Status:
COMPLETED
Non-interventional Study to Evaluate Patient and Healthcare Provider Satisfaction of Daratumumab Use in the Treatment of First-line Daratumumab, Lenalidomide, Dexamethasone (DRd) Multiple Myeloma Patients in Germany Depending on Application Route (sc or iv)
Lead Sponsor:
iOMEDICO AG
Conditions:
Multiple Myeloma
Newly Diagnosed
Eligibility:
All Genders
18+ years
Brief Summary
MYLENE is a prospective, multicenter, NIS to evaluate the patient and HCP satisfaction of sc and iv application of daratumumab in routine clinical practice in Germany. Patients observed in this study ...
Detailed Description
Therapy options for MM are mainly dependent on the age and fitness of the patients. NDMM patients up to the age of 65-70 years in whom autologous stem cell transplantation is not indicated, anti-myelo...
Eligibility Criteria
Inclusion
- Patients aged 18 years or older
- Newly diagnosed multiple myeloma (NDMM) and decision for first-line treatment with daratumumab/lenalidomide/dexamethasone (DRd) according to SmPCs of daratumumab
- Each patient must sign an informed consent form (ICF) indicating that he or she understands the purpose of the study and is willing to participate in the study
- Willingness and ability to read, understand and complete patients' questionnaires due to the primary objective of the NIS (i.e., patient satisfaction using the Patient Satisfaction and Time Questionnaire (PatSTQ)).
Exclusion
- Participation in an interventional clinical trial (participation in another non-Janssen sponsored NIS or registry is allowed)
- Prior anti-myeloma therapy, with the exception of local radiation therapy or an emergency use of a short course of corticosteroids before treatment
- Any restrictions/limitations preventing to be treated with DRd as per SmPCs of daratumumab
Key Trial Info
Start Date :
July 6 2022
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
September 20 2024
Estimated Enrollment :
96 Patients enrolled
Trial Details
Trial ID
NCT05284591
Start Date
July 6 2022
End Date
September 20 2024
Last Update
October 1 2024
Active Locations (1)
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1
Centrum für Hämatologie und Onkologie Bethanien
Frankfurt am Main, Hesse, Germany, 60389