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Carfilzomib is administered in treatment of Multiple Myeloma intravenously on two consecutive days, each week for three weeks (days 1, 2, 8, 9, 15, and 16), followed by a 12-day rest period (days 17 to 28). With COVID pandemic, the investigators had to limit patient visits to the hospital. The treatment protocols were modified by switching to weekly injections of carfilzomib according to the PLEIADES and ARROW 2 studies.
Considering the frequency of intravenous (IV) administration, home-based chemotherapy in Hospital-at-Home (HaH) setting is an attractive and suitable alternative to standard hospital-based chemotherapy in Outpatient-Hospital (OH), and is expected to provide both cost-savings for the Health Insurance (HI) and improvement in patient quality of life (QoL).
The purpose of the study is to assess the cost-utility of home-based compared to hospital-based carfilzomib administration in multiple myeloma.
The investigators are also planning on assessing healthcare resource utilization and related costs, adverse and intercurrent events, and patients' quality of life and satisfaction, for each strategy.
All participants receive the first cycle of treatment in OH. They are then randomized between exclusive OH treatment and combined treatment in OH and at home with HaH services.
For the HaH group, the first injection of each cycle is delivered in OH. The rest of the cycle is delivered at home by HaH after a clinical examination (by nurse or general practitionner).
Primary and secondary endpoints are collected at day 1 of cycle 3, 6, 9, 12, 18 and one month after the end of treatment.
Participants we leave the protocol prematurely in case of treatment failure, toxicity or if participant ask to. For those patients, the end of study visit will be done one month after ending treatment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Carfilzomib delivered in OH only | Active Comparator | Patients receive the whole treatment in OH. Primary and secondary endpoints are collected at day 1 of cycle 3, 6, 9, 12, 18 and one month after. Patients leave the protocol prematurely due to treatment failure, toxicity or patient wishes. For those patients, the end of study visit will be done one month after ending treatment. |
|
| Carfilzomib delivered in OH and HaH combined | Experimental | Patients receive the first cycle of treatment in OH. Then, they are randomized between exclusive OH treatment and combined treatment in OH and at home with HaH services. For the HaH patients group, the first injection of each cycle is delivered in OH. The rest of the cycle is delivered at home by HaH after a clinical examination (by nurse or general practitionner). Primary and secondary endpoints are collected at day 1 of cycle 3, 6, 9, 12, 18 and one month after. Patients leave the protocol prematurely due to treatment failure, toxicity or patient wishes. For those patients, the end of study visit will be done one month after ending treatment. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Carfilzomib delivered in OH only | Other | Patients receive the whole treatment en OH. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incremental cost-utility ratio (ICUR) expressed in euros per QALY. | Incremental cost-utility ratio (ICUR) of home-based compared to hospital-based carfilzomib administration in multiple myeloma, expressed in euros per QALY according to EQ-5D-5L questionnaire (EuroQOL 5 dimensions 5 levels) from 0 to 1 (1 being the best state with no problem) | Up to 20 months |
| Differences of quality of life in cancer patients between each group | Difference of quality of life according to EORTC QLQ-C30 questionnaire (European Organisation for Research and Treatment of Cancer Quality of life Questionnaire with 30 questions, answer from 1 to 4, 1 being the best state with no problem) | Up to 20 months |
| Differences of quality of life in myeloma patients between each group | Difference of quality of life according to EORTC QLQ-MY20 questionnaire (European Organisation for Research and Treatment of Cancer Quality of life Questionnaire with 20 questions related to myeloma symptoms, answer from 1 to 4, 1 being the best state with no problem) | Up to 20 months |
| Cost of care | Cost for Health Insurance by patients, at the end of treament: Total costs per patient and average cost per injection | Up to 20 month |
| Measure | Description | Time Frame |
|---|---|---|
| Healthcare resource utilization |
| Up to 20 months |
| Adverse events related to myeloma treatment |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Andreia CARVALHO DE FREITAS | Contact | 0383859305 | a.carvalhodefreitas@chru-nancy.fr | |
| Pierre FEUGIER | Contact | 0383853283 | p.feugier@chru-nancy.fr |
| Name | Affiliation | Role |
|---|---|---|
| Pierre FEUGIER | Central Hospital, Nancy, France | Principal Investigator |
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| ID | Term |
|---|---|
| D009101 | Multiple Myeloma |
| ID | Term |
|---|---|
| D054219 | Neoplasms, Plasma Cell |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D020141 | Hemostatic Disorders |
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| ID | Term |
|---|---|
| C031356 | hydroxide ion |
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| Carfilzomib delivered in OH and HaH combined | Other | Patients receive the first cycle of treatment in OH. Then, they are randomized between exclusive OH treatment and combined treatment in OH and at home with HaH services. |
|
|
| Up to 20 months |
| Patients and caregivers' satisfaction | - Patients' and Caregivers' Satisfaction Scores at the end of the treatment according to questionnaires with (opened and closes-questions) : 4 questions for OH group 9 questions for OH and HaH group 7 questions for caregiver | Up to 20 months |
| 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 |