Safety and Durability of Sirolimus for Treatment of LAM



Status:Recruiting
Conditions:Lymphoma, Endocrine
Therapuetic Areas:Endocrinology, Oncology
Healthy:No
Age Range:18 - Any
Updated:4/17/2018
Start Date:March 2015
End Date:April 2020
Contact:Francis X McCormack, MD
Email:frank.mccormack@uc.edu
Phone:(513) 558-0588

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

The MIDAS study aims to follow women with LAM who are currently taking, have previously
failed or been intolerant of, or are considering treatment with mTOR inhibitors sirolimus or
everolimus as part of their clinical care.

Lymphangioleiomyomatosis (LAM) is an uncommon disease affecting women. It is associated with
cystic lung destruction and progressive respiratory failure. The Multicenter International
LAM Efficacy of Sirolimus (MILES) Trial, led by the investigators' research team,
demonstrated that mTOR (mammalian target of rapamycin) inhibition with sirolimus was an
effective therapy that stabilized decline in FEV1 (forced expiratory volume). However, lung
function decline resumed when the drug was stopped at the one year point in MILES, suggesting
that therapy is suppressive rather than remission-inducing, and may need to be lifelong. The
investigators therefore need to know whether long-term therapy with sirolimus is safe and
effective. To accomplish this goal, the investigators will conduct the Multicenter
International Durability and Safety of Sirolimus in LAM Trial (MIDAS). This is an
observational "registry" trial. The investigators propose to enroll 300 LAM patients who are
on, have previously failed or been intolerant of or are considering taking sirolimus or
everolimus for clinical reasons in a longitudinal observational study. This registry will
follow lung function tests and adverse events over periods of at least 2 years. The mTOR
inhibitor therapy will be initiated and managed by the participant's clinician. The study is
planned to use the collected data from standard of care. This study will help us to refine
treatment for patients with LAM and determine if long term suppressive therapy with sirolimus
can prevent progression to later stages of disease. This research will be accomplished as
part of the Rare Lung Disease Clinical Network Consortium, with data stored and analyzed by
the Database Management Coordinating Center (DMCC) as part of the NIH-supported Rare Disease
Consortium.

Inclusion Criteria:

- Female, age 18 or over

- Diagnosis of LAM

- 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
We found this trial at
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5300 Tallman Ave NW
Seattle, Washington 98122
(206) 782-2700
Phone: 206-320-6500
Swedish Medical Center Since 1910, Swedish has been the region's hallmark for excellence in health...
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1648 Pierce Dr NE
Atlanta, Georgia 30322
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1720 2nd Ave S
Birmingham, Alabama 35233
(205) 934-4011 
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75 Francis street
Boston, Massachusetts 02115
(617) 732-5500
Phone: 617-355-9049
Brigham and Women's Hosp Boston’s Brigham and Women’s Hospital (BWH) is an international leader in...
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9500 Euclid Avenue
Cleveland, Ohio 44106
216.444.2200
Phone: 216-444-4222
Cleveland Clinic Cleveland Clinic is committed to principles as presented in the United Nations Global...
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1211 Medical Center Dr
Nashville, Tennessee 37232
(615) 322-5000
Phone: 615-343-4761
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3181 Southwest Sam Jackson Park Road
Portland, Oregon 97239
503 494-8311
Phone: 503-494-7680
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601 Elmwood Avenue
Rochester, New York 14642
(585) 275-2100
Phone: 585-275-4161
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500 S State St
Ann Arbor, Michigan 48109
(734) 764-1817
Phone: 734-936-5047
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Bethesda, Maryland 20892
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171 Ashley Avenue
Charleston, South Carolina 29425
843-792-1414
Phone: 843-792-2153
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2600 Clifton Ave
Cincinnati, Ohio 45267
(513) 556-6000
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1801 Inwood Rd
Dallas, Texas 75390
(214) 645-3300
Phone: 214-648-9095
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1400 Jackson St
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(303) 388-4461
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Houston, Texas 77030
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Jacksonville, Florida 32216
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Maywood, Illinois 60153
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630 W 168th St
New York, New York
212-305-2862
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Philadelphia, Pennsylvania
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200 First Street SW
Rochester, Minnesota 55905
507-284-2511
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660 S Euclid Ave
Saint Louis, Missouri 63110
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Salt Lake City, Utah 84132
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300 Pasteur Dr
Stanford, California 94305
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