Study of GSK2857196 in pts. with RRMM who have failed on Daratumumab
Research type
Research Study
Full title
A Phase II, Open Label, Randomized, Two-Arm Study to Investigate the Efficacy and Safety of two doses of the Antibody Drug Conjugate GSK2857916 in participants with Relapsed/Refractory Multiple Myeloma who had 3 or more prior lines of treatment, are refractory to proteasome inhibitor, and immunomodulatory agent and have failed an Anti-CD38 Antibody (DREAMM 2)
IRAS ID
242654
Contact name
Rakesh Popat
Contact email
Sponsor organisation
GlaxoSmithKline
Eudract number
2017-004810-25
Clinicaltrials.gov Identifier
N/A, N/A
Duration of Study in the UK
1 years, 11 months, 29 days
Research summary
Multiple Myeloma (MM) is an incurable cancer and accounts for approximately 1% of all cancers and 10% of all blood-related cancer. Despite significant advances in treatment options most MM patients will ultimately develop resistance to existing treatments.\n\nGSK2857916 is a humanised immunoglobulin antibody, which binds to BCMA, a target widely shown on malignant white blood cells in MM. Early clinical data from an ongoing study in patients with relapsed/refractory multiple myeloma (RRMM) who have been previously treated with other medicines has shown significant efficacy and an acceptable safety profile which warrant further exploration. \n\nThis study is an open label, 2 arm, randomized, Phase 2 trial to establish safety and efficacy of GSK2857916 at 2 different dose levels in participants with RRMM who have received at least three prior types of anti-myeloma therapy (including a proteasome inhibitor and an immunomodulatory agent) and who were previously treated with an anti CD38 antibody. The objective of this study is to evaluate the clinical efficacy of GSK2857916 by overall response rate (a confirmed partial response or better).\n\nEligible participants will begin treatment (Cycle 1) after completing screening. Screening will involve an x-ray, blood sample collection, vital signs, ECG, physical exam and an eye exam. Participants will receive GSK2857916 every 3 weeks via intravenous injection given over 30 mins. A blood sample will be collected at every visit and participants will complete a number of questionnaires and have an ECG , physical and eye exam. Participants will be treated until disease progression, unacceptable side effects or death. It is anticipated most participants will be in the study for approximately 12 months (16 Cycles). Once treatment has stopped participants will be followed up monthly if they have ongoing eye problems at the end of treatment and 3 monthly for survival information. \n
REC name
London - South East Research Ethics Committee
REC reference
18/LO/1002
Date of REC Opinion
29 Jun 2018
REC opinion
Favourable Opinion