Multiple MyelomaMYRIAMNCT03308474
Myeloma Registry Platform (MYRIAM)
An observational study of Multiple Myeloma, run by iOMEDICO AG at 1 site in Germany.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Multiple Myeloma
- What is being tested?
- Routine care as per site standard.
- How many people
- 2,200 participants
- Where
- 1 siteGermany
- Study dates
- 25 Sep 2017to Dec 2028
- How long will I take part?
- 5 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult patients with multiple myeloma (MM) requiring systemic treatment
Who may be able to join
- 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
Who cannot join
- No systemic therapy for myeloma
- Patients already enrolled in studies that prohibit any participation in other studies
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Germany1 site, 1 recruiting
- Recruiting
Multiple sites all over germany
Multiple Sites
iOMEDICO AG, +49 761 152420, info@iomedico.com
About this study
Official title: Clinical Research Platform for Molecular Testing, Treatment and Outcome of Patients With Multiple Myeloma (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.
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.
- Conditions
- Multiple Myeloma
- Being tested
- Routine care as per site standard.
- Medical subject headings
- Multiple Myeloma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Routine care as per site standard.Other
Physician's choice according to patient's needs.
What is being measured
The primary outcome is the main question the study is designed to answer.
Course of treatment (treatment reality)
Documentation of anamnestic data and therapy sequences
Measured: 5 years per patient
Secondary outcomes (6)
Best Response
Documentation of response rates per line of treatment.
Measured: 5 years per patient
Progression-free survival
Documentation of progression-free survival per line of treatment.
Measured: 5 years per patient
Overall survival
Documentation of overall survival time.
Measured: 5 years per patient
Health-related quality of life (Patient-reported outcome)
EORTC QLQ-C30 core questionnaire.
Measured: 5 years per patient
Myeloma-specific health-related quality of life (Patient-reported outcome)
EORTC QLQ-MY20, the myeloma specific module.
Measured: 5 years per patient
Quality of life (Patient-reported outcome)
Brief Pain Inventory (BPI)
Measured: 5 years per patient
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Oct 2017
- Study start25 Sep 2017
- Primary completionDec 2026 (estimated)
- Study completionDec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Multiple MyelomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 2,200 participants (estimated)
- Target duration
- 5 Years
Sponsor and investigators
- Lead sponsor
- iOMEDICO AG
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Deutsche Studiengruppe Multiples Myelom (DSMM)
- Responsible party
- Sponsor
- Investigators
- Hermann Einsele, Prof MD, Study chair, Wuerzburg University HospitalMonika Engelhardt, Prof MD, Study chair, University Hospital FreiburgTobias Dechow, Prof MD, Study chair, Onkologie RavensburgWolfgang Knauf, Prof MD, Study chair, Centrum für Hämatologie und Onkologie BethanienNorbert Marschner, MD, Study chair, Praxis für interdisziplinäre Onkologie & Hämatologie
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03308474
- Sponsor's protocol ID
- iOM-060331
- Acronym
- MYRIAM
- Status last verified
- Jul 2026
- First submitted
- 25 Sep 2017
- Last updated
- 13 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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
Study at a glance
From the registry record, last updated by the sponsor on 13 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Research Platform for Molecular Testing, Treatment and Outcome of Patients With Multiple Myeloma (Myeloma Registry Platform; MYRIAM)
- ClinicalTrials.gov ID
- NCT03308474
- Acronym / sponsor ID
- MYRIAM / iOM-060331
- Conditions
- Multiple Myeloma
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 2,200 participants (estimated)
- Lead sponsor
- iOMEDICO AGIndustry (pharma, biotech, devices)
- Collaborators
- Deutsche Studiengruppe Multiples Myelom (DSMM)
- Study start
- 25 Sep 2017 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2028 (estimated)
- First posted
- 12 Oct 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 5 Years
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients with multiple myeloma (MM) requiring systemic treatment
Key inclusion criteria (6 listed)
- MM requiring systemic (first-, second- or third-line) treatment (closed for first-line / second-line recruitment)
- Age ≥ 18 years
- Written informed consent
- Sufficient German language skills for participation in the PRO satellite
Key exclusion criteria (2 listed)
- No systemic therapy for myeloma
- Patients already enrolled in studies that prohibit any participation in other studies
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Routine care as per site standard.Physician's choice according to patient's needs. | Other | – |
Primary outcome
Course of treatment (treatment reality)
Time frame: 5 years per patient
Documentation of anamnestic data and therapy sequences
6 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jul 2026.
- Derived from this study: PubMed 33218965Engelhardt 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Hermann Einsele, Prof MD study chair
Wuerzburg University Hospital
Monika Engelhardt, Prof MD study chair
University Hospital Freiburg
Tobias Dechow, Prof MD study chair
Onkologie Ravensburg
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Multiple Myeloma, run by iOMEDICO AG at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 13 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Martina Jänicke, PhD (+49 761 15242-0, info@iomedico.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Course of treatment (treatment reality) (time frame: 5 years per patient). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03308474, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jul 2026.