GMMG Multiple Myeloma Registry
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Multiple Myeloma. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Germany
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
National, Observational, Non-interventional, Retro- and Prospective Clinical Multiple Myeloma Registry GMMG
Overview
The goal of this observational study is to collect long-term clinical follow-up data on patients with multiple myeloma who participated in a therapy study of the German-Speaking Myeloma Multicenter Group (GMMG). Target variables of interest are: Overall survival, progression-free survival and follow-up time. The relevant registry data will be provided and evaluated together with the therapy study data for scientific research projects. This allows seamless documentation of patient data from the end of the trial to long-term follow-up.
Detailed description
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.
Primary outcome measures
- progression free survival [Time frame: after 5 years, and then through study completion, an average of 1 year]
Eligibility criteria
Inclusion criteria
- Previous participation in a a therapy study of the GMMG study group
Exclusion criteria
- patients with organ amyloidosis at time of diagnosis
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Other
Study locations
Germany · 35 centers
- HELIOS Klinikum, Klinik für Hämatologie, Onkologie und Immunologie — Berlin
- Charité Campus Benjamin Franklin, III. Med. Abt. (Hämatologie/Onkologie) — Berlin
- Klinikum Bielefeld, Klinik für Hämatologie, Onkologie und Palliativmedizin — Bielefeld
- Medizinische Universitätsklinik, Knappschaftskrankenhaus — Bochum
- Universitätsklinikum Bonn, Medizinische Klinik und Poliklinik III, Schwerpunkt Onkologie, — Bonn
- Klinikum Chemnitz GmbH, Innere Medizin III — Chemnitz
- Universitätsklinikum Köln, Klinik I - Innere Medizin — Cologne
- Onkologisches Studienzentrum Darmstadt — Darmstadt
- … and 27 more centers
Identifiers
NCT: NCT07111884 · GMMG Myeloma Registry · DRKS00026970