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

Celgene238 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

238

Conditions

Multiple Myeloma

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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)

Secondary Outcomes

Quality of Life

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

Time frame: Up to approximatly 24 months

Lenalidomide usage patterns

Registration in case report form (CRF) and evaluation of usage patterns in daily clinical practice

Time frame: Up to approximatly 4 years

Lenalodomide dose modifications

Registration in case report form (CRF) and evaluation of dose modifications in daily clinical practice

Time frame: Up to approximatly 4 years

Reasons for discontinuation of lenalidomide

Registration in case report form (CRF) and evaluation of reasons of discontinuation in daily clinical practice

Time frame: Up to approximatly 4 years

Clinical outcome

Clinical outcome will be measured using routine assessment criteria (i.e. IMWG)

Time frame: Up to approximately 4 years