  • Uniwersytecki Szpital Kliniczny im Jana Mikulicza Radeckiego we Wroclawiu

    Wroclaw, 50 367

Other trials in Poland

South Korea7 sites

  • Kyungpook National University Hospital

    Daegu, 41944

  • Gachon University Gil Medical Center

    Incheon, 21565

  • Chonnam National University Hwasun Hospital

    Jeollanam-do, 58128

  • Seoul National University Hospital

    Seoul, 03080

  • Severance Hospital Yonsei University Health System

    Seoul, 03722

  • Samsung Medical Center

    Seoul, 06351

  • The Catholic University of Korea Seoul St Marys Hospital

    Seoul, 06591

Other trials in South Korea

Sweden7 sites

  • Falu Lasarett

    Falun, 791 82

  • Sahlgrenska University Hospital

    Gothenburg, 413 45

  • Helsingborgs lasarett

    Helsingborg, 25187

  • Sunderby Sjukhus

    Luleå, 971 80

  • Skanes universitetssjukhus

    Lund, 221 85

  • Norrlands Universitetssjukhus

    Umeå, 901 85

  • Akademiska Sjukhuset

    Uppsala, 75185

Other trials in Sweden

United Kingdom6 sites

  • Blackpool Teaching Hospitals NHS Foundation Trust

    Blackpool, FY3 8NR

  • Ninewells Hospital & Medical School

    Dundee, DD1 9SY

  • Kings College Hospital

    London, SE5 9RS

  • Oxford University Hospitals NHS Foundation Trust

    Oxford, OX3 7LE

  • University Hospitals Plymouth NHS Trust

    Plymouth, PL6 8DH

  • Royal Marsden Hospital

    Sutton, SM2 5PT

Other trials in United Kingdom

Canada5 sites

  • Arthur J E Child Comprehensive Cancer Centre

    Calgary, Alberta, T2N 5G2

  • Cross Cancer Institute

    Edmonton, Alberta, T6G 1Z2

  • QEII Health Sciences

    Halifax, Nova Scotia, B3H 2Y9

  • Princess Margaret Cancer Centre University Health Network

    Toronto, Ontario, M5G 1X6

  • BC Cancer Agency - Vancouver BC

    Vancouver, British Columbia, V5Z 4E6

Other trials in Canada

Denmark5 sites

  • Aalborg University Hospital

    Aalborg, DK-9000

  • Aarhus University Hospital

    Aarhus N, DK-8200

  • Rigshospitalet

    Copenhagen, 2100

  • Odense Universitets Hospital

    Odense, 5000

  • Vejle Hospital

    Vejle, DK-7100

Other trials in Denmark

Netherlands5 sites

  • VU Medisch Centrum

    Amsterdam, 1081 HV

  • Universitair Medisch Centrum Groningen

    Groningen, 9713 GZ

  • Sint Antonius Ziekenhuis - Afd.Interne - INT

    Nieuwegein, 3435 CM

  • Radboudumc

    Nijmegen, 6525GA

  • Isala Kliniek

    Zwolle, 8025 AB

Other trials in Netherlands

Turkey (Türkiye)4 sites

  • Ankara University Medical Faculty

    Ankara, 06590

  • Ondokuz Mayis University

    Atakum, 55280

  • Medipol University Hospital

    Istanbul, 34214

  • Dokuz Eylul University Medical Faculty

    Izmir, 35340

Other trials in Turkey (Türkiye)

Argentina3 sites

  • Hospital Italiano de Buenos Aires

    Buenos Aires, C1199ABB

  • Hospital Aleman

    CABA, C1118AAT

  • Hospital Privado Centro Medico de Cordoba

    Córdoba, X5016KEH

Other trials in Argentina

Greece3 sites

  • Alexandra General Hospital of Athens

    Athens Attica, 115 28

  • Anticancer Hospital of Thessaloniki Theageneio

    Thessaloniki, 546 39

  • G.Papanikolaou

    Thessaloniki, 57010

Other trials in Greece

Russia3 sites

  • S.P. Botkin Moscow City Clinical Hospital 1

    Moscow, 125284

  • S.P. Botkin Moscow City Clinical Hospital

    Moscow, 125284

  • Clinical Research Institute of Hematology and Transfusiology

    Saint Petersburg, 191024

Other trials in Russia

Taiwan3 sites

  • China Medical University Hospital

    Taichung, 40447

  • National Cheng Kung University Hospital

    Tainan, 704

  • Chang Gung Memorial Hospital

    Taoyuan, 333

Other trials in Taiwan

About this study

Official title: A Phase 3 Randomized Study Comparing Teclistamab in Combination With Daratumumab SC (Tec-Dara) Versus Daratumumab SC, Pomalidomide, and Dexamethasone (DPd) or Daratumumab SC, Bortezomib, and Dexamethasone (DVd) in Participants With Relapsed or Refractory Multiple Myeloma

The purpose of this study is to compare the efficacy of teclistamab daratumumab (Tec-Dara) with daratumumab subcutaneously (SC) in combination with pomalidomide and dexamethasone (DPd) or daratumumab SC in combination with bortezomib and dexamethasone (DVd).

