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Recruiting Phase 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)

Phase 2 – studying effectiveness and dosage
Conditions: Relapsed or Refractory Multiple Myeloma

Sponsor: Glaxosmithkline Research & Development Limited

trial.available_in: БГ
Overview
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).
Description
• 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
Who can participate
Age group: 18-64 years, 65+ years Gender: Female, Male Target enrollment: 45 participants
Interventions
POMALIDOMIDE
Drug
POMALIDOMIDE
Drug
DEXAMETHASONE
Drug
CARFILZOMIB
Drug
BORTEZOMIB
Drug
POMALIDOMIDE
Drug
CARFILZOMIB
Drug
POMALIDOMIDE
Drug
CARFILZOMIB
Drug
DEXAMETHASONE
Drug
Locations 5
France (1)
Germany (1)
Greece (1)
Netherlands (1)
Spain (1)
Technical details
Status
Recruiting
Phase
Phase 2
Study type
INTERVENTIONAL
Sex
Male and female
Minimum age
18 Years
Healthy volunteers
No
Start date
13.04.2026
Registry ID
2025-523117-28-00
Source
euclinicaltrials.eu
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