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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Celgene Corporation
ClinicalTrials.gov Identifier:
NCT01347944
First received: October 29, 2010
Last updated: June 4, 2013
Last verified: June 2013

October 29, 2010
June 4, 2013
January 2011
September 2013   (final data collection date for primary outcome measure)
  • Number of subjects achieving red blood cell (RBC) transfusion independence [ Time Frame: 14 months ] [ Designated as safety issue: No ]
  • Number of subjects achieving an erythroid response [ Time Frame: 14 months ] [ Designated as safety issue: No ]
  • Number of subjects achieving a cytogenetic response [ Time Frame: 14 months ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01347944 on ClinicalTrials.gov Archive Site
  • Number of participants with adverse events [ Time Frame: 14 months ] [ Designated as safety issue: Yes ]
  • Duration of RBC transfusion independence [ Time Frame: 14 months ] [ Designated as safety issue: No ]
  • Duration of cytogenetic response [ Time Frame: 14 months ] [ Designated as safety issue: No ]
  • Time to RBC transfusion independence [ Time Frame: 14 months ] [ Designated as safety issue: No ]
  • Progression to acute myeloid leukemia (AML) [ Time Frame: 14 months ] [ Designated as safety issue: No ]
  • Number of participants alive [ Time Frame: 14 months ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
MORE - Monitoring Revlimid - Collecting of Patient Information From Myelodysplastic Syndrome (MDS) Italian National Registry
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.

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

Observational
Observational Model: Cohort
Not Provided
Not Provided
Non-Probability Sample

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

Myelodysplastic Syndrome
Drug: lenalidomide
Patients who were prescribed Revlimid from 31October 2008 to present.
Other Name: Revlimid®
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
211
December 2013
September 2013   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Italy
 
NCT01347944
NIPMS- Celgene-MDS-ITA-002
Yes
Celgene Corporation
Celgene Corporation
Not Provided
Study Director: Sante Cundari, PhD, MSc Celgene s.r.l.
Celgene Corporation
June 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP