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

Официальное название

A Phase 1/2, First-in-Human, Open-Label, Dose Escalation Study of Talquetamab, a Humanized GPRC5D x CD3 Bispecific Antibody, in Subjects With Relapsed or Refractory Multiple Myeloma

Обзор

The purpose of this study is to evaluate the efficacy and safety of talquetamab in participants with relapsed or refractory multiple myeloma at the recommended Phase 2 dose(s) (RP2Ds) (Part 3).

Вмешательства

• Препарат Talquetamab
  Talquetamab will be administered SC until disease progression.

Первичные конечные точки

• Overall Response Rate (ORR) [Срок оценки: Up to 2 years and 10 months]

Вторичные конечные точки (12)

• Duration of Response (DOR) [Срок оценки: Up to 2 years and 10 months]
• Very Good Partial Response (VGPR) or Better Rate [Срок оценки: Up to 2 years and 10 months]
• Complete Response (CR) or Better Rate [Срок оценки: Up to 2 years and 10 months]
• Stringent Complete Response (sCR) Rate [Срок оценки: Up to 2 years and 10 months]
• Time to Response (TTR) [Срок оценки: Up to 2 years and 10 months]
• Progression-Free Survival (PFS) [Срок оценки: Up to 2 years and 10 months]
• Overall Survival (OS) [Срок оценки: Up to 2 years and 10 months]
• Minimal Residual Disease (MRD) Negative Rate [Срок оценки: Up to 2 years and 10 months]
• Number of Participants with Adverse Events (AEs) as a Measure of Safety and Tolerability [Срок оценки: Up to 2 years and 10 months]
• Number of Participants with Serious Adverse Events (SAEs) as a Measure of Safety and Tolerability [Срок оценки: Up to 2 years and 10 months]
• Number of Participants with AEs by Severity [Срок оценки: Up to 2 years and 10 months]
• Number of Participants with Abnormalities in Clinical Laboratory Values [Срок оценки: Up to 2 years and 10 months]

Критерии участия

Критерии включения

• Documented initial diagnosis of multiple myeloma according to international myeloma working group (IMWG) diagnostic criteria
• Part 3: Measurable disease cohort A, cohort B, cohort C and cohort D: multiple myeloma must be measurable by central laboratory assessment; Cohort E: Multiple myeloma must be measurable by local laboratory assessment
• Eastern Cooperative Oncology Group (ECOG) performance status score of 0 to 2
• Women of childbearing potential must have a negative pregnancy test at screening and prior to the first dose of study drug using a highly sensitive pregnancy test either serum (beta human chorionic gonadotropin \[hCG\]) or urine
• Willing and able to adhere to the prohibitions and restrictions specified in this protocol

Критерии исключения

• Part 3 only: Cohort A and Cohort C only: exposed to a CAR-T or T cell redirection therapy at any time. Cohort B, Cohort D and Cohort E: T cell redirection therapy within 3 months
• Toxicities from previous anticancer therapies should have resolved to baseline levels or to Grade 1 or less except for alopecia or peripheral neuropathy
• Received a cumulative dose of corticosteroids equivalent to >= 140 milligram (mg) of prednisone within the 14-day period before the first dose of study drug (does not include pretreatment medication)
• Stroke or seizure within 6 months prior to signing the informed consent form (ICF)

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Нерандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

США · 14 центров

• University of Alabama Birmingham — Birmingham
• University of Arkansas for Medical Sciences — Little Rock
• City of Hope — Duarte
• Memorial Healthcare System — Hollywood
• Emory University Winship Cancer Institute — Atlanta
• University of Chicago — Chicago
• Norton Cancer Institute — Louisville
• University of Michigan Health System — Ann Arbor
• … и ещё 6 центров

Япония · 13 центров

• Kameda Medical Center — Chiba
• Fukuoka University Hospital — Fukuoka
• Ogaki Municipal Hospital — Gifu
• Teine Keijinkai Hospital — Hokkaido
• Kobe City Medical Center General Hospital — Kobe
• Dokkyo Medical University Saitama Medical Center — Koshigaya
• Kumamoto University Hospital — Kumamoto
• Kurashiki Central Hospital — Kurashiki
• … и ещё 5 центров

