Elranatamab Post Trial Access Study for Participants With Multiple Myeloma (MM)

Официальное название

ELRANATAMAB POST TRIAL ACCESS: AN OPEN-LABEL, SINGLE-ARM STUDY FOR PARTICIPANTS WITH MULTIPLE MYELOMA CONTINUING FROM PFIZER-SPONSORED ELRANATAMAB CLINICAL STUDIES

Обзор

This is a post-trial access (PTA) open-label, single-arm study in Multiple Myeloma participants who continue to derive clinical benefit from elranatamab monotherapy in the Pfizer-sponsored elranatamab Parent Studies.

Подробное описание

This is a single-arm elranatamab post-trial access study. Participants will receive elranatamab. All participants will receive elranatamab until disease progression, unacceptable toxicity, withdrawal of consent, study termination or, elranatamab becomes commercially accessible in the participant's country.

Вмешательства

• Препарат Elranatamab
  Elranatamab is a heterodimeric humanized full-length bispecific IgG2 kappa antibody that targets BCMA on MM cells and CD3 on T cells

Первичные конечные точки

• Incidence of nonserious adverse events (AEs) leading to permanent discontinuation [Срок оценки: A minimum of 90 days after the last dose of study drug]
• Incidence of serious adverse events (SAEs) [Срок оценки: A minimum of 90 days after the last dose of study drug]

Критерии участия

Критерии включения

• Participants must agree to follow the reproductive criteria as outlined in the protocol
• Participants have completed a qualifying Parent Study, were still receiving elranatamab when the Parent Study terminated or completed, and are deriving clinical benefit from elranatamab (as determined by the investigator).

Критерии исключения

• Any medical or psychiatric condition including recent (within the past year) or active suicidal ideation/behavior or laboratory abnormality that may increase the risk of study participation or, in the investigator's judgment, make the participant inappropriate for the study.
• Participants not previously enrolled or who have discontinued study treatment in a Parent Study are ineligible for participation in this study.

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

США · 17 центров

• UCI Health - Irvine Infusion Pharmacy ACC — Irvine
• UC Irvine Health — Orange
• UCI Health — Orange
• UCHealth Poudre Valley Hospital — Fort Collins
• UCHealth Harmony — Fort Collins
• UCHealth Greeley Hospital — Greeley
• Longs Peak Hospital — Longmont
• UCHealth Longs Peak Medical Center — Longmont
• … и ещё 9 центров

Китай · 4 центра

• Peking University Third Hospital — Пекин
• Sun Yat-sen University Cancer Center — Гуанчжоу
• Shandong Provincial Hospital — Цзинань
• The first Affiliated Hospital, Zhejiang University School of Medicine — Ханчжоу

Австралия · 3 центра

• Epworth Freemasons — Melbourne
• Epworth Hospital — Richmond
• Slade Pharmacy — Richmond

Канада · 3 центра

• Arthur J.E. Child Comprehensive Cancer Centre — Calgary
• Cross Cancer Institute — Edmonton
• McGill University Health Centre — Montreal

Япония · 2 центра

• Japanese Red Cross Medical Center — Shibuya-ku
• University Hospital,Kyoto Prefectural University of Medicine — Kyoto

Испания · 2 центра

• Clinica Universidad de Navarra — Pamplona
• Hospital Universitario Doctor Peset — Valencia

Тайвань · 2 центра

• National Taiwan University Hospital — Taipei
• Taipei Veterans General Hospital — Taipei

Идентификаторы

NCT: NCT06057402 · C1071015 · 2023-505200-33-00

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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