Myeloma Registry Platform (MYRIAM)

Recruiting

• Conditions: Multiple Myeloma

• Registration Number: NCT03308474
• Lead Sponsor: iOMEDICO AG

Brief Summary

The purpose of the project is to set up a national, prospective, longitudinal, multicenter cohort study with associated satellites, a tumor registry platform, to document uniform data on characteristics, molecular diagnostics, treatment and course of disease, to collect patient-reported outcomes and to establish a decentralized biobank for patients with Multiple Myeloma in Germany.

Detailed Description

MYRIAM is a national, observational, prospective, longitudinal, multicenter cohort study (tumor registry platform) with the purpose to record information on the antineoplastic treatment of multiple myeloma in Germany. The registry will follow patients for up to five years. It will identify common therapeutic sequences and changes in the treatment of the disease. At inclusion, data in patient characteristics, comorbidities, tumor characteristics and previous treatments are collected. During the course of observation data on all systemic treatments, radiotherapies, surgeries, and outcome are documented.

Health-realted quality of life in patients with multiple myeloma (MyLife) will be evaluated for up to five years.

Study Timeline

• Study Start: 2017-09-25
• Study First Submitted: 2017-09-25
• Study First Submitted QC: 2017-10-11
• Study First Posted: 2017-10-12
• Status Verified: 2024-10
• Last Update Submitted: 2024-10-11
• Last Update Posted: 2024-10-15
• Primary Completion: 2026-12
• Study Completion: 2028-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 2200

Inclusion Criteria

• MM requiring systemic (first-, second- or third-line) treatment (closed for first-line / second-line recruitment)

• Age ≥ 18 years

• Written informed consent

  • Patients participating in the PRO satellite: signing of informed consent and completion of baseline questionnaire before, but not more than eight weeks before the start of respective systemic treatment
  • Patients not participating in the PRO satellite: signing of informed consent not later than four weeks after start of respective treatment, and not more than eight weeks before the start of respective systemic treatment

• Sufficient German language skills for participation in the PRO satellite

Exclusion Criteria

• No systemic therapy for myeloma
• Patients already enrolled in studies that prohibit any participation in other studies

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Course of treatment (treatment reality)	5 years per patient	Documentation of anamnestic data and therapy sequences

Secondary Outcome Measures

Name	Time	Method
Health-related quality of life (Patient-reported outcome)	5 years per patient	EORTC QLQ-C30 core questionnaire.
Best Response	5 years per patient	Documentation of response rates per line of treatment.
Progression-free survival	5 years per patient	Documentation of progression-free survival per line of treatment.
Myeloma-specific health-related quality of life (Patient-reported outcome)	5 years per patient	EORTC QLQ-MY20, the myeloma specific module.
Quality of life (Patient-reported outcome)	5 years per patient	Brief Pain Inventory (BPI)
Overall survival	5 years per patient	Documentation of overall survival time.

Trial Locations

Locations (1)

Multiple sites all over germany; 🇩🇪 Multiple Locations, Germany