Global Immunotherapy Database in Relapsed/Refractory Multiple Myeloma
Research type
Research Study
Full title
INTERNATIONAL MYELOMA FOUNDATION STUDY OF THE OUTCOMES OF PATIENTS WITH RELAPSED OR HIGH-RISK MYELOMA RECEIVING NOVEL IMMUNOTHERAPIES
IRAS ID
321530
Contact name
Rakesh Popat
Contact email
Sponsor organisation
International Myeloma Foundation
Duration of Study in the UK
2 years, 0 months, 1 days
Research summary
This is a prospective observational study designed to develop a database collecting data from patients with relapsed/refractory and high-risk multiple myeloma (RRMM) that have received or are intending to receive novel immunotherapy at participating International Myeloma Working Group (IMWG) sites globally.
The database is subject to US approvals with the UK contributing by recording patient data to this US lead database.The database has been set-up with the goal for researchers to utilize this global immunotherapy database to assess regional/geographic differences in treatment selection for multiple myeloma, toxicities and outcomes following treatment with these novel immunotherapies, differences in how, when and in what sequence these treatments are given, and outcomes from salvage therapy (treatment given after cancer has not responded to other treatments) after the first or subsequent novel immunotherapy treatment.
Data will be captured from the date of diagnosis and patients will be followed-up after immunotherapy treatment and following any further treatment.The database will include an optional “virtual tissue bank (VTB)” which will allow sharing of information/results produced from experiments performed on already collected biological samples (tissue, blood, bone marrow etc.). The virtual tissue bank terminology is referenced in the Protocol, no biological material will be obtained.
The study aims to utilise health reported questionnaires. This part of the study is referenced in the protocol, but not active yet and will be introduced at a later date via substantial amendment.The study will aim to recruit 5700-5750 patients with RRMM who are receiving immunotherapy globally with an additional 250-300 RRMM patient who are not receiving immunotherapy to be used as a control.
The major goal of this database is to serve as a data repository to answer important questions as we enter an “immunotherapy and cellular therapy” era for the treatment of multiple myeloma.
REC name
South Central - Berkshire B Research Ethics Committee
REC reference
23/SC/0127
Date of REC Opinion
5 May 2023
REC opinion
Further Information Favourable Opinion