Revlimid® Capsules Special Drug Use-results Survey (in Pa... | NCT02741544

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

NCT02741544

Sponsor

Celgene

Status

Completed

Last Update Posted

Jun 21, 2022Actual

Enrollment

578Actual

Phase

Not provided

Conditions

Multiple Myeloma

Interventions

Not provided

Countries

Japan

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
U1111-1181-9845	Registry Identifier	WHO

Status Module

Record Verification Date

Jun 2022

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 3, 2016Actual

Primary Completion Date

Aug 20, 2020Actual

Completion Date

Aug 20, 2020Actual

First Submitted Date

Apr 5, 2016

First Submission Date that Met QC Criteria

Apr 13, 2016

First Posted Date

Apr 18, 2016Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 17, 2022

Last Update Posted Date

Jun 21, 2022Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

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.
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

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

578Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Patients with newly-diagnosed multiple myeloma (NDMM)		Patients with newly-diagnosed multiple myeloma (NDMM) who are treated with Revlimid Capsules (Revlimid)

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Adverse Events (AEs)	Number of participants with adverse events	Up to approximately 6 months

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Newly-diagnosed multiple myeloma who are treated with Revlimid Capsules

Exclusion Criteria:

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

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).

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Bristol-Myers Squibb	Bristol-Myers Squibb	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Shinko Hospital		Kobe	Hyōgo	651-0072	Japan

Condition Browse Module

MeSH Terms

ID	Term
D009101	Multiple Myeloma
D016609	Neoplasms, Second Primary
D002386	Cataract

Ancestor Terms

ID	Term
D054219	Neoplasms, Plasma Cell
D009370	Neoplasms by Histologic Type
D009369	Neoplasms
D020141	Hemostatic Disorders

Browse Leaves

Not provided

Browse Branches

Not provided