UVEA - Ixa
Research type
Research Study
Full title
Use Via Early Access to Ixazomib
IRAS ID
245359
Contact name
Bhuvan Kishore
Contact email
Sponsor organisation
Takeda Pharmaceuticals International AG
Duration of Study in the UK
2 years, 3 months, 1 days
Research summary
The development of Ixazomib for treating multiple myeloma was completed in November 2015. The time interval from completing the studies, to obtaining a licence in Nov 2017 left a gap in which subjects may not have had treatment with Ixazomib. The sponsor provided the medication during this period on a named patient supply basis in the UK and in 8 other European counties.
The sponsor received a governmental request from the UK National Health Service to provide additional data for this patient population in terms of clinical characteristics, therapeutic path, outcomes of the patients involved in this program.
The objective of this study is to look at the effectiveness of the drug and safety in 10 hospital sites in the UK, 45 sites in total. Enroll approximately 450 subjects in total over a nine month period. The study is both retrospective (for the deceased subjects) and prospective for those that still alive for a one year period by reviewing information from their clinical notes. No subject assessments or questionnaires are to be performed.REC name
London - London Bridge Research Ethics Committee
REC reference
18/LO/0778
Date of REC Opinion
4 May 2018
REC opinion
Favourable Opinion