Safety and Durability of Sirolimus for Treatment of LAM
MIDAS
Multicenter International Durability and Safety of Sirolimus in LAM Trial (MIDAS)
2 other identifiers
observational
600
1 country
20
Brief Summary
The MIDAS study aims to follow male and female LAM patients who are currently taking, have previously failed or been intolerant of, or may (at some time in the future) take mTOR inhibitors (sirolimus or everolimus) as part of their clinical care. Adult female TSC patients may also enroll, with or without lung cysts.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Mar 2015
Longer than P75 for all trials
20 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2015
CompletedFirst Submitted
Initial submission to the registry
March 4, 2015
CompletedFirst Posted
Study publicly available on registry
May 4, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 31, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
July 31, 2025
CompletedDecember 24, 2024
December 1, 2024
10.4 years
March 4, 2015
December 18, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
Long term safety of mTOR inhibitor treatment in LAM
Symptoms and adverse events will be recorded
2-5 years
Efficacy - FEV1 slope
Rate of change in FEV1 in ml/month
2-5 years
Efficacy -10% reduction in FEV1
time from enrollment to 10% or greater reduction in FEV1(forced expiratory volume) in months
2-5 years
Secondary Outcomes (1)
Effect of long term sirolimus on quality of life
2-5 years
Study Arms (2)
Everolimus
women over age 18 who have LAM and are currently taking, have previously failed or been intolerant of, or who are considering taking everolimus as part of their clinical care
Sirolimus
women over age 18 who have LAM and are currently taking, have previously failed or been intolerant of, or who are considering taking sirolimus as part of their clinical care
Interventions
Sirolimus treatment will be part of a participant's clinical care and will be managed by their physician.
Everolimus treatment will be part of a participant's clinical care and will be managed by their physician.
Eligibility Criteria
Rare Lung Disease Clinical Network Consortium Clinics
You may qualify if:
- 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
You may not qualify if:
- Inability to attend at least one RLD Clinic visit per year
- Inability to give informed consent
- Inability or unwillingness to perform pulmonary function testing
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Cincinnatilead
- Rare Diseases Clinical Research Networkcollaborator
- National Institutes of Health (NIH)collaborator
- National Heart, Lung, and Blood Institute (NHLBI)collaborator
- The LAM Foundationcollaborator
Study Sites (20)
Stanford University Medical Center
Stanford, California, 94305, United States
National Jewish Health
Denver, Colorado, 80206, United States
Mayo Clinic Jacksonville
Jacksonville, Florida, 32224, United States
Emory University School of Medicine
Atlanta, Georgia, 33136, United States
Loyola University Medical Center, Chicago
Maywood, Illinois, 60153, United States
Brigham and Women's Hospital
Boston, Massachusetts, 02115, United States
University of Michigan
Ann Arbor, Michigan, 48109, United States
Mayo Clinic Rochester
Rochester, Minnesota, 55905, United States
Washington University School of Medicine
St Louis, Missouri, 63110, United States
University of Rochester Medical Center
Rochester, New York, 14642-8692, United States
University of Cincinnati
Cincinnati, Ohio, 45267, United States
Cleveland Clinic
Cleveland, Ohio, 44195, United States
Oregon Health and Science University
Portland, Oregon, 97239, United States
University of Pennsylvania Medical Center
Philadelphia, Pennsylvania, 19104, United States
Medical University of South Carolina
Charleston, South Carolina, 29425, United States
Vanderbilt University Medical Center
Nashville, Tennessee, 37232-2650, United States
University of Texas Southwestern Medical Center
Dallas, Texas, 75390, United States
University of Texas Health Center
Houston, Texas, 77030, United States
University of Utah School of Medicine
Salt Lake City, Utah, 84132, United States
Swedish Medical Center
Seattle, Washington, 98104, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Francis X McCormack, MD
University of Cincinnati
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
March 4, 2015
First Posted
May 4, 2015
Study Start
March 1, 2015
Primary Completion
July 31, 2025
Study Completion
July 31, 2025
Last Updated
December 24, 2024
Record last verified: 2024-12