Испания · 11 центров

• Hosp. Univ. Germans Trias I Pujol — Badalona
• Hosp Univ Vall D Hebron — Barcelona
• Inst. Cat. Doncologia-H Duran I Reynals — Barcelona
• Hosp Univ Fund Jimenez Diaz — Madrid
• Hosp. Univ. 12 de Octubre — Madrid
• Hosp. Univ. Virgen de La Arrixaca — Murcia
• Clinica Univ. de Navarra — Pamplona
• Hosp. Quiron Madrid Pozuelo — Pozuelo de Alarcón
• … и ещё 3 центра

Китай · 8 центров

• Peking University Third Hospital — Пекин
• Sun Yat Sen University Cancer Center — Гуанчжоу
• The 1st Affiliated Hospital Of Medical College Zhejiang University 1 — Ханчжоу
• The 1St Affiliated Hospital of Medical College Zhejiang University — Ханчжоу
• First Affiliated Hospital SooChow University — Сучжоу
• Institute of Hematology & Blood Disease Hospital Chinese Academy of Medical Science — Тяньцзинь
• The Second Affiliated Hospital of Xi'an Jiaotong University — Сиань
• The First Affiliated Hospital of Xian Jiaotong University — Сиань

Франция · 6 центров

• CHU Henri Mondor — Créteil
• Hospices Civils de Lyon HCL — Lyon
• CHU de Montpellier Hopital Saint Eloi — Montpellier
• C.H.U. Hotel Dieu - France — Nantes
• CHU de Bordeaux - Hospital Haut-Leveque — Pessac
• Pôle IUC Oncopole CHU — Toulouse

South Korea · 6 центров

• Chonnam National University Hwasun Hospital — Jeollanam-do
• Seoul National University Hospital — Seoul
• Severance Hospital Yonsei University Health System — Seoul
• Asan Medical Center — Seoul
• Samsung Medical Center — Seoul
• The Catholic University of Korea Seoul St Marys Hospital — Seoul

Израиль · 5 центров

• Rambam Medical Center — Haifa
• Carmel Medical Center — Haifa
• Hadassah Medical Center — Jerusalem
• Sheba Medical Center — Ramat Gan
• Tel Aviv Sourasky Medical Center — Tel Aviv

Польша · 5 центров

• Uniwersyteckie Centrum Kliniczne — Gdansk
• Narodowy Instytut Onkologii im Marii Sklodowskiej Curie Panstwowy Instytut BadawczyOddz w — Gliwice
• Uniwersytecki Szpital Kliniczny w Poznaniu — Poznan
• Narodowy Instytut Onkologii im Marii Sklodowskiej Curie Panstwowy Instytut Badawczy — Warsaw
• Uniwersytecki Szpital Kliniczny im Jana Mikulicza Radeckiego we Wroclawiu — Wroclaw

Бельгия · 4 центра

• UZ Antwerpen — Edegem
• UZ Leuven — Leuven
• CHU de Liège - Domaine Universitaire du Sart Tilman — Liège
• UCL - Saint Luc — Woluwe-Saint-Lambert

Германия · 4 центра

• Charite Campus Benjamin Franklin — Berlin
• Universitaetsklinikum Heidelberg — Heidelberg
• Universitaetsklinikum Muenster — Münster
• Universitatsklinikum Wurzburg — Würzburg

