GMMG Multiple Myeloma Registry

Recruiting

• Conditions: Multiple Myeloma

• Registration Number: NCT07111884
• Lead Sponsor: Prof. Dr. Hartmut Goldschmidt

Brief Summary

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will be observed while the patient is being treated with standard of care until death, lost to follow-up or consent withdrawn.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.

Study Timeline

• Study Start: 2022-12-08
• Study First Submitted: 2024-07-30
• Status Verified: 2025-08
• Study First Submitted QC: 2025-08-05
• Last Update Submitted: 2025-08-05
• Study First Posted: 2025-08-08
• Last Update Posted: 2025-08-08
• Primary Completion: 2027-03
• Study Completion: 2027-03-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 999

Inclusion Criteria

• Previous participation in a a therapy study of the GMMG study group

Exclusion Criteria

• patients with organ amyloidosis at time of diagnosis

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
progression free survival	after 5 years, and then through study completion, an average of 1 year

Trial Locations

Locations (35)

HELIOS Klinikum, Klinik für Hämatologie, Onkologie und Immunologie; 🇩🇪 Berlin, Germany

Charité Campus Benjamin Franklin, III. Med. Abt. (Hämatologie/Onkologie); 🇩🇪 Berlin, Germany

Klinikum Bielefeld, Klinik für Hämatologie, Onkologie und Palliativmedizin; 🇩🇪 Bielefeld, Germany

Medizinische Universitätsklinik, Knappschaftskrankenhaus; 🇩🇪 Bochum, Germany

Universitätsklinikum Bonn, Medizinische Klinik und Poliklinik III, Schwerpunkt Onkologie, Hämatologie und Rheumatologie; 🇩🇪 Bonn, Germany

Klinikum Chemnitz GmbH, Innere Medizin III; 🇩🇪 Chemnitz, Germany

Onkologisches Studienzentrum Darmstadt; 🇩🇪 Darmstadt, Germany

Klinikum Darmstadt, Med. Klinik V, Hämatologie/Onkologie; 🇩🇪 Darmstadt, Germany

Universitätsklinikum Düsseldorf, Klinik für Hämatologie,Onkologie und Klin. Immunologie; 🇩🇪 Düsseldorf, Germany

Universitätsklinik Erlangen; 🇩🇪 Erlangen, Germany

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