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A Study to Determine Final Geriatric Assessment in Haematology (GAH) Score as a Tool for Predicting Tolerance to Treatment in Elderly Patients (≥ 65 Years) With Haematologic Neoplasms

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ClinicalTrials.gov Identifier: NCT02842229
Recruitment Status : Completed
First Posted : July 22, 2016
Last Update Posted : July 26, 2017
Sponsor:
Information provided by (Responsible Party):
Celgene

Brief Summary:
This is a post-authorization, retrospective multicentre observational nationwide study (PAS-OD). It will be conducted by reviewing medical records and database of patients who participated in the validation of the psychometric properties of the GAH study (CEL-GAH-2011-01). In all cases, only data prior to the start date of the study will be collected to ensure its retrospective nature, thereby reflecting routine clinical practice and non-interference in the physician's clinical practice

Condition or disease
Myelodysplastic Syndromes Leukemia Myeloid Acute Multiple Myeloma Leukemia, Lymphocytic, Chronic, B-Cell

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Study Type : Observational
Actual Enrollment : 117 participants
Observational Model: Case-Only
Time Perspective: Retrospective
Official Title: Retrospective Study to Determine Final Geriatric Assessment in Haematology (GAH) Score as a Tool for Predicting Tolerance to Treatment in Elderly Patients (≥ 65 Years) With Haematologic Neoplasms
Actual Study Start Date : July 20, 2016
Actual Primary Completion Date : February 2, 2017
Actual Study Completion Date : February 2, 2017


Group/Cohort
Patients with Haematologic Neoplasms

Patients with Myelodysplastic Syndromes (MDS), any IPSS (International Prognostic Scoring System) risk, or Acute Myeloid Leukemia (AML) who participated in the Geriatric Assessment in Haematology (GAH) study(CEL-GAH-2011-01).

Patients with Multiple Myeloma (MM), symptomatic or asymptomatic who participated in the Geriatric Assessment in Haematology (GAH) study (CEL-GAH-2011-01).

Patients with Chronic Lymphocytic Leukemia who participated in the Geriatric Assessment in Haematology (GAH) study (CEL-GAH-2011-01).




Primary Outcome Measures :
  1. Assessment of the tolerability of the treatment administered [ Time Frame: Up to approximately 4 months ]
    Number of patients, which suspend or modify treatment due to toxicity

  2. The score of number of drugs on the Geriatric Assessment in Haematology (GAH) scale [ Time Frame: Up to approximately 4 months ]
    Determination of number of drugs that patients were taken.

  3. The time of gait velocity on the Geriatric Assessment in Haematology (GAH) scale [ Time Frame: Up to approximately 4 months ]
    To determine the time taken to walk four meters at a normal pace.

  4. The score of activities of daily living on th Geriatric Assessment in Haematology (GAH) scale [ Time Frame: Up to approximately 4 months ]
    Assessment of so-called basic activities of daily living (ADLs), including the skills necessary for life such as dressing, grooming, bathing and feeding

  5. The score of subjective health status on the Geriatric Assessment in Haematology (GAH) scale [ Time Frame: Up to approximately 4 months ]
    The patient rating his or her own health

  6. The score of nutrition on the Geriatric Assessment in Haematology (GAH) scale [ Time Frame: Up to approximately 4 months ]
    To determine nutritional deficit

  7. The score of mental State on the Geriatric Assessment in Haematology (GAH) scale [ Time Frame: Up to approximately 4 months ]
    To evaluate mental state

  8. The score of comorbidity on the Geriatric Assessment in Haematology (GAH) scale [ Time Frame: Up to approximately 4 months ]
    Six variables of comorbidity and habits were considered (diabetes mellitus, cancer, lung disease, heart failure, smoking)


Secondary Outcome Measures :
  1. Therapeutic approach according to clinical judgment [ Time Frame: Up to approximately 4 months ]
    Number of patients that due to their fragility, the physician decided to modify the planned start treatment.

