NCT02921802

Brief 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. 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
4,626

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jul 2010

Typical duration 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

July 20, 2010

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 29, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 29, 2013

Completed
3.5 years until next milestone

First Submitted

Initial submission to the registry

September 30, 2016

Completed
3 days until next milestone

First Posted

Study publicly available on registry

October 3, 2016

Completed
Last Updated

June 14, 2022

Status Verified

June 1, 2022

Enrollment Period

2.7 years

First QC Date

September 30, 2016

Last Update Submit

June 13, 2022

Conditions

Multiple MyelomaMyelodysplastic Syndromes

Keywords

TeratogenicityThrombocytopenia and haemorrhageNeutropenia and infectionVenous thromboembolismAllergic reactionsDiarrhoea or constipationPeripheral neuropathyCardiac failureArrhythmiaRenal failureMyocardial infarctionInterstitial lung diseaseTumour lysis syndromeTransformation from myelodysplastic syndrome to acute myeloid leukemia

Outcome Measures

Primary Outcomes (1)

  • Adverse Events (AEs)

    Number of participants with adverse events for 6 month treatment

    Up to 6 months

Study Arms (1)

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.

Eligibility Criteria

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

You may qualify if:

  • 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.

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 MyelomaMyelodysplastic SyndromesTeratogenesisThrombocytopeniaHemorrhageNeutropeniaInfectionsVenous ThromboembolismHypersensitivityDiarrheaConstipationPeripheral Nervous System DiseasesHeart FailureArrhythmias, CardiacRenal InsufficiencyMyocardial InfarctionLung Diseases, InterstitialTumor Lysis Syndrome

Condition Hierarchy (Ancestors)

Neoplasms, Plasma CellNeoplasms by Histologic TypeNeoplasmsHemostatic DisordersVascular DiseasesCardiovascular DiseasesParaproteinemiasBlood Protein DisordersHematologic DiseasesHemic and Lymphatic DiseasesHemorrhagic DisordersLymphoproliferative DisordersImmunoproliferative DisordersImmune System DiseasesBone Marrow DiseasesPathologic ProcessesPathological Conditions, Signs and SymptomsBlood Platelet DisordersCytopeniaAgranulocytosisLeukopeniaLeukocyte DisordersThromboembolismEmbolism and ThrombosisSigns and Symptoms, DigestiveSigns and SymptomsNeuromuscular DiseasesNervous System DiseasesHeart DiseasesKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesMyocardial IschemiaInfarctionIschemiaNecrosisLung DiseasesRespiratory Tract DiseasesLymphatic 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

September 30, 2016

First Posted

October 3, 2016

Study Start

July 20, 2010

Primary Completion

March 29, 2013

Study Completion

March 29, 2013

Last Updated

June 14, 2022

Record last verified: 2022-06

Locations

JP(1)