About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
No systemic therapy for myeloma
Patients already enrolled in studies that prohibit any participation in other studies
Trial population
Adult patients with multiple myeloma (MM) requiring systemic treatment
Trial design
Cohort
Prospective
Treatments tested in this trial
Routine care as per site standard.
Other interventionPhysician's choice according to patient's needs.
Treatment groups
Trial outcomes
Primary outcomes
Course of treatment (treatment reality)
Documentation of anamnestic data and therapy sequences
Secondary outcomes
Best Response
Documentation of response rates per line of treatment.
Progression-free survival
Documentation of progression-free survival per line of treatment.
Overall survival
Documentation of overall survival time.
Health-related quality of life (Patient-reported outcome)
EORTC QLQ-C30 core questionnaire.
Locations
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Sponsors and contacts
Click on the lead sponsor to view all of their trials.
iOMEDICO AG
Lead sponsor
Deutsche Studiengruppe Multiples Myelom (DSMM)
Collaborator