CClinicalTrials.gg
CompletedNCT02922543Updated Jun 14, 2022

A Safety and Efficacy Study of Revlimid® 5 mg Capsules in Patients With Relapsed or Refractory Multiple Myeloma Who Have Received Long-term Treatment With it Under the Actual Condition of Use

An observational study in Multiple Myeloma, 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
361
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 patients with "relapsed or refractory multiple myeloma" (hereinafter referred to as "relapsed or refractory MM") who have received long-term treatment with it under the actual condition of use.

  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, 300, is reached (estimated to be approximately 1 year and 3 moths).
  2. Planned surveillance period This period started on the date of initial marketing of Revlimid and will end 3 years after the last enrolled patient begins receiving Revlimid (estimated to be approximately 4 years and 3 months).
02

Conditions studied

  • Multiple Myeloma

Keywords

  • Multiple Myeloma
  • 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
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 361 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

Relapsed or refractory multiple myeloma (MM) patients in the special use-results surveillance (all-case surveillance) (hereinafter referred to as the all-case surveillance) who have received Revlimid treatment for at least 7 cycles at institutions cooperating in performing the all-case surveillance and this surveillance.

Inclusion criteria

  • Relapsed or refractory MM patients in the special use-results surveillance (all-case surveillance) (hereinafter referred to as the all-case surveillance) who have received Revlimid treatment for at least 7 cycles at institutions cooperating in performing the all-case surveillance and this surveillance.

Exclusion criteria

Exclusion Criteria:

N/A

05

Study design

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

Groups and cohorts

  • Relapsed or refractory multiple myeloma (MM) patients

    Relapsed or refractory MM patients in the special use-results surveillance (all-case surveillance) (hereinafter referred to as the all-case surveillance) who have received Revlimid treatment for at least 7 cycles at institutions cooperating in performing the all-case surveillance and this surveillance.

06

What researchers measure

Primary outcomes

  1. Adverse Events (AEs)

    Number of participants with adverse events

    Time frame: 3 years

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
NCT02922543
Lead sponsor
Celgene
Responsible party
Sponsor
First posted
Oct 4, 2016
Start date
Feb 18, 2011
Primary completion
Oct 11, 2014
Completion
Oct 11, 2014
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.

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