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NCT Number: NCT03308474

Myeloma Registry Platform (MYRIAM)

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.

Recruiting

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Routine care as per site standard.

Other

Physician's choice according to patient's needs.

Primary outcomes

  1. Course of treatment (treatment reality)

    Time frame: 5 years per patient

    Documentation of anamnestic data and therapy sequences

Secondary outcomes

  1. Best Response

    Time frame: 5 years per patient

    Documentation of response rates per line of treatment.

  2. Progression-free survival

    Time frame: 5 years per patient

    Documentation of progression-free survival per line of treatment.

  3. Overall survival

    Time frame: 5 years per patient

    Documentation of overall survival time.

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

    Time frame: 5 years per patient

    EORTC QLQ-C30 core questionnaire.

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

    Time frame: 5 years per patient

    EORTC QLQ-MY20, the myeloma specific module.

  6. Quality of life (Patient-reported outcome)

    Time frame: 5 years per patient

    Brief Pain Inventory (BPI)

Study contacts

Contact information is provided by the study sponsor or research team.

Martina Jänicke, PhD

CONTACT

[email protected]

+49 761 15242-0

Sponsors and collaborators

Lead sponsor

iOMEDICO AG

Industry

Collaborators

  • Deutsche Studiengruppe Multiples Myelom (DSMM)

Registry information

Official study title

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

Acronym: MYRIAM

Important dates

Study start
2017
Primary completion
2026
Study completion
2028
First posted
Oct 12, 2017
Registry last updated
Jul 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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