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Hematological MalignanciesPhase 2MajesTEC-1NCT04557098

A Study of Teclistamab in Participants With Relapsed or Refractory Multiple Myeloma

A Phase 2 study testing Teclistamab in people with Hematological Malignancies, run by Janssen Research & Development, LLC at 51 sites in 11 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 evaluate the efficacy of teclistamab at the recommended Phase 2 dose (RP2D). Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Hematological Malignancies
What is being tested?
Teclistamab
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
194 participants
Where
51 sitesin 11 countries
Study dates
17 Sep 2020to 28 May 2027
Phase
Phase 2
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 according to IMWG diagnostic criteria
  • Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0 or 1
  • Measurable disease: Cohort A and Cohort C: Multiple myeloma must be measurable by central laboratory assessment
  • A female participant of childbearing potential must have a negative pregnancy test at screening
  • Willing and able to adhere to the prohibitions and restrictions specified in this protocol
  • Cohort A: received at least >=3 prior lines of therapy and previously received a PI, an IMiD and an anti-CD38 monoclonal antibody; Cohort C: received >= 3 prior lines of therapy that included a PI, an IMiD, an anti-CD38 monoclonal antibody, and an anti-B cell maturation antigen (BCMA) treatment (with CART-T cells or an antibody drug conjugate (ADC)

Who cannot join

  • Plasma cell leukemia, Waldenström's macroglobulinemia, POEMS syndrome, or primary amyloid light-chain amyloidosis
  • The following medical conditions: Pulmonary compromise requiring supplemental oxygen use to maintain adequate oxygenation, human immunodeficiency virus (HIV) infection, hepatitis B or C infection, stroke or seizure less than or equal to (<=) 6 m, autoimmune disease, uncontrolled systemic infection, cardiac conditions (Myocardial Infarction <= 6 m, stage III-IV congestive heart failure, etc)
  • Received any therapy that is targeted to BCMA, with the exception of Cohort C in Part 3
  • Prior antitumor therapy, within 21 days (PI or radiotherapy within 14 days, IMiDs within 7 days, Gene modified adoptive cell therapy within 3 months) prior to first dose of study drug
  • Toxicities from previous anticancer therapies that have not resolved to baseline or to <= grade 1 (except for alopecia or peripheral neuropathy)
  • Received a cumulative dose of corticosteroids equivalent to >=140 mg of prednisone within the 14-day period before the first dose of study drug (does not include pretreatment medication)
Show all 11Show fewer
  • Known active central nervous system (CNS) involvement or exhibits clinical signs of meningeal involvement of multiple myeloma (MM)
  • Myelodysplastic syndrome or active malignancies other than relapsed/refractory multiple myeloma with exceptions are: 1) Non-muscle invasive bladder cancer treated within the last 24 months that is considered completely cured 2) Skin cancer (non-melanoma or melanoma) treated within the last 24 months that is considered completely cured. 3) Noninvasive cervical cancer treated within the last 24 months that is considered completely cured. 4) Localized prostate cancer (N0M0) 5) Breast cancer: Adequately treated lobular carcinoma in situ or ductal carcinoma in situ, or history of localized breast cancer and receiving antihormonal agents and considered to have a very low risk of recurrence. 6) Malignancy that is considered cured with minimal risk of recurrence
  • Prior allogenic stem cell transplant <=6 months
  • Prior autologous stem cell transplant <=12 weeks
  • Live, attenuated vaccine within 4 weeks prior to the first dose of teclistamab

Trial locations and contacts

51 sites in 11 countries.

