Идёт набор NCT06158841

Study Assessing Activity of Intravenous (IV) Etentamig Monotherapy Versus Standard Available Therapies in Adult Participants With Relapsed or Refractory Multiple Myeloma

Фаза III С лечением Multiple Myeloma

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают: В протоколе указаны: Etentamig, Carfilzomib, Pomalidomide, Elotuzumab.
Кому может быть актуально: Состояния в реестре: Multiple Myeloma. Базовые параметры: от 18 лет · Все.
Что важно проверить: Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится: США, Австралия, Австрия, Бельгия, Канада +20
Следующий шаг: Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Официальное название

A Phase 3, Multicenter, Randomized, Open Label Study of Etentamig Compared With Standard Available Therapies in Subjects With Relapsed or Refractory Multiple Myeloma (3L+ RRMM Monotherapy Study)

Обзор

Multiple myeloma (MM) is a cancer of the blood's plasma cells. The cancer is typically found in the bones and bone marrow (the spongy tissue inside of the bones) and can cause bone pain, fractures, infections, weaker bones, and kidney failure. Treatments are available, but MM can come back (relapsed) or may not get better (refractory) with treatment. This is a study to determine change in disease symptoms of etentamig compared to standard available therapies in adult participants with relapsed/refractory (R/R) MM. Etentamig is an investigational drug being developed for the treatment of R/R MM. This study is broken into 2 Arms; Arm A and Arm B. In Arm A, participants will receive etentamig as a monotherapy. In Arm B, participants will receive the standard available therapy (SAT) identified by the Investigator during screening, in accordance with the local (or applicable) approved label, package insert, summary of product characteristics, and/or the institutional guidelines, as applicable. Around 380 adult participants with relapsed/refractory multiple myeloma will be enrolled at approximately 140 sites across the world. In Arm A participants will receive etentamig as an infusion into the vein in 28 day cycles, during the 3.5 year study duration. In Arm B, participants will receive the SAT identified by the Investigator during screening, in accordance with the local (or applicable) approved label, package insert, summary of product characteristics, and/or the institutional guidelines, as applicable, during the 3.5 year study duration. There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests, checking for side effects and questionnaires.

Вмешательства

Препарат Etentamig
Intravenous (IV) Infusion
Препарат Carfilzomib
IV Infusion
Препарат Pomalidomide
Oral Capsule
Препарат Elotuzumab
IV Infusion
Препарат Selinexor
Oral Tablet
Препарат Bortezomib
Subcutaneous or IV Injection
Препарат Dexamethasone
Oral Tablet or IV Infusion

Первичные конечные точки

Progression Free Survival (PFS) [Срок оценки: Up to Approximately 5 Years]
Objective Response Rate (ORR) [Срок оценки: Up to Approximately 5 Years]

Вторичные конечные точки (12)

Overall Survival (OS) [Срок оценки: Up to Approximately 5 Years]
Change in Rate of Very Good Partial Response (VGPR) or Better (>= VGPR) [Срок оценки: Up to Approximately 5 Years]
Change in Rate of CR or Better (>=CR) [Срок оценки: Up to Approximately 5 Years]
Change in Rate of Minimum Residual Disease (MRD) negativity with >= CR [Срок оценки: Up to Approximately 5 Years]
Change from Baseline in Disease Symptoms as Measured by the Disease Symptoms Domain of the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Multiple Myeloma Module (EORTC QLQ-MY20) [Срок оценки: Up to 6 Months]
Change from Baseline in Physical Functioning as Measured by the Physical Functioning Domain of the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Core 30 (EORTC QLQ-C30) [Срок оценки: Up to 6 Months]
Time to Response (TTR) [Срок оценки: Up to Approximately 5 Years]
Duration of Response (DOR) [Срок оценки: Up to Approximately 5 Years]
Time-to-Progression (TTP) [Срок оценки: Up to Approximately 5 Years]
Time to Next Anti-lymphoma Therapy (TTNT) [Срок оценки: Up to Approximately 5 Years]
Number of Participants with Event-free Survival (EFS) [Срок оценки: Up to Approximately 5 Years]
Change from Baseline in Patient-Reported Outcomes Measurement Information System Fatigue Short Form 7a (PROMIS Fatigue SF 7a) [Срок оценки: Up to Approximately 6 Months]

Критерии участия

Критерии включения

Eastern Cooperative Oncology Group (ECOG) performance of <= 2.
Diagnosis of relapsed/refractory (R/R) multiple myeloma (MM) during or after the participant's last treatment as stated in the protocol.
Must have measurable disease with at least 1 of the following assessed within 28 days of enrollment:

Serum M-protein >= 0.5 g/dL (>= 5 g/L).
Urine M-protein >= 200 mg/24 hours.
In participants without measurable serum or urine M protein, serum free light chain (FLC) >= 100 mg/L (10 mg/dL) (involved light chain)and an abnormal serum kappa lambda ratio.
Must have received at least 2 or more lines of therapy, including a proteasome inhibitor (PI), an immunomodulatory imide (IMiD), and an anti-CD38 monoclonal antibody (mAb).

\-- US and Puerto Rico only: Participant must have received at least 1 or more line of therapy, including exposure to a PI, an IMiD, and an anti-CD38 mAb.

Must be eligible to receive the Investigator's choice standard available therapy (SAT) based on approved prescribing information, previous MM treatment history, and institutional guidelines.

Критерии исключения

Clinically significant (per Investigator's judgment) drug or alcohol abuse within the last 6 months.
Clinically significant conditions such as but not limited to the following: neurologic, psychiatric, endocrine, metabolic, immunologic, cardiovascular, pulmonary, or hepatic disease within the last 6 months that would adversely affect the participant's participation in the study.
Central nervous system involvement of MM.
Has received B-cell maturation antigen (BCMA)-targeted therapy.

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

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University of Alabama at Birmingham - Main /ID# 261434 — Birmingham
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Alta Bates Summit Medical Center for Research /ID# 261438 — Berkeley
Providence - St. Jude Medical Center /ID# 262031 — Fullerton
VA Loma Linda Healthcare System /ID# 261015 — Loma Linda
Cedars-Sinai Medical Center /ID# 261008 — Los Angeles
Rocky Mountain Cancer Centers - Lone Tree /ID# 278320 — Lone Tree
Mayo Clinic Hospital Jacksonville /ID# 263324 — Jacksonville
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Sun Yat-Sen University Cancer Center /ID# 245542 — Гуанчжоу
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