Bubble
Research type
Research Study
Full title
Bubble: Phase 1B Study of buparlisib with Bortezomib in Defined Genetic Subgroups of Patients with Relapsed or Refractory Multiple Myeloma
IRAS ID
162246
Contact name
Godwill Iheagwaram
Contact email
Eudract number
2014-002477-10
ISRCTN Number
22287432
Clinicaltrials.gov Identifier
, RG_14-144
Duration of Study in the UK
4 years, 0 months, 1 days
Research summary
Multiple myeloma (MM) is an incurable disease that affects approximately 15-20 per 100,000 people in the Western World. Advances in our understanding of the biology of MM have shown that there are different forms of the disease, because of the range of genetic lesions. This represents a major challenge in the development of therapies, and there is a great need to develop new drugs for patients with poor outcomes,
linked to specific genetic abnormalities. Studies have shown that bortezomib (Bz) may be effective in improving the outcome of such patients, however, the survival in this group is still poorer compared to patients without these particular genetic abnormalities. Our group have identified that a new class of drugs may play a crucial role in targeting specific sub-types of MM. One such drug is BKM120 (BKM), which has shown to be effective in patients with other haematological cancers. We propose to evaluate the combination of BKM-Bz in patients with a specific genetic sub-type of MM in this early phase study. Initially, we aim to identify a safe dose of BKM-Bz and then explore whether this dose is effective in treating patients with MM. Up to 60 patients in the UK will be recruited to this study.REC name
London - Chelsea Research Ethics Committee
REC reference
15/LO/0304
Date of REC Opinion
17 Apr 2015
REC opinion
Further Information Favourable Opinion