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Impacts on Health Outcomes and Resources Utilization of Hospital-at-home for Elderly Patients With Multiple Myeloma

Study Purpose

The study aims to compare the overall survival adjusted to quality of life of 2 groups of patients with multiple myeloma, depending on the type of care:

  • (1) day hospitalization exclusively or (2) day hospitalization combined with hospital-at-home.
As secondary objectives, the study aims to compare the impacts of the two types of care organization on:
  • - the survival of patients and response to treatments according to criteria of the International Myeloma Working Group, - psychological status of patients, - specific toxicity related to treatment used (haematological and infectious toxicity, neurotoxicity, .
..),
  • - health outcomes, - the caregiver's burden, This study is combined with a qualitative study about the incentives and the barriers, and in order to set up the patient's typology.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

 No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

 Observational
Eligible Ages 65 Years and Over
Gender All
More Inclusion & Exclusion Criteria

Inclusion Criteria:

  • - Patient > 65 years; - Resident of the departments in Île-de-France region (75, 92, 93 and 94); - Symptomatic multiple myeloma (relapsed or no); - Patient planned to receive one of the following chemotherapy protocols including bortezomib (VELCADE®): VMP (Velcade, Melphalan, Prednisone), VCD (Velcade, Cyclophosphamide, Dexamethasone), VelDex (Velcade, Dexamethasone), VRD (Velcade, Revlimid, Dexamethasone); - Ineligible for autologous hematopoietic stem-cell transplantation (ASCT); - Covered by a health insurance; - Patient who does not oppose to the use of his/her medical data for the purpose of clinical research.
  • - Adult patients under guardianship will can be enrolled in the study, a consent of tutor is needed completed by patient's consent.

Exclusion Criteria:

  • - Resident of the departments of 77, 78 and 91 in Île-de-France region; - Asymptomatic myeloma; - Life expectancy < 6 months; - Patient does not understand French language.

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

 NCT03490084
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

 Assistance Publique - Hôpitaux de Paris
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

 Bénédicte MITTAINE-MARZAC, PharmDMatthieu de STAMPA, MD
Principal Investigator Affiliation Hospitalisation à domicile (HAD), APHPHospitalisation à domicile (HAD), APHP
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

 Other
Overall Status Recruiting
Countries France
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

 Multiple Myeloma
Additional Details

Multiple myeloma, a malignant blood disease with about 5000 new cases diagnosed annually in France, essentially in the elderly population, is associated with alteration of quality of life resulting from pathology and therapies. Multiples cycles of chemotherapies are administered in a regular manner, as outpatient treatment or day hospitalization. In this study aiming to explore the impacts on health outcomes and resources utilization of hospital-at-home for elderly patients with multiple myeloma, all patients will be treated by 4 standardized protocols of treatment including bortezomib by subcutaneous administration. 9 centers will participate to the study. The study will not change the usual practices of care of these centers:

  • - 6 centers organize patient care through day hospitalization combined with hospital-at-home, - 3 other centers rely exclusively on day hospitalization.
The study will target overall the inclusion of 300 patients for the 9 centers and 70 participants (35 for each arm: 10 patients, 10 caregivers, 15 from healthcare team) for the qualitative study. The individual follow up of each patient will last 12 months. The patient's vital status will be documented at the 24th month.

Arms & Interventions

Arms

: Association of day hospitalization with hospital-at-home

Patients receive the first administration of chemotherapy through day hospitalization in the hematology department, then 3 weekly administrations of chemotherapy at home.

: Day hospitalization exclusively

Patients receive 4 weekly administrations of chemotherapy through day hospitalization in the hematology department.

Interventions

Other: - Association of day hospitalization with hospital-at-home

Patients receive the first administration of chemotherapy through day hospitalization in the hematology department, then 3 weekly administrations of chemotherapy at home.

Other: - Day hospitalization exclusively

Patients receive 4 weekly administrations of chemotherapy through day hospitalization in the hematology department.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

International Sites

HAD, Paris, Île-de-France, France

Status

Recruiting

Address

HAD

Paris, Île-de-France, 75005

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