Interventional Validation of an MDS-Specific Measure of Quality of Life: Assessing the Responsiveness of the Quality of Life in Myelodysplasia Scale (QUALMS-1) to Different Hypomethylating Agent Regimens for Low and Intermediate Risk Disease



Status:Recruiting
Conditions:Blood Cancer, Leukemia
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:9/7/2018
Start Date:February 2015
End Date:February 2023
Contact:Guillermo Garcia-Manero, MD
Phone:713-745-3428

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The goal of this research study is to test a quality-of-life questionnaire called QUALMS-1 in
patients with MDS.

This is an investigational study.

Up to 240 participants will be enrolled in this multicenter study. Up to 175 will take part
at MD Anderson.

If you agree to take part in this study, you will be asked to complete questionnaires twice
during your participation in the 2014-0112 study.

During your first treatment visit, you will be asked to complete the QUALMS-1 questionnaire
and another questionnaire that asks about your well-being.

After your 4th cycle of treatment or when you stop receiving treatment, you will be asked to
complete the QUALMS-1 questionnaire again and another questionnaire to rate any changes in
your health since you started the study.

It should take about 20 minutes total to complete the questionnaires each time.

Information will also be collected from your medical record. This information will include
the results of lab tests and other information relating to your health.

Length of Study Participation:

After you complete the questionnaires the second time, your participation in this study will
be complete.

Inclusion Criteria:

1. Sign an Institutional Review Board (IRB)-approved informed consent document.

2. Age greater than or equal to 18 years

3. de novo or secondary International Prognostic Scoring Status (IPSS) low- or
intermediate-1-risk MDS, including Chronic Myelomonocytic Leukemia (CMML)-1

4. Eastern Cooperative Oncology Group (ECOG) performance status of greater than or equal
to 3 at study entry

5. Organ function as defined below: Serum creatine greater than or equal to mg/dL x upper
limit of normal (ULN); Total bilirubin greater than or equal to 2 x ULN; Alanine
transaminase (ALT; Serum glutamic pyruvic transaminase=SGPT) greater than or equal to
2 x ULN

6. Women of childbearing potential must have a negative serum or urine pregnancy test
within 7 days and will also need to use contraceptives. Men must agree not to father a
child and agree to use a condom if his partner is of child bearing potential.

Exclusion Criteria:

1. Breast feeding females

2. Prior therapy with decitabine or azacitidine

3. Prior participation in the development of the QUALMS-1 (Dana-Farber Cancer
Institute=DFCI)

4. Non-English speaking patients
We found this trial at
6
sites
450 Brookline Ave
Boston, Massachusetts 2215
617-632-3000
Dana-Farber Cancer Institute Since it’s founding in 1947, Dana-Farber has been committed to providing adults...
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Boston, MA
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3400 N Charles St
Baltimore, Maryland 21205
410-516-8000
Johns Hopkins University The Johns Hopkins University opened in 1876, with the inauguration of its...
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Baltimore, MD
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12902 USF Magnolia Dr
Tampa, Florida 33612
(888) 663-3488
H. Lee Moffitt Cancer Center & Research Institute Moffitt Cancer Center in Tampa, Florida, has...
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Tampa, FL
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2049 E 100th St
Cleveland, Ohio 44106
(216) 444-2200
Cleveland Clinic Foundation The Cleveland Clinic (formally known as The Cleveland Clinic Foundation) is a...
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Cleveland, OH
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1515 Holcombe Blvd
Houston, Texas 77030
 713-792-2121
University of Texas M.D. Anderson Cancer Center The mission of The University of Texas MD...
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Houston, TX
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445 E 69th St
New York, New York 10021
(212) 746-1067
Weill Medical College of Cornell University Founded in 1898, and affiliated with what is now...
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New York, NY
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