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RecruitingNCT03308474MYRIAMUpdated Jul 13, 2026

Myeloma Registry Platform (MYRIAM)

An observational study in Multiple Myeloma, sponsored by iOMEDICO AG. Recruiting at 1 site in Germany. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-07-13.

Sponsored by iOMEDICO AG · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
2,200
Ages
18 Years and older
Sex
All
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Study 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.

Read the 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.

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Conditions studied

  • Multiple Myeloma

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03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Adult patients with multiple myeloma (MM) requiring systemic treatment

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

Exclusion Criteria:

  • No systemic therapy for myeloma
  • Patients already enrolled in studies that prohibit any participation in other studies
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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
2,200 participants (estimated)
Target follow-up
5 Years
Patient registry
Yes

Interventions

  • OtherRoutine care as per site standard.

    Physician's choice according to patient's needs.

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What researchers measure

Primary outcomes

  1. Course of treatment (treatment reality)

    Documentation of anamnestic data and therapy sequences

    Time frame: 5 years per patient

Secondary outcomes

  1. Best Response

    Documentation of response rates per line of treatment.

    Time frame: 5 years per patient

  2. Progression-free survival

    Documentation of progression-free survival per line of treatment.

    Time frame: 5 years per patient

  3. Overall survival

    Documentation of overall survival time.

    Time frame: 5 years per patient

  4. Health-related quality of life (Patient-reported outcome)

    EORTC QLQ-C30 core questionnaire.

    Time frame: 5 years per patient

  5. Myeloma-specific health-related quality of life (Patient-reported outcome)

    EORTC QLQ-MY20, the myeloma specific module.

    Time frame: 5 years per patient

  6. Quality of life (Patient-reported outcome)

    Brief Pain Inventory (BPI)

    Time frame: 5 years per patient

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Study locations

1 of 1 sites recruiting
  • Multiple sites all over germany
    Multiple Sites, Germany
    Recruiting
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References and documents

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. PubMed 33218965 ↗

Individual participant data

Plan to share: No

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Registry details

Key details

Study ID
NCT03308474
Lead sponsor
iOMEDICO AG
Collaborators
Deutsche Studiengruppe Multiples Myelom (DSMM)
Responsible party
Sponsor
First posted
Oct 12, 2017
Start date
Sep 25, 2017
Primary completion
Dec 2026 (estimated)
Completion
Dec 2028 (estimated)
Last update
Jul 13, 2026

Study contacts

Martina Jänicke, PhD
Contact
info@iomedico.de
+49 761 15242-0
Hermann Einsele, Prof MD
study chair · Wuerzburg University Hospital
Monika Engelhardt, Prof MD
study chair · Universitätsklinikum Freiburg
Tobias Dechow, Prof MD
study chair · Onkologie Ravensburg
Wolfgang Knauf, Prof MD
study chair · Centrum für Hämatologie und Onkologie Bethanien
Norbert Marschner, MD
study chair · Praxis für interdisziplinäre Onkologie & Hämatologie

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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