NCT02922543

Brief 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. 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. 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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
361

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Feb 2011

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

February 18, 2011

Completed
3.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 11, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 11, 2014

Completed
2 years until next milestone

First Submitted

Initial submission to the registry

September 30, 2016

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 4, 2016

Completed
Last Updated

June 14, 2022

Status Verified

June 1, 2022

Enrollment Period

3.6 years

First QC Date

September 30, 2016

Last Update Submit

June 13, 2022

Conditions

Multiple Myeloma

Keywords

Multiple MyelomaTeratogenicityThrombocytopenia and haemorrhageNeutropenia and infectionVenous thromboembolismAllergic reactionsDiarrhoea or constipationPeripheral neuropathyCardiac failureArrhythmiaRenal failureMyocardial infarctionInterstitial lung diseaseTumour lysis syndrome

Outcome Measures

Primary Outcomes (1)

  • Adverse Events (AEs)

    Number of participants with adverse events

    3 years

Study Arms (1)

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.

Eligibility Criteria

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

You may qualify if:

  • 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.

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 MyelomaTeratogenesisThrombocytopeniaHemorrhageNeutropeniaInfectionsVenous 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 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 4, 2016

Study Start

February 18, 2011

Primary Completion

October 11, 2014

Study Completion

October 11, 2014

Last Updated

June 14, 2022

Record last verified: 2022-06

Locations

JP(1)