Myeloma Registry Platform (MYRIAM)

iOMEDICO

Status: Enrolling

Conditions: Multiple Myeloma

Treatments: Other: Routine care as per site standard.

Study type: Observational

Funder types: Industry; Other

Identifiers

NCT03308474

iOM-060331

Details and patient eligibility

About

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.

Full 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.

Enrollment: 2,200 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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

Exclusion criteria

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