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)

Condition studied

Relapsed or Refractory Multiple Myeloma

Investigational medicinal product(s)

Eligibility

Primary endpoint

ORR, defined as the percentage of participants with a confirmed PR or better (i.e., PR, VGPR, CR, sCR).

Endpoint detail

• 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