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| ID | Type | Description | Link |
|---|---|---|---|
| KLS-6127-08-2024-R | Other Grant/Funding Number | Krebsliga Schweiz |
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| Name | Class |
|---|---|
| University Hospital, Zürich | OTHER |
| Insel Gruppe AG, University Hospital Bern | OTHER |
| Swiss Cancer Institute | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| geriatric assessment group |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| pragmatic geriatric assessment | Other | observational study |
| |
| Measure | Description | Time Frame |
|---|---|---|
| treatment toxicity | primary endpoint will be the composite rate of death or any one of ≥ grade 3 toxicity | From enrollment to 3 month after end of treatment |
| Measure | Description | Time Frame |
|---|---|---|
| health related quality of life | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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patients age ≥ 65 years and older, treated at the University Hospitals in Bern and Zurich and undergoing CAR-T-cell or bsAB therapy
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Wiebke Rösler, Dr. med. | Contact | +4144 255 11 11 | wiebke.roesler@usz.ch | |
| Wiebke Gagesch, PD Dr. med. | Contact | +4144 417 11 11 | michael.gagesch@stadtspital.ch |
| Name | Affiliation | Role |
|---|---|---|
| Wiebke Rösler, Dr. med. | Universitätsspital Zürich | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Inselspital Bern | Recruiting | Bern | Switzerland |
under discussion
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| pragmatic geriatric assessment |
| Other |
pragmatic geriatric assessment |
|
| From enrollment to 3 month after end of treatment |
| Universitätsspital Zürich | Recruiting | Zurich | 8091 | Switzerland |
|
| ID | Term |
|---|---|
| D009101 | Multiple Myeloma |
| D008223 | Lymphoma |
| ID | Term |
|---|---|
| D054219 | Neoplasms, Plasma Cell |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D020141 | Hemostatic Disorders |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D010265 | Paraproteinemias |
| D001796 | Blood Protein Disorders |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D006474 | Hemorrhagic Disorders |
| D008232 | Lymphoproliferative Disorders |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| D008206 | Lymphatic Diseases |
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