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

NCT04557098 | Active Not Recruiting Phase 2 FDA Drug

• 4 other identifiers: CR108859TECLIMMY1001-P32016-002122-362023-503438-40-00
• Study Type: interventional
• Target: 194
• Locations: 11 countries
• Sites: 51

Brief Summary

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

Conditions

Hematological Malignancies

Outcome Measures

Primary Outcomes (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.

  Up to 2.9 years

Secondary Outcomes (18)

• Cohorts A and C: Duration of Response (DOR)

  Up to 2.9 years

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

  Up to 2.9 years

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

  Up to 2.9 years

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

  Up to 2.9 years

• Cohorts A and C: Time to Response (TTR)

  Up to 2.9 years

Study Arms (1)

Part 3: Teclistamab

EXPERIMENTAL

Participants will receive teclistamab subcutaneously (SC) at recommended Phase 2 dose (RP2D) in Cohort A and Cohort C.

Drug: Teclistamab

Interventions

Teclistamab DRUG

Teclistamab will be administered SC.

Also known as: JNJ-64007957

Part 3: Teclistamab

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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)
• 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

Sponsors & Collaborators

• Janssen Research & Development, LLC: lead

Study Sites (51)

University of Alabama at Birmingham

Birmingham, Alabama, 35294, United States

Location

City of Hope

Duarte, California, 91010, United States

Location

University of California San Francisco

San Francisco, California, 94143, United States

Location

Stanford University Medical Center

Stanford, California, 94305-5623, United States

Location

Winship Cancer Institute Emory University

Atlanta, Georgia, 30322, United States

Location

Barbara Ann Karmanos Cancer Institute

Detroit, Michigan, 48201, United States

Location

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

New York, New York, 10029, United States

Location

Memorial Sloan-Kettering Cancer Center

New York, New York, 10065, United States

Location

Levine Cancer Institute

Charlotte, North Carolina, 28204, United States

Location

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

Universitair Ziekenhuis Gent - UZ GENT

Ghent, 9000, Belgium

Location

Universitaire Ziekenhuizen Leuven

Leuven, 3000, Belgium

Location

Arthur J E Child Comprehensive Cancer Centre

Calgary, Alberta, T2N 5G2, Canada

Location

Cross Cancer Institute

Edmonton, Alberta, T6G 1Z2, Canada

Location

University Health Network UHN Princess Margaret Cancer Centre

Toronto, Ontario, M5G 2M9, Canada

Location

McGill University Health Centre

Montreal, Quebec, H4A 3J1, Canada

Location

Peking University First Hospital

Beijing, 100034, China

Location

West China Hospital Si Chuan University

Chengdu, 610041, China

Location

Sun Yat -Sen University Cancer Center

Guangzhou, 510060, China

Location

First affiliated Hospital of Zhejiang University

Hangzhou, 310003, China

Location

Shanghai Changzheng Hospital

Shanghai, 200003, China

Location

Shengjing Hospital Of China Medical University

Shenyang, 110134, China

Location

Tianjin Medical University Cancer Institute and Hospital

Tianjin, 30060, China

Location

The Second Affiliated Hospital of Xi'an Jiaotong University

Xi'an, 710004, China

Location

Centre Hospitalier Régional Universitaire de Lille, Hôpital Claude Huriez

Lille, 59000, France

Location

Centre Hospitalier Lyon Sud

Lyon, 69002, France

Location

C.H.U. Hotel Dieu - France

Nantes, 44093, France

Location

CHU Poitiers - Hopital la Miletrie

Poitiers, 86000, France

Location

Pôle IUC Oncopole CHU

Toulouse, 31059, France

Location

CHRU Hôpital Bretonneau

Tours, 37044, France

Location

Universitaetsklinikum Heidelberg

Heidelberg, 69120, Germany

Location

Universitaetsklinikum Leipzig

Leipzig, 04103, Germany

Location

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

Tübingen, 72076, Germany

Location

Universitatsklinikum Wurzburg

Würzburg, 97080, Germany

Location

Azienda Ospedaliera Papa Giovanni XXIII

Bergamo, 24127, Italy

Location

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

Bologna, 40138, Italy