Нидерланды · 2 центра

• VU Medisch Centrum — Amsterdam
• UMCU — Utrecht

Публикации

• Schinke C, Touzeau C, Oriol A, Mateos MV, Stevens D, Rasche L, Moreau P, San-Miguel J, Rodriguez-Otero P, Kato K, Bathija S, Katz EG, Masterson T, Tomlinson C, Chari A. A plain language summary describing how talquetamab affects the way people with multiple myeloma feel and function in the MonumenTAL-1 study. Future Oncol. 2026 Jun;22(14):1651-1668. doi: 10.1080/14796694.2026.2669331. Epub 2026 Ju PMID 42299486
• Ito S, Kuroda Y, Sunami K, Matsue K, Imada K, Tamura H, Fujikawa E, Yamazaki H, Takamoto M, Pei L, Qin X, Masterson TJ, Campagna M, Vreys V, Lau BW, Takamatsu Y. Talquetamab in Japanese patients with relapsed/refractory multiple myeloma in the MonumenTAL-1 study. Int J Hematol. 2026 Apr;123(4):580-592. doi: 10.1007/s12185-025-04134-6. Epub 2025 Dec 17. PMID 41405810
• Einsele H, Moreau P, Bahlis N, Bhutani M, Vincent L, Karlin L, Perrot A, Goldschmidt H, van de Donk NWCJ, Ocio EM, Martinez Lopez J, Rodriguez-Otero P, Dytfeld D, Jakubowiak A, Schinke C, Besemer B, Anguille S, Manier S, Rasche L, Teipel R, Scheid C, Pawlyn C, Cavo M, Diels J, Ghilotti F, Lau BW, Renaud T, Orel O, Ong F, Ramos DF, Ammann E, Parekh T, Albrecht C, Weisel K, Mateos MV. Comparative Ef PMID 41313549
• van de Donk NWCJ, Chari A, Martin T, Krishnan A, Rasche L, Ye JC, Popat R, Lipe B, Rodriguez C, Schinke C, Skerget S, Vishwamitra D, Verona R, Gong J, Singh I, Campagna M, Masterson T, Hilder B, Tolbert J, Renaud T, Smit MD, Heuck C, Mateos MV. Characterization and Management of Cytokine Release Syndrome From the MonumenTAL-1 Study of Talquetamab in Patients With Relapsed/Refractory Multiple Myelo PMID 41036677
• Schinke C, Rodriguez-Otero P, van de Donk NWCJ, Lipe B, Lavi N, Rasche L, Parekh S, Van Oekelen O, Vishwamitra D, Skerget S, Cortes-Selva D, Verona R, Hilder B, Masterson T, Campagna M, Khedkar S, Renaud T, Tolbert J, Kane C, Gray KS, Saber I, Heuck C, Chari A. Infections and parameters of humoral immunity with talquetamab in relapsed/refractory multiple myeloma in MonumenTAL-1. Blood Adv. 2025 No PMID 40864183
• Schinke C, Touzeau C, Oriol A, Mateos MV, Stevens D, Rasche L, Qin X, Kato K, Bathija S, Katz EG, Gries KS, Campagna M, Masterson T, Hilder BW, Tolbert J, Renaud T, Heuck C, Tomlinson C, Moreau P, San-Miguel J, Rodriguez-Otero P, Chari A. Talquetamab improves patient-reported symptoms and health-related quality of life in relapsed or refractory multiple myeloma: Results from the phase 1/2 MonumenT PMID 40631904
• Chari A, Touzeau C, Schinke C, Minnema MC, Berdeja JG, Oriol A, van de Donk NWCJ, Rodriguez-Otero P, Morillo D, Martinez-Chamorro C, Mateos MV, Costa LJ, Caers J, Rasche L, Krishnan A, Ye JC, Karlin L, Lipe B, Vishwamitra D, Skerget S, Verona R, Ma X, Qin X, Ludlage H, Campagna M, Masterson T, Hilder B, Tolbert J, Renaud T, Goldberg JD, Kane C, Heuck C, San-Miguel J, Moreau P. Safety and activity PMID 40090350
• Catamero D, Ray C, Purcell K, Leahey S, Esler E, Rogers S, Hefner K, O'Rourke L, Gray K, Tolbert J, Renaud T, Patel S, Hannemann L, Shenoy S. Nursing Considerations for the Clinical Management of Adverse Events Associated with Talquetamab in Patients with Relapsed or Refractory Multiple Myeloma. Semin Oncol Nurs. 2024 Oct;40(5):151712. doi: 10.1016/j.soncn.2024.151712. Epub 2024 Aug 17. PMID 39155155

Идентификаторы

NCT: NCT04634552 · CR108920 · TALMMY1001-PT3 · 2017-002400-26 · 2023-504581-29-00

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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