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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 : May 15, 2018
Sponsor:
Information provided by (Responsible Party):
Celgene

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 Intervention/treatment
Multiple Myeloma Drug: Revlimid (lenalidomide)

Study Type : Observational [Patient Registry]
Estimated Enrollment : 888 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 8 Years
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 31, 2017
Estimated Primary Completion Date : March 31, 2025
Estimated Study Completion Date : March 31, 2025

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Multiple Myeloma

Group/Cohort 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




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.



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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
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.

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): NCT03106324


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

  Show 85 Study Locations
Sponsors and Collaborators
Celgene
Investigators
Study Director: Elisabeth Kueenburg, MD Study physician for Celgene

Responsible Party: Celgene
ClinicalTrials.gov Identifier: NCT03106324     History of Changes
Other Study ID Numbers: CC-5013-MM-034
U1111-1194-5810 ( Other Identifier: World Health Organization )
First Posted: April 10, 2017    Key Record Dates
Last Update Posted: May 15, 2018
Last Verified: May 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Celgene:
Multiple Myeloma
Non transplant eligible
Revlimid
PASS
Non-interventional
Lenalidomide

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