NCT02917239

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jul 2014

Typical duration for all trials

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2014

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2016

Completed
25 days until next milestone

First Submitted

Initial submission to the registry

September 26, 2016

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 28, 2016

Completed
Last Updated

October 4, 2016

Status Verified

October 1, 2016

Enrollment Period

2.2 years

First QC Date

September 26, 2016

Last Update Submit

October 3, 2016

Conditions

Multiple Myeloma

Outcome Measures

Primary Outcomes (1)

  • 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

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients diagnosed with symptomatic multiple myeloma on treatment and/or on follow-up after treatment for multiple myeloma.

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Multiple Myeloma

Condition Hierarchy (Ancestors)

Neoplasms, Plasma CellNeoplasms by Histologic TypeNeoplasmsHemostatic DisordersVascular DiseasesCardiovascular DiseasesParaproteinemiasBlood Protein DisordersHematologic DiseasesHemic and Lymphatic DiseasesHemorrhagic DisordersLymphoproliferative DisordersImmunoproliferative DisordersImmune System Diseases

Study Officials

  • Vittorio Montefusco, MD

    Fondazione IRCCS Istituto Nazionale dei Tumori, Milano

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Medical Doctor

Study Record Dates

First Submitted

September 26, 2016

First Posted

September 28, 2016

Study Start

July 1, 2014

Primary Completion

September 1, 2016

Study Completion

September 1, 2016

Last Updated

October 4, 2016

Record last verified: 2016-10

Data Sharing

IPD Sharing
Will not share