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