51 sites in 11 countries

United States10 sites

  • Winship Cancer Institute Emory University

    Atlanta, Georgia, 30322

  • University of Alabama at Birmingham

    Birmingham, Alabama, 35294

  • Levine Cancer Institute

    Charlotte, North Carolina, 28204

  • Barbara Ann Karmanos Cancer Institute

    Detroit, Michigan, 48201

  • City of Hope

    Duarte, California, 91010

  • Icahn School of Medicine at Mount Sinai Program for the Protection of Human Subjects

    New York, New York, 10029

  • Memorial Sloan-Kettering Cancer Center

    New York, New York, 10065

  • University of Pennsylvania

    Philadelphia, Pennsylvania, 19104

  • University of California San Francisco

    San Francisco, California, 94143

  • Stanford University Medical Center

    Stanford, California, 94305-5623

Other trials in United States

China8 sites

  • Peking University First Hospital

    Beijing, 100034

  • West China Hospital Si Chuan University

    Chengdu, 610041

  • Sun Yat -Sen University Cancer Center

    Guangzhou, 510060

  • First affiliated Hospital of Zhejiang University

    Hangzhou, 310003

  • Shanghai Changzheng Hospital

    Shanghai, 200003

  • Shengjing Hospital Of China Medical University

    Shenyang, 110134

  • Tianjin Medical University Cancer Institute and Hospital

    Tianjin, 30060

  • The Second Affiliated Hospital of Xi'an Jiaotong University

    Xi'an, 710004

Other trials in China

Spain7 sites

  • Hosp. Univ. Germans Trias I Pujol

    Badalona, 08916

  • Hosp Clinic de Barcelona

    Barcelona, 08036

  • Hosp. Univ. 12 de Octubre

    Madrid, 28041

  • 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

Other trials in Spain

France6 sites

  • Centre Hospitalier Régional Universitaire de Lille, Hôpital Claude Huriez

    Lille, 59000

  • Centre Hospitalier Lyon Sud

    Lyon, 69002

  • C.H.U. Hotel Dieu - France

    Nantes, 44093

  • CHU Poitiers - Hopital la Miletrie

    Poitiers, 86000

  • Pôle IUC Oncopole CHU

    Toulouse, 31059

  • CHRU Hôpital Bretonneau

    Tours, 37044

Other trials in France

Canada4 sites

  • Arthur J E Child Comprehensive Cancer Centre

    Calgary, Alberta, T2N 5G2

  • Cross Cancer Institute

    Edmonton, Alberta, T6G 1Z2

  • McGill University Health Centre

    Montreal, Quebec, H4A 3J1

  • University Health Network UHN Princess Margaret Cancer Centre

    Toronto, Ontario, M5G 2M9

Other trials in Canada

Germany4 sites

  • Universitaetsklinikum Heidelberg

    Heidelberg, 69120

  • Universitaetsklinikum Leipzig

    Leipzig, 04103

  • Universitaetsklinikum Tuebingen der Eberhard-Karls-Universitaet, Abteilung fuer Innere Medizin II,

    Tübingen, 72076

  • Universitatsklinikum Wurzburg

    Würzburg, 97080

Other trials in Germany

Italy3 sites

  • Azienda Ospedaliera Papa Giovanni XXIII

    Bergamo, 24127

  • Istituto di Ematologia Seràgnoli azienda ospedaliera univeristaria Policlinico S.Orsola-Malpighi

    Bologna, 40138

  • Fondazione IRCCS Istituto Nazionale dei Tumori

    Milan, 20133

Other trials in Italy

Sweden3 sites

  • Sahlgrenska University Hospital

    Gothenburg, 413 45

  • Skane University Hospital

    Lund, 221 85

  • Haematology Centre, R 51

    Stockholm, SE-141 86

Other trials in Sweden

United Kingdom3 sites

  • University College Hospital

    London, NW1 2PG

  • University Hospital Southampton

    Sothampton, SO16 6YD

  • Royal Marsden Hospital

    Sutton, SM2 5PT

Other trials in United Kingdom

Belgium2 sites

  • Universitair Ziekenhuis Gent - UZ GENT

    Ghent, 9000

  • Universitaire Ziekenhuizen Leuven

    Leuven, 3000

Other trials in Belgium

Netherlands1 site

  • VU Medisch Centrum

    Amsterdam, 1081 HV

Other trials in Netherlands

About this study

Official title: TECLIMMY1001-P3: A Phase 1/2, First-in-Human, Open-Label, Dose Escalation Study of Teclistamab, a Humanized BCMA x CD3 Bispecific Antibody, in Subjects With Relapsed or Refractory Multiple Myeloma

The purpose of this study is to evaluate the efficacy of teclistamab at the recommended Phase 2 dose (RP2D).

