CClinicalTrials.gg
CompletedNCT02921828Updated Jul 5, 2022

A Safety and Efficacy of Pomalyst® Capsules Under the Actual Use in All Patients Who Are Treated With Pomalyst at a Dose of 1 mg, 2 mg, 3 mg, or 4 mg

An observational study in Multiple Myeloma, sponsored by Celgene. Completed at 2 sites in 2 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-07-05.

Sponsored by Celgene · Observational

Study type
Observational
Model
Case-only
Time perspective
Prospective
Enrollment
1,149
Ages
18 Years and older
Sex
All
01

Study summary

  1. Planned enrollment period One year (The planned number of patients to be enrolled is set to 400 patients.) Since all patients who are prescribed with Pomalyst are registered in RevMate®, enrollment using the Registration Form of the surveillance will be completed at the time when the planned number of patients to be enrolled is reached. During a period until conditions for approval are removed, a system enabling to retrospectively collect appropriate information based on patient data from RevMate® will be, as necessary, maintained.
  2. Planned duration of the surveillance Anticipated to be 2 years and 6 months from the start date of release of Pomalyst
02

Conditions studied

  • Multiple Myeloma

Browse trials for

Keywords

  • Pomalyst
  • Teratogenicity
  • bone marrow suppression
  • thromboembolism
  • peripheral neuropathy
  • infection
  • tumour lysis syndrome
  • somnolence
  • depressed level of consciousness
  • confusion
  • fatigue
  • dizziness
  • acute renal failure
  • heart failure
  • arrhythmia
  • interstitial pneumonia
  • hypersensitivity
  • hepatic function disorder
  • jaundice
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 1,149 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 patients, all patients who received Pomalyst will be targeted in this surveillance.

Inclusion criteria

  • Among relapsed or refractory multiple myeloma patients, all patients who received Pomalyst will be targeted in this surveillance.

Exclusion criteria

Exclusion Criteria:

  • N/A
05

Study design

Observational model
Case-only
Time perspective
Prospective
Enrollment
1,149 participants (actual)
Patient registry
No

Groups and cohorts

  • Multiple myeloma patients who received Pomalyst

    Among relapsed or refractory multiple myeloma patients, all patients who received Pomalyst will be targeted in this surveillance.

06

What researchers measure

Primary outcomes

  1. Adverse event (AE)

    Number of participants with adverse events

    Time frame: 3 years

07

Study locations

2 sites
  • Local Institution - Japan
    No City Provided, New Jersey 00000, United States
  • 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 Jul 5, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02921828
Lead sponsor
Celgene
Responsible party
Sponsor
First posted
Oct 3, 2016
Start date
Apr 30, 2015
Primary completion
Dec 10, 2015
Completion
Dec 10, 2015
Last update
Jul 5, 2022

Study contacts

Jinshu Cho
study director · Celgene

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.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion