A Non-interventional Observational Post Authorization Study to Assess Safety and Outcome of the Various Medication Usage Patterns in Clinical Routine Practice in Patients Receiving Lenalidomide (REVIEW)

Celgene0 sites238 target enrollmentMay 1, 2011

ConditionsMultiple Myeloma

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Multiple Myeloma
Sponsor: Celgene
Enrollment: 238
Primary Endpoint: Adverse Event (AE)
Status: Completed
Last Updated: 5 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

The study is designed as a prospective, non-interventional, observational single arm study. Hundred-fifty patients over 18 with stable disease or at least partial response while on treatment with lenalidomide will be recruited from approximately 20 haematology/oncology sites in the Netherlands. Recruitment will continue until 150 patients have started the study. When this target is reached, all patients on lenalidomide will continue to be followed until the last patient has been followed for 36 months.

Registry

clinicaltrials.gov

Start Date

May 1, 2011

End Date

January 15, 2018

Last Updated

5 years ago

Study Type

Observational

Sex

All

Investigators

Sponsor

Celgene

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Patients over 18 years of age who understand and voluntarily sign an informed consent form.
•Patients with multiple myeloma who are currently receiving lenalidomide treatment and who have taken lenalidomide for \> 2 cycles and \< 6 cycles.
•Patients with currently stable disease or meeting the criteria for complete response, very good partial response or partial response while on lenalidomide treatment.

Exclusion Criteria

•Refusal to participate in the study.
•Women who are pregnant or breast-feeding.
•Women of childbearing potential unless all of the conditions of the Pregnancy Prevention Programme are met.
•Hypersensitivity to the active substance or to any of the excipients.

Outcomes

Primary Outcomes

Adverse Event (AE)

Time Frame: Up to approximatly 4 years

Adverse events will be classified using the MedDRA classification system. The severity of the toxicities will be graded according to the NCI CTCAE VERSION 4.03 whenever possible