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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.
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:
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:
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| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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Patients diagnosed with symptomatic multiple myeloma on treatment and/or on follow-up after treatment for multiple myeloma.
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| Name | Affiliation | Role |
|---|---|---|
| Vittorio Montefusco, MD | Fondazione IRCCS Istituto Nazionale dei Tumori, Milano | Principal Investigator |
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| ID | Term |
|---|---|
| D009101 | Multiple Myeloma |
| ID | Term |
|---|---|
| D054219 | Neoplasms, Plasma Cell |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D020141 | Hemostatic Disorders |
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| D014652 |
| Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D010265 | Paraproteinemias |
| D001796 | Blood Protein Disorders |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D006474 | Hemorrhagic Disorders |
| D008232 | Lymphoproliferative Disorders |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |