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Trial record 25 of 228 for:    special | Japan

Revlimid® Capsules Special Drug Use-results Survey (in Patients With Newly-diagnosed Multiple Myeloma [NDMM])

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ClinicalTrials.gov Identifier: NCT02741544
Recruitment Status : Active, not recruiting
First Posted : April 18, 2016
Last Update Posted : March 2, 2018
Sponsor:
Information provided by (Responsible Party):
Celgene

Brief Summary:

To understand the safety and efficacy of Revlimid® 2.5mg and 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

Study Type : Observational
Actual Enrollment : 578 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Revlimid® Capsules Special Drug Use-results Survey (in Patients With Newly-diagnosed Multiple Myeloma [NDMM])
Actual Study Start Date : March 3, 2016
Estimated Primary Completion Date : August 21, 2021
Estimated Study Completion Date : August 21, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Multiple Myeloma

Group/Cohort
Patients with newly-diagnosed multiple myeloma (NDMM)
Patients with newly-diagnosed multiple myeloma (NDMM) who are treated with Revlimid Capsules (Revlimid)



Primary Outcome Measures :
  1. Adverse Events (AEs) [ Time Frame: Up to approximately 6 months ]
    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 patients with newly-diagnosed multiple myeloma (hereinafter referred to as "NDMM") who are treated with Revlimid Capsules (hereinafter referred to as "Revlimid", used by both 2.5 mg and 5 mg capsules).
Criteria

Inclusion Criteria:

  • Newly-diagnosed multiple myeloma who are treated with Revlimid Capsules

Exclusion Criteria:


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): NCT02741544


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

Responsible Party: Celgene
ClinicalTrials.gov Identifier: NCT02741544     History of Changes
Other Study ID Numbers: NIS-Celgene-JP-PMS-003
First Posted: April 18, 2016    Key Record Dates
Last Update Posted: March 2, 2018
Last Verified: March 2018

Keywords provided by Celgene:
Second primary cancers
Cataracts
Newly-diagnosed multiple myeloma
Revlimid capsules

Additional relevant MeSH terms:
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
Lenalidomide
Immunologic Factors
Physiological Effects of Drugs
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Growth Inhibitors
Antineoplastic Agents