Myeloma Registry Platform (MYRIAM)

Multiple Myeloma Clinical Trial

— MYRIAM  

Official title:

Clinical Research Platform for Molecular Testing, Treatment and Outcome of Patients With Multiple Myeloma (Myeloma Registry Platform; MYRIAM)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03308474
• Other study ID #: iOM-060331
• Status: Recruiting
• Start date: September 25, 2017
• Est. completion date: December 2028

Study information

• Verified date: August 2023
• Source: iOMEDICO AG
• Contact: Martina Jänicke, PhD
• Phone: +49 761 15242-0
• Email: info[@]iomedico.de
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 2200
• Est. completion date: December 2028
• Est. primary completion date: December 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

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

Related Conditions & MeSH terms

• Multiple Myeloma
• Neoplasms, Plasma Cell

Intervention

Other:
• Routine care as per site standard.
Physician's choice according to patient's needs.

Locations

Country	Name	City	State
Germany	Multiple sites all over germany	Multiple Locations

Sponsors (2)

Lead Sponsor	Collaborator
iOMEDICO AG	Deutsche Studiengruppe Multiples Myelom (DSMM)

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Course of treatment (treatment reality)	Documentation of anamnestic data and therapy sequences	5 years per patient
Secondary	Best Response	Documentation of response rates per line of treatment.	5 years per patient
Secondary	Progression-free survival	Documentation of progression-free survival per line of treatment.	5 years per patient
Secondary	Overall survival	Documentation of overall survival time.	5 years per patient
Secondary	Health-related quality of life (Patient-reported outcome)	EORTC QLQ-C30 core questionnaire.	5 years per patient
Secondary	Myeloma-specific health-related quality of life (Patient-reported outcome)	EORTC QLQ-MY20, the myeloma specific module.	5 years per patient
Secondary	Quality of life (Patient-reported outcome)	Brief Pain Inventory (BPI)	5 years per patient