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

NCT02528838 | Completed

• 1 other identifier: NIPMS-Celgene-NETH-001
• Study Type: observational
• Target: 238
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Multiple Myeloma

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Quality of Life

  Up to approximatly 24 months

• Lenalidomide usage patterns

  Up to approximatly 4 years

• Lenalodomide dose modifications

  Up to approximatly 4 years

• Reasons for discontinuation of lenalidomide

  Up to approximatly 4 years

• Clinical outcome

  Up to approximately 4 years

Study Arms (1)

Patients receiving Revlimid according to clinical practice

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients already successfully, i.e. with currently stable disease or meeting the criteria for complete response, very good partial response or partial response, on-treatment for maximally up to 6 cycles with lenalidomide at each site will be enrolled into the study. In all cases, the decision to treat the patient with lenalidomide was already made prior to the decision to enter the subject into the study.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Celgene: lead

MeSH Terms

Conditions

Multiple Myeloma; Neoplasms, Plasma Cell

Condition Hierarchy (Ancestors)

Neoplasms by Histologic Type; Neoplasms; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Paraproteinemias; Blood Protein Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemorrhagic Disorders; Lymphoproliferative Disorders; Immunoproliferative Disorders; Immune System Diseases

Study Officials

• Jeroen Stevens, MSc

  Celgene BV

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 6, 2015
• First Posted: August 19, 2015
• Study Start: May 1, 2011
• Primary Completion: June 30, 2016
• Study Completion: January 15, 2018
• Last Updated: May 27, 2020

Record last verified: 2020-05