NCT02741544

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. 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
578

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2016

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 3, 2016

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

April 5, 2016

Completed
13 days until next milestone

First Posted

Study publicly available on registry

April 18, 2016

Completed
4.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 20, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 20, 2020

Completed
Last Updated

June 21, 2022

Status Verified

June 1, 2022

Enrollment Period

4.5 years

First QC Date

April 5, 2016

Last Update Submit

June 17, 2022

Conditions

Multiple Myeloma

Keywords

Second primary cancersCataractsNewly-diagnosed multiple myelomaRevlimid capsules

Outcome Measures

Primary Outcomes (1)

  • Adverse Events (AEs)

    Number of participants with adverse events

    Up to approximately 6 months

Study Arms (1)

Patients with newly-diagnosed multiple myeloma (NDMM)

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

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability 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).

You may qualify if:

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

You may not qualify if:

  • N/A

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Shinko Hospital

Kobe, Hyōgo, 651-0072, Japan

Location

MeSH Terms

Conditions

Multiple MyelomaNeoplasms, Second PrimaryCataract

Condition Hierarchy (Ancestors)

Neoplasms, Plasma CellNeoplasms by Histologic TypeNeoplasmsHemostatic DisordersVascular DiseasesCardiovascular DiseasesParaproteinemiasBlood Protein DisordersHematologic DiseasesHemic and Lymphatic DiseasesHemorrhagic DisordersLymphoproliferative DisordersImmunoproliferative DisordersImmune System DiseasesLens DiseasesEye Diseases

Study Officials

  • Bristol-Myers Squibb

    Bristol-Myers Squibb

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 5, 2016

First Posted

April 18, 2016

Study Start

March 3, 2016

Primary Completion

August 20, 2020

Study Completion

August 20, 2020

Last Updated

June 21, 2022

Record last verified: 2022-06

Locations

JP(1)