Belantamab Mafodotin in newly diagnosed multiple myeloma
Research type
Research Study
Full title
A Phase 1, Randomized, Dose and Schedule Evaluation Study to Investigate the Safety, Pharmacokinetics, Pharmacodynamics and Clinical Activity of Belantamab Mafodotin Administered in Combination with Standard of Care in Participants with Newly Diagnosed Multiple Myeloma
IRAS ID
271139
Contact name
Mamta Garg
Contact email
Sponsor organisation
GSK
Eudract number
2019-003047-30
Clinicaltrials.gov Identifier
Duration of Study in the UK
10 years, 1 months, 2 days
Research summary
Multiple myeloma (MM) is an incurable cancer of the blood plasma cells. Current treatment for fit MM patients is high-dose chemotherapy, with a stem cell transplant (ASCT) however, some patients, especially the elderly, are not able to have a transplant due to frailty or other illnesses.
B-cell maturation antigen (BCMA) is a protein present on the surface of certain white blood cells (B-cells) and on tumour cells in patients with MM. Belantamab mafodotin, which is currently in development for the treatment of MM, is a type of antibody, which binds to BCMA and can kill tumour cells. In previous studies it has shown significant benefit with acceptable side effects which warrant further exploration.
This study is for patients who are ineligible for ASCT. It consists of two parts, the Dose Selection part (Part 1) will evaluate the safety and tolerability of increasing doses of belantamab mafodotin in combination with bortezomib (Velcade), Lenalidomide (Revlimid), and dexamethasone (VRd). Part 1will determine the recommended dose for Part 2 (RP3D). Part 2 will evaluate the efficacy and safety of the RP3D of belantamab mafodotin plus VRd compared with VRd alone.
Eligible participants for both parts will begin treatment after completing screening. Screening will involve imaging (x-ray, CT or MRI), blood samples, a bone marrow sample, vital signs, ECG, physical exam and an eye exam. Participants will receive belantamab mafodotin either as a single dose, or a split dose over 2 days, every 3 weeks via injection in a vein, reducing to every 4 weeks. A blood sample will be collected at every visit and participants will complete a number of questionnaires, have an ECG and eye exam. Participants will be treated until disease progression or unacceptable side effects. It is anticipated most participants will be in the study for an average of 44 months.
REC name
London - City & East Research Ethics Committee
REC reference
19/LO/1921
Date of REC Opinion
3 Feb 2020
REC opinion
Further Information Favourable Opinion