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Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 01/25/2021.
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Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 01/25/2021.

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

Clinicaltrials.gov identifier NCT03106324

Recruitment Status Recruiting

First Posted April 10, 2017

Last update posted September 25, 2020

Study Description

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.

  • Condition or Disease:Multiple Myeloma
  • Intervention/Treatment: Drug: Revlimid (lenalidomide)
  • Phase: N/A
Detailed Description

N/A

Study Design
  • Study Type: Observational [Patient Registry]
  • Estimated Enrollment: 888 participants
  • Observational Model: Cohort
  • Time Perspective: Prospective
  • 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])
  • Actual Study Start Date: March 2017
  • Estimated Primary Completion Date: March 2025
  • Estimated Study Completion Date: March 2025
Groups and Cohorts
Groups/Cohorts Intervention/treatment
: 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
Drug: Revlimid (lenalidomide)
Treatment with first line Revlimid containing regimen as prescribed in routine clinical practice
: 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
Drug: Revlimid (lenalidomide)
Treatment with first line Revlimid containing regimen as prescribed in routine clinical practice
Outcome Measures
  • Primary Outcome Measures: 1. Incidence of cardiovascular events [ Time Frame: Approximately 8 years ]
    Number of participants with cardiovascular adverse events
  • Secondary Outcome Measures: 1. 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
  • 2. 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.
  • 3. 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.
Eligibility Criteria
  • 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: 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.
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.

Contacts and Locations
Contacts

Contact: Associate Director Clinical Trial Disclosure 1-888-260-1599 clinicaltrialdisclosure@celgene.com

Locations
Show 135 Study Locations
Sponsors and Collaborators

Celgene

Investigators

Study Director: Elisabeth Kueenburg, MD Study physician for Celgene

More Information
  • Responsible Party: Celgene
  • ClinicalTrials.gov Identifier: NCT03106324 History of Changes
  • Other Study ID Numbers: CC-5013-MM-034, U1111-1194-5810
  • First Posted: April 10, 2017 Key Record Dates
  • Last Update Posted: September 25, 2020
  • Last Verified: September 2020
  • Individual Participant
    Data (IPD) Sharing
    Statement:
  • Plan to Share IPD: No
  • Keywords provided by Celgene: Multiple Myeloma
    Non transplant eligible
    Revlimid
    PASS
    Non-interventional
    Lenalidomide
  • Additional relevant MeSH terms: Multiple Myeloma Neoplasms, Plasma Cell