*GSK2857916 in Relapsed or Refractory Multiple Myeloma (DREAMM-14)
Research type
Research Study
Full title
A Phase 2, Randomized, Parallel, Open-Label Study to Investigate the Safety, Efficacy, and Pharmacokinetics of Various Dosing Regimens of Single-Agent Belantamab Mafodotin (GSK2857916) in Participants with Relapsed or Refractory Multiple Myeloma (DREAMM-14)
IRAS ID
1004239
Contact name
Suzan Yuen
Contact email
Sponsor organisation
GlaxoSmithKline Research & Development Ltd
Eudract number
2021-004151-16
Clinicaltrials.gov Identifier
Research summary
This research study is being done to learn more about multiple myeloma (MM) and if the investigational treatment, belantamab mafodotin, can help patients with multiple myeloma whose disease has already failed other treatments (called relapsed/refractory multiple myeloma or RRMM).
Belantamab mafodotin is approved for use in RRMM patients in some countries.
This study’s aim is to find out if a lower dose and/or longer gaps between doses of belantamab mafodotin causes less eye-related side effects than the approved dose and work as well as the approved dose for the treatment of RRMM. The doses and schedules being tested have been used before in other studies where patients typically continued to receive benefit but with less eye-related side effects.
Participants will undergo screening to assess their eligibility, involving review of blood tests (for safety and to assess the disease), vital signs, ECG, physical exam and disease assessment scans (such as CT-scan). All eligible participants will receive belantamab mafodotin either every 3 or 6 weeks (a cycle) at either the standard approved dose or at a lower dose, given over at least 30 mins via intravenous injection. A computer will decide the treatment dose and schedule that participants will receive. Neither the participants nor the study doctor can choose the treatment or will know what treatment the participant is receiving.
Assessments before each treatment include safety blood samples, completion of health questionnaires and a brief physical exam. Participants will be treated until disease progression (assessed by blood tests and repeat scans), unacceptable side effects or death. Some additional blood samples will also be collected to further help understand the effects of belantamab mafodotin.
It is anticipated most participants will be on treatment for 6 months before progression. Once treatment has stopped participants will be followed-up to document their further treatment(s) and survival information.REC name
South Central - Berkshire Research Ethics Committee
REC reference
22/SC/0284
Date of REC Opinion
16 May 2022
REC opinion
Further Information Favourable Opinion