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CompletedNCT02921802Updated Jun 14, 2022

A Study of Special Use Results Surveillance of Revlimid 5mg Capsules

An observational study in Multiple Myeloma and Myelodysplastic Syndromes, sponsored by Celgene. Completed at 1 site in Japan. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-06-14.

Sponsored by Celgene · Observational

Study type
Observational
Model
Case-only
Time perspective
Prospective
Enrollment
4,626
Ages
18 Years and older
Sex
All
01

Study summary

To understand the safety and efficacy of Revlimid® 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.
02

Conditions studied

  • Multiple Myeloma
  • Myelodysplastic Syndromes

Keywords

  • Teratogenicity
  • Thrombocytopenia and haemorrhage
  • Neutropenia and infection
  • Venous thromboembolism
  • Allergic reactions
  • Diarrhoea or constipation
  • Peripheral neuropathy
  • Cardiac failure
  • Arrhythmia
  • Renal failure
  • Myocardial infarction
  • Interstitial lung disease
  • Tumour lysis syndrome
  • Transformation from myelodysplastic syndrome to acute myeloid leukemia
03

In context

Multiple Myeloma

3,632 studies on the registry are indexed under Multiple Myeloma; 745 are open to participants now.

This study's enrollment of 4,626 is above the median of 140 across 468 observational studies indexed under Multiple Myeloma.

Browse Multiple Myeloma studies →

Lead sponsor

Celgene is the lead sponsor of 419 studies on the registry; 13 are open to participants now.

Of its 100 completed or terminated interventional studies of FDA-regulated products, 29 (29%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Among relapsed or refractory multiple myeloma and Myelodysplastic syndrome (MDS) with a deletion 5q cytogenetic abnormality patients, all patients who received Pomalyst will be targeted in this surveillance.

Inclusion criteria

  • Among relapsed or refractory multiple myeloma and Myelodysplastic syndrome (MDS) with a deletion 5q cytogenetic abnormality patients, all patients who received Revlimid will be targeted in this surveillance.

Exclusion criteria

Exclusion Criteria:

N/A

05

Study design

Observational model
Case-only
Time perspective
Prospective
Enrollment
4,626 participants (actual)
Patient registry
No

Groups and cohorts

  • Patients who received Revlimid

    Among relapsed or refractory multiple myeloma and Myelodysplastic syndrome (MDS) with a deletion 5q cytogenetic abnormality patients, all patients who received Revlimid will be targeted in this surveillance.

06

What researchers measure

Primary outcomes

  1. Adverse Events (AEs)

    Number of participants with adverse events for 6 month treatment

    Time frame: Up to 6 months

07

Study locations

1 site
  • Shinko Hospital
    Kobe, Hyogo 651-0072, Japan
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 14, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02921802
Lead sponsor
Celgene
Responsible party
Sponsor
First posted
Oct 3, 2016
Start date
Jul 20, 2010
Primary completion
Mar 29, 2013
Completion
Mar 29, 2013
Last update
Jun 14, 2022

Study contacts

Bristol-Myers Squibb
study director · Bristol-Myers Squibb

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jun 2022. You cannot join it, but the record below documents what was studied.

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