Clinical trial NCT03308474: Myeloma Registry Platform (MYRIAM)
Official title: Clinical Research Platform for Molecular Testing, Treatment and Outcome of Patients With Multiple Myeloma (Myeloma Registry Platform; MYRIAM)
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Multiple Myeloma
Lead sponsor: iOMEDICO AG
Sponsor class: INDUSTRY
Collaborators: name: Deutsche Studiengruppe Multiples Myelom (DSMM)
First posted: 2017-10-12
Enrollment: 2200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult patients with multiple myeloma (MM) requiring systemic treatment

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.

Eligibility criteria: 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

Primary outcomes:
measure: Course of treatment (treatment reality)
timeFrame: 5 years per patient
Secondary outcomes:
measure: Best Response
timeFrame: 5 years per patient
measure: Progression-free survival
timeFrame: 5 years per patient
measure: Overall survival
timeFrame: 5 years per patient
measure: Health-related quality of life (Patient-reported outcome)
timeFrame: 5 years per patient
measure: Myeloma-specific health-related quality of life (Patient-reported outcome)
timeFrame: 5 years per patient
measure: Quality of life (Patient-reported outcome)
timeFrame: 5 years per patient
Other outcomes:
Locations:
city: Multiple Locations
country: Germany
facility: Multiple sites all over germany
Study officials:
affiliation: Wuerzburg University Hospital
name: Hermann Einsele, Prof MD
role: STUDY_CHAIR
affiliation: Universitätsklinikum Freiburg
name: Monika Engelhardt, Prof MD
role: STUDY_CHAIR
affiliation: Onkologie Ravensburg
name: Tobias Dechow, Prof MD
role: STUDY_CHAIR
affiliation: Centrum für Hämatologie und Onkologie Bethanien
name: Wolfgang Knauf, Prof MD
role: STUDY_CHAIR
affiliation: Praxis für interdisziplinäre Onkologie & Hämatologie
name: Norbert Marschner, MD
role: STUDY_CHAIR
References:
citation: 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.