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

What participants receive

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

  • DaratumumabDrug

    Daratumumab will be administered SC injection.

  • PomalidomideDrug

    Pomalidomide will be administered orally.

  • DexamethasoneDrug

    Dexamethasone will be administered orally or intravenously.

  • BortezomibDrug

    Bortezomib will be administered SC injection.

  • TeclistamabDrug

    Also called JNJ-64007957

    Teclistamab will be administered SC injection.

Study groups in NCT05083169
Study groupRoleWhat they receive
Arm A: Teclistamab-daratumumab (Tec-Dara)ExperimentalParticipants will receive teclistamab and daratumumab by subcutaneous (SC) injection. Step-up doses of teclistamab will be given prior to the first full dose. 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: Daratumumab; Drug: Teclistamab
Arm B: DPd or DVdExperimentalParticipants will be randomized either to daratumumab, pomalidomide, dexamethasone (DPd) treatment to receive daratumumab SC injection; pomalidomide orally; dexamethasone orally or intravenously, or to Daratumumab, Bortezomib, Dexamethasone (DVd) treatment to receive daratumumab SC injection; bortezomib SC injection, and dexamethasone orally or intravenously. Participants randomized to Arm B who do not cross over to Tec-Dara may continue DPd/DVd treatment during the LTE phase. Following the completion of LTE phase, participants who crossed over to Tec-Dara during the LTE may enter the DA LTE and continue to receive study treatment with Tec Dara. Any participants still receiving DPd/DVd at the end of the LTE may not cross over to Tec-Dara and will not continue into the DA-LTE.
Receives: Drug: Daratumumab; Drug: Pomalidomide; Drug: Dexamethasone; Drug: Bortezomib

What is being measured

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

  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) criteria, or death due to any cause, whichever occurs first.

    Measured: Up to 5 years

Secondary outcomes (20)

  1. Overall Response (Partial Response [PR] or Better)

    Overall response (PR or better) is defined as participants who have a PR or better per IMWG criteria.

    Measured: Up to 5 years

  2. Very Good Partial Response (VGPR) or Better

    VGPR or better is defined as participants who achieve a VGPR or better response per IMWG criteria.

    Measured: Up to 5 years

  3. Complete Response (CR) or Better

    CR or better is defined as participants who achieve a CR or better response per IMWG criteria.

    Measured: Up to 5 years

  4. Minimal Residual Disease (MRD)-negativity

    MRD-negativity is defined as participants who achieve MRD negativity at a threshold of 10^-5 at any timepoint after the date of randomization and before disease progression or start of subsequent antimyeloma therapy.

    Measured: Up to 5 years

  5. 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 5 years

  6. Overall Survival (OS)

    OS is measured from the date of randomization to the date of the participant's death.

    Measured: Up to 5 years

  7. Time to Next Treatment (TTNT)

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

    Measured: Up to 5 years

  8. Duration of Response

    Duration of response will be calculated among responders (with a PR or better response) from the date of initial documentation of a response (PR or better) to the date of first documented evidence of progressive disease according to the IMWG response criteria, or death due to any cause, whichever occurs first.

    Measured: Up to 5 years

  9. Number of Participants with Adverse Events (AEs) by Severity

    Number of participants with AEs by Severity will be reported.

    Measured: Up to 5 years

  10. Serum Concentration of Teclistamab

    Serum samples will be analyzed to determine concentrations of teclistamab using a validated, specific, and sensitive method.

    Measured: Up to 5 years

  11. Number of Participants with Anti-drug Antibodies (ADAs) to Teclistamab and Daratumumab

    Number of participants with ADAs to teclistamab and daratumumab will be reported.

    Measured: Up to 5 years

  12. Time to Worsening of Symptoms

    Time to worsening is measured as the interval from the date of randomization to the start date of meaningful change.

    Measured: Up to 5 years

  13. Change from Baseline in Symptoms, Functioning, and Overall Health-related Quality of Life (HRQoL) as Assessed by European Organization for Research and Treatment of Cancer Quality-of-life Questionnaire Core 30 (EORTC-QLQ-C30)

    The EORTC-QLQ-C30 Version 3 includes 30 items in 5 functional scales (physical, role, emotional, cognitive, and social), 1 global health status scale, 3 symptom scales (pain, fatigue, and nausea/vomiting), and 6 single symptom items (dyspnea, insomnia, appetite loss, constipation, diarrhea, and financial difficulties). The responses are reported using a verbal and numeric rating scales. The item and scale scores are transformed to a 0 to 100 scale. A high scale score represents a higher response level. Thus, a high score for a functional scale represents a high/healthy level of functioning and a high score for the global health status represents high HRQoL, but a high score for a symptom scale/item represents a high level of symptomatology/problems.

