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

• Register: ClinicalTrials.gov
• Last refreshed on: 6 June 2022
• Main ID: NCT03106324
• Date of registration: 29/03/2017
• Prospective Registration: Yes
• Primary sponsor: Celgene
• Public title: A Safety Study of Lenalidomide in Previously Untreated Adult Multiple Myeloma Patients Who Are Not Eligible for Transplant
• Scientific 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])
• Date of first enrolment: March 31, 2017
• Target sample size: 911
• Recruitment status: Active, not recruiting
• URL: https://clinicaltrials.gov/show/NCT03106324
• Study type: Observational [Patient Registry]

Countries of recruitment

Austria, Belgium, Denmark, France, Germany, Ireland, Italy, Netherlands, Norway, Spain, Sweden, United Kingdom

Contacts

• Name: Bristol-Myers Squibb, MD
• Affiliation: Bristol-Myers Squibb

Key inclusion & exclusion 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.



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Multiple Myeloma

Intervention(s)

Drug: Revlimid (lenalidomide)

Primary Outcome(s)

Incidence of cardiovascular events [Time Frame: Approximately 8 years]

Secondary Outcome(s)

Incidence of Second primary malignancy (SPM) in TNE NDMM patients treated with any first line regimen [Time Frame: Approximately 8 years]

Incidence of infections in NDMM patients [Time Frame: Approximately 8 years]

Incidence of renal impairment in NDMM patients [Time Frame: Approximately 8 years]

Secondary ID(s)

CC-5013-MM-034

U1111-1194-5810

Source(s) of Monetary Support

Please refer to primary and secondary sponsors