Myeloma Registry Platform (MYRIAM)
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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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 Design
Outcome Measures
Primary Outcome Measures
- Course of treatment (treatment reality) [5 years per patient]
Documentation of anamnestic data and therapy sequences
Secondary Outcome Measures
- 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.
- Overall survival [5 years per patient]
Documentation of overall survival time.
- Health-related quality of life (Patient-reported outcome) [5 years per patient]
EORTC QLQ-C30 core questionnaire.
- 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)
Eligibility Criteria
Criteria
Inclusion Criteria:
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MM requiring systemic (first-, second- or third-line) treatment
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Age ≥ 18 years
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Written informed consent
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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
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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
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Sufficient German language skills for participation in the PRO satellite
Exclusion Criteria:
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No systemic therapy for myeloma
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Patients already enrolled in studies that prohibit any participation in other studies
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Multiple sites all over germany | Multiple Locations | Germany |
Sponsors and Collaborators
- iOMEDICO AG
- Deutsche Studiengruppe Multiples Myelom (DSMM)
Investigators
- Study Chair: Hermann Einsele, Prof MD, Wuerzburg University Hospital
- Study Chair: Monika Engelhardt, Prof MD, Universitätsklinikum Freiburg
- Study Chair: Tobias Dechow, Prof MD, Onkologie Ravensburg
- Study Chair: Wolfgang Knauf, Prof MD, Centrum für Hämatologie und Onkologie Bethanien
- Study Chair: Norbert Marschner, MD, Praxis für interdisziplinäre Onkologie & Hämatologie
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- iOM-060331