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Observational Study of Sirolimus and Everolimus for LAM

This study, called MIDAS, is looking at the long-term safety and effectiveness of sirolimus and everolimus for people with Lymphangioleiomyomatosis (LAM). LAM is a rare lung disease that mostly affects women. Researchers want to see if these medications, which work by targeting a pathway called mTOR, help stabilize lung function over time. You may be able to join if you are 18 or older, have a LAM diagnosis, and are currently taking, have previously tried, or are considering taking sirolimus or everolimus. The study will consider the treatment successful if it helps maintain your lung function (measured by FEV1, a breathing test) and is safe over 2 to 5 years. The current status of this study is unclear.

Study design
This is an observational study, meaning researchers will follow 600 participants over time. It is not a randomized trial.
What's involved
You would need to attend at least one clinic visit per year. The study will collect information from your routine clinical care.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for at least 2 to 5 years to assess long-term safety and effectiveness.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT02432560

Safety and Durability of Sirolimus for Treatment of LAM

Recruiting
Not specifiedAges 18+Observational
University of Cincinnati
~600 participants
Updated 2024-12-24 on ClinicalTrials.gov
What's tested:SirolimusEverolimus

At a glance

Recruiting sites
8 of 20 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Long term safety of mTOR inhibitor treatment in LAM
Measured over 2-5 years
+2 more outcomes measured

Conditions

Lymphangioleiomyomatosis

Explore related trials

LymphangioleiomyomatosisTuberous Sclerosis

Where it's being run

20 sites across 18 states
Ohio2
Texas2
California1
Colorado1
Florida1
Georgia1
Illinois1
Massachusetts1

Study leadership

  • Francis X McCormack, MD · STUDY_DIRECTOR · University of Cincinnati

Who to contact

Susan McMahan Sellers, BSN, RN
[email protected]
(513) 558-4376
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

Female or male, age 18 or over
Diagnosis of LAM based on ATS/JRS criteria
Signed and dated informed consent
On chronic therapy, newly treated or may be considered for therapy with mTOR inhibitors or previously intolerant of or having failed mTOR inhibitor therapy

Exclusion

Inability to attend at least one RLD Clinic visit per year
Inability to give informed consent
Inability or unwillingness to perform pulmonary function testing

What this trial measures

  • Long term safety of mTOR inhibitor treatment in LAM2-5 years

    Symptoms and adverse events will be recorded

  • Efficacy - FEV1 slope2-5 years

    Rate of change in FEV1 in ml/month

  • Efficacy -10% reduction in FEV12-5 years

    time from enrollment to 10% or greater reduction in FEV1(forced expiratory volume) in months