NCT03308474

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2,200

participants targeted

Target at P75+ for all trials

Timeline
31mo left

Started Sep 2017

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress77%
Sep 2017Dec 2028

First Submitted

Initial submission to the registry

September 25, 2017

Completed
Same day until next milestone

Study Start

First participant enrolled

September 25, 2017

Completed
17 days until next milestone

First Posted

Study publicly available on registry

October 12, 2017

Completed
9.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2026

Expected
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2028

Last Updated

January 27, 2026

Status Verified

January 1, 2026

Enrollment Period

9.2 years

First QC Date

September 25, 2017

Last Update Submit

January 26, 2026

Conditions

Multiple Myeloma

Outcome Measures

Primary Outcomes (1)

  • Course of treatment (treatment reality)

    Documentation of anamnestic data and therapy sequences

    5 years per patient

Secondary Outcomes (6)

  • Best Response

    5 years per patient

  • Progression-free survival

    5 years per patient

  • Overall survival

    5 years per patient

  • Health-related quality of life (Patient-reported outcome)

    5 years per patient

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

    5 years per patient

  • +1 more secondary outcomes

Interventions

Routine care as per site standard.OTHER

Physician's choice according to patient's needs.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Adult patients with multiple myeloma (MM) requiring systemic treatment

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Multiple sites all over germany

Multiple Sites, Germany

RECRUITING

Related Publications (1)

  • 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: 33218965DERIVED

MeSH Terms

Conditions

Multiple Myeloma

Condition Hierarchy (Ancestors)

Neoplasms, Plasma CellNeoplasms by Histologic TypeNeoplasmsHemostatic DisordersVascular DiseasesCardiovascular DiseasesParaproteinemiasBlood Protein DisordersHematologic DiseasesHemic and Lymphatic DiseasesHemorrhagic DisordersLymphoproliferative DisordersImmunoproliferative DisordersImmune System Diseases

Study Officials

  • 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

    STUDY CHAIR

Central Study Contacts

Martina Jänicke, PhD

CONTACT

+49 761 15242-0info@iomedico.de

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
5 Years
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 25, 2017

First Posted

October 12, 2017

Study Start

September 25, 2017

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

December 1, 2028

Last Updated

January 27, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will not share

Locations

DE(1)