  2. Discontinuation of the planned treatment due to toxicity [ Time Frame: Up to approximately 4 months ]
    Percentage of patients who discontinued the planned treatment due to toxicity

  3. Modification of the planned treatment regimen due to toxicity [ Time Frame: Up to approximately 4 months ]
    Percentage of patients who modified the planned treatment regimen due to toxicity

  4. Percentage of patients with toxicity [ Time Frame: Up to approximately 4 months ]
    Percentage of patients who suspend or amend the treatment regimen due toxicity

  5. Number of participants visit to hospital as a result of toxicity [ Time Frame: Up to approximately 4 months ]
    Number of patients who were admitted to hospital as a result of toxicity



Information from the National Library of Medicine

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Ages Eligible for Study:   65 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
At least 80 patients will be included who participated in the Geriatric Assessment in Haematology (GAH) study (CEL-GAH-2011-01), who are scheduled to start treatment less than three months after completion of the GAH assessment (basal, test-retest or sensitivity to change) and who give their informed consent to data collection as long as such consent is possible.
Criteria

Inclusion Criteria:

  • Patients who were participating in the GAH study (CEL-GAH-2011-01).
  • Patients who have been scheduled to start treatment at a date less than three months after completion of the GAH (CEL-GAH-2011-01) scale in one of these visits: baseline, test-retest or sensitivity to change.
  • Patients who give informed consent to participate in the study as long as such consent is possible.

Exclusion Criteria:

• Not applicable


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02842229


Locations
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Spain
Hospital Universitario Central de Asturias
Oviedo, Asturias, Spain, 33006
Hospital Germans Trias i Pujol
Badalona, Barcelona, Spain, 08916
Hospital Durán I Reynals
L'Hospitalet de Llobregat, Barcelona, Spain, 08908
Hospital Parc Taulí
Sabadell, Barcelona, Spain, 08208
C. H. Navarra
Pamplona, Navarra, Spain, 31008
Hospital Universitario de Canarias
San Cristóbal de la Laguna, Tenerife, Spain, 38320
Hospital Ntra. Sra. La Candelaria
Santa Cruz de Tenerife, Tenerife, Spain, 38010
Hospital La Ribera
Alzira, Valencia, Spain, 46600
Hospital Vall d' Hebrón
Barcelona, Spain, 08035
C.H. Universitario A Coruña
La Coruña, Spain, 15006
Hospital U. Gregorio Marañón
Madrid, Spain, 28007
Hospital Infanta Leonor
Madrid, Spain, 28031
Hospital de Segovia
Segovia, Spain, 40002
Hospital La Fe
Valencia, Spain, 46026
Hospital Txagorritxu
Vitoria, Álava, Spain, 01009
Sponsors and Collaborators
Celgene
Investigators
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Study Director: Marta Duran, PhD Celgene Corporation
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Responsible Party: Celgene
ClinicalTrials.gov Identifier: NCT02842229    
Other Study ID Numbers: CEL-GAH-2016-01
First Posted: July 22, 2016    Key Record Dates
Last Update Posted: July 26, 2017
Last Verified: July 2017
Keywords provided by Celgene:
Myelodysplastic Syndromes
Leukemia Myeloid Acute
Multiple Myeloma
Leukemia, Lymphocytic, Chronic
Elderly Patients
Haematological malignancy
Elderly
Health Status
Scale validation
Retrospective
Additional relevant MeSH terms:
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Leukemia
Multiple Myeloma
Preleukemia
Leukemia, Lymphoid
Leukemia, Lymphocytic, Chronic, B-Cell
Leukemia, Myeloid
Hematologic Neoplasms
Myelodysplastic Syndromes
Neoplasms
Neoplasms by Histologic Type
Neoplasms, Plasma Cell
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Paraproteinemias
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Lymphoproliferative Disorders
Immunoproliferative Disorders
Immune System Diseases
Bone Marrow Diseases
Precancerous Conditions
Lymphatic Diseases
Leukemia, B-Cell
Neoplasms by Site