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Non-interventional Study of Lenalidomide in the Clinical Routine Treatment of TD Patients With IPSS Low or Int-1 MDS and Isolated Del(5q) (PASS MDS del5q)

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ClinicalTrials.gov Identifier: NCT02279654
Recruitment Status : Recruiting
First Posted : October 31, 2014
Last Update Posted : May 23, 2018
Sponsor:
Information provided by (Responsible Party):
Celgene

Brief Summary:

This registry is a prospective, non-interventional, post authorisation safety study for patients diagnosed with Transfusion Dependent, IPSS low or intermediate-1-Risk Myelodysplastic Syndrome (MDS), associated to a single abnormality of the chromosome 5 [del(5q)].

The purpose of this study is to collect additional data about the safety of an oral drug (lenalidomide, Revlimid®) that may have been prescribed to relieve anemia and decrease the need of blood transfusions. However, also patients affected by the MDS del(5q) who receive other treatments different from lenalidomide can be included in this study, if they agree.


Condition or disease Intervention/treatment
Myelodysplastic Syndrome Drug: Lenalidomide

Study Type : Observational [Patient Registry]
Estimated Enrollment : 1800 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 3 Years
Official Title: A Post-authorization, Non-interventional, Safety Study Study of Patients With Myelodysplastic Syndromes (MDS) Treated With Lenalidomide.
Actual Study Start Date : December 17, 2014
Estimated Primary Completion Date : December 31, 2021
Estimated Study Completion Date : December 31, 2022

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Lenalidomide Population
Patients with transfusion-dependent, low- or intermediate (int)-1risk MDS and isolated del (5q) who receive at least 1 dose of lenalidomide after 15th June 2007 and have been followed up for on the registry for 3 years or until death/consent withdrawal
Drug: Lenalidomide
Lenalidomide as prescribed in routine clinical practice for low to intermediate-1 risk MDS
Other Names:
  • Revlimid
  • CC-5013

Background Population
All MDS patients who have been diagnosed on 15th June 2007 or later, have never been exposed to lenalidomide and have been followed up on the registry for 3 years or until death/consent withdrawal
Drug: Lenalidomide
Lenalidomide as prescribed in routine clinical practice for low to intermediate-1 risk MDS
Other Names:
  • Revlimid
  • CC-5013




Primary Outcome Measures :
  1. Ascertain the Disease Progression to AML (through calculation of product limit estimators and incidence rates) for those with transfusion dependent Low to Intermediate 1 risk MDS del 5 q and have been treated with Revlimid [ Time Frame: Up to 3 years ]
    Incidence, as well as the attributable risk (AR) and AR percent (%). Progressive Disease criteria includes increasing monoclonal paraprotein levels, bone marrow findings, worsening lytic bone disease, progressively enlarging extramedullary plasmacytomas, or hypercalcemia.

  2. Overall Survival for patients with transfusion-dependent low to intermediate 1 risk MDS and isolated del (5q) and who have been treated with Lenalidomide [ Time Frame: Up to 3 years ]
    Number of MDS participants who survive


Secondary Outcome Measures :
  1. Overall Survival for patients with transfusion-dependent low to intermediate 1 risk MDS and isolated del (5q) and who have been treated with Lenalidomide [ Time Frame: Up to 3 years ]
    Number of MDS participants who survive who have never been treated with Lenalidomide

  2. Adverse Events [ Time Frame: Up to 3 years ]
    Type, frequency, severity of advere events and relationship of adverse events to Lenalidomide. An adverse ecent is defined as any untoward medical occurrence in a patient administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment, ie, any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product whether or not considered related to the medicinal product

  3. Evaluate risk factors associated with progression of AML [ Time Frame: Up to 3 years ]
    Employ Cox proportional hazards models among MDS patients included in the primary population who have been treated with lenalidomide

  4. Clinical practice [ Time Frame: Up to 3 years ]
    Provide insight into treatment regimens and therapy sequence in clinical practice as they relate to clinical outcomes (response, overall survival, progression-free survival) in patients in MDS participants



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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 who have received at least 1 dose of any treatment or treatment modality after the patient signs the informed consent form

  • Lenalidomide cohort: All patients treated with lenalidomide
  • Background cohort: All patients treated with therapeutic modalities other than lenalidomide

For each population 3 datasets will be described and will form the basis of subsequent analyses:

  • A baseline demographic dataset ("population dataset")
  • An exposure dataset
  • An outcome dataset
Criteria

Inclusion Criteria:

  • Are ≥ 18 years old at the time of signing the Informed consent form (ICF)
  • Are transfusion dependent or have an history of transfusion dependence; for the purpose of the current Myelodysplastic syndromes (MDS) Post-authorization safety study (PASS), transfusion-dependence is defined as requiring ≥2 RBC units over an 8 week period prior to the date of signature on the ICF (due to MDS-related causes and not because of hemorrhage, trauma, or other acute cause)
  • Are on active treatment with lenalidomide (Lenalidomide Cohort) or have never been exposed to lenalidomide at the time of signing the ICF (Background Cohort)
  • Have confirmed diagnosis of IPSS low or intermediate-1-risk MDS with isolated del (5q) (with morphological and cytogenetic information) diagnosed on 15 June 2007 (date of Revlimid first approved in Europe) or later

Exclusion Criteria:

  • Refuse to participate in the Myelodysplastic syndromes (MDS) Post-authorization safety study (PASS),
  • Are currently participating in an interventional therapeutic clinical trial for MDS (except for erythropoiesis-stimulating agents [ESAs] and granulocyte colonystimulating growth factors)
  • Receive any investigational agent the time of signing the ICF
  • Have previously been treated with lenalidomide and are no longer on active treatment with lenalidomide at the time of signing the ICF

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): NCT02279654


Contacts
Contact: Associate Director Clinical Trial Disclosure 1-888-260-1599 clinicaltrialdisclosure@celgene.com

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Sponsors and Collaborators
Celgene
Investigators
Study Director: Alberto Vasconcelos, MD Medical Affairs Myeloid Diseases Lead for Celgene Europe

Responsible Party: Celgene
ClinicalTrials.gov Identifier: NCT02279654     History of Changes
Other Study ID Numbers: CC-5013-MDS-010
First Posted: October 31, 2014    Key Record Dates
Last Update Posted: May 23, 2018
Last Verified: May 2018

Keywords provided by Celgene:
Lenalidomide
Revlimid
Transfusion-dependent
international Prognostic Scoring System (IPSS) low
Intermediate-1-risk
MDS
Isolated del(5q)
Prospective
Non-interventional
Post-authorization safety study (PASS)
Disease registry

Additional relevant MeSH terms:
Syndrome
Myelodysplastic Syndromes
Preleukemia
Disease
Pathologic Processes
Bone Marrow Diseases
Hematologic Diseases
Precancerous Conditions
Neoplasms
Lenalidomide
Thalidomide
Immunologic Factors
Physiological Effects of Drugs
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Growth Inhibitors
Antineoplastic Agents
Immunosuppressive Agents
Leprostatic Agents
Anti-Bacterial Agents
Anti-Infective Agents