National, Observational, Non-interventional, Retro- and Prospective Clinical Multiple Myeloma Registry GMMG

The German-speaking Myeloma Multicenter Group (GMMG) registry is a national, observational, non-interventional, retro-and prospective clinical myeloma registry of multiple myeloma patients in Germany. The registry includes the study database of the prospective trials led by the GMMG, with basic data, diagnosis, therapy and longtime follow-up. The sample size is unlimited.

The Myeloma Registry was activated on December 8, 2022. Currently 35 GMMG centers in Germany are participating. The first longtime follow-up data set included in the registry was the GMMG-HD 6 trial. The GMMG-HD6 trial is a phase 3 trial which investigated the efficacy of the addition of the anti-SLAMF7 monoclonal antibody, elotuzumab, to the standard induction and consolidation therapy consisting of lenalidomide, bortezomib and dexamethasone in transplant-eligible patients with newly diagnosed multiple myeloma.

Target variables of interest are progression-free survival (PFS) from randomization, overall survival (OS), the follow-up time, the cause of death and the therapy free time after first relapse and its treatment. Further objectives will be defined and analyzed for each evaluation.

Participations will be observed while the patient is being treated with standard of care until death, lost to follow-up or consent withdrawn. Follow-ups will be documented every six months until the 1st Progression Disease and then annually. The pseudonymized clinical data is stored in a separate database (eCRF) and is monitored centrally on a regular basis. The eCRF contain automated plausibility checks, so called queries.