Status: Ongoing
First registered on:
12/05/2017
Last updated on:
22/02/2021
1. Study identification
EU PAS Register NumberEUPAS10153
Official titleA prospective non-interventional post-authorization safety study (PASS) of lenalidomide in previously untreated adult multiple myeloma patients who are not eligible for transplant (“transplant noneligible” [TNE]) (“Revlimid® TNE NDMM PASS”)
Study title acronymCC-5013-MM-034
Study typeObservational study
Brief description of the studyThe purpose of the Revlimid TNE NDMM Registry is to provide accurate clinical information regarding the safety profile of lenalidomide relative to other first-line regimens when prescribed for TNE NDMM patients across a variety of diverse clinical settings, particularly with respect to the cardiovascular safety profile of lenalidomide.
The study will gather extensive risk factor information at baseline and throughout follow-up to aid in the interpretation of any observed differences in the incidence of cardiovascular events between the two cohorts. Other safety endpoints of interest will be characterized through standard follow-up procedures.
Was this study requested by a regulator?Yes: EMA
Is the study required by a Risk Management Plan (RMP)?
EU RMP category 1 (imposed as condition of marketing authorisation)
Regulatory procedure number (RMP Category 1 and 2 studies only)
Other study registration identification numbers and URLs as applicableUTN number: U1111-1194-5810
2. Research centres and Investigator details
Coordinating study entity
Centre nameCELGENE INTERNATIONAL SARL
Centre locationBOUDRY SWITZERLAND
Details of (Primary) lead investigator
Title Ms
Last name Celgene International Sarl
First name Medical Affairs
Is this study being carried out with the collaboration of a research network?
No
Other centres where this study is being conducted
Multiple centres
In total how many centres are involved in this Study?118
see attached document for site list, see attached document for site list
Countries in which this study is being conducted
International study
Austria
Belgium
Denmark
France
Germany
Ireland
Italy
Netherlands
Norway
Spain
Sweden
United Kingdom
3. Study timelines: initial administrative steps, progress reports and final report
PlannedActual
Date when funding contract was signed10/05/201610/05/2016
Start date of data collection31/03/201731/03/2017
Start date of data analysis
Date of interim report, if expected
Date of final study report13/10/2026
4. Sources of funding
Please provide estimates of the percentage of funding by source for this study
Names(s)Approximate % funding
Pharmaceutical companiesCELGENE INTERNATIONAL SARL100
Charities
Government body
Research councils
EU funding scheme
5. Contact details for enquiries
Scientific Enquiries
Title Ms
Last name Celgene International Sarl
First name Medical Affairs
Address line 1Route des Perreux 1
Address line 2
Address line 3
CityBoudry
Postcode2017
CountrySwitzerland
Phone number (incl. country code)41-3272-98500
Alternative phone number
Fax number (incl. country code)
Public Enquiries
Title Ms
Last name Celgene International Sarl
First name Medical Affairs
Address line 1Route des Perreux 1
Address line 2
Address line 3
CityBoudry
Postcode2017
CountrySwitzerland
Phone number (incl. country code)41-3272-98500
Alternative phone number
Fax number (incl. country code)
6. Study drug(s) information
Not applicable (disease/epidemiology study)
7. Medical conditions to be studied
Medical condition(s)Yes
Plasma cell myeloma
8. Population under study
Age
Adults (18 - 44 years)
Adults (45 - 64 years)
Adults (65 - 74 years)
Adults (75 years and over)
Sex
Male
Female
9. Number of subjects
Estimated total number of subjects888
Additional information
The total sample size for this PASS is 888 TNE NDMM patients, composed of 444 patients treated with a first-line lenalidomide-containing regimen and 444 patients treated with a first-line nonlenalidomide containing regimen
10. Source of data
Is this study being carried out with an established data source?No
Sources of data
Prospective patient-based data collection
11. Scope of the study
What is the scope of the study?
Risk assessment
Drug utilisation study
Primary scope : Risk assessment
12. Main objective(s)
What is the main objective of the study?
To compare the incidence of cardiovascular events between TNE NDMM patients treated with a first-line lenalidomide-containing regimen and those treated with a first-line nonlenalidomide-containing regimen.
Are there primary outcomes?Yes
To identify, quantify, and characterize risk factors for cardiovascular events in this population of TNE NDMM patients.
Are there secondary outcomes?Yes
Document renal function throughout therapy and to ascertain the incidence of renal dysfunction
Document the incidence and severity of infections, including but not limited to pneumonia
Describe the incidence of SPM (including hematologic and nonhematologic invasive malignancies and non-melanoma skin cancers)
Characterize the safety profile of first-line regimens among TNE NDMM patients
13. Study design
What is the design of the study?
Cohort study
Drug utilisation study
14. Follow-up of patients
Will patients be followed up?Yes
Please describe duration of follow up
All patients will be followed on-treatment for up to 3 years from the index date and followed up for cardiovascular events at 6 months past the date of the last first-line treatment dose. For patients on treatment at 3 years post-index date, follow up for cardiovascular events will be limited to one 6-month assessment for 3.5 years total. Follow-up for SPM and survival will continue for 5 years.
15. Data analysis plan
Please provide a brief summary of the analysis method
Continuous demographic and baseline variables will be summarized using descriptive statistics while categorical variables will be summarized using frequency tabulations. Dose and duration information for lenalidomide and other first-line MM therapies other medications included in the treatment regimen other supportive care medications, concomitant medications for thromboprophylaxis, and concomitant medications used for lenalidomide, cardiovascular/cerebrovascular disease/diabetes will be summarized. Pertinent risk factor information for cardiovascular events will be tabulated and presented separately for patients treated with a lenalidomide-containing regimen and patients treated with other first-line regimens. Patients treated with other first-line regimens will be subgrouped by main therapy for descriptive purposes Individual patient listings will be provided. All concomitant treatment usage documented during the study period will be summarized in frequency tabulations
16. ENCePP seal
Are you requesting the ENCePP seal for this study?
No
17. Full protocol
Not submitted
18. Study Results
Not submitted
Please list the 5 most relevant publications using data from your study
ReferenceLink to web-publication
None
19. Other relevant documents
Conflict(s) of interest of
investigator(s)Not submitted
Composition of Steering Group and
ObserversNot submitted
Other documents
DescriptionDocumentLatest version
Signed Code of
Conduct Checklist
Not submitted
Signed Code of Conduct Declaration
Not submitted
Signed Checklist for Study
Protocols
Not submitted
