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 | Completed

• 1 other identifier: 54767414MMY4047
• Study Type: observational
• Target: 96
• Locations: 1 country
• Sites: 1

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 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

Keywords

Daratumumab; DARZALEX; Lenalidomide; Dexamethasone

Outcome Measures

Primary Outcomes (1)

• Patient Satisfaction and Time with the application route of daratumumab (iv/sc)

  The primary objective of this NIS is to exploratively analyze patients' satisfaction of sc and iv application of daratumumab over time as measured by the "Patient Satisfaction and Time Questionnaire" (PatSTQ). Overall patients´ satisfaction with daratumumab administration will be displayed as the result of one defined question in the PatSTQ, with descriptive statistics and boxplots. Results of PatSTQ will be displayed with frequencies per group and by time point. Additionally, stacked bar plots with questionnaire results (including missings) per item and time point will be presented

  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.

Secondary Outcomes (9)

• HCP satisfaction and time with the application route of daratumumab (iv/sc)

  Time frame will be approx. 12 months depending on switch of application route.

• Proportion of HCP active time spent on activities

  Time frame will be approx. 12 months depending on switch of application route.

• Patients' chair time over time

  Time frame will be approx. 12 months depending on switch of application route.

• Patients' overall time spent at doctor's office

  Time frame will be approx. 12 months depending on switch of application route.

• Switch rate (proportion of patients) of daratumumab application routes

  Time frame will be approx. 12 months depending on switch of application route.

Other Outcomes (1)

• Safety and tolerability of daratumumab treatment. Occurence and number of patients with adverse events as assessed by CTCAE.

  Time frame will be approx. 12 months depending on switch of application route. (On-treatment period: from day of first dose of daratumumab to 30 days after last dose of daratumumab, or end of documentation period, whatever comes first.)

Study Arms (2)

DRd with daratumumab iv de novo

Patients either continue DRd with daratumumab iv, switch to daratumumab sc or switch multiple times iv/sc

Biological: Daratumumab

DRd with daratumumab sc de novo

Patients either continue DRd with daratumumab sc, switch to daratumumab iv or switch multiple times sc/iv

Biological: Daratumumab

Interventions

Daratumumab BIOLOGICAL

intravenous or subcutaneous

Also known as: Darzalex

DRd with daratumumab iv de novo; DRd with daratumumab sc de novo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

MYLENE is focusing on the satisfaction of all involved stakeholders (i.e., patients and HCPs) mainly in private practices, since this patient collective is treated preferentially in these institutions, allowing to receive direct feedback about the use of daratumumab sc application and its potential hurdles or/and limitations.

You may qualify if:

• 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)).

You may not qualify if:

• 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

Sponsors & Collaborators

• iOMEDICO AG: lead

Study Sites (1)

Centrum für Hämatologie und Onkologie Bethanien

Frankfurt am Main, Hesse, 60389, Germany

Location

MeSH Terms

Conditions

Multiple Myeloma; Patient Satisfaction; Patient Preference; Personal Satisfaction

Interventions

daratumumab

Condition Hierarchy (Ancestors)

Neoplasms, Plasma Cell; Neoplasms by Histologic Type; Neoplasms; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Paraproteinemias; Blood Protein Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemorrhagic Disorders; Lymphoproliferative Disorders; Immunoproliferative Disorders; Immune System Diseases; Treatment Adherence and Compliance; Health Behavior; Behavior

Study Officials

• Wolfgang Knauf, Prof. Dr.

  Centrum für Hämatologie und Onkologie Bethanien, Frankfurt/ Main

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 17, 2022
• First Posted: March 17, 2022
• Study Start: July 6, 2022
• Primary Completion: September 20, 2024
• Study Completion: September 20, 2024
• Last Updated: October 1, 2024

Record last verified: 2024-09

Locations

DE (1)