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NCT Number: NCT02528838

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

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.

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Key information

Conditions

Multiple Myeloma Blood Protein Disorders Cardiovascular Diseases Hematologic Diseases Hemic and Lymphatic Diseases Hemorrhagic Disorders Hemostatic Disorders Immune System Diseases Immunoproliferative Disorders Lymphoproliferative Disorders Neoplasms Neoplasms by Histologic Type Neoplasms, Plasma Cell Paraproteinemias Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. Adverse Event (AE)

    Time frame: 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 outcomes

  1. Quality of Life

    Time frame: 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

  2. Lenalidomide usage patterns

    Time frame: Up to approximatly 4 years

    Registration in case report form (CRF) and evaluation of usage patterns in daily clinical practice

  3. Lenalodomide dose modifications

    Time frame: Up to approximatly 4 years

    Registration in case report form (CRF) and evaluation of dose modifications in daily clinical practice

  4. Reasons for discontinuation of lenalidomide

    Time frame: Up to approximatly 4 years

    Registration in case report form (CRF) and evaluation of reasons of discontinuation in daily clinical practice

  5. Clinical outcome

    Time frame: Up to approximately 4 years

    Clinical outcome will be measured using routine assessment criteria (i.e. IMWG)

Sponsors and collaborators

Lead sponsor

Celgene

Industry

Registry information

Official study 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)

Acronym: REVIEW

Important dates

Study start
2011
Primary completion
2016
Study completion
2018
First posted
Aug 19, 2015
Registry last updated
May 27, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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