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

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)

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02528838

Acronym

REVIEW

Enrollment

238

Registered

2015-08-19

Start date

2011-05-01

Completion date

2018-01-15

Last updated

2020-05-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Multiple Myeloma

Keywords

Myeloma, Non-interventional, Observational, Lenalidomide, REVIEW, Post-authorization, Netherlands

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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
Lenalidomide usage patterns	Up to approximatly 4 years	Registration in case report form (CRF) and evaluation of usage patterns in daily clinical practice
Lenalodomide dose modifications	Up to approximatly 4 years	Registration in case report form (CRF) and evaluation of dose modifications 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
Clinical outcome	Up to approximately 4 years	Clinical outcome will be measured using routine assessment criteria (i.e. IMWG)

Outcome results