MORE - Monitoring Revlimid - Collecting of Patient Information From Myelodysplastic Syndrome (MDS) Italian National Registry (MORE)

November 14, 2019 updated by: Celgene

Observational, Non-interventional, Multicenter Study Aimed at Collecting Retrospective/Prospective 648/96 Italian Registry Data Related to Lenalidomide (Revlimid®) Prescription to Patients With Myelodysplastic Syndromes

The purpose of this study is to collect clinical and laboratory data for patients affected by intermediate 1 and low risk Myelodysplastic Syndrome (MDS) associated by deletion 5q who were prescribed Revlimid from 31October 2008 to present. Revlimid is available in Italy for these patients since October 2008 based on a local disposition of the Italian Drug Agency (AIFA) issued according to a National law named 648/96.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

There will be retrospective collection and integration of clinical laboratory data as well as prospective data collection on the same patients.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
149

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Alessandria, Italy, 15121
        • Dipartimento Onco - Ematologico Azienda Ospedaliera SS Antonio, Biagio e Cesare Arrigo
      • Ancona, Italy, 60100
        • Unità Operativa Clinica di Ematologia Azianda Ospedaliero Universitaria Ospedali Riuniti di Ancona
      • Asti, Italy, 14100
        • Dipartimento di Oncologia Medica Ospedale Cardinale G. Massaia
      • Bari, Italy, 70124
        • Ematologia Azienda Ospedaliera Universitaria Policlinico di Bari
      • Belluno, Italy, 32100
        • Dipartimento di Ematologia Ospedale dell'U.L.S.S. n.1 Belluno
      • Bergamo, Italy, 24128
        • Ematologia A.O. Ospedale Riuniti di Bergamo
      • Biella, Italy, 13900
        • Dip. Medicina Interna Ospedale degli Infermi di Biella
      • Brescia, Italy, 25123
        • Dipartimento di Ematologia Spedale Civili di Brescia
      • Brescia, Italy, 25123
        • Dipartimento Trapianto di Midollo Allogenico Spedale Civili di Brescia
      • Cagliari, Italy, 09126
        • Dipartimento di Ematologia Ospedale R. Binaghi
      • Caserta, Italy, 81100
        • Dip. Di Oncoematologia A.O. S.Anna e S. Sebastiano
      • Cremona, Italy, 26100
        • Dip. Di Ematologia A.O. Istituti Ospedalieri
      • Firenze, Italy, 50139
        • Dip. Di Ematologia Az. Ospedaliero-Universitaria Careggi
      • Genova, Italy, 10-1632
        • Dip. Di Ematologia A.O. Universitaria S. Martino
      • Genova, Italy, 10-1632
        • Dip. Di Medicina Interna A.O. Universitaria S. Martino
      • Giovanni Rotondo, Italy, 71013
        • Struttura di Ematologia, Dip. di Oncoematologia IRCCS Casa Sollievo della Sofferenza
      • Lecce, Italy, 73100
        • Dip. Di Ematologia Azienda Ospedaliera V. Fazzi
      • Milano, Italy, 20122
        • Centro Trapianti di Midollo Ospedale Maggiore Policlinico
      • Modena, Italy, 41124
        • Dip. Di Ematologia Policlinico, Az. Ospedaliero- Universitaria
      • Monza, Italy, 20052
        • Dip. Di Ematologia Azienda Ospedaliera S. Gerardo
      • Napoli, Italy, 80131
        • Dip. Di Oncoematologia A.O. Universitaria Federico II
      • Nocera Inferiore, Italy, 84014
        • Dip. Di Ematologia Presidio Ospedaliero Umberto I
      • Nuoro, Italy, 08100
        • Dip. Di Ematologia Ospedale S. Francesco
      • Padova, Italy, 35127
        • Dip. di Ematologia Azienda Ospedaliera
      • Parma, Italy, 43100
        • Dip. di Ematologia Azienda Ospedaliera
      • Perugia, Italy, 06156
        • Dip. Di Ematologia Azienda Ospedaliera - Osp. S. Maria della Misericordia
      • Pesaro, Italy, 61100
        • Dip. Di Ematologia Azienda Ospedaliera s. Salvatore
      • Potenza, Italy, 85100
        • Dip. Di Ematologia Az. Ospedaliera Regionale S. Carlo
      • Reggio Emilia, Italy, 42100
        • Servizio di Ematologia - Dip. di Oncologia Az. Ospedaliera di Reggio Emilia - Arcispedale S. Maria Nuova
      • Revenna, Italy, 48100
        • Dip. Di Ematologia Ospedale S. Maria delle Croci
      • Roma, Italy, 00133
        • U. O. Ematologia Az. Ospedaliero-Universitaria Policlinico Tor Vergata
      • Roma, Italy, 00144
        • U.O.C Ematologia Ospedale S. Eugenio, Piazzale dell'Umanesimo
      • Roma, Italy, 00161
        • Dip. di Ematologia Policlinico Umberto I
      • Roma, Italy, 00168
        • U.O.C. Ematologia Policlinico Universitario Gemelli
      • Rossano, Italy, 87068
        • Dip. di Oncoematologia Ospedale Civile Giannettasio
      • Rovigo, Italy, 45100
        • Dip. di Oncoematologia Az. ULSS 18
      • Sassari, Italy, 07100
        • Dip. di Ematologia Policlinico Universitario di Sassari
      • Sienna, Italy, 53100
        • Divisione di Ematologia e Trapianti Spedali Riuniti
      • Torino, Italy, 10126
        • Dip. di Ematologia 1 A.O. Universitaria S.Giovanni Battista
      • Torino, Italy, 10126
        • Dip. di Ematologia 2 A.O. Universitaria S.Giovanni Battista
      • Torino, Italy, 10128
        • Dip. di Ematologia e Terapie Cellulari Ospedale Mauriziano Umberto I
      • Treviso, Italy, 31033
        • Unità Operativa Trasfusionale ed Immunologia Centro di riferimento per le malattie rare e centro regionale per le malattie del sangue Ospedale S. Giacomo Apostolo
      • Venezia, Italy, 30174
        • Ospedale Dell'Angelo USL12 - Venezia (Mestre)
      • Vicenza, Italy, 36100
        • Dip. Funzionale di Terapie Cellulari e Ematologia Azienda Sanitaria ULSS 6 - Osp. di Vicenza
      • Viterbo, Italy, 01100
        • Dip. Di Ematologia Ospedale di Belcolle

