A Study to Evaluate Preventive Treatments for GPRC5D-related Oral Events

Официальное название

A Phase 2, Open-label, Randomized Study to Evaluate GPRC5D-related Oral Events

Обзор

The purpose of this study is to identify preventive treatments that can minimize the occurrence, severity, and duration of talquetamab-related taste changes (dysgeusia), during the prophylaxis (preventive) treatment phase, to better characterize the signs or symptoms of talquetamab-related taste changes and to better characterize the signs or symptoms of ramantamig-related taste changes.

Вмешательства

• Препарат Talquetamab
  Talquetamab will be administered subcutaneously.
• Препарат Prophylaxis A
  Prophylaxis A will be administered orally.
• Препарат Prophylaxis B
  Prophylaxis B will be administered orally.
• Препарат Prophylaxis C
  Prophylaxis C will be administered orally.
• Препарат Prophylaxis D
  Prophylaxis D will be administered topically.
• Препарат Ramantamig
  Ramantamig will be administered subcutaneously.

Первичные конечные точки

• Percentage of Participants With Occurrence of Dysgeusia as Assessed by the Total Waterless Empirical Taste Test (WETT) Testing Score During the Prophylaxis Treatment Phase [Срок оценки: Up to 12 months]
• Percentage of Participants With Occurrence of Severe Dysgeusia During the Prophylaxis Treatment Phase [Срок оценки: Up to 12 months]
• Time to the First Onset of Severe Dysgeusia During the Prophylaxis Treatment Phase [Срок оценки: Up to 12 months]
• Percentage of Participants Who Report Resolution/Improvement of Dysgeusia During the Prophylaxis Treatment Phase [Срок оценки: End of Month 3]
• Percentage of Participants Who Report Resolution/Improvement of Dysgeusia During the Prophylaxis Treatment Phase [Срок оценки: End of Month 7]

Вторичные конечные точки (12)

• Change From Baseline in WETT Testing Score Over Time [Срок оценки: Baseline up to 36 months]
• Percentage of Time with Dysgeusia During the Prophylaxis Treatment Phase [Срок оценки: Up to 12 months]
• Percentage of Participants with Treatment-Emergent Oral Toxicities (Dysgeusia, Oral Mucositis, Dysphagia, and Xerostomia) During the Prophylaxis Treatment Phase [Срок оценки: Up to 12 months]
• Percentage of Participants with Treatment-Emergent Oral Toxicities (Dysgeusia, Oral Mucositis, Dysphagia, and Xerostomia) During the Study [Срок оценки: Up to 30 days after the last dose of study treatment (that is, approximately up to 36 months)]
• Time to the First Onset of Treatment-Emergent Oral Toxicities (Dysgeusia, Oral Mucositis, Dysphagia, and Xerostomia) [Срок оценки: Up to 36 months]
• Duration of Treatment-emergent Oral Toxicities (Dysgeusia, Oral Mucositis, Dysphagia, and Xerostomia) [Срок оценки: Up to 36 months]
• Change From Baseline in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core-30 items (EORTC-QLQ-C30) Domains Scores Over Time [Срок оценки: From Baseline, up to 12 months (Cohorts A to E); up to 24 months (for Cohort F)]
• Change From Baseline in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Oral Health (EORTC-QLQ-OH15) Domains Scores Over Time [Срок оценки: From Baseline, up to 12 months (Cohorts A to E); up to 24 months (for Cohort F)]
• Percentage of Participants Reporting Oral Symptoms Using the Patient-reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) [Срок оценки: Up to 12 months (Cohorts A to E); Up to 24 months (for Cohort F)]
• Percentage of Participants Reporting Oral Symptoms Using the Short Xerostomia Inventory (SXI) Score [Срок оценки: Up to 12 months (Cohorts A to E); Up to 24 months (for Cohort F)]
• Percentage of Participants Reporting Oral Symptoms Using the Epstein Taste Survey (ETS) [Срок оценки: Up to 12 months (Cohorts A to E); Up to 24 months (for Cohort F)]
• Percentage of Participants Reporting Oral Symptoms Using the Scale of Subjective Total Taste Acuity (STTA) [Срок оценки: Up to 12 months (Cohorts A to E); Up to 24 months (for Cohort F)]

