NCT05284591Completed
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)
Prospective, Multicenter, 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 as Per Routine Clinical Practice in Germany Depending on Application Route (sc or iv)
Source: ClinicalTrials.gov · Last updated 1 Oct 2024
Brief summary (registry, in English)
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 will be transplant ineligible NDMM patients for which the physician foresees an anti-myeloma therapy using DRd regimen as per local label. 250 NDMM patients treated with DRd will be enrolled (excluding screening failures, i.e., enrolled patients not fulfilling selection criteria identified before treatment start will be replaced) within 12 months in a proportion of approximately 1/3 patients receiving daratumumab sc and 2/3 patients receiving daratumumab iv as per physician's decision.
- Status (registry)
- Completed
- Study type
- Observational
- Enrollment
- 96 (actual)
- First submitted
- 17 Feb 2022
- Start date
- 6 Jul 2022
- Primary completion date
- 20 Sept 2024
- Lead sponsor
- iOMEDICO AG
- Diseases
- Multiple myeloma
- NCT number
- NCT05284591
What you commit to
- Study type: Observational
- Participants enrolled: 96
- From 6 Jul 2022 to the primary completion date, 20 Sept 2024
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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
Other
- Participation in an interventional clinical trial (participation in another non-Janssen sponsored NIS or registry is allowed)
Who the study is looking for
- 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)).
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Centrum für Hämatologie und Onkologie Bethanien Coordinator of this site? Confirm its status | Frankfurt am Main | Germany | Unknown status |
Related publications
- Patient and Healthcare Provider Satisfaction With Subcutaneous Versus Intravenous Administration of Daratumumab in Combination With Lenalidomide and Dexamethasone as First-Line Treatment in Patients With Newly Diagnosed Non-Transplant Eligible Multiple Myeloma: Final Results of the MYLENE Study.Eur J Haematol · 2026 · PMID 42820722
This page is information, not medical advice. Discuss any trial with your doctor.