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| ID | Type | Description | Link |
|---|---|---|---|
| TECLIMMY1001-P3 | Other Identifier | Janssen Research & Development, LLC | |
| 2016-002122-36 | EudraCT Number | ||
| 2023-503438-40-00 | Registry Identifier | EUCT number |
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The purpose of this study is to evaluate the efficacy of teclistamab at the recommended Phase 2 dose (RP2D).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Part 3: Teclistamab | Experimental | Participants will receive teclistamab subcutaneously (SC) at recommended Phase 2 dose (RP2D) in Cohort A and Cohort C. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Teclistamab | Drug | Teclistamab will be administered SC. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Up to 2.9 years |
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Inclusion Criteria: -
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Janssen Research & Development, LLC Clinical Trial | Janssen Research & Development, LLC | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Alabama at Birmingham | Birmingham | Alabama | 35294 | United States | ||
| City of Hope |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 42273947 | Derived | 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. | |
| 41886220 |
| Label | URL |
|---|---|
| Dose Escalation Study of JNJ-64007957, a Humanized BCMA CD3 DuoBody® Antibody, in Participants With Relapsed or Refractory Multiple Myeloma | View source |
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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
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| 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. |
| Up to 2.9 years |
| 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. | Up to 2.9 years |
| 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. | Up to 2.9 years |
| 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. | Up to 2.9 years |
| 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. | Up to 2.9 years |
| 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. | Up to 2.9 years |
| 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 | Up to 2.9 years |
| 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. | Up to 2.9 years |
| 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. | Up to 2.9 years |
| 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. | Up to 2.9 years |
| 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. | Up to 2.9 years |
| Cohorts A and C: Serum Concentration of Teclistamab | Serum concentrations of teclistamab will be reported. | Up to 3 months |
| Cohorts A and C: Number of Participants with Teclistamab Antibodies | Antibodies to teclistamab will be assessed to evaluate potential immunogenicity. | Up to 2.9 years |
| 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. | Baseline, up to 2.9 years |
| 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. | Baseline, up to 2.9 years |
| 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). | Baseline, up to 2.9 years |
| 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). | Up to 2.9 years |
| Duarte |
| California |
| 91010 |
| United States |
| University of California San Francisco | San Francisco | California | 94143 | United States |
| Stanford University Medical Center | Stanford | California | 94305-5623 | United States |
| Winship Cancer Institute Emory University | Atlanta | Georgia | 30322 | United States |
| Barbara Ann Karmanos Cancer Institute | Detroit | Michigan | 48201 | United States |
| Icahn School of Medicine at Mount Sinai Program for the Protection of Human Subjects | New York | New York | 10029 | United States |
| Memorial Sloan-Kettering Cancer Center | New York | New York | 10065 | United States |
| Levine Cancer Institute | Charlotte | North Carolina | 28204 | United States |
| University of Pennsylvania | Philadelphia | Pennsylvania | 19104 | United States |
| Universitair Ziekenhuis Gent - UZ GENT | Ghent | 9000 | Belgium |
| Universitaire Ziekenhuizen Leuven | Leuven | 3000 | Belgium |
| Arthur J E Child Comprehensive Cancer Centre | Calgary | Alberta | T2N 5G2 | Canada |
| Cross Cancer Institute | Edmonton | Alberta | T6G 1Z2 | Canada |
| University Health Network UHN Princess Margaret Cancer Centre | Toronto | Ontario | M5G 2M9 | Canada |
| McGill University Health Centre | Montreal | Quebec | H4A 3J1 | Canada |
