Clinical trial Recruiting at 8 sites Observational Ages 18 and up Women only

Long-term safety and effectiveness of sirolimus for treating LAM

Official title: Multicenter International Durability and Safety of Sirolimus in LAM Trial (MIDAS)

Run by University of Cincinnati · NCT02432560 · Data updated 2026-11-12

This study is testing how safe and effective sirolimus is for people with lymphangioleiomyomatosis (LAM) over a long period of time while keeping track of their lung health and any side effects.

Quick facts

Study typeObservational
Ages18 Years and up
SexWomen only
Enrollment600 (estimated)
SponsorUniversity of Cincinnati
Academic / other
Locations20 sites (Stanford, California and 19 other locations)
StatusRecruiting
StartedMarch 2015
Main results expectedJuly 31, 2025
Study endsJuly 31, 2025
Registry record updatedDecember 24, 2024
Trial IDNCT02432560 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates include adults aged 18 and over diagnosed with LAM who are currently on or considering mTOR inhibitor therapy.

Probably not a fit

Patients unable to attend regular clinic visits or those who cannot provide informed consent may not benefit from this study.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

The MIDAS study is an observational registry that aims to follow patients with lymphangioleiomyomatosis (LAM) who are currently on or considering treatment with mTOR inhibitors like sirolimus or everolimus. The study will enroll 600 participants to monitor lung function and adverse events over a minimum of two years. This research builds on previous findings that indicated sirolimus can stabilize lung function decline but may require ongoing treatment. The decision to initiate therapy will be made collaboratively between the clinician and the patient.

Why it matters

Potential benefit: If successful, this study could provide insights into the long-term safety and effectiveness of sirolimus, potentially improving treatment strategies for LAM patients.

How similar studies have gone: Previous studies have shown that mTOR inhibitors can stabilize lung function in LAM patients, but this study aims to explore long-term outcomes, making it a continuation rather than a novel approach.

Who can join: the full rules

Show full inclusion / exclusion criteria
Inclusion Criteria:

* 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 Criteria:

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

Where it's running

  • Stanford University Medical Center
    Stanford, California, United States
    Recruiting
  • National Jewish Health
    Denver, Colorado, United States
    Recruiting
  • Mayo Clinic Jacksonville
    Jacksonville, Florida, United States
    Recruiting
  • Emory University School of Medicine
    Atlanta, Georgia, United States
    Recruiting
  • Brigham and Women's Hospital
    Boston, Massachusetts, United States
    Recruiting
  • University of Michigan
    Ann Arbor, Michigan, United States
    Recruiting
Show 14 more locations
  • Washington University School of Medicine
    St Louis, Missouri, United States
    Recruiting
  • University of Rochester Medical Center
    Rochester, New York, United States
    Recruiting
  • Loyola University Medical Center, Chicago
    Maywood, Illinois, United States
    Active not recruiting
  • Mayo Clinic Rochester
    Rochester, Minnesota, United States
    Active not recruiting
  • University of Cincinnati
    Cincinnati, Ohio, United States
    Active not recruiting
  • Cleveland Clinic
    Cleveland, Ohio, United States
    Active not recruiting
  • Oregon Health and Science University
    Portland, Oregon, United States
    Active not recruiting
  • University of Pennsylvania Medical Center
    Philadelphia, Pennsylvania, United States
    Active not recruiting
  • Medical University of South Carolina
    Charleston, South Carolina, United States
    Active not recruiting
  • Vanderbilt University Medical Center
    Nashville, Tennessee, United States
    Active not recruiting
  • University of Texas Southwestern Medical Center
    Dallas, Texas, United States
    Active not recruiting
  • University of Texas Health Center
    Houston, Texas, United States
    Active not recruiting
  • University of Utah School of Medicine
    Salt Lake City, Utah, United States
    Active not recruiting
  • Swedish Medical Center
    Seattle, Washington, United States
    Active not recruiting

Study contacts

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.