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Myeloma Registry Platform (MYRIAM) (MYRIAM)

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ClinicalTrials.gov Identifier: NCT03308474
Recruitment Status : Recruiting
First Posted : October 12, 2017
Last Update Posted : January 10, 2019
Sponsor:
Collaborator:
Deutsche Studiengruppe Multiples Myelom (DSMM)
Information provided by (Responsible Party):
iOMEDICO AG

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.

Condition or disease Intervention/treatment
Multiple Myeloma Other: Routine care as per site standard.

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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Study Type : Observational
Estimated Enrollment : 2000 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Clinical Research Platform for Molecular Testing, Treatment and Outcome of Patients With Multiple Myeloma (Myeloma Registry Platform; MYRIAM)
Actual Study Start Date : September 25, 2017
Estimated Primary Completion Date : December 2026
Estimated Study Completion Date : December 2027

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Multiple Myeloma


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


Primary Outcome Measures :
  1. Course of treatment (treatment reality) [ Time Frame: 5 years per patient ]
    Documentation of anamnestic data and therapy sequences


Secondary Outcome Measures :
  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)



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Adult patients with multiple myeloma (MM) requiring systemic treatment
Criteria

Inclusion Criteria:

  • MM requiring systemic (first- or second-line) treatment
  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03308474


Contacts
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Contact: Martina Jänicke, PhD +49 761 15242-0 info@iomedico.de

Locations
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Germany
Multiple sites all over germany Recruiting
Multiple Locations, Germany
Contact: iOMEDICO AG    +49 761 152420    info@iomedico.com   
Sponsors and Collaborators
iOMEDICO AG
Deutsche Studiengruppe Multiples Myelom (DSMM)
Investigators
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Study Chair: Hermann Einsele, Prof MD Wuerzburg University Hospital
Study Chair: Monika Engelhardt, Prof MD Universitätsklinikum Freiburg
Study Chair: Tobias Dechow, Prof MD Onkologie Ravensburg
Study Chair: Wolfgang Knauf, Prof MD Centrum für Hämatologie und Onkologie Bethanien
Study Chair: Norbert Marschner, MD Praxis für interdisziplinäre Onkologie & Hämatologie

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Responsible Party: iOMEDICO AG
ClinicalTrials.gov Identifier: NCT03308474     History of Changes
Other Study ID Numbers: iOM-060331
First Posted: October 12, 2017    Key Record Dates
Last Update Posted: January 10, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Multiple Myeloma
Neoplasms, Plasma Cell
Neoplasms by Histologic Type
Neoplasms
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Paraproteinemias
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Lymphoproliferative Disorders
Immunoproliferative Disorders
Immune System Diseases