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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Celgene Corporation
ClinicalTrials.gov Identifier:
NCT01347944
First received: October 29, 2010
Last updated: March 23, 2016
Last verified: March 2016
October 29, 2010
March 23, 2016
January 2011
June 2013   (Final data collection date for primary outcome measure)
  • Number of subjects achieving red blood cell (RBC) transfusion independence [ Time Frame: 14 months ]
  • Number of subjects achieving an erythroid response [ Time Frame: 14 months ]
  • Number of subjects achieving a cytogenetic response [ Time Frame: 14 months ]
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 ]
  • Duration of RBC transfusion independence [ Time Frame: 14 months ]
  • Duration of cytogenetic response [ Time Frame: 14 months ]
  • Time to RBC transfusion independence [ Time Frame: 14 months ]
  • Progression to acute myeloid leukemia (AML) [ Time Frame: 14 months ]
  • Number of participants alive [ Time Frame: 14 months ]
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.
 
Completed
149
June 2013
June 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
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Italy
 
 
NCT01347944
NIPMS- Celgene-MDS-ITA-002
Yes
Not Provided
Not Provided
Celgene Corporation
Celgene Corporation
Not Provided
Study Director: Sante Cundari, PhD, MSc Celgene s.r.l.
Celgene Corporation
March 2016

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