    Measured: Baseline up to 5 years

  14. Change from Baseline in Symptoms, Functioning, and Overall HRQoL as Assessed by Multiple Myeloma Symptom and Impact Questionnaire (MySIm-Q) Scale Score

    The MySIm-Q is a disease-specific PRO assessment complementary to the EORTC-QLQ-C30. It includes 17 items resulting in a symptom subscale and an impact subscale. The recall period is the "past 7 days", and responses are reported on a 5-point verbal rating scale.

    Measured: Baseline up to 5 years

  15. Change from Baseline in Symptoms, Functioning, and Overall HRQoL as Assessed by Patient-reported Outcomes Measurement Information System Short Form v2.0 - Physical Function 8c (PROMIS PF 8c)

    The PROMIS-SD is used to assess self-reported perceptions of sleep quality, sleep depth and restoration associated with sleep. The 8-item short form will be used in this study, in which responses are scored 1 to 5 for each item. Higher overall score indicates more sleep disturbance.

    Measured: Baseline up to 5 years

  16. Change from Baseline in Symptoms, Functioning, and Overall HRQoL as Assessed by Patient-reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE )

    The National Cancer Institute's (NCI's) PRO-CTCAE is an item library of common adverse events experienced by people with cancer that are appropriate for self-reporting of treatment tolerability. Each symptom selected for inclusion can be rated by up to 3 attributes characterizing the presence/frequency, severity, and/or interference of the AEs. It ranges from 0 to 4 with higher scores indicating higher frequency or greater severity/impact.

    Measured: Baseline up to 6 months

  17. Change from Baseline in Symptoms, Functioning, and Overall HRQoL as Assessed by EuroQol Five Dimension Questionnaire 5-Level (EQ-5D-5L)

    The EQ-5D-5L is a generic measure of health status. The EQ-5D-5L is a 5-item questionnaire that assesses 5 domains including mobility, self-care, usual activities, pain/discomfort, and anxiety/depression plus a visual analog scale rating "health today" with anchors ranging from 0 (worst imaginable health state) to 100 (best imaginable health state).

    Measured: Baseline up to 5 years

  18. Change from Baseline in Symptoms, Functioning, and Overall HRQoL as Assessed by Patient Global Impression - Severity (PGI-S)

    The PGIS contains 2 questions on how the participant would currently rate severity of symptoms and impacts with a 7-day recall period. The response options are presented as a 5-point verbal rating scale from 1="none" to 5="very severe."

    Measured: Baseline up to 5 years

  19. PFS in Participants with High-risk Molecular Features

    PFS in participants with high-risk molecular features will be reported.

    Measured: Up to 5 years

  20. 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 5 years

Timeline

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

  1. First posted19 Oct 2021
  2. Study start14 Oct 2021
  3. Primary completion1 Aug 2025
  4. Study completion15 Sep 2028 (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
587 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05083169
Sponsor's protocol ID
CR109049
Other IDs
64007957MMY3001, 2020-004742-11, 2023-503441-55-00, 2023
Acronym
MajesTEC-3
Status last verified
Nov 2026
First submitted
8 Oct 2021
Last updated
3 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 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

  • Costa LJ, Bahlis NJ, Perrot A, Nooka AK, Lu J, Pawlyn C, Mina R, Caeiro G, Kentos A, Hungria V, Reece D, Niu T, Mylin AK, Hansen CT, Teipel R, Besemer B, Dimopoulos MA, Zamagni E, Yoshihara S, Kim K, Min CK, Geerts P, Van Leeuwen-Segarceanu E, Tyczynska A, Reguera JL, Johansson M, Hansson M, Turgut M, Grey M, Sidana S, Rodriguez-Otero P, Martinez-Lopez J, Hashmi H, Carson R, Kobos R, Sun W, Lantz K, Seifert A, Briseno-Toomey D, O'Rourke L, Rubin M, Vieyra D, Kang L, Mateos MV; MajesTEC-3 Trial Investigators. Teclistamab plus Daratumumab in Relapsed or Refractory Multiple Myeloma. N Engl J Med. 2026 Feb 19;394(8):739-752. doi: 10.1056/NEJMoa2514663. Epub 2025 Dec 9.

    PubMed 41363801

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Daratumumab, Pomalidomide and Dexamethasone in people with Multiple Myeloma, run by Janssen Research & Development, LLC at 176 sites in 21 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 5 inclusion and 8 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 3 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 176 sites in China, Japan, United States, Spain, Brazil and 16 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?

Progression Free Survival (PFS) (time frame: Up to 5 years). 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 NCT05083169, 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 3 Nov 2026.

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