ProMMise
Research type
Research Study
Full title
A Platform trial for Relapsed patients to evaluate Ongoing novel therapies in Multiple Myeloma In combination with Standard of care therapies.
IRAS ID
1003553
Contact name
Sadie Roberts
Contact email
Sponsor organisation
University of Leeds
Eudract number
2020-004058-31
ISRCTN Number
ISRCTN19869915
Research summary
ProMMise is a study for patients with relapsed Multiple Myeloma (MM). Relapsed means it has returned after treatment. MM is rare, but the number of people living with it is increasing. Currently it is incurable. However, new treatments mean more people are surviving for longer, and around one third of patients are now living for 10 years after diagnosis. Although survival has improved, new treatments are required to extend life expectancy still further, and to provide new options for hard to treat patients. Belantamab mafodotin (known as belamaf) is a new drug that attacks myeloma cells. Initial trials have shown a good response; on average the disease didn’t return (progress) for 12 months. This was in a group of patients with refractory MM, meaning it had returned after various treatments.
Belamaf is well tolerated. The main side effects are blurred vision and a reduced number of platelets in the blood (thrombocytopenia). Both of these effects resolve if treatment is paused, and in most cases treatment could continue. This is a platform study, which means there will be several arms each looking at different treatment combinations. This will start with 2 or 3 trial arms, with other arms added later. The first arm will use belamaf alone. More arms will be added to look at belamaf used in combination with known myeloma drugs. The design means arms can be added easily as new combinations become available.
This study has two phases, which will take place sequentially for each arm. Participants will take part in one of these only. The first phase is focused on safety, providing close monitoring to check the doses of the drugs are safe and side effects are tolerable. There will then be an expansion phase, which will give researchers an indication of how effective the drugs are. Due to the new way belamaf works and it’s as yet limited identified side-effects, combining this with existing myeloma drugs has the potential to improve the outlook for patients.REC name
West of Scotland REC 1
REC reference
21/WS/0065
Date of REC Opinion
16 Jul 2021
REC opinion
Further Information Favourable Opinion