Observational Study Towards the Impact of Newly Started Treatment in MDS on QoL

Myelodysplastic Syndromes Clinical Trial

— Be-QUALMS  

Official title:

A Multicenter Observational Belgian Study Assessing the Impact of Newly Started Treatment on the QOL in Patients Suffering From Myelodysplastic Syndromes.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04053933
• Other study ID #: B300201938708
• Status: Recruiting
• Start date: August 1, 2019
• Est. completion date: February 1, 2022

Study information

• Verified date: August 2019
• Source: University Hospital, Antwerp
• Contact: Bert Heyrman, MD
• Phone: +32.3.280.34.59
• Email: bert.heyrman[@]zna.be
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

Study type An observational study conducted in different hematological centers in Belgium.

Study objectives

Primary objective:

To assess the impact of newly started treatments on the QOL of patients suffering from myelodysplastic syndromes.

Secondary objectives:

• To assess the impact of newly started therapy on disease perception in MDS patients

• To study the relation between disease perception and quality of life

• To examine which clinical and disease specific factors determine QOL in MDS patients

• Collect information on the transfusion threshold in Belgian hematological centers and evaluate the impact on quality of life.

• To evaluate whether changes in QOL are related to hematological respons.

Study design

• Newly diagnosed MDS patients who are about to start a treatment or previously diagnosed MDS patients who are starting with a new line of therapy.

• QOL assessment with the QUALMS.

• Disease perception measurement using the B-IPQ.

• Measurement at diagnosis/before start of therapy, at 4 weeks, 12 weeks, and at 24 weeks into treatment.

Study endpoints

Primary endpoint:

Change in QUALMS score at visit timepoints 4 - 12 - 24 weeks after the start of a new treatment.

Secondary endpoint:

• Change in B-IPQ score at visit timepoints 4 - 12 - 24 weeks after the start of a new treatment

• Association between B-IPQ and QUALMS score.

• Association between clinical and disease specific factors and QUALMS score

• Association between transfusion threshold and QUALMS score.

• Association between hematological response and QUALMS score

Summary of eligibility criteria

• Adult patients with a new diagnosis of MDS (according to WHO 2016 definitions (3) or known patients with MDS who are about to start a new treatment.

• Signed informed consent.

• Patients enrolled in an unblinded interventional therapeutic trial are eligible.

Exclusion criteria

• Patients with acute leukemia defined as >20% bone marrow blasts.

• Patients suffering from an overlap syndrome myelodysplastic/myeloproliferative disease.

• Patients in post allogeneic transplant setting.

• Patients enrolled in a blinded interventional therapeutic trial.

• Patients starting with multiple treatments under investigation at the same moment apart from intensive chemotherapy.

• Newly diagnosed patients who do not start with treatment.

• Patients who started a previous treatment less then 12 weeks ago apart from packed cell transfusion (up to 4 weeks allowed).

• Diagnosis of any previous or concomitant malignancy except when the patient successfully completed treatment (chemotherapy and/or surgery and/or radiotherapy) with curative intent for this malignancy at least 3 months prior to inclusion.

• Patients refusing to sign informed consent.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 350
• Est. completion date: February 1, 2022
• Est. primary completion date: September 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Newly diagnosed patients with myelodysplastic syndromes defined by WHO 2016 criteria that are about to start treatment.

• Patients with a known diagnosis of MDS, irrespective of IPSS and irrespective of time of diagnosis that are about to start a new therapy.

• Signed informed consent

Exclusion criteria

• Patients with acute leukemia defined as >20% bone marrow blasts.

• Patients suffering from a myelodysplastic/myeloproliferative overlap syndrome. In this case the disease has both dysplastic and proliferative features but cannot be properly categorized to either group. This category includes chronic myelomonocytic leukemia (CMML), juvenile myelomonocytic leukemia (JMML), atypial chronic myeloid leukemia (aCML) and myelodysplastic/myeloproliferative disease unclassifiable.

• Patients in post allogeneic transplant setting.

• Patients enrolled in a blinded interventional therapeutic trial.

• Patients starting with multiple MDS treatments at the same moment apart from intensive chemotherapy.

• Newly diagnosed patients who do not start with treatment.

• Patients who started a previous MDS related treatment less then 4 weeks ago.

• Patients who started a previous MDS related treatment less then 12 weeks ago apart from packed cell transfusions.

• Diagnosis of any previous or concomitant malignancy except when the patient successfully completed treatment (chemotherapy and/or surgery and/or radiotherapy) with curative intent for this malignancy at least 3 months prior to inclusion.

• Patients refusing to sign informed consent

Related Conditions & MeSH terms

• Myelodysplastic Syndromes
• Preleukemia
• Syndrome

Locations

Country	Name	City	State
Belgium	GasthuisZusters Antwerpen	Antwerpen
Belgium	Ziekenhuis Netwerk Antwerpen	Antwerpen
Belgium	Imelda	Bonheiden	Antwerpen
Belgium	AZ KLINA	Brasschaat	Antwerpen
Belgium	AZ Sint Jan Brugge	Brugge	West Vlaanderen
Belgium	Institute Jules Bordet	Brussel	Vlaams Brabant
Belgium	UZA	Edegem	Antwerp
Belgium	Sint-Dimpna Ziekenhuis Geel	Geel	Antwerpen
Belgium	UZ Gent	Gent	Oost Vlaanderen
Belgium	UZ Brussel	Jette	Vlaams Brabant
Belgium	CH Jolimont	La Louvière	Henegouwen
Belgium	UZ Leuven Gasthuisberg	Leuven	Vlaams Brabant
Belgium	Heilig Hart Ziekenhuis	Lier	Antwerpen
Belgium	CHR Mons Hainaut	Mons	Henegouwen
Belgium	CHU Ambroise Paré	Mons	Henegouwen
Belgium	CHR Namur	Namur
Belgium	AZ Damiaan Oostende	Oostende	West Vlaanderen
Belgium	BR Clinic Saint Pierre Ottignies	Ottignies-Louvain-la-Neuve
Belgium	AZ Nikolaas	Sint-Niklaas	Oost Vlaanderen
Belgium	Cliniques Universitaires Saint-Luc	Woluwe-Saint-Lambert	Vlaams Brabant
Belgium	CHU - UCL Namur site Godinne	Yvoir	Namur

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Antwerp

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in QUALMS-score	Change in quality of life-score after the start of a new MDS related treatment	6 months
Primary	Change in IPQ-score	Change of ilness perception score after the start of a new MDS related treatment	6 months