Clinical trial · Observational
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
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (6)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Multiple Myeloma | Multiple Myeloma | CURATED_EXACT | 0.92 |
| Newly Diagnosed | — | UNRESOLVED | — |
| Patient Preference | — | UNRESOLVED | — |
| Patient Satisfaction | — | UNRESOLVED | — |
| Personal Satisfaction | — | UNRESOLVED | — |
| Transplant Ineligible | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Daratumumab | Biological | Daratumumab | ALIAS |
Design
Arms and outcomes
Arms (2)
- label
- DRd with daratumumab iv de novo
- description
- Patients either continue DRd with daratumumab iv, switch to daratumumab sc or switch multiple times iv/sc
- interventionNames
- Biological: Daratumumab
- label
- DRd with daratumumab sc de novo
- description
- Patients either continue DRd with daratumumab sc, switch to daratumumab iv or switch multiple times sc/iv
- interventionNames
- Biological: Daratumumab
Primary outcomes (1)
- measure
- Patient Satisfaction and Time with the application route of daratumumab (iv/sc)
- timeFrame
- For patients with continuous application route the time frame will be 12 months. For patients with switch of application route, at least 4 daratumumab applications after the first switch should be documented.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * 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 Criteria: * 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
References
Publications (0)
Data not yet available