Clinical Research Platform for Molecular Testing, Treatment and Outcome of Patients With Multiple Myeloma (Myeloma Registry Platform; MYRIAM)
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- iOMEDICO AG
- Enrollment
- 2,200
- Locations
- 1
- Primary Endpoint
- Course of treatment (treatment reality)
Study Overview
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.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts 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
Outcomes
Primary Outcomes
Course of treatment (treatment reality)
Time Frame: 5 years per patient
Documentation of anamnestic data and therapy sequences
Secondary Outcomes
- Health-related quality of life (Patient-reported outcome)(5 years per patient)
- Best Response(5 years per patient)
- Progression-free survival(5 years per patient)
- Myeloma-specific health-related quality of life (Patient-reported outcome)(5 years per patient)
- Quality of life (Patient-reported outcome)(5 years per patient)
- Overall survival(5 years per patient)