Prevalence of Ocular Disorders in Multiple Myeloma (MM-OO-16)

Overall survival of multiple myeloma (MM) patients has increased significantly due to the availability of the new drugs. Moreover, since MM is an incurable disease, patients are exposed to repeated lines of therapy with different agents. It is therefore increasingly important to monitor the long-term side-effects of treatments. In the present study we focused on ocular disorders. This is an observational study aiming to assess the prevalence of ocular disorders in 100 patients on treatment or follow-up for MM.

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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

About this study

This is an observational study aiming to assess the prevalence of ocular disorders in patients on treatment or follow-up for MM.

Study population Patients diagnosed with multiple myeloma on treatment and/or on follow-up after treatment for multiple myeloma. The study aims to enroll 100 patients.

Endpoints Primary endpoint: To determinate prevalence and main characteristics of ocular disorders in patients on treatment / or previously treated for Multiple Myeloma.

Secondary endpoints:

To evaluate the relation between the kind of treatment for multiple myeloma and the development of ocular disorders
To evaluate the relation between patient's characteristics and comorbidities (such as sex, age, smoking, hypertension, diabetes, autoimmune diseases) and the presence of ocular disorders in this population of patients.

Study design Patients will be enrolled in the study at any time starting for the 3rd month of treatment, regardless if they are still on treatment or not.

Patients will undergo an ocular evaluation including visual acuity analysis, evaluation of the anterior ocular segment, fundus oculi analysis, ocular pressure measurement, Schirmer's Test.

If clinically required by the ophthalmologist, the patient will also undergo:

Optical computerized tomography
Fundus autofluorescence
Fluorescein angiography
Computerized visual field

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

Age > 18 years
Diagnosis of Multiple Myeloma
Patients have started an active treatment for Multiple Myeloma since at least two months
Patients on active treatment for relapsed/refractory multiple myeloma
Patients on follow-up after previous active treatment for multiple myeloma

Exclusion criteria

Bilateral blindness preceding the diagnosis of multiple myeloma
No signature of the informed consent
Patients have started an active treatment for Multiple Myeloma since less than two months

Treatment and study plan

Primary outcomes

To assess prevalence of reduced visual acuity (>/= 20/40), cataract (graded according to LOCS III grading scale), dry eye, retinopathy, elevated intraocular pressure (> 21 mmHg) in patients on treatment for Multiple Myeloma

Time frame: 12 months

Sponsors and collaborators

Lead sponsor

Fondazione IRCCS Istituto Nazionale dei Tumori, Milano

Other

Registry information

Official study title

Prevalence Analysis of Ocular Disorders in Patients on Treatment for Symptomatic Multiple Myeloma

Important dates

Study start: 2014
Primary completion: 2016
Study completion: 2016
First posted: Sep 28, 2016
Registry last updated: Oct 4, 2016

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.

Published trials that share one or more normalized conditions with this study.

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