An Observational Study to Assess Safety and Outcome of the Various Medication Usage Patterns in Clinical Routine Practice in Patients Receiving Lenalidomide. (REVIEW)
May 26, 2020 updated by: Celgene
A Non-interventional Observational Post Authorization Study to Assess Safety and Outcome of the Various Medication Usage Patterns in Clinical Routine Practice in Patients Receiving Lenalidomide (REVIEW)
The study is designed as a prospective, non-interventional, observational single arm study.
Hundred-fifty patients over 18 with stable disease or at least partial response while on treatment with lenalidomide will be recruited from approximately 20 haematology/oncology sites in the Netherlands.
Recruitment will continue until 150 patients have started the study.
When this target is reached, all patients on lenalidomide will continue to be followed until the last patient has been followed for 36 months.
Study Overview
Status
Completed
Conditions
Study Type
Observational
Enrollment (Actual)
238
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Patients already successfully, i.e. with currently stable disease or meeting the criteria for complete response, very good partial response or partial response, on-treatment for maximally up to 6 cycles with lenalidomide at each site will be enrolled into the study.
In all cases, the decision to treat the patient with lenalidomide was already made prior to the decision to enter the subject into the study.
Description
Inclusion Criteria:
- Patients over 18 years of age who understand and voluntarily sign an informed consent form.
- Patients with multiple myeloma who are currently receiving lenalidomide treatment and who have taken lenalidomide for > 2 cycles and < 6 cycles.
- Patients with currently stable disease or meeting the criteria for complete response, very good partial response or partial response while on lenalidomide treatment.
Exclusion Criteria:
- Refusal to participate in the study.
- Women who are pregnant or breast-feeding.
- Women of childbearing potential unless all of the conditions of the Pregnancy Prevention Programme are met.
- Hypersensitivity to the active substance or to any of the excipients.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
|---|
|
Patients receiving Revlimid according to clinical practice
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Adverse Event (AE)
Time Frame: Up to approximatly 4 years
|
Adverse events will be classified using the MedDRA classification system.
The severity of the toxicities will be graded according to the NCI CTCAE VERSION 4.03 whenever possible
|
Up to approximatly 4 years
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Quality of Life
Time Frame: Up to approximatly 24 months
|
Quality of life will be measured by using the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire(EORTC QL Q-C30) and EORTC QLQ-MY20
|
Up to approximatly 24 months
|
|
Lenalidomide usage patterns
Time Frame: Up to approximatly 4 years
|
Registration in case report form (CRF) and evaluation of usage patterns in daily clinical practice
|
Up to approximatly 4 years
|
|
Lenalodomide dose modifications
Time Frame: Up to approximatly 4 years
|
Registration in case report form (CRF) and evaluation of dose modifications in daily clinical practice
|
Up to approximatly 4 years
|
|
Reasons for discontinuation of lenalidomide
Time Frame: Up to approximatly 4 years
|
Registration in case report form (CRF) and evaluation of reasons of discontinuation in daily clinical practice
|
Up to approximatly 4 years
|
|
Clinical outcome
Time Frame: Up to approximately 4 years
|
Clinical outcome will be measured using routine assessment criteria (i.e.
IMWG)
|
Up to approximately 4 years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Jeroen Stevens, MSc, Celgene BV
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
May 1, 2011
Primary Completion (ACTUAL)
June 30, 2016
Study Completion (ACTUAL)
January 15, 2018
Study Registration Dates
First Submitted
August 6, 2015
First Submitted That Met QC Criteria
August 18, 2015
First Posted (ESTIMATE)
August 19, 2015
Study Record Updates
Last Update Posted (ACTUAL)
May 27, 2020
Last Update Submitted That Met QC Criteria
May 26, 2020
Last Verified
May 1, 2020
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Cardiovascular Diseases
- Vascular Diseases
- Immune System Diseases
- Neoplasms by Histologic Type
- Neoplasms
- Lymphoproliferative Disorders
- Immunoproliferative Disorders
- Hematologic Diseases
- Hemorrhagic Disorders
- Hemostatic Disorders
- Paraproteinemias
- Blood Protein Disorders
- Neoplasms, Plasma Cell
- Multiple Myeloma
Other Study ID Numbers
- NIPMS-Celgene-NETH-001
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.