This trial is active, not recruiting.

Condition multiple myeloma
Sponsor Celgene
Start date May 2011
End date June 2016
Trial size 238 participants
Trial identifier NCT02528838, NIPMS-Celgene-NETH-001


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.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Observational model cohort
Time perspective prospective

Primary Outcomes

Adverse Event (AE)
time frame: Up to approximatly 4 years

Secondary Outcomes

Quality of Life
time frame: Up to approximatly 24 months
Lenalidomide usage patterns
time frame: Up to approximatly 4 years
Lenalodomide dose modifications
time frame: Up to approximatly 4 years
Reasons for discontinuation of lenalidomide
time frame: Up to approximatly 4 years
Clinical outcome
time frame: Up to approximately 4 years

Eligibility Criteria

All participants at least 18 years old.

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.

Additional Information

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)
Trial information was received from ClinicalTrials.gov and was last updated in February 2017.
Information provided to ClinicalTrials.gov by Celgene.