| Peking University First Hospital | Beijing | 100034 | China |
| West China Hospital Si Chuan University | Chengdu | 610041 | China |
| Sun Yat -Sen University Cancer Center | Guangzhou | 510060 | China |
| First affiliated Hospital of Zhejiang University | Hangzhou | 310003 | China |
| Shanghai Changzheng Hospital | Shanghai | 200003 | China |
| Shengjing Hospital Of China Medical University | Shenyang | 110134 | China |
| Tianjin Medical University Cancer Institute and Hospital | Tianjin | 30060 | China |
| The Second Affiliated Hospital of Xi'an Jiaotong University | Xi'an | 710004 | China |
| Centre Hospitalier Régional Universitaire de Lille, Hôpital Claude Huriez | Lille | 59000 | France |
| Centre Hospitalier Lyon Sud | Lyon | 69002 | France |
| C.H.U. Hotel Dieu - France | Nantes | 44093 | France |
| CHU Poitiers - Hopital la Miletrie | Poitiers | 86000 | France |
| Pôle IUC Oncopole CHU | Toulouse | 31059 | France |
| CHRU Hôpital Bretonneau | Tours | 37044 | France |
| Universitaetsklinikum Heidelberg | Heidelberg | 69120 | Germany |
| Universitaetsklinikum Leipzig | Leipzig | 04103 | Germany |
| Universitaetsklinikum Tuebingen der Eberhard-Karls-Universitaet, Abteilung fuer Innere Medizin II, | Tübingen | 72076 | Germany |
| Universitatsklinikum Wurzburg | Würzburg | 97080 | Germany |
| Azienda Ospedaliera Papa Giovanni XXIII | Bergamo | 24127 | Italy |
| Istituto di Ematologia Serà gnoli azienda ospedaliera univeristaria Policlinico S.Orsola-Malpighi | Bologna | 40138 | Italy |
| Fondazione IRCCS Istituto Nazionale dei Tumori | Milan | 20133 | Italy |
| VU Medisch Centrum | Amsterdam | 1081 HV | Netherlands |
| Hosp. Univ. Germans Trias I Pujol | Badalona | 08916 | Spain |
| Hosp Clinic de Barcelona | Barcelona | 08036 | Spain |
| Hosp. Univ. 12 de Octubre | Madrid | 28041 | Spain |
| Clinica Univ. de Navarra | Pamplona | 31008 | Spain |
| Hosp. Quiron Madrid Pozuelo | Pozuelo de Alarcón | 28223 | Spain |
| Hosp Clinico Univ de Salamanca | Salamanca | 37007 | Spain |
| Hosp. Univ. Marques de Valdecilla | Santander | 39008 | Spain |
| Sahlgrenska University Hospital | Gothenburg | 413 45 | Sweden |
| Skane University Hospital | Lund | 221 85 | Sweden |
| Haematology Centre, R 51 | Stockholm | SE-141 86 | Sweden |
| University College Hospital | London | NW1 2PG | United Kingdom |
| University Hospital Southampton | Sothampton | SO16 6YD | United Kingdom |
| Royal Marsden Hospital | Sutton | SM2 5PT | United Kingdom |
| Derived |
| 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. |
| 41574880 | Derived | 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. |
| 41485109 | Derived | 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. |
| 40495704 | Derived | 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. |
| 40332715 | Derived | 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. |
| 39172760 | Derived | 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. |
| 38657201 | Derived | 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. |
| 38110653 | Derived | 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. |
| 38052709 | Derived | 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. |
| 38052042 | Derived | 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. |
| 37960969 | Derived | 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. |
| 37713090 | Derived | 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. |
| 37132225 | Derived | 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. |
| 36991547 | Derived | 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. |
| 36961654 | Derived | Moreau P, van de Donk NWCJ, Delforge M, Einsele H, De Stefano V, Perrot A, Besemer B, Pawlyn C, Karlin L, Manier S, Leleu X, Weisel K, Ghilotti F, Diels J, Elsada A, Morano R, Strulev V, Pei L, Kobos R, Smit J, Slavcev M, Mateos MV. Comparative Efficacy of Teclistamab Versus Current Treatments in Real-World Clinical Practice in the Prospective LocoMMotion Study in Patients with Triple-Class-Exposed Relapsed and/or Refractory Multiple Myeloma. Adv Ther. 2023 May;40(5):2412-2425. doi: 10.1007/s12325-023-02480-7. Epub 2023 Mar 24. |
| 35661166 | Derived | 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. |
| ID | Term |
|---|---|
| D019337 | Hematologic Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
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