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| Name | Class |
|---|---|
| Deutsche Studiengruppe Multiples Myelom (DSMM) | UNKNOWN |
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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.
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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Routine care as per site standard. | Other | Physician's choice according to patient's needs. |
| Measure | Description | Time Frame |
|---|---|---|
| Course of treatment (treatment reality) | Documentation of anamnestic data and therapy sequences | 5 years per patient |
| Measure | Description | Time Frame |
|---|---|---|
| Best Response | Documentation of response rates per line of treatment. | 5 years per patient |
| Progression-free survival | Documentation of progression-free survival per line of treatment. |
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Inclusion Criteria:
MM requiring systemic (first-, second- or third-line) treatment (closed for first-line / second-line recruitment)
Age ≥ 18 years
Written informed consent
Sufficient German language skills for participation in the PRO satellite
Exclusion Criteria:
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Adult patients with multiple myeloma (MM) requiring systemic treatment
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Martina Jänicke, PhD | Contact | +49 761 15242-0 | info@iomedico.de |
| Name | Affiliation | Role |
|---|---|---|
| Hermann Einsele, Prof MD | Wuerzburg University Hospital | Study Chair |
| Monika Engelhardt, Prof MD | Universitätsklinikum Freiburg | Study Chair |
| Tobias Dechow, Prof MD |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Multiple sites all over germany | Recruiting | Multiple Sites | Germany |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33218965 | Derived | Engelhardt M, Ihorst G, Singh M, Rieth A, Saba G, Pellan M, Lebioda A. Real-World Evaluation of Health-Related Quality of Life in Patients With Multiple Myeloma From Germany. Clin Lymphoma Myeloma Leuk. 2021 Feb;21(2):e160-e175. doi: 10.1016/j.clml.2020.10.002. Epub 2020 Oct 24. |
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| ID | Term |
|---|---|
| D009101 | Multiple Myeloma |
| ID | Term |
|---|---|
| D054219 | Neoplasms, Plasma Cell |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D020141 | Hemostatic Disorders |
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| 5 years per patient |
| Overall survival | Documentation of overall survival time. | 5 years per patient |
| Health-related quality of life (Patient-reported outcome) | EORTC QLQ-C30 core questionnaire. | 5 years per patient |
| Myeloma-specific health-related quality of life (Patient-reported outcome) | EORTC QLQ-MY20, the myeloma specific module. | 5 years per patient |
| Quality of life (Patient-reported outcome) | Brief Pain Inventory (BPI) | 5 years per patient |
| 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 Chair |
| D014652 |
| Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D010265 | Paraproteinemias |
| D001796 | Blood Protein Disorders |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D006474 | Hemorrhagic Disorders |
| D008232 | Lymphoproliferative Disorders |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |