Myeloma Registry Platform (MYRIAM) (MYRIAM)

August 28, 2023 updated by: iOMEDICO AG

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Estimated)

2200

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Martina Jänicke, PhD
  • Phone Number: +49 761 15242-0
  • Email: info@iomedico.de

Study Locations

  • Germany
      • Multiple Locations, Germany
        • Recruiting
        • Multiple sites all over germany
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Adult patients with multiple myeloma (MM) requiring systemic treatment

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Course of treatment (treatment reality)
Time Frame: 5 years per patient
Documentation of anamnestic data and therapy sequences
5 years per patient

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

iOMEDICO AG

Collaborators

Deutsche Studiengruppe Multiples Myelom (DSMM)

Investigators

  • Study Chair: Hermann Einsele, Prof MD, Wuerzburg University Hospital
  • Study Chair: Monika Engelhardt, Prof MD, Universitatsklinikum Freiburg
  • Study Chair: Tobias Dechow, Prof MD, Onkologie Ravensburg
  • Study Chair: Wolfgang Knauf, Prof MD, Centrum fur Hamatologie und Onkologie Bethanien
  • Study Chair: Norbert Marschner, MD, Praxis für interdisziplinäre Onkologie & Hämatologie

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 25, 2017

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

December 1, 2028

Study Registration Dates

First Submitted

September 25, 2017

First Submitted That Met QC Criteria

October 11, 2017

First Posted (Actual)

October 12, 2017

Study Record Updates

Last Update Posted (Actual)

August 29, 2023

Last Update Submitted That Met QC Criteria

August 28, 2023

Last Verified

August 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • iOM-060331

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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