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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02741544

Enrollment

578

Registered

2016-04-18

Start date

2016-03-03

Completion date

2020-08-20

Last updated

2022-06-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Multiple Myeloma

Keywords

Second primary cancers, Cataracts, Newly-diagnosed multiple myeloma, Revlimid capsules

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.

Interventions

None listed

Study design

Observational model

CASE_ONLY

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

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

Exclusion criteria

* N/A

Design outcomes

Primary

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

Countries

Japan

Outcome results