Myelodysplastic SyndromesGAHNCT02164071
Validation of a Comprehensive Health Status Assessment Scale in Elderly Patients (≥ 65 Years) With Hematological Malignancies
An observational study of Myelodysplastic Syndromes and Leukemia Myeloid Acute, run by Celgene at 22 sites in Spain.
Trial summary
The elderly comprise the most prevalent population in oncology practice. The available evidence suggests that old patients are undertreated patients, mainly because of their advanced age, regardless of whether they are highly functional patients, they do not present co morbidities and could benefit from oncology… Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Myelodysplastic Syndromes, Leukemia Myeloid Acute, Multiple Myeloma
- What is being tested?
- Geriatric Assessment of Health Status Scale administration
- How many people
- 363 participants
- Where
- 22 sitesSpain
- Study dates
- 11 Apr 2012to 4 Jul 2015
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Study population: Eligible patients, even being naïve to treatment, are eligible to receive treatment at any time as per clinical practice. Patients ≥ 65 years old, newly diagnosed, naïve to treatment, belonging to one of the 3 following groups. 1.- Patients with Myelodysplastic Syndromes (any risk according to) or Acute myeloid leukemia; 2.- Patients with Multiple Myeloma, either symptomatic or asymptomatic; or 3.- Patients with Chronic lymphocytic leukemia (including stadium A).
Who may be able to join
- Patients ≥ 65 years old. Treatment-naïve patients
- Newly diagnosed patients who belong to one of the 3 following groups:
- Patients with MDS (any risk grade as per IPSS) or AML Patients with multiple myeloma (symptomatic or not) or Patients with chronic lymphocytic leukemia (including A status) Patients who have granted their informed consent.
Who cannot join
- Not fulfilling selection criteria
Trial locations and contacts
22 sites in 1 country.
22 sites in 1 country
Spain22 sites
C.H. Universitario A Coruna
A Coruña, 15006
Hospital La Ribera
Alzira, Valencia, 46600
Hospital Germans Trias i Pujol
Badalona, 08916
Hospital Vall d'Hebron
Barcelona, 08035
Hospital Clinic
Barcelona, 08036
Hospital de Donostia
Donostia / San Sebastian, Guipuzcoa, 20080
Hospital Sant Joan de Deu
Espluges de Llobregat, Barcelona, 08950
Hospital Virgen de las Nieves
Granada, 18014
Hospital Duran I Reynals
L'Hospitalet de Llobregat, Barcelona, 08908
Arnau de Vilanova
Lleida, 25198
Hospital U. Gregorio Maranon
Madrid, 28007
Hospital Infanta Leonor
Madrid, 28031
Hospital U. Puerta de Hierro
Majadahonda, Madrid, 28222
Hospital Universitario Central de Asturias
Oviedo, Principality of Asturias, 33006
C.H. Navarra
Pamplona, Navarre, 31008
Hospital Parc Tauli
Sabadell, Barcelona, 08208
Hospital Universitario de Canarias
San Cristóbal de La Laguna, Tenerife, 38320
Hospital Ntra. Sra. La Candelaria
Santa Cruz de Tenerife, Tenerife, 38010
Hospital de Segovia
Segovia, 40002
Hospital Virgen del Rocio
Seville, 41013
Hospital La Fe
Valencia, 46026
Hospital Txagorritxu
Vitoria-Gasteiz, Alava, 01009
About this study
The elderly comprise the most prevalent population in oncology practice. The available evidence suggests that old patients are undertreated patients, mainly because of their advanced age, regardless of whether they are highly functional patients, they do not present co morbidities and could benefit from oncology therapies.
Treatment planning must consider several health indices that are useful when it comes to detecting geriatric problems that could affect the patient's treatment experience. The complete comprehensive geriatric evaluation stands out as cornerstone among other validated tools that do not work as isolated instruments; however, its length and complexity may hinder its routine use in clinical practice for decision making.
Read more
The purpose of this study is to validate a comprehensive health status assessment scale in elderly patients (≥65 years) with hematological malignancies that, while integrating the essential dimensions of geriatric assessment and, with the same precision as the currently available valid tools, is shorter and easier to apply, so it can be incorporated into the daily practice and that aids in clinical decision making objectively.
If so, this information would help identify patients that could benefit from a specific oncology treatment, thus contributing to developing a targeted intervention plan and to optimizing the cancer results in this patient population.
- Conditions
- Myelodysplastic Syndromes, Leukemia Myeloid Acute, Multiple Myeloma, Leuklemia, Lymphocytic, Chronic
- Being tested
- Geriatric Assessment of Health Status Scale administration
- Keywords
- Haematological malignancy, Elderly, Health Status, Scale validation
- Medical subject headings
- Myelodysplastic Syndromes, Leukemia, Myeloid, Acute, Multiple Myeloma, Bronchiolitis Obliterans Syndrome, Hematologic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Geriatric Assessment of Health Status Scale administrationOther
Also called Geriatric Assessment of Health Status Scale
Scale will be administered to all patients (3 cohorts) at baseline and then after 5 and not more than 15 days
| Study group | Role | What they receive |
|---|---|---|
| Multiple Myeloma (MM) | Patients with Myltiple Myeloma, symptomatic or asymptomatic Receives: Other: Geriatric Assessment of Health Status Scale administration | |
| Myelodysplastic Syndromes or Acute Myeloid Leukemia | Patients with Myelodysplastic Syndromes (MDS), any International Prognostic Scoring System (IPSS) risk, or Acute Myeloid Leukemia (AML) Receives: Other: Geriatric Assessment of Health Status Scale administration | |
| Chronic Lymphocytic Leukemia (CLL) | Patients with Chronic Lymphocytic Leukemia Receives: Other: Geriatric Assessment of Health Status Scale administration |
What is being measured
The primary outcome is the main question the study is designed to answer.