Location

Fondazione IRCCS Istituto Nazionale dei Tumori

Milan, 20133, Italy

Location

VU Medisch Centrum

Amsterdam, 1081 HV, Netherlands

Location

Hosp. Univ. Germans Trias I Pujol

Badalona, 08916, Spain

Location

Hosp Clinic de Barcelona

Barcelona, 08036, Spain

Location

Hosp. Univ. 12 de Octubre

Madrid, 28041, Spain

Location

Clinica Univ. de Navarra

Pamplona, 31008, Spain

Location

Hosp. Quiron Madrid Pozuelo

Pozuelo de Alarcón, 28223, Spain

Location

Hosp Clinico Univ de Salamanca

Salamanca, 37007, Spain

Location

Hosp. Univ. Marques de Valdecilla

Santander, 39008, Spain

Location

Sahlgrenska University Hospital

Gothenburg, 413 45, Sweden

Location

Skane University Hospital

Lund, 221 85, Sweden

Location

Haematology Centre, R 51

Stockholm, SE-141 86, Sweden

Location

University College Hospital

London, NW1 2PG, United Kingdom

Location

University Hospital Southampton

Sothampton, SO16 6YD, United Kingdom

Location

Royal Marsden Hospital

Sutton, SM2 5PT, United Kingdom

Location

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• 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 Mar 26. doi: 10.1007/s11523-026-01205-4. Online ahead of print.

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• 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.

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• 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.

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• 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.

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• 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.

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• 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.

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• 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.

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• 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.

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• 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.

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• 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.

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• 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.

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• 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.

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• Martin TG, Mateos MV, Nooka A, Banerjee A, Kobos R, Pei L, Qi M, Verona R, Doyle M, Smit J, Sun W, Trancucci D, Uhlar C, van de Donk NWCJ, Rodriguez C. Detailed overview of incidence and management of cytokine release syndrome observed with teclistamab in the MajesTEC-1 study of patients with relapsed/refractory multiple myeloma. Cancer. 2023 Jul 1;129(13):2035-2046. doi: 10.1002/cncr.34756. Epub 2023 Mar 29.

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• Moreau P, Garfall AL, van de Donk NWCJ, Nahi H, San-Miguel JF, Oriol A, Nooka AK, Martin T, Rosinol L, Chari A, Karlin L, Benboubker L, Mateos MV, Bahlis N, Popat R, Besemer B, Martinez-Lopez J, Sidana S, Delforge M, Pei L, Trancucci D, Verona R, Girgis S, Lin SXW, Olyslager Y, Jaffe M, Uhlar C, Stephenson T, Van Rampelbergh R, Banerjee A, Goldberg JD, Kobos R, Krishnan A, Usmani SZ. Teclistamab in Relapsed or Refractory Multiple Myeloma. N Engl J Med. 2022 Aug 11;387(6):495-505. doi: 10.1056/NEJMoa2203478. Epub 2022 Jun 5.

  PMID: 35661166 DERIVED

Related Links

• Dose Escalation Study of JNJ-64007957, a Humanized BCMA CD3 DuoBody® Antibody, in Participants With Relapsed or Refractory Multiple Myeloma

MeSH Terms

Conditions

Hematologic Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases

Study Officials

• Janssen Research & Development, LLC Clinical Trial

  Janssen Research & Development, LLC

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 17, 2020
• First Posted: September 21, 2020
• Study Start: September 17, 2020
• Primary Completion: November 9, 2021
• Study Completion (Estimated): May 28, 2027
• Last Updated: April 13, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share

Locations

CA (4); DE (4); FR (6); NL (1); ES (7); SE (3); GB (3); US (10); CN (8); BE (2); IT (3)