Being tested
Teclistamab
Medical subject headings
Hematologic Neoplasms

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 SC.

Study groups in NCT04557098
Study groupRoleWhat they receive
Part 3: TeclistamabExperimentalParticipants will receive teclistamab subcutaneously (SC) at recommended Phase 2 dose (RP2D) in Cohort A and Cohort C.
Receives: Drug: Teclistamab

What is being measured

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

  1. Cohorts A and C: Overall Response Rate (ORR)

    ORR is defined as the proportion of participants who have a partial response (PR) or better according to the International Myeloma Working Group (IMWG) criteria.

    Measured: Up to 2.9 years

Secondary outcomes (18)

  1. Cohorts A and C: Duration of Response (DOR)

    DOR 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, as defined in the IMWG criteria, or death due to PD, whichever occurs first.

    Measured: Up to 2.9 years

  2. Cohorts A and C: Very Good Partial Response (VGPR) or Better Rate

    VGPR or better rate is defined as the percentage of patients who achieve a VGPR or better according to IMWG response criteria.

    Measured: Up to 2.9 years

  3. Cohorts A and C: Cohorts A and C: Complete Response (CR) or Better Rate

    CR or better rate is defined as the percentage of patients who achieve a complete response (CR) or better according to IMWG response criteria.

    Measured: Up to 2.9 years

  4. Cohorts A and C: Stringent Complete Response (sCR) Rate

    sCR rate is defined as the percentage of patients who achieve a stringent complete response (sCR) according to IMWG response criteria.

    Measured: Up to 2.9 years

  5. Cohorts A and C: Time to Response (TTR)

    TTR is defined as the time between date of first dose of study drug and the first efficacy evaluation that the participant has met all criteria for PR or better.

    Measured: Up to 2.9 years

  6. Cohorts A and C: Progression-free Survival (PFS)

    PFS is defined as the time from the date of first dose of study drug to the date of first documented disease progression, as defined in the IMWG criteria, or death due to any cause, whichever occurs first.

    Measured: Up to 2.9 years

  7. Cohorts A and C: Overall Survival (OS)

    OS is defined as the time from the date of first dose of study drug to the date of the participant's death.

    Measured: Up to 2.9 years

  8. Cohorts A and C: Minimal Residual Disease (MRD) Negative Rate

    MRD-negative rate is defined as the proportion of participants who achieved MRD-negative status to a threshold of 10^-5 at any timepoint after initial dose of teclistamab and before disease progression or starting subsequent therapy

    Measured: Up to 2.9 years

  9. Cohorts A and C: Number of Participants with Adverse Events (AEs) as a Measure of Safety and Tolerability

    An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study.

    Measured: Up to 2.9 years

  10. Cohorts A and C: Number of Participants with Serious Adverse Events (SAEs) as a Measure of Safety and Tolerability

    An SAE is any AE that results in: death, persistent or significant disability/incapacity, requires inpatient hospitalization or prolongation of existing hospitalization, is life-threatening experience, is a congenital anomaly/birth defect and may jeopardize participant and/or may require medical or surgical intervention to prevent one of the outcomes listed above.

    Measured: Up to 2.9 years

  11. Cohorts A and C: Number of Participants with AEs by Severity

    Severity will be graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE). Severity scale ranges from Grade 1 (Mild) to Grade 5 (Death). Grade 1= Mild, Grade 2= Moderate, Grade 3= Severe, Grade 4= Life-threatening, and Grade 5= Death related to adverse event.

    Measured: Up to 2.9 years

  12. Cohorts A and C: Number of Participants with Laboratory Abnormalities in Clinical Laboratory Values

    Number of participants with laboratory abnormalities in clinical laboratory values (such as hemoglobin, platelets) will be reported.

    Measured: Up to 2.9 years

  13. Cohorts A and C: Serum Concentration of Teclistamab

    Serum concentrations of teclistamab will be reported.

    Measured: Up to 3 months

  14. Cohorts A and C: Number of Participants with Teclistamab Antibodies

    Antibodies to teclistamab will be assessed to evaluate potential immunogenicity.

