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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05001087
Recruitment Status : Recruiting
First Posted : August 11, 2021
Last Update Posted : August 11, 2021
Sponsor:
Information provided by (Responsible Party):
Fondazione EMN Italy Onlus

Brief Summary:
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.

Condition or disease Intervention/treatment
Multiple Myeloma Other: Observation

Detailed Description:
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.

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 1900 participants
Observational Model: Cohort
Time Perspective: Other
Target Follow-Up Duration: 3 Years
Official Title: A "Physician & Patient-powered" Cohort Registry
Actual Study Start Date : March 1, 2021
Estimated Primary Completion Date : March 1, 2024
Estimated Study Completion Date : March 1, 2024

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Multiple Myeloma

Group/Cohort Intervention/treatment
Patients registry

Non-interventional, multicentre, retrospective and prospective registry. In order to increase the sample size and the validity of the Registry, patients who were diagnosed with myeloma since 1st January 2019 will also be included retrospectively, once their informed consent has been obtained by the enrolling centre. Being a registry, patients will be enrolled consecutively according to their appointments at the centre, at the discretion of their doctor and only once the patient has signed the informed consent form.

Also patients participating in interventional or other observational studies can be enrolled. In case of patients enrolled in interventional trials, only baseline and survival data can be collected for the period in with the patient is in interventional trial.

The data will be collected using an electronic data capture (EDC) platform. Hospital visits are planned every 6 months.

Other: Observation
Not applicable-Observational study




Primary Outcome Measures :
  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 Outcome Measures :
  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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
The registry will include approximately 30 Italian haematology facilities. On the basis of the centres' enrolment capacity and incidence and epidemiology data it is reasonable to presume that at least 1900 patients will be enrolled in 3 years. Only patients who meet the eligibility criteria will be included in the registry.
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05001087


Contacts
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Contact: Mario Boccadoro +390110243236 clinicaltrialoffice@emnitaly.org

Locations
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Italy
AOU Ospedali Riuniti Umberto I Recruiting
Ancona, Italy
Contact: Massimo Offidani         
Policlinico S. Orsola Recruiting
Bologna, Italy
Contact: Michele Cavo         
AOU Policlinico Vittorio Emanuele Recruiting
Catania, Italy
Contact: Francesco Di Raimondo         
Istituto Nazionale Tumori Recruiting
Milano, Italy
Contact: Paolo Corradini         
Ospedale Maggiore Recruiting
Novara, Italy
Contact: Lorenzo De Paoli         
Policlinico Umberto I - Università La Sapienza Not yet recruiting
Roma, Italy
Contact: Maurizio Martelli         
IRCCS Ospedale Casa Sollievo della Sofferenza Recruiting
San Giovanni Rotondo, Italy
Contact: Nicola Cascavilla         
A.O. Santa Maria Recruiting
Terni, Italy
Contact: Anna Marina Liberati         
AOU Città della Salute e della Scienza di Torino Recruiting
Torino, Italy
Contact: Alessandra Larocca         
Policlinico Universitario di Udine Recruiting
Udine, Italy
Contact: Francesca Patriarca         
Sponsors and Collaborators
Fondazione EMN Italy Onlus
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Responsible Party: Fondazione EMN Italy Onlus
ClinicalTrials.gov Identifier: NCT05001087    
Other Study ID Numbers: 535/2020
First Posted: August 11, 2021    Key Record Dates
Last Update Posted: August 11, 2021
Last Verified: August 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Multiple Myeloma
Neoplasms, Plasma Cell
Neoplasms by Histologic Type
Neoplasms
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Paraproteinemias
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Lymphoproliferative Disorders
Immunoproliferative Disorders
Immune System Diseases