Myeloma Registry Platform (MYRIAM)

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Multiple Myeloma

Intervention / Treatment
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* Other: Routine care as per site standard.


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: Routine care as per site standard.|Physician's choice according to patient's needs.|

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

| Outcome Measure | 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. | 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 |