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Trial record 49 of 52 for:    LENALIDOMIDE AND Leukemia AND Acute Myeloid Leukemia

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

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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01347944
Recruitment Status : Completed
First Posted : May 5, 2011
Last Update Posted : November 18, 2019
Sponsor:
Information provided by (Responsible Party):
Celgene

Brief Summary:
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.

Condition or disease Intervention/treatment
Myelodysplastic Syndrome Drug: lenalidomide

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

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Study Type : Observational
Actual Enrollment : 149 participants
Observational Model: Cohort
Time Perspective: Other
Official Title: 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
Actual Study Start Date : January 1, 2011
Actual Primary Completion Date : June 30, 2013
Actual Study Completion Date : June 30, 2013



Intervention Details:
  • Drug: lenalidomide
    Patients who were prescribed Revlimid from 31October 2008 to present.
    Other Name: Revlimid®


Primary Outcome Measures :
  1. Number of subjects achieving red blood cell (RBC) transfusion independence [ Time Frame: 14 months ]
  2. Number of subjects achieving an erythroid response [ Time Frame: 14 months ]
  3. Number of subjects achieving a cytogenetic response [ Time Frame: 14 months ]

Secondary Outcome Measures :
  1. Number of participants with adverse events [ Time Frame: 14 months ]
  2. Duration of RBC transfusion independence [ Time Frame: 14 months ]
  3. Duration of cytogenetic response [ Time Frame: 14 months ]
  4. Time to RBC transfusion independence [ Time Frame: 14 months ]
  5. Progression to acute myeloid leukemia (AML) [ Time Frame: 14 months ]
  6. Number of participants alive [ Time Frame: 14 months ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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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:   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.
Criteria

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

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): NCT01347944


Locations
Show Show 45 study locations
Sponsors and Collaborators
Celgene
Investigators
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Study Director: Sante Cundari, PhD, MSc Celgene s.r.l.

Publications:
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Responsible Party: Celgene
ClinicalTrials.gov Identifier: NCT01347944    
Other Study ID Numbers: NIPMS- Celgene-MDS-ITA-002
First Posted: May 5, 2011    Key Record Dates
Last Update Posted: November 18, 2019
Last Verified: November 2019
Keywords provided by Celgene:
MORE
Monitoring Revlimid
Myelodysplastic Syndrome
Transfusion-dependent anemia
5q deletion
lenalidomide
Additional relevant MeSH terms:
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Lenalidomide
Preleukemia
Myelodysplastic Syndromes
Syndrome
Disease
Pathologic Processes
Bone Marrow Diseases
Hematologic Diseases
Precancerous Conditions
Neoplasms
Immunologic Factors
Physiological Effects of Drugs
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Growth Inhibitors
Antineoplastic Agents