An Observational Study to Assess Safety and Outcome of the Various Medication Usage Patterns in Clinical Routine Practice in Patients Receiving Lenalidomide.

Completed

• Conditions: Multiple Myeloma

• Registration Number: NCT02528838
• Lead Sponsor: Celgene

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-05-01
• Study First Submitted: 2015-08-06
• Study First Submitted QC: 2015-08-18
• Study First Posted: 2015-08-19
• Primary Completion: 2016-06-30
• Study Completion: 2018-01-15
• Status Verified: 2020-05
• Last Update Submitted: 2020-05-26
• Last Update Posted: 2020-05-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 238

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Adverse Event (AE)	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

Secondary Outcome Measures

Name	Time	Method
Lenalidomide usage patterns	Up to approximatly 4 years	Registration in case report form (CRF) and evaluation of usage patterns in daily clinical practice
Reasons for discontinuation of lenalidomide	Up to approximatly 4 years	Registration in case report form (CRF) and evaluation of reasons of discontinuation in daily clinical practice
Quality of Life	Up to approximatly 24 months	Quality of life will be measured by using the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire(EORTC QL Q-C30) and EORTC QLQ-MY20
Lenalodomide dose modifications	Up to approximatly 4 years	Registration in case report form (CRF) and evaluation of dose modifications in daily clinical practice
Clinical outcome	Up to approximately 4 years	Clinical outcome will be measured using routine assessment criteria (i.e. IMWG)