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A Safety and Efficacy of Pomalyst® Capsules Under the Actual Use in All Patients Who Are Treated With Pomalyst at a Dose of 1 mg, 2 mg, 3 mg, or 4 mg

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: NCT02921828
Recruitment Status : Active, not recruiting
First Posted : October 3, 2016
Last Update Posted : June 4, 2019
Sponsor:
Information provided by (Responsible Party):
Celgene

Brief Summary:
  1. Planned enrollment period One year (The planned number of patients to be enrolled is set to 400 patients.) Since all patients who are prescribed with Pomalyst are registered in RevMate®, enrollment using the Registration Form of the surveillance will be completed at the time when the planned number of patients to be enrolled is reached. During a period until conditions for approval are removed, a system enabling to retrospectively collect appropriate information based on patient data from RevMate® will be, as necessary, maintained.
  2. Planned duration of the surveillance Anticipated to be 2 years and 6 months from the start date of release of Pomalyst

Condition or disease
Multiple Myeloma

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Study Type : Observational
Actual Enrollment : 1149 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Pomalyst®Capsules Special Use-results Surveillance (All-case Surveillance)
Actual Study Start Date : May 21, 2015
Estimated Primary Completion Date : May 20, 2025
Estimated Study Completion Date : May 20, 2025

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Multiple Myeloma

Group/Cohort
Multiple myeloma patients who received Pomalyst
Among relapsed or refractory multiple myeloma patients, all patients who received Pomalyst will be targeted in this surveillance.



Primary Outcome Measures :
  1. Adverse event (AE) [ Time Frame: 3 years ]
    Number of participants with adverse events



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 patients, all patients who received Pomalyst will be targeted in this surveillance.
Criteria

Inclusion Criteria:

  • Among relapsed or refractory multiple myeloma patients, all patients who received Pomalyst 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): NCT02921828


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: NCT02921828     History of Changes
Other Study ID Numbers: NIS-Celgene-JP-PMS-002
First Posted: October 3, 2016    Key Record Dates
Last Update Posted: June 4, 2019
Last Verified: June 2019
Keywords provided by Celgene:
Pomalyst
Teratogenicity
bone marrow suppression
thromboembolism
peripheral neuropathy
infection
tumour lysis syndrome
somnolence
depressed level of consciousness
confusion
fatigue
dizziness
acute renal failure
heart failure
arrhythmia
interstitial pneumonia
hypersensitivity
hepatic function disorder
jaundice
Additional relevant MeSH terms:
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Multiple Myeloma
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
Pomalidomide
Immunologic Factors
Physiological Effects of Drugs
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Growth Inhibitors
Antineoplastic Agents