International Treatment-extension Study in Adult Participants With Multiple Myeloma and Who Have Derived Clinical Benefit From Isatuximab

Официальное название

International, Multi-center, Open-label, Treatment Extension Study in Patients With Multiple Myeloma Who Are Still Benefitting From Isatuximab-based Therapy Following Completion of a Phase 1, 2, or 3 Parental Study

Обзор

* This is a multi-center, open-label, Phase 2 treatment extension study in participants with multiple myeloma who are still benefitting from isatuximab based therapy following completion of a Phase 1, 2, or 3 parental study. * This Treatment Extension study has the purpose to provide continued access to isatuximab. Adult participants with multiple myeloma who have enrolled on an isatuximab parental study for which study objectives are completed will be eligible to be enrolled in this Treatment Extension study. * The primary objective of the study is to assess long-term safety of isatuximab as study treatment.

Подробное описание

Participants can continue the treatment until disease progression, unacceptable adverse events, participant wish to discontinue study treatment, study treatment is commercially available and reimbursed in participant's country, or for any other reason, whichever comes first. The overall study duration will be of approximately 42 months.

Вмешательства

• Препарат Isatuximab intravenous (IV)
  Route of administration: IV infusion; Pharmaceutical form: Vial
• Препарат Cemiplimab (SAR439684)
  Route of administration: IV infusion; Pharmaceutical form: Vial
• Препарат Dexamethasone
  Route of administration: Oral or IV infusion; Pharmaceutical form: Tablets/single use vial
• Препарат Lenalidomide
  Route of administration: Oral; Pharmaceutical form: Capsules
• Препарат Pomalidomide
  Route of administration: Oral; Pharmaceutical form: Hard capsules
• Препарат Isatuximab subcutaneous (SC)
  Route of administration: SC injection with the investigational isatuximab injector device; Pharmaceutical form: Vial
• Препарат Carfilzomib
  Route of administration: IV infusion; Pharmaceutical form: Vial

Первичные конечные точки

• Number of participants with treatment-emergent adverse events [Срок оценки: Baseline to 42 months]

Критерии участия

Критерии включения

• Participant must be ≥18 years of age (or the legal age of consent in the jurisdiction in which the study is taking place), at the time of signing the informed consent.
• Participants of a parental Phase 1, 2, or 3 clinical study assessing isatuximab monotherapy or in a combination regimen with all the study objectives completed.
• Participants still receiving isatuximab at the time of the parental study closure, who are continuing to benefit from isatuximab as monotherapy or in combination, as determined by the treating physician, and who meet the criteria to initiate a subsequent cycle of therapy as described in the parental study protocol. A participant not receiving isatuximab at the end of the parental study who does not have access locally to the ongoing treatment may also be included.
• Contraception (with double contraception methods) for male and female participants; not pregnant or breastfeeding for female participants; no sperm donation for male participants.
• Capable of giving signed informed consent.

Критерии исключения

• Participant has evidence of progressive disease during or at the time of the parental study closure.
• Participant has not recovered to ≤Grade 2 from nonhematologic AEs (as per NCI CTCAE v5.0) related to any anticancer therapy received prior to signing informed consent on the extension study.
• As the latest line of treatment participant received an antimyeloma therapy other than the isatuximab-based therapy in the parental study before the first IMP in this study.
• Individuals accommodated in an institution because of regulatory or legal order; prisoners or participants who are legally institutionalized.
• Participant not suitable for participation, whatever the reason, as judged by the Investigator, including medical or clinical conditions, or participants potentially at risk of noncompliance to study procedures.
• Participants are employees of the clinical study site or other individuals directly involved in the conduct of the study, or immediate family members of such individuals.
• Any country-related specific regulation that would prevent the participant from entering the study.

The above information is not intended to contain all considerations relevant to a potential participation in a clinical trial.

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Испания · 7 центров

• Investigational Site Number : 7240006 — Seville
• Investigational Site Number : 7240004 — Santander
• Investigational Site Number : 7240005 — Badalona
• Investigational Site Number : 7241001 — Madrid
• Investigational Site Number : 7240001 — Pamplona
• Investigational Site Number : 7240003 — Madrid
• Investigational Site Number : 7240002 — Salamanca

Австралия · 6 центров

• Investigational Site Number : 0360006 — Blacktown
• Investigational Site Number : 0360001 — Saint Leonards
• Investigational Site Number : 0360003 — Wollongong
• Investigational Site Number : 0360004 — Melbourne
• Investigational Site Number : 0360005 — Melbourne
• Investigational Site Number : 0360002 — Richmond

Бразилия · 3 центра

• Hospital Mae de Deus- Site Number : 0760003 — Porto Alegre
• Hospital das Clinicas da Faculdade de Medicina da Universidade de Sao Paulo - HCFMUSP- Sit — São Paulo
• Instituto Americas - Ensino, Pesquisa e Inovação - Rio de Janeiro - Avenida Jorge Curi- Si — Rio de Janeiro

Чехия · 3 центра

• Investigational Site Number : 2030002 — Brno
• Investigational Site Number : 2030003 — Ostrava
• Investigational Site Number : 2030001 — Prague

Греция · 3 центра

• Investigational Site Number : 3000004 — Athens
• Investigational Site Number : 3000003 — Athens
• Investigational Site Number : 3000001 — Pátrai

Новая Зеландия · 2 центра

• Investigational Site Number : 5540002 — Auckland
• Investigational Site Number : 5540001 — Wellington

Россия · 2 центра

• Investigational Site Number : 6430002 — Kirov
• Investigational Site Number : 6430001 — Moscow

South Korea · 2 центра

• Investigational Site Number : 4100001 — Seoul
• Investigational Site Number : 4100002 — Seoul

США · 1 центр

• Washington University- Site Number : 8400001 — St Louis

Чили · 1 центр

• Investigational Site Number : 1520001 — Temuco

Китай · 1 центр

• Investigational Site Number : 1560001 — Тяньцзинь

Финляндия · 1 центр

• Investigational Site Number : 2460001 — Helsinki

Франция · 1 центр

• Investigational Site Number : 2500002 — Nantes

Италия · 1 центр

• Investigational Site Number : 3800002 — Torino

Япония · 1 центр

• Investigational Site Number : 3920001 — Okayama

Швеция · 1 центр

• Investigational Site Number : 7520004 — Luleå

Тайвань · 1 центр

• Investigational Site Number : 1580001 — Taichung

Идентификаторы

NCT: NCT05669989 · LTS17704 · U1111-1277-6635 · 2023-507180-19 · 2022-002253-26

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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