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients affected by intermediate-1 and low risk MDS associated by deletion 5q who were prescribed Revlimid from 31October 2008 to present.

Description

Inclusion Criteria:

  • intermediate 1 and low risk MDS patients associated with:

    1. transfusion dependency anemia (at least 2 units per 8 weeks before starting of Revlimid treatment )

    2. 5q31-33 deletion isolated or associated to other chromosomal abnormalities.

      Exclusion Criteria:

  • patients with serum creatinine > 2.5mg/dl
  • child bearing potential females who do not use adequate contraceptive methods

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Number of subjects achieving red blood cell (RBC) transfusion independence
Time Frame: 14 months
14 months
Number of subjects achieving an erythroid response
Time Frame: 14 months
14 months
Number of subjects achieving a cytogenetic response
Time Frame: 14 months
14 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
Number of participants with adverse events
Time Frame: 14 months
14 months
Duration of RBC transfusion independence
Time Frame: 14 months
14 months
Duration of cytogenetic response
Time Frame: 14 months
14 months
Time to RBC transfusion independence
Time Frame: 14 months
14 months
Progression to acute myeloid leukemia (AML)
Time Frame: 14 months
14 months
Number of participants alive
Time Frame: 14 months
14 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Celgene

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Sante Cundari, PhD, MSc, Celgene s.r.l.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 1, 2011

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 30, 2013

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 30, 2013

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 29, 2010

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 4, 2011

First Posted (ESTIMATE)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 5, 2011

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 18, 2019

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 14, 2019

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • NIPMS- Celgene-MDS-ITA-002

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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