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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

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ClinicalTrials.gov Identifier: NCT02922543
Recruitment Status : Active, not recruiting
First Posted : October 4, 2016
Last Update Posted : June 5, 2018
Sponsor:
Information provided by (Responsible Party):
Celgene

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. 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).

Condition or disease
Multiple Myeloma

Study Type : Observational
Actual Enrollment : 361 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Revlimid 5 mg Capsules Special Use-results Surveillance of Long Term Use
Actual Study Start Date : February 18, 2011
Estimated Primary Completion Date : December 31, 2019
Estimated Study Completion Date : December 31, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Multiple Myeloma

Group/Cohort
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.



Primary Outcome Measures :
  1. Adverse Events (AEs) [ Time Frame: 3 years ]
    Number of participants with adverse events



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   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.
Criteria

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:


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02922543


Locations
Japan
Shinko Hospital
Kobe, Hyogo, Japan, 651-0072
Sponsors and Collaborators
Celgene
Investigators
Study Director: Kyoko Matsui Celgene

Responsible Party: Celgene
ClinicalTrials.gov Identifier: NCT02922543     History of Changes
Other Study ID Numbers: NIS-Celgene-JP-PMS-001b
First Posted: October 4, 2016    Key Record Dates
Last Update Posted: June 5, 2018
Last Verified: June 2018

Keywords provided by Celgene:
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

Additional relevant MeSH terms:
Multiple Myeloma
Neoplasms, Plasma Cell
Neoplasms by Histologic Type
Neoplasms
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Paraproteinemias
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Lymphoproliferative Disorders
Immunoproliferative Disorders
Immune System Diseases
Lenalidomide
Thalidomide
Immunologic Factors
Physiological Effects of Drugs
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Growth Inhibitors
Antineoplastic Agents
Immunosuppressive Agents
Leprostatic Agents
Anti-Bacterial Agents
Anti-Infective Agents