Myeloma Registry Platform (MYRIAM)

Studien-Informationen Einschlusskriterien Studien-Rationale Geprüfte Regime

Rekrutierend

NCT-Nummer:
NCT03308474

Studienbeginn:
September 2017

Letztes Update:
29.08.2023

Wirkstoff:
-

Indikation (Clinical Trials):
Multiple Myeloma, Neoplasms, Plasma Cell

Geschlecht:
Alle

Altersgruppe:
Erwachsene (18+)

Phase:
-

Sponsor:
iOMEDICO AG

Collaborator:
Deutsche Studiengruppe Multiples Myelom (DSMM)

Studienleiter

Hermann Einsele, Prof MD
Study Chair
Wuerzburg University Hospital

Monika Engelhardt, Prof MD
Study Chair
Universitätsklinikum Freiburg

Tobias Dechow, Prof MD
Study Chair
Onkologie Ravensburg

Wolfgang Knauf, Prof MD
Study Chair
Centrum für Hämatologie und Onkologie Bethanien

Norbert Marschner, MD
Study Chair
Praxis für interdisziplinäre Onkologie & Hämatologie

Kontakt

Martina Jänicke, PhD
Kontakt:
Phone: +49 761 15242-0
E-Mail: info@iomedico.de» Kontaktdaten anzeigen

Studienlocations
(1 von 1)

Multiple sites all over germany
Multiple Locations
GermanyRekrutierend» Google-Maps
Ansprechpartner:
iOMEDICO AG
Phone: +49 761 152420
E-Mail: info@iomedico.com» Ansprechpartner anzeigen

Studien-Informationen

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.

Ein-/Ausschlusskriterien

Inclusion Criteria:

- MM requiring systemic (first-, second- or third-line) treatment (closed for first-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

Studien-Rationale

Primary outcome:

1. Course of treatment (treatment reality) (Time Frame - 5 years per patient):
Documentation of anamnestic data and therapy sequences

Secondary outcome:

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)

Geprüfte Regime

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

Quelle: ClinicalTrials.gov

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