Geriatric Health Assessment (GHA) Questionnaire
A composite variable comprised of all the dimensions that make up the GHA questionnaire will be obtained on stable patients as a result of the implementation of a questionnaire by two independent evaluators: one investigator and one duly trained health professional.
Measured: Approximately 2.5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jun 2014 (estimated)
- Study start11 Apr 2012
- Primary completion3 Dec 2013
- Study completion4 Jul 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Myelodysplastic SyndromesStudies of the same condition, open and under way.
- More trials run by CelgeneThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 363 participants (actual)
Sponsor and investigators
- Lead sponsor
- Celgene
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jose Luis Garcia, PhD, Study director, Celgene
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02164071
- Sponsor's protocol ID
- CEL-GAH-2011-01
- Acronym
- GAH
- Status last verified
- Nov 2019
- First submitted
- 12 Jun 2014
- Last updated
- 18 Nov 2019
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validation of a Comprehensive Health Status Assessment Scale in Elderly Patients (≥ 65 Years) With Hematological Malignancies
- ClinicalTrials.gov ID
- NCT02164071
- Acronym / sponsor ID
- GAH / CEL-GAH-2011-01
- Conditions
- Myelodysplastic Syndromes, Leukemia Myeloid Acute, Multiple Myeloma, Leuklemia, Lymphocytic, Chronic
- Keywords
- Haematological malignancy, Elderly, Health Status, Scale validation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 363 participants (actual)
- Lead sponsor
- CelgeneIndustry (pharma, biotech, devices)
- Study start
- 11 Apr 2012 (actual)
- Primary completion
- 3 Dec 2013 (actual)
- Study completion
- 4 Jul 2015 (actual)
- First posted
- 16 Jun 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The elderly comprise the most prevalent population in oncology practice. The available evidence suggests that old patients are undertreated patients, mainly because of their advanced age, regardless of whether they are highly functional patients, they do not present co morbidities and could benefit from oncology therapies.
Treatment planning must consider several health indices that are useful when it comes to detecting geriatric problems that could affect the patient's treatment experience. The complete comprehensive geriatric evaluation stands out as cornerstone among other validated tools that do not work as isolated instruments; however, its length and complexity may hinder its routine use in clinical practice for decision making.
The purpose of this study is to validate a comprehensive health status assessment scale in elderly patients (≥65 years) with hematological malignancies that, while integrating the essential dimensions of geriatric assessment and, with the same precision as the currently available valid tools, is shorter and easier to apply, so it can be incorporated into the daily practice and that aids in clinical decision making objectively.
If so, this information would help identify patients that could benefit from a specific oncology treatment, thus contributing to developing a targeted intervention plan and to optimizing the cancer results in this patient population.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Multiple Myeloma (MM) | – | Other: Geriatric Assessment of Health Status Scale administrationPatients with Myltiple Myeloma, symptomatic or asymptomatic |
| Myelodysplastic Syndromes or Acute Myeloid Leukemia | – | Other: Geriatric Assessment of Health Status Scale administrationPatients with Myelodysplastic Syndromes (MDS), any International Prognostic Scoring System (IPSS) risk, or Acute Myeloid Leukemia (AML) |
| Chronic Lymphocytic Leukemia (CLL) | – | Other: Geriatric Assessment of Health Status Scale administrationPatients with Chronic Lymphocytic Leukemia |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- Study population
- Eligible patients, even being naïve to treatment, are eligible to receive treatment at any time as per clinical practice. Patients ≥ 65 years old, newly diagnosed, naïve to treatment, belonging to one of the 3 following groups. 1.- Patients with Myelodysplastic Syndromes (any risk according to) or Acute myeloid leukemia; 2.- Patients with Multiple Myeloma, either symptomatic or asymptomatic; or 3.- Patients with Chronic lymphocytic leukemia (including stadium A).
Key inclusion criteria (3 listed)
- Patients ≥ 65 years old. Treatment-naïve patients
- Patients with MDS (any risk grade as per IPSS) or AML Patients with multiple myeloma (symptomatic or not) or Patients with chronic lymphocytic leukemia (including A status) Patients who have granted their informed consent.
Key exclusion criteria (1 listed)
- Not fulfilling selection criteria
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Geriatric Assessment of Health Status Scale administrationAlso: Geriatric Assessment of Health Status ScaleScale will be administered to all patients (3 cohorts) at baseline and then after 5 and not more than 15 days | Other | Chronic Lymphocytic Leukemia (CLL), Multiple Myeloma (MM), Myelodysplastic Syndromes or Acute Myeloid Leukemia |
Primary outcome
Geriatric Health Assessment (GHA) Questionnaire
Time frame: Approximately 2.5 years
A composite variable comprised of all the dimensions that make up the GHA questionnaire will be obtained on stable patients as a result of the implementation of a questionnaire by two independent evaluators: one investigator and one duly trained health professional.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jose Luis Garcia, PhD study director
Celgene
22 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Myelodysplastic Syndromes and Leukemia Myeloid Acute, run by Celgene at 22 sites in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Nov 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 22 sites in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Geriatric Health Assessment (GHA) Questionnaire (time frame: Approximately 2.5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Nov 2019.