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A Safety Study of Lenalidomide in Previously Untreated Adult Multiple Myeloma Patients Who Are Not Eligible for Transplant

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ClinicalTrials.gov Identifier: NCT03106324
Recruitment Status : Recruiting
First Posted : April 10, 2017
Last Update Posted : November 2, 2020
Sponsor:
Information provided by (Responsible Party):
Celgene

Tracking Information
First Submitted Date March 29, 2017
First Posted Date April 10, 2017
Last Update Posted Date November 2, 2020
Actual Study Start Date March 31, 2017
Estimated Primary Completion Date March 31, 2025   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: April 4, 2017)
Incidence of cardiovascular events [ Time Frame: Approximately 8 years ]
Number of participants with cardiovascular adverse events
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: April 4, 2017)
  • Incidence of renal impairment in NDMM patients [ Time Frame: Approximately 8 years ]
    To document renal function among TNE NDMM patients treated with a first-line regimen
  • Incidence of infections in NDMM patients [ Time Frame: Approximately 8 years ]
    To document the severity of infections among TNE NDMM patients treated with a first-line regimen.
  • Incidence of Second primary malignancy (SPM) in TNE NDMM patients treated with any first line regimen [ Time Frame: Approximately 8 years ]
    Secondary primary malignancies will be categorized according to whether they are invasive and non-invasive malignancies.
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title A Safety Study of Lenalidomide in Previously Untreated Adult Multiple Myeloma Patients Who Are Not Eligible for Transplant
Official Title A 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])
Brief Summary This post authorization safety study is designed as prospective non interventional study for patients with newly diagnosed multiple myeloma who are not eligible for transplant. The objective is to compare the incidence of cardiovascular events between patients treated with a first-line lenalidomide containing regimen and those treated with a first-line non-lenalidomide containing regimen. Treatment in both cohorts will be done according to standard care. The study will gather risk factor information at baseline and throughout follow-up. Any cardiovascular event occurring will be assessed by an independent committee. Other safety endpoints will be collected through standard procedures. Observation period will be 3 years on treatment, with an additional evaluation of cardiovascular events 6 months' post treatment and a follow up period until 5 years after inclusion. During follow up the incidence of second primary malignancies (SPM) and overall survival will be assessed.
Detailed Description Not Provided
Study Type Observational [Patient Registry]
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration 8 Years
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Patients with newly diagnosed multiple myeloma (NDMM) who are not eligible for transplant (TNE) starting their first treatment for multiple myeloma. Patients receiving any first line regimen can be included into the study. Decision for treatment needs to be done before inclusion into the trial.
Condition Multiple Myeloma
Intervention Drug: Revlimid (lenalidomide)
Treatment with first line Revlimid containing regimen as prescribed in routine clinical practice
Study Groups/Cohorts
  • TNE NDMM patients treated with lenalidomide regimen
    Newly diagnosed multiple myeloma patients who are not eligible for transplant and who are treated with a first-line regimen containing lenalidomide
    Intervention: Drug: Revlimid (lenalidomide)
  • TNE NDMM patients treated with non-lenalidomide
    Newly diagnosed multiple myeloma patients who are not eligible for transplant and who are treated with a first-line regimen not containing lenalidomide
    Intervention: Drug: Revlimid (lenalidomide)
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: April 4, 2017)
888
Original Estimated Enrollment Same as current
Estimated Study Completion Date March 31, 2025
Estimated Primary Completion Date March 31, 2025   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  1. Must have understood and voluntarily signed the Informed Consent Form (ICF)
  2. Age ≥ 18 years at the time of signing the ICF
  3. Newly diagnosed with multiple myeloma
  4. Must not be eligible for transplant
  5. Will be treated with a first-line lenalidomide-containing or nonlenalidomide-containing regimen, or currently is being treated with a first-line regimen and has received less than 2 cycles.

Exclusion Criteria:

  1. Prior treatment for Monoclonal gammopathy of undetermined significance (MGUS) or smoldering myeloma with lenalidomide, thalidomide, or pomalidomide or any agent considered to be a first-line Multiple myeloma (MM) therapy.
  2. Prior treatment with lenalidomide, thalidomide, or pomalidomide or any agent considered to be a first-line MM therapy through clinical trial participation or patient access program
  3. Two or more complete cycles of first-line therapy or any agent considered to be a firstline MM therapy for newly diagnosed multiple myeloma (NDMM) treatment before study enrollment
  4. Refusal to participate in the Revlimid Transplant noneligible (TNE) Newly diagnosed multiple myeloma (NDMM) Post-authorization safety study (PASS) or current participation in the treatment phase of an interventional clinical trial.
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts
Contact: Associate Director Clinical Trial Disclosure 1-888-260-1599 clinicaltrialdisclosure@celgene.com
Listed Location Countries Spain,   Austria,   Belgium,   Denmark,   France,   Germany,   Ireland,   Italy,   Netherlands,   Norway,   Sweden,   United Kingdom
Removed Location Countries  
 
Administrative Information
NCT Number NCT03106324
Other Study ID Numbers CC-5013-MM-034
U1111-1194-5810 ( Other Identifier: World Health Organization )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party Celgene
Study Sponsor Celgene
Collaborators Not Provided
Investigators
Study Director: Elisabeth Kueenburg, MD Study physician for Celgene
PRS Account Celgene
Verification Date October 2020