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

Multiple Myeloma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02917239
• Other study ID #: MM-OO-16
• Status: Completed
• Phase: N/A
• First received: September 26, 2016
• Last updated: October 3, 2016
• Start date: July 2014
• Est. completion date: September 2016

Study information

• Verified date: October 2016
• Source: Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: National Monitoring Centre for Clinical Trials - Ministry of Health
• Study type: Observational

Clinical Trial Summary

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.

Description:

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:

1. To evaluate the relation between the kind of treatment for multiple myeloma and the development of ocular disorders

2. 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: September 2016
• Est. primary completion date: September 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• Multiple Myeloma
• Neoplasms, Plasma Cell

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Fondazione IRCCS Istituto Nazionale dei Tumori, Milano

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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		12 months	No