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

Celgene

Status: Completed

Conditions: Multiple Myeloma

Study type: Observational

Funder types: Industry

Identifiers

NCT02528838

NIPMS-Celgene-NETH-001

Details and patient eligibility

About

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.

Enrollment: 238 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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.

Trial design

238 participants in 1 patient group

Patients receiving Revlimid according to clinical practice