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

Multiple Myeloma Clinical Trial

— REVIEW  

Official title:

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02528838
• Other study ID #: NIPMS-Celgene-NETH-001
• Status: Completed
• Start date: May 1, 2011
• Est. completion date: January 15, 2018

Study information

• Verified date: May 2020
• Source: Celgene
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 238
• Est. completion date: January 15, 2018
• Est. primary completion date: June 30, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Multiple Myeloma

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Celgene

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Adverse Event (AE)	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	Up to approximatly 4 years
Secondary	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	Up to approximatly 24 months
Secondary	Lenalidomide usage patterns	Registration in case report form (CRF) and evaluation of usage patterns in daily clinical practice	Up to approximatly 4 years
Secondary	Lenalodomide dose modifications	Registration in case report form (CRF) and evaluation of dose modifications in daily clinical practice	Up to approximatly 4 years
Secondary	Reasons for discontinuation of lenalidomide	Registration in case report form (CRF) and evaluation of reasons of discontinuation in daily clinical practice	Up to approximatly 4 years
Secondary	Clinical outcome	Clinical outcome will be measured using routine assessment criteria (i.e. IMWG)	Up to approximately 4 years