Validation of a Comprehensive Health Status Assessment Scale in Elderly Patients (≥ 65 Years) With Hematological Malignancies (GAH)

Celgene

Status: Completed

Conditions: Multiple Myeloma; Leukemia Myeloid Acute; Leuklemia, Lymphocytic, Chronic; Myelodysplastic Syndromes

Treatments: Other: Geriatric Assessment of Health Status Scale administration

Study type: Observational

Funder types: Industry

Identifiers

NCT02164071

CEL-GAH-2011-01

Details and patient eligibility

About

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.

Enrollment: 363 patients

Sex: All

Ages: 65+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

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.

Exclusion criteria

Not fulfilling selection criteria

Trial design

363 participants in 3 patient groups

Multiple Myeloma (MM)

Description:

Patients with Myltiple Myeloma, symptomatic or asymptomatic

Treatment:

Other: Geriatric Assessment of Health Status Scale administration

Myelodysplastic Syndromes or Acute Myeloid Leukemia

Description:

Patients with Myelodysplastic Syndromes (MDS), any International Prognostic Scoring System (IPSS) risk, or Acute Myeloid Leukemia (AML)

Treatment:

Other: Geriatric Assessment of Health Status Scale administration

Chronic Lymphocytic Leukemia (CLL)

Description:

Patients with Chronic Lymphocytic Leukemia

Treatment:

Other: Geriatric Assessment of Health Status Scale administration