Details
Description
Inclusion Criteria
Exclusion Criteria
Details
Title Interventional Validation of an MDS-Specific Measure of Quality of Life: Assessing the Responsiveness of the QUALMS-1 to Different Hypomethylating Agent Regimens for Low and Intermediate Risk Disease
IRB DFCI1914
CC 14-1480
Hospital Fairview, Hillcrest, Independence, Main Campus, Mansfield, North Coast Cancer, South Pointe, Strongsville, Wooster
Phase Phase 2
Disease Myelodisplastic Syndrome (MDS)
Description
Assess the responsiveness of the QUALMS-1 through an interventional design (2different regimens of hypomethylating agents). Specifically, to determine whether changesin MDS treatments lead to changes in the QoL of patients with MDS as measured by the QUALMS-1.Inclusion Criteria
- Sign an IRB-approved informed consent document.
- Age ≥ 18 years.
- de novo or secondary IPSS low- or intermediate-1–risk MDS, including CMML-1
- ECOG performance status of ≤ 3 at study entry
- Organ function as defined below:
- Serum creatinine ≤ 2 mg/dL x ULN
- Total bilirubin ≤ 2 x ULN
- ALT (SGPT) ≤ 2 x ULN
- 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
- Breast feeding females
- Prior therapy with decitabine or azacitidine
- Prior participation in the development of the QUALMS-1 (DFCI)
- Non-English speaking patients
