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Recruiting NCT03308474

Myeloma Registry Platform (MYRIAM)

— Observational Multiple Myeloma

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Routine care as per site standard..
Who it may be relevant to
Registry conditions: Multiple Myeloma. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Germany
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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

  • Other Routine care as per site standard.
    Physician's choice according to patient's needs.

Primary outcome measures

  • Course of treatment (treatment reality) [Time frame: 5 years per patient]
Secondary outcome measures (6)
  • Best Response [Time frame: 5 years per patient]
  • Progression-free survival [Time frame: 5 years per patient]
  • Overall survival [Time frame: 5 years per patient]
  • Health-related quality of life (Patient-reported outcome) [Time frame: 5 years per patient]
  • Myeloma-specific health-related quality of life (Patient-reported outcome) [Time frame: 5 years per patient]
  • Quality of life (Patient-reported outcome) [Time frame: 5 years per patient]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

Germany · 1 center
  • Multiple sites all over germany — Multiple Sites

Publications

  • 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. PMID 33218965

Identifiers

NCT: NCT03308474 · iOM-060331

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