Elranatamab EAMS research database’
Research type
Research Database
IRAS ID
318097
Contact name
Luke Kuttschreuter
Contact email
Research summary
A multicentre Early Access to Medicines Scheme (EAMS) for elranatamab monotherapy used to treat relapsed & refractory multiple myeloma
REC name
East of England - Cambridge East Research Ethics Committee
REC reference
22/EE/0297
Date of REC Opinion
23 Jan 2023
REC opinion
Further Information Favourable Opinion
Data collection arrangements
The Early Access to Medicines Scheme (EAMS) is a procedure, regulated by the Medicines and Healthcare products Regulatory Agency (MHRA), to provide medicines in development to patients with an unmet healthcare need. These medicines, if given positive opinion by the MHRA, are available for clinical care of patients before they have been approved in the UK. Within this particular EAMS, a medicine in development, elranatamab, is being provided to patients with multiple myeloma (a type of cancer of the bone marrow) that is ‘relapsed’ or ‘refractory’ to certain other available therapies.
A requirement stipulated by the MHRA is that data is collected on patients who consent to treatment within the EAMS. This data describes the eligibility of patients for the EAMS, any necessary details about their myeloma, and side effects while treated. Additionally, if additional consent is given, voluntary data on the response to treatment, quality of life, and healthcare resource use will be collected from the treating clinician or from the EAMS patient. This data will form part of the EAMS research database. No identifiable data will be stored, and patients will be identified using a pseudo-anonymised EAMS number.Research programme
The data collected within this EAMS will form a secure research database. The mandatory data on safety and eligibility will be provided to the MHRA in 3-monthly reports to support the ongoing safe use of the medicine. The purpose of the total database set is to collect data to understand better how the treatment is used and how well it works in clinical practice. The database will not be used for any primary research itself but will retain the possibility of use in subsequent research. This could be used to support future submissions to regulatory authorities or health technology assessments which will support the multiple myeloma patient community through enabling approval/reimbursement of elranatamab and widespread use within clinical care.
Research database title
A multicentre Early Access to Medicines Scheme (EAMS) for elranatamab monotherapy used to treat relapsed & refractory multiple myeloma
Establishment organisation
Pfizer Ltd
Establishment organisation address
Walton Oaks
Dorking Road, Tadworth
Surrey
KT20 7NS