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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)

NCT05284591 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 96

Last updated 2024-10-01

No results posted yet for this study

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 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

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

Interventions

BIOLOGICAL

Daratumumab

intravenous or subcutaneous

Sponsors & Collaborators

  • iOMEDICO AG

    lead INDUSTRY

Principal Investigators

  • Wolfgang Knauf, Prof. Dr. · Centrum für Hämatologie und Onkologie Bethanien, Frankfurt/ Main

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-07-06
Primary Completion
2024-09-20
Completion
2024-09-20

Countries

  • Germany

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05284591 on ClinicalTrials.gov