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

NCT ID: NCT02741544

Last Updated: 2022-06-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

578 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-03-03

Study Completion Date

2020-08-20

Brief Summary

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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.

Detailed Description

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Conditions

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Multiple Myeloma

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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Patients with newly-diagnosed multiple myeloma (NDMM)

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

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* N/A
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Celgene

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Bristol-Myers Squibb

Role: STUDY_DIRECTOR

Bristol-Myers Squibb

Locations

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Shinko Hospital

Kobe, Hyōgo, Japan

Site Status

Countries

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Japan

Other Identifiers

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U1111-1181-9845

Identifier Type: REGISTRY

Identifier Source: secondary_id

NIS-Celgene-JP-PMS-003

Identifier Type: -

Identifier Source: org_study_id

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