    Measured: Up to 2.9 years

  15. Cohorts A and C: Change from Baseline in Health-Related Quality of Life (HRQoL) as Assessed by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core-30 item (EORTC QLQ-C30)

    The EORTC- QLQ-Core-30 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 recall period is 1 week ("past week"), and responses are reported using a verbal and numeric rating scales. The item and scale scores are transformed to a 0 to 100 scale. A higher score represents greater HRQoL, better functioning, and more (worse) symptoms.

    Measured: Baseline, up to 2.9 years

  16. Cohorts A and C: Change from Baseline in HRQoL as Assessed by EuroQol Five Dimension Five Level Questionnaire (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). The scores for the 5 separate questions are categorical and cannot be analyzed as cardinal numbers.

    Measured: Baseline, up to 2.9 years

  17. Cohorts A and C: Change from Baseline in HRQoL as Assessed by Patient Global Impression of Severity (PGIS)

    The PGIS is a single item that assesses severity of the participant's health state, on a 5-point verbal rating scale. Score ranges from 1 (None) to 5 (Very Severe).

    Measured: Baseline, up to 2.9 years

  18. Cohorts A and C: Overall Response Rate (ORR) in Participants with High-risk Molecular Features

    ORR in participants with high risk is defined as the overall response rate among the high-risk molecular subgroups (del17p, t(4;14), t(14;16), or other high-risk molecular subtypes).

    Measured: Up to 2.9 years

Timeline

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

  1. First posted21 Sep 2020
  2. Study start17 Sep 2020
  3. Primary completion9 Nov 2021
  4. Study completion28 May 2027 (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 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
194 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04557098
Sponsor's protocol ID
CR108859
Other IDs
TECLIMMY1001-P3, 2016-002122-36, 2023-503438-40-00, 2023, 2016
Acronym
MajesTEC-1
Status last verified
Jul 2026
First submitted
17 Sep 2020
Last updated
31 Jul 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: The data sharing policy of the Janssen Pharmaceutical Companies of Johnson \& Johnson is available at www.janssen.com/clinicaltrials/ 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

Publications

  • Cai Z, Xia Z, He A, Dong Y, Wang Y, Liao A, Song Y, Chen H, Zuppa A, Chastain K, Watkins L, Luo X, Huang L, Xu H, Zhou L, Chen W, Zhu A, Wang X, Du J, Niu T, Fu W. Efficacy and Safety of Teclistamab in Relapsed/Refractory Multiple Myeloma: 2-Year Follow-Up From MajesTEC-1 China Cohort. EJHaem. 2026 Jul 30;7(4):e70340. doi: 10.1002/jha2.70340. eCollection 2026 Aug.

    PubMed 42534634

  • Vishwamitra D, Skerget S, Cortes-Selva D, Perova T, Lau O, Davis C, Boominathan R, Patel J, Berge KVD, Guo Y, Miao X, Stephenson T, Hodin C, Uhlar C, Pei L, Trancucci D, Zuppa AF, Chastain K, Banerjee A, Kobos R, Bahlis NJ, Van de Donk NWCJ, Verona RI. Longitudinal mechanisms of response, resistance and relapse to teclistamab in multiple myeloma: results from MajesTEC-1. Haematologica. 2026 Jun 11. doi: 10.3324/haematol.2026.300526. Online ahead of print.

    PubMed 42273947

  • Carde NAQ, Niu J, Guo Y, Zhou J, Qiu X, Su Y, Perez-Ruixo C, Vishwamitra D, Hodin C, Stephenson T, Zuppa A, Chastain K, Kobos R, Samtani MN, Wang W, Haddish-Berhane N, Van de Donk NWCJ, Garfall AL, Matous JV. Revised Recommendations for Restarting Teclistamab Following Dose Delays: Insights from the MajesTEC-1 Study on Clinical Safety, and from Simulated Pharmacokinetics and Cytokine Dynamics. Target Oncol. 2026 May;21(3):373-383. doi: 10.1007/s11523-026-01205-4. Epub 2026 Mar 26.

