A Study to Evaluate Preventive Treatments for GPRC5D-related Oral Events
NCT06500884
Blood Protein Disorders, Cardiovascular Diseases
San Francisco, California, United States
View Trial DetailsNCT Number: NCT07111884
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.
Interested in participating?
Request Info18 year and older
All sexes
Observational
Charité Campus Benjamin Franklin, III. Med. Abt. (Hämatologie/Onkologie), Berlin, Germany
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will be observed while the patient is being treated with standard of care until death, lost to follow-up or consent withdrawn.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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Time frame: after 5 years, and then through study completion, an average of 1 year
Time frame: after 5 years, and then through study completion, an average of 1 year
Time frame: 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.
Time frame: after 5 years, and then through study completion, an average of 1 year
Time frame: after 5 years, and then through study completion, an average of 1 year
Contact information is provided by the study sponsor or research team.
Prof. Dr. Hartmut Goldschmidt
Other
National, Observational, Non-interventional, Retro- and Prospective Clinical Multiple Myeloma Registry GMMG
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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