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

Use our guide to learn which trials are right for you!

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
23
sites
1801 Inwood Rd
Dallas, Texas 75390
(214) 645-3300
Phone: 214-648-9095
University of Texas Southwestern Medical Center UT Southwestern is an academic medical center, world-renowned for...
?
mi
from
Dallas, TX
Click here to add this to my saved trials
1648 Pierce Dr NE
Atlanta, Georgia 30322
(404) 727-5640
Emory University School of Medicine Emory University School of Medicine has 2,359 full- and part-time...
?
mi
from
Atlanta, GA
Click here to add this to my saved trials
1720 2nd Ave S
Birmingham, Alabama 35233
(205) 934-4011 
Phone: 205-996-9405
University of Alabama at Birmingham The University of Alabama at Birmingham (UAB) traces its roots...
?
mi
from
Birmingham, AL
Click here to add this to my saved trials
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...
?
mi
from
Boston, MA
Click here to add this to my saved trials
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...
?
mi
from
Cleveland, OH
Click here to add this to my saved trials
1211 Medical Center Dr
Nashville, Tennessee 37232
(615) 322-5000
Phone: 615-343-4761
Vanderbilt Univ Med Ctr Vanderbilt University Medical Center (VUMC) is a comprehensive healthcare facility dedicated...
?
mi
from
Nashville, TN
Click here to add this to my saved trials
3181 Southwest Sam Jackson Park Road
Portland, Oregon 97239
503 494-8311
Phone: 503-494-7680
Oregon Health and Science University In 1887, the inaugural class of the University of Oregon...
?
mi
from
Portland, OR
Click here to add this to my saved trials
601 Elmwood Avenue
Rochester, New York 14642
(585) 275-2100
Phone: 585-275-4161
Univ of Rochester Medical Center One of the nation's top academic medical centers, the University...
?
mi
from
Rochester, NY
Click here to add this to my saved trials
500 S State St
Ann Arbor, Michigan 48109
(734) 764-1817
Phone: 734-936-5047
University of Michigan The University of Michigan was founded in 1817 as one of the...
?
mi
from
Ann Arbor, MI
Click here to add this to my saved trials
Bethesda, Maryland 20892
Phone: 301-496-3632
?
mi
from
Bethesda, MD
Click here to add this to my saved trials
171 Ashley Avenue
Charleston, South Carolina 29425
843-792-1414
Phone: 843-792-2153
Medical University of South Carolina The Medical University of South Carolina (MUSC) has grown from...
?
mi
from
Charleston, SC
Click here to add this to my saved trials
2600 Clifton Ave
Cincinnati, Ohio 45267
(513) 556-6000
Phone: 513-558-4376
University of Cincinnati The University of Cincinnati offers students a balance of educational excellence and...
?
mi
from
Cincinnati, OH
Click here to add this to my saved trials
1400 Jackson St
Denver, Colorado 80206
(303) 388-4461
Phone: 303-398-1436
National Jewish Health National Jewish Health is known worldwide for treatment of patients with respiratory,...
?
mi
from
Denver, CO
Click here to add this to my saved trials
Houston, Texas 77030
Phone: 832-325-7222
?
mi
from
Houston, TX
Click here to add this to my saved trials
Jacksonville, Florida 32216
Phone: 904-953-2381
?
mi
from
Jacksonville, FL
Click here to add this to my saved trials
Maywood, Illinois 60153
Phone: 708-216-4946
?
mi
from
Maywood, IL
Click here to add this to my saved trials
630 W 168th St
New York, New York
212-305-2862
Phone: 212-305-3745
Columbia University Medical Center Situated on a 20-acre campus in Northern Manhattan and accounting for...
?
mi
from
New York, NY
Click here to add this to my saved trials
Philadelphia, Pennsylvania
Phone: 215-349-5488
?
mi
from
Philadelphia, PA
Click here to add this to my saved trials
200 First Street SW
Rochester, Minnesota 55905
507-284-2511
Phone: 507-284-2447
Mayo Clinic Rochester Mayo Clinic is a nonprofit worldwide leader in medical care, research and...
?
mi
from
Rochester, MN
Click here to add this to my saved trials
660 S Euclid Ave
Saint Louis, Missouri 63110
(314) 362-5000
Phone: 314-362-6904
Washington University School of Medicine Washington University Physicians is the clinical practice of the School...
?
mi
from
Saint Louis, MO
Click here to add this to my saved trials
Salt Lake City, Utah 84132
Phone: 801-581-7806
?
mi
from
Salt Lake City, UT
Click here to add this to my saved trials
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...
?
mi
from
Seattle, WA
Click here to add this to my saved trials
300 Pasteur Dr
Stanford, California 94305
(650) 723-4000
Phone: 650-723-6381
Stanford Univ Med Ctr The Medical Center is uniquely advantaged by its location on the...
?
mi
from
Stanford, CA
Click here to add this to my saved trials