Критерии участия

Критерии включения

• Multiple myeloma (MM) according to IMWG diagnostic criteria
• Were triple-class exposed (received prior treatment with a PI, an IMiD, and anti CD38 mAb)
• 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-performance status (ECOG-PS) of 0 or 1 at screening. Participants with ECOG-PS 2 or 3 are eligible for the study if the ECOG-PS score is related to stable physical limitations (e.g., wheelchair-bound due to prior spinal cord injury) and not related to multiple myeloma or associated therapy
• Be willing and able to adhere to the lifestyle restrictions specified in the protocol

Критерии исключения

• Contraindications or life-threatening known allergies, hypersensitivity, or intolerance to any study drug or its excipients
• Stroke, transient ischemic attack, or seizure within 6 months prior to screening
• Any of the following within 6 months prior to the first dose of study treatment: severe or unstable angina, myocardial infarction; major thromboembolytic event (e.g., pulmonary embolism, cerebrovascular accident), clinically significant ventricular arrythmia or heart failure New York Heart Association functional classification Class III or IV. Uncomplicated deep vein thrombosis is not considered exclusionary
• Major surgery or had significant traumatic injury within 2 weeks prior to the start of administration of study treatment, or will not have fully recovered from surgery, or has major surgery planned during the time the participant is expected to be treated in the study or within 2 weeks after administration of the last dose of study treatment
• A WETT score indicating severe dysgeusia at screening and confirmed prior to randomization. Also unresolved/severe dysgeusia referred by the participant or a finding in the physical examination/oral cavity inspection. Some examples include leukoplakia, prior mouth cancers, extensive dental caries, severe periodontitis, active oral infections, candidiasis, parotic gland removal, or radiotherapy with resultant xerostomia

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

США · 9 центров

• University of California San Francisco — San Francisco
• Colorado Blood Cancer Institute — Denver
• Yale University School Of Medicine — New Haven
• Icahn School of Medicine at Mt. Sinai — New York
• University of Rochester Medical Center — Rochester
• Duke University Medical Center — Durham
• University Hospitals Cleveland Medical Center — Cleveland
• Virginia Commonwealth University - Massey Cancer Center — Richmond
• … и ещё 1 центр

Испания · 8 центров

• Hosp. Univ. Germans Trias I Pujol — Badalona
• Hosp Clinic de Barcelona — Barcelona
• Hosp. Univ. Virgen de La Arrixaca — El Palmar
• Hosp. de Jerez de La Frontera — Jerez de la Frontera
• Hosp. Univ. Ramon Y Cajal — Madrid
• Hosp. Univ. 12 de Octubre — Madrid
• Hosp. Quiron Madrid Pozuelo — Pozuelo de Alarcón
• Hosp Clinico Univ de Salamanca — Salamanca

Великобритания · 8 центров

• Belfast City Hospital — Belfast
• Colchester Hospital University NHS — Colchester
• Eastbourne District General Hospital — Eastbourne
• The Clatterbridge Cancer Centre — Liverpool
• University College London Hospitals — London
• Hammersmith Hospital — London
• The Christie NHS Foundation Trust Christie Hospital — Manchester
• Newcastle Freeman Hospital — Newcastle upon Tyne

Бразилия · 6 центров

• Hospitais Integrados da Gavea SA DF Star — Brasília
• Fundacao Universidade de Caxias do Sul — Caxias do Sul
• Hospital Erasto Gaertner- Liga Paranaense de Combate ao Cancer — Curitiba
• Instituto D Or de Pesquisa e Ensino — Salvador
• Clinica Medica Sao Germano S/S LTDA — São Paulo
• Instituto D Or de Pesquisa e Ensino IDOR — São Paulo

Нидерланды · 3 центра

• VUMC Amsterdam — Amsterdam
• Albert Schweitzer Ziekenhuis — Dordrecht
• Erasmus MC — Rotterdam

South Korea · 3 центра

• Seoul National University Hospital — Seoul
• The Catholic University of Korea Seoul St Mary s Hospital — Seoul
• Samsung Medical Center — Seoul

Пуэрто-Рико · 1 центр

• Hospital Espanol Auxilio Mutuo Auxilio Mutuo Cancer Center — San Juan

Идентификаторы

NCT: NCT06500884 · 64407564MMY2006 · 2023-506260-14-00

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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