Bispecific Antibody, CART Therapy, Geriatric Hematology, Multiple Myeloma (MM), Lymphoma, Large B-Cell, Diffuse (DLBCL), Lymphoma
Conditions
Keywords
geriatric assessment, lymphoma, multiple myeloma, bispecific antibodies, chimeric antigen receptor, outcome assessment, toxicity, health related quality of life
Brief summary
CAR-T cell or bispecific antibody therapies are a new treatment option for adult patients with aggressive forms of lymphoma or so-called plasma cell diseases ('multiple myeloma', 'plasma cell myeloma') that could not be cured with other, less intensive approaches. However, these are intensive therapies that can be associated with severe and potentially life-threatening side effects. Although there is no age limit for these therapies, we know little about the short- and long-term side effects of these treatments in people of advanced age. Although a small number of patients in the pivotal studies were even over 80 years old, their number was too small to be able to assess the tolerability and success specifically in people over 65. At present, the treating physicians decide whether and, if so, which patients are considered 'fit' enough for this therapy. An objective assessment of the kind we want to investigate in our study does not currently exist on a regular basis. In this study, we therefore want to use simple clinical methods to investigate the effects of these forms of therapy in different areas of everyday function that are important for people in older age (mobility, memory, self-care skills, nutrition). We want to find out whether these investigations help to predict the risk of severe and/or long-term side effects. Based on the results, a pragmatic geriatric assessment could be introduced as standard before these therapies. Older patients could thus expect an improvement in their quality of life thanks to more predictable risks and side effects. Standardized screening could lead to lower healthcare costs for treatment and aftercare for both forms of therapy.
Interventions
OTHERpragmatic geriatric assessment
observational study
Sponsors
University Hospital, Zürich
Insel Gruppe AG, University Hospital Bern
Swiss Cancer Institute
University of Zurich
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
65 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* male or female patients age ≥ 65 years, * scheduled for CAR-T-cell or bsAB treatments * signed informed consent * sufficient knowledge of the German or French language
Exclusion criteria
* inability to understand or sign informed consent * refuse to consent
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| treatment toxicity | From enrollment to 3 month after end of treatment | primary endpoint will be the composite rate of death or any one of ≥ grade 3 toxicity |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| health related quality of life | From enrollment to 3 month after end of treatment | Secondary endpoints will be the rate of transfer to intensive care units, the length of hospital stay, the discharge home versus to rehab or nursing-care facilities as well as changes in physical function, cognitive function, nutritional status, ability of self-care and the quality-of-life at discharge and three months after start of therapy. In addition premature CAR-T or bsAB discontinuation, the frequency of treatment-specific toxicities such as the cytokine-release syndrome (CRS) and the immune effector cell-associated neurotoxicity syndrome (ICANS) will be captured |
Countries
Switzerland
Contacts
Primary ContactWiebke Rösler, Dr. med.
Backup ContactWiebke Gagesch, PD Dr. med.
Outcome results
None listed