Multiple Myeloma
Conditions
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.
Interventions
Physician's choice according to patient's needs.
Sponsors
iOMEDICO AG
Deutsche Studiengruppe Multiples Myelom (DSMM)
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Course of treatment (treatment reality) | 5 years per patient | Documentation of anamnestic data and therapy sequences |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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) |
Countries
Germany
Contacts
CONTACTMartina Jänicke, PhD
STUDY_CHAIRHermann Einsele, Prof MD
Wuerzburg University Hospital
STUDY_CHAIRMonika Engelhardt, Prof MD
Universitätsklinikum Freiburg
STUDY_CHAIRTobias Dechow, Prof MD
Onkologie Ravensburg
STUDY_CHAIRWolfgang Knauf, Prof MD
Centrum für Hämatologie und Onkologie Bethanien
STUDY_CHAIRNorbert Marschner, MD
Praxis für interdisziplinäre Onkologie & Hämatologie
Outcome results
None listed