    PubMed 41886220

  • Martin TG, van de Donk NWCJ, Rodriguez-Otero P, Mateos MV, Kobos R, Chastain K, Doyle M, Nooka AK. Plain language summary of the management of certain side effects of teclistamab in people with multiple myeloma. Future Oncol. 2026 Feb;22(3):285-297. doi: 10.1080/14796694.2025.2597732. Epub 2026 Jan 23.

    PubMed 41574880

  • Martin TG, Mateos MV, Yi JH, van de Donk NWCJ, Cai Z, Fu W, Garfall AL, Iida S, Jung SH, Kuroda Y, Niu T, Nooka AK, Min CK, Sidana S, Chastain K, Doyle M, Nishikawa K, Wang X, Song Y, Yamazaki H, Izumi Y, Zhuo J, Zhu A, Yoon DH, Du J, Ishida T. Efficacy and safety of teclistamab in triple-class exposed relapsed/refractory multiple myeloma: Pooled findings from three clinical cohorts and a retrospective cohort. Cancer. 2026 Jan 1;132(1):e70237. doi: 10.1002/cncr.70237.

    PubMed 41485109

  • Gordan LN, Bensimon AG, Mu F, Kim N, Wu B, Lin D, Paner A, Fowler J, Marshall A, Van Sanden S, Ammann E, Goble J, Zhang X, Le HH, Min EE, Garrison LP Jr. Cost per responder for teclistamab and elranatamab in relapsed or refractory multiple myeloma in the United States. J Med Econ. 2025 Dec;28(1):910-920. doi: 10.1080/13696998.2025.2514909. Epub 2025 Jun 14.

    PubMed 40495704

  • Guo Y, Niu J, Carde NAQ, Wu L, Miao X, Hanson S, Su Y, Ruixo CP, Vishwamitra D, Chastain K, Samtani MN, Wang W, Haddish-Berhane N. Teclistamab Dosing in Responders: Modeling and Simulation Results from the MajesTEC-1 Study in Relapsed/Refractory Multiple Myeloma. Target Oncol. 2025 Jul;20(4):651-661. doi: 10.1007/s11523-025-01149-1. Epub 2025 May 7.

    PubMed 40332715

  • Touzeau C, Krishnan AY, Moreau P, Perrot A, Usmani SZ, Manier S, Cavo M, Martinez Chamorro C, Nooka AK, Martin TG, Karlin L, Leleu X, Bahlis NJ, Besemer B, Pei L, Stein S, Wang Lin SX, Trancucci D, Verona RI, Girgis S, Miao X, Uhlar CM, Chastain K, Garfall AL. Efficacy and safety of teclistamab in patients with relapsed/refractory multiple myeloma after BCMA-targeting therapies. Blood. 2024 Dec 5;144(23):2375-2388. doi: 10.1182/blood.2023023616.

    PubMed 39172760

  • Cortes-Selva D, Perova T, Skerget S, Vishwamitra D, Stein S, Boominathan R, Lau O, Calara-Nielsen K, Davis C, Patel J, Banerjee A, Stephenson T, Uhlar C, Kobos R, Goldberg J, Pei L, Trancucci D, Girgis S, Wang Lin SX, Wu LS, Moreau P, Usmani SZ, Bahlis NJ, van de Donk NWCJ, Verona RI. Correlation of immune fitness with response to teclistamab in relapsed/refractory multiple myeloma in the MajesTEC-1 study. Blood. 2024 Aug 8;144(6):615-628. doi: 10.1182/blood.2023022823.

    PubMed 38657201

  • Moreau P, Mateos MV, Gonzalez Garcia ME, Einsele H, De Stefano V, Karlin L, Lindsey-Hill J, Besemer B, Vincent L, Kirkpatrick S, Delforge M, Perrot A, van de Donk NWCJ, Pawlyn C, Manier S, Leleu X, Martinez-Lopez J, Ghilotti F, Diels J, Morano R, Albrecht C, Strulev V, Haddad I, Pei L, Kobos R, Smit J, Slavcev M, Marshall A, Weisel K. Comparative Effectiveness of Teclistamab Versus Real-World Physician's Choice of Therapy in LocoMMotion and MoMMent in Triple-Class Exposed Relapsed/Refractory Multiple Myeloma. Adv Ther. 2024 Feb;41(2):696-715. doi: 10.1007/s12325-023-02738-0. Epub 2023 Dec 19.

