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NCT Number: NCT05001087

A "Physician & Patient-powered" Cohort Registry (MY MYELOMA)

The aim of this observational study is the creation of a national multiple myeloma registry to monitor the current routine clinical practice in Italy and describe the standard of care adopted for the diagnosis and treatment of patients with multiple myeloma in the different Italian hematology centers.

Recruiting

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

A.O.U di Careggi, Florence, Firenze, Italy

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About this study

In Italy, myeloma accounts for 1.3% of all tumour diagnoses in males and for 1.2% of all tumour diagnoses in women. The incidence is 9.5 new cases per 100,000 males and 8.1 cases per 100,000 females. Median age at diagnosis is 68 years and approximately 2% of patients experience onset before the age of 4011. Therefore is to establish a national disease registry to monitor current routine clinical practice in Italy and to describe the standard of care adopted for the diagnosis and treatment of patients with myeloma. National registries have already been established in some countries and a recently-published meta-analysis highlighted certain differences in treatment, survival and the demographic characteristics of patients. An Italian national registry is important for analysing the current situation, in order to deal with the changes that lie ahead. In addition to the standard epidemiological registry - as described in the statistical methods section - a patientpowered registry (PPR) will also be established to encourage patient participation.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients of both sexes
  • Age ≥ 18 years
  • Diagnosis of active/symptomatic multiple myeloma (according to CRAB and biological parameters) no earlier than 1st January 2019
  • Able and willing to sign an informed consent form

Exclusion criteria

  • None considered

Treatment and study plan

observation

Other

Not applicable-Observational study

Primary outcomes

  1. Overall survival (OS)

    Time frame: 3 years

    Time between diagnosis and death.

  2. Time to next treatment (TTNT)

    Time frame: 3 years

    Time to next treatment will be measured from the screening to the date of next anti-myeloma therapy, for each treatment regime.

Secondary outcomes

  1. Patient reported outcomes (PROs)

    Time frame: 3 years

    Periodic completion of the EORTC-QLQ-C30 to evaluate the quality of life of the patients.

  2. Costs incurred by the patients

    Time frame: 3 years

    Evaluation of the costs incurred by the patients related to the therapy based on the different treatments.

Study contacts

Contact information is provided by the study sponsor or research team.

Mario Boccadoro

CONTACT

[email protected]

+390110243236

Sponsors and collaborators

Lead sponsor

Fondazione EMN Italy Onlus

Other

Collaborators

  • Amgen
  • Bristol-Myers Squibb
  • GlaxoSmithKline
  • Janssen-Cilag S.p.A.
  • Sanofi
  • Takeda

Registry information

Official study title

A "Physician & Patient-powered" Cohort Registry

Acronym: MY MYELOMA

Important dates

Study start
2021
Primary completion
2027
Study completion
2027
First posted
Aug 11, 2021
Registry last updated
Feb 27, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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