Clinical trial NCT02917239: Prevalence of Ocular Disorders in Multiple Myeloma (MM-OO-16)
Official title: Prevalence Analysis of Ocular Disorders in Patients on Treatment for Symptomatic Multiple Myeloma
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Multiple Myeloma
Lead sponsor: Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
Sponsor class: OTHER
First posted: 2016-09-28
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Patients diagnosed with symptomatic multiple myeloma on treatment and/or on follow-up after treatment for multiple myeloma.

Brief 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.

Detailed 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

Eligibility criteria: 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

Primary outcomes:
measure: 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
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
name: Vittorio Montefusco, MD
role: PRINCIPAL_INVESTIGATOR
References: