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A Study of Special Use Results Surveillance of Revlimid 5mg Capsules

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ClinicalTrials.gov Identifier: NCT02921802
Recruitment Status : Active, not recruiting
First Posted : October 3, 2016
Last Update Posted : June 5, 2019
Sponsor:
Information provided by (Responsible Party):
Celgene

Brief Summary:

To understand the safety and efficacy of Revlimid® 5 mg Capsules (hereinafter referred to as Revlimid) in all patients who are treated with it under the actual condition of use pursuant to the conditions of approval.

  1. Planned registration period This period started on the date of initial marketing of Revlimid and will end at the time when the planned number of patients to be enrolled is reached.
  2. Planned surveillance period This period started on the date of initial marketing of Revlimid and will end on the day when the approval condition related to all-case surveillance is terminated.

Condition or disease
Multiple Myeloma Myelodysplastic Syndromes

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Study Type : Observational
Actual Enrollment : 4626 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Revlimid 5 mg Capsules Special Use-results Surveillance (All-case Surveillance)
Actual Study Start Date : July 20, 2010
Estimated Primary Completion Date : June 19, 2020
Estimated Study Completion Date : June 19, 2020


Group/Cohort
Patients who received Revlimid
Among relapsed or refractory multiple myeloma and Myelodysplastic syndrome (MDS) with a deletion 5q cytogenetic abnormality patients, all patients who received Revlimid will be targeted in this surveillance.



Primary Outcome Measures :
  1. Adverse Events (AEs) [ Time Frame: Up to 6 months ]
    Number of participants with adverse events for 6 month treatment



Information from the National Library of Medicine

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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
Among relapsed or refractory multiple myeloma and Myelodysplastic syndrome (MDS) with a deletion 5q cytogenetic abnormality patients, all patients who received Pomalyst will be targeted in this surveillance.
Criteria

Inclusion Criteria:

  • Among relapsed or refractory multiple myeloma and Myelodysplastic syndrome (MDS) with a deletion 5q cytogenetic abnormality patients, all patients who received Revlimid will be targeted in this surveillance.

Exclusion Criteria:

N/A


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): NCT02921802


Locations
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Japan
Shinko Hospital
Kobe, Hyogo, Japan, 651-0072
Sponsors and Collaborators
Celgene
Investigators
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Study Director: Jinshu Cho Celgene

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Responsible Party: Celgene
ClinicalTrials.gov Identifier: NCT02921802     History of Changes
Other Study ID Numbers: NIS-Celgene-JP-PMS-001a
First Posted: October 3, 2016    Key Record Dates
Last Update Posted: June 5, 2019
Last Verified: June 2019
Keywords provided by Celgene:
Teratogenicity
Thrombocytopenia and haemorrhage
Neutropenia and infection
Venous thromboembolism
Allergic reactions
Diarrhoea or constipation
Peripheral neuropathy
Cardiac failure
Arrhythmia
Renal failure
Myocardial infarction
Interstitial lung disease
Tumour lysis syndrome
Transformation from myelodysplastic syndrome to acute myeloid leukemia
Additional relevant MeSH terms:
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Multiple Myeloma
Preleukemia
Myelodysplastic Syndromes
Syndrome
Disease
Pathologic Processes
Neoplasms, Plasma Cell
Neoplasms by Histologic Type
Neoplasms
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Paraproteinemias
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Lymphoproliferative Disorders
Immunoproliferative Disorders
Immune System Diseases
Bone Marrow Diseases
Precancerous Conditions
Lenalidomide
Immunologic Factors
Physiological Effects of Drugs
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Growth Inhibitors
Antineoplastic Agents