Multiple Myeloma
Conditions
Keywords
registry, longtime follow-up, elotuzumab, real world data
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will be observed while the patient is being treated with standard of care until death, lost to follow-up or consent withdrawn.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.
Interventions
None listed
Sponsors
Dietmar Hopp Stiftung
KKS Netzwerk
German Cancer Research Center
Prof. Dr. Hartmut Goldschmidt
Study design
Observational model
OTHER
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Previous participation in a a therapy study of the GMMG study group
Exclusion criteria
* patients with organ amyloidosis at time of diagnosis
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| progression free survival | after 5 years, and then through study completion, an average of 1 year |
Other
| Measure | Time frame | Description |
|---|---|---|
| overall survival | after 5 years, and then through study completion, an average of 1 year | — |
| follow-up time | after 5 years, and then through study completion, an average of 1 year | The follow-up time of a patient in the ITT is estimated using the reverse Kaplan-Meier method. It is defined as the time from the date of randomization to the last known contact. |
| cause of death | after 5 years, and then through study completion, an average of 1 year | — |
| therapy free time after first relapse and its treatment | after 5 years, and then through study completion, an average of 1 year | — |
Countries
Germany
Contacts
Primary ContactEileen Kurre
Outcome results
None listed