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Набира участници Фаза 2 2025-523117-28-00

A Phase 2, multicenter, open label, non-randomized study to evaluate the efficacy and safety of extended dosing of belantamab mafodotin in different combinations with standard of care regimens in participants with relapsed-refractory multiple myeloma (DREAMM-15)

Фаза 2 – изследване на ефективността и дозировката
Заболявания: Relapsed or Refractory Multiple Myeloma

Спонсор: Glaxosmithkline Research & Development Limited

Налично на: БГ
Обобщение
Trial status: Authorised • CRR, defined as the percentage of participants with a confirmed CR or better. • MRD negativity rate, defined as the percentage of participants who achieve MRD negative status at least once during the time of confirmed CR or better response as per IMWG. • DoR, defined as the time from first documented evidence of PR or better until PD or death due to any cause., • Incidence and severity of AEs and SAEs; • Incidence of AEs leading to dose modifications or study intervention discontinuation; • Incidence and severity of ocular findings on ophthalmic exam (changes in VA and cornea findings)., OSDI, PRO-CTCAE (ocular), PROSIM-Q, and CTCAEs (eye disorders – other) concordance with KVA ORR, defined as the percentage of participants with a confirmed PR or better (i.e., PR, VGPR, CR, sCR).
Описание
• CRR, defined as the percentage of participants with a confirmed CR or better. • MRD negativity rate, defined as the percentage of participants who achieve MRD negative status at least once during the time of confirmed CR or better response as per IMWG. • DoR, defined as the time from first documented evidence of PR or better until PD or death due to any cause., • Incidence and severity of AEs and SAEs; • Incidence of AEs leading to dose modifications or study intervention discontinuation; • Incidence and severity of ocular findings on ophthalmic exam (changes in VA and cornea findings)., OSDI, PRO-CTCAE (ocular), PROSIM-Q, and CTCAEs (eye disorders – other) concordance with KVA
Кой може да участва
Age group: 18-64 years, 65+ years Gender: Female, Male Target enrollment: 45 participants
Интервенции
POMALIDOMIDE
Drug
POMALIDOMIDE
Drug
DEXAMETHASONE
Drug
CARFILZOMIB
Drug
BORTEZOMIB
Drug
POMALIDOMIDE
Drug
CARFILZOMIB
Drug
POMALIDOMIDE
Drug
CARFILZOMIB
Drug
DEXAMETHASONE
Drug
Места на провеждане 5
Франция (1)
Германия (1)
Гърция (1)
Нидерландия (1)
Испания (1)
Технически детайли
Статус
Набира участници
Фаза
Фаза 2
Вид изследване
INTERVENTIONAL
Пол
Мъже и жени
Минимална възраст
18 Years
Здрави доброволци
Не
Начална дата
13.04.2026
Регистрационен номер
2025-523117-28-00
Източник
euclinicaltrials.eu
Запитване за медицински туризъм

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