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 type | Observational |
|---|---|
| Ages | 18 Years and up |
| Sex | Women only |
| Enrollment | 600 (estimated) |
| Sponsor | University of Cincinnati Academic / other |
| Locations | 20 sites (Stanford, California and 19 other locations) |
| Status | Recruiting |
| Started | March 2015 |
| Main results expected | July 31, 2025 |
| Study ends | July 31, 2025 |
| Registry record updated | December 24, 2024 |
| Trial ID | NCT02432560 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
- Study coordinator: Susan McMahan Sellers, BSN, RN
- Email: susan.mcmahan@uc.edu
- Phone: (513) 558-4376
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
-
Long-term safety of Imatinib for patients with Lymphangioleiomyomatosis
This study is testing if the cancer drug Imatinib is safe and can help women with Lymphangioleiomyomatosis by seeing how it affects their lung health over time.
-
Registry for pregnant women with Tuberous Sclerosis Complex and Lymphangioleiomyomatosis
This study is collecting information from pregnant women with Tuberous Sclerosis Complex and Lymphangioleiomyomatosis to see how their health and their babies' health are affected during pregnancy.
-
Collection of biosamples and clinical data for tuberous sclerosis and lymphangioleiomyomatosis
This study is collecting blood and tissue samples from people with tuberous sclerosis and lymphangioleiomyomatosis to help researchers learn more about these conditions and how they affect the body over time.
-
Comparing nebulized and inhaled albuterol for lung function in women with LAM
This study is testing whether using a nebulizer or an inhaler for albuterol helps women with LAM breathe better.
-
Registry for lymphangioleiomyomatosis cases in France
This study is gathering information about people with lymphangioleiomyomatosis in France to better understand how the disease affects them and how it is being treated.
-
Understanding the disease process of lymphangioleiomyomatosis
This study looks at how lymphangioleiomyomatosis affects the lungs in women and tries to find out what causes the disease to help develop better treatments.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.