NCT02432560

Safety and Durability of Sirolimus for Treatment of LAM

Study Contact:

Susan McMahan Sellers, BSN, RN - Role: CONTACT - Phone: (513) 558-4376 - Email: susan.mcmahan@uc.edu
Francis X McCormack, MD - Role: CONTACT - Phone: (513) 558-0588 - Email: frank.mccormack@uc.edu

Study Phase:

Recruitment Status:

RECRUITING

NCT ID:

NCT02432560

Principal Investigator:

Study Type:

OBSERVATIONAL

Official Title:

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

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.

Eligibility

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

Disease(s) and\or Condition(s)

Lymphangioleiomyomatosis

Primary Purpose

Intervention/Treatment

- Type: DRUG
- Name: Sirolimus
- Description: Sirolimus treatment will be part of a participant's clinical care and will be managed by their physician.
- Arm Group Labels: Sirolimus
- Type: DRUG
- Name: Everolimus
- Description: Everolimus treatment will be part of a participant's clinical care and will be managed by their physician.
- Arm Group Labels: Everolimus

Sponsor

University of Cincinnati