    PubMed 38110653

  • Martin TG, Moreau P, Usmani SZ, Garfall A, Mateos MV, San-Miguel JF, Oriol A, Nooka AK, Rosinol L, Chari A, Karlin L, Krishnan A, Bahlis N, Popat R, Besemer B, Martinez-Lopez J, Delforge M, Trancucci D, Pei L, Kobos R, Fastenau J, Gries KS, van de Donk NWCJ. Teclistamab Improves Patient-Reported Symptoms and Health-Related Quality of Life in Relapsed or Refractory Multiple Myeloma: Results From the Phase II MajesTEC-1 Study. Clin Lymphoma Myeloma Leuk. 2024 Mar;24(3):194-202. doi: 10.1016/j.clml.2023.11.001. Epub 2023 Nov 14.

    PubMed 38052709

  • Frerichs KA, Verkleij CPM, Mateos MV, Martin TG, Rodriguez C, Nooka A, Banerjee A, Chastain K, Perales-Puchalt A, Stephenson T, Uhlar C, Kobos R, van der Holt B, Kruyswijk S, Kuipers MT, Groen K, Vishwamitra D, Skerget S, Cortes-Selva D, Doyle M, Zaaijer HL, Zweegman S, Verona RI, van de Donk NWCJ. Teclistamab impairs humoral immunity in patients with heavily pretreated myeloma: importance of immunoglobulin supplementation. Blood Adv. 2024 Jan 9;8(1):194-206. doi: 10.1182/bloodadvances.2023011658.

    PubMed 38052042

  • Nooka AK, Rodriguez C, Mateos MV, Manier S, Chastain K, Banerjee A, Kobos R, Qi K, Verona R, Doyle M, Martin TG, van de Donk NWCJ. Incidence, timing, and management of infections in patients receiving teclistamab for the treatment of relapsed/refractory multiple myeloma in the MajesTEC-1 study. Cancer. 2024 Mar 15;130(6):886-900. doi: 10.1002/cncr.35107. Epub 2023 Nov 14.

    PubMed 37960969

  • Miao X, Wu LS, Lin SXW, Xu Y, Chen Y, Iwaki Y, Kobos R, Stephenson T, Kemmerer K, Uhlar CM, Banerjee A, Goldberg JD, Trancucci D, Apte A, Verona R, Pei L, Desai R, Hickey K, Su Y, Ouellet D, Samtani MN, Guo Y, Garfall AL, Krishnan A, Usmani SZ, Zhou H, Girgis S. Population Pharmacokinetics and Exposure-Response with Teclistamab in Patients With Relapsed/Refractory Multiple Myeloma: Results From MajesTEC-1. Target Oncol. 2023 Sep;18(5):667-684. doi: 10.1007/s11523-023-00989-z. Epub 2023 Sep 15.

    PubMed 37713090

  • Moreau P, van de Donk NW, Nahi H, Oriol A, Nooka AK, Martin T, Rosinol L, Karlin L, Benboubker L, Mateos MV, Popat R, Martinez-Lopez J, Sidana S, Delforge M, Pei L, Trancucci D, Olyslager Y, Uhlar C, Stephenson T, Rampelbergh RV, Banerjee A, Kobos R, Usmani SZ. Plain language summary of the MajesTEC-1 study of teclistamab for the treatment of people with relapsed or refractory multiple myeloma. Future Oncol. 2023 Apr;19(12):811-818. doi: 10.2217/fon-2023-0171. Epub 2023 May 3.

    PubMed 37132225

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Teclistamab in people with Hematological Malignancies, run by Janssen Research & Development, LLC at 51 sites in 11 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 11 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 31 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 51 sites in United States, China, Spain, France, Canada and 6 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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?

Cohorts A and C: Overall Response Rate (ORR) (time frame: Up to 2.9 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 NCT04557098, which also lists 18 linked publications.

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 31 Jul 2026.

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