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)

Sponsor
iOMEDICO AG
Study ID
NCT05284591
Status
Completed

Conditions

  • Multiple Myeloma
  • Newly Diagnosed
  • Patient Preference
  • Patient Satisfaction
  • Personal Satisfaction
  • Transplant Ineligible

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

Study Details

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.

Key Dates

Start date
Jul 6, 2022
Status verified
Sep 2024
Primary completion
Sep 20, 2024
Completion
Sep 20, 2024

Study Design

Enrollment
96 participants (actual)

Arms

  • Arm: DRd with daratumumab iv de novo
    Patients either continue DRd with daratumumab iv, switch to daratumumab sc or switch multiple times iv/sc
  • Arm: DRd with daratumumab sc de novo
    Patients either continue DRd with daratumumab sc, switch to daratumumab iv or switch multiple times sc/iv

Primary Outcome Measure

Patient Satisfaction and Time with the application route of daratumumab (iv/sc) [ Time Frame: 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. ]

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