An observational study in Multiple Myeloma in Relapse, sponsored by University Hospital, Toulouse. Recruiting at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-02-26.
Sponsored by University Hospital, Toulouse · Observational
Multiple myeloma is the second most common haematological cancer. Recent innovations have made it possible for relapsed/refractory patients to benefit from the innovative immunotherapy of bispecific antibodies. These antibodies stimulate the immune system to attack tumour cells. The treatment involves an escalating dose of three subcutaneous injections every 2 to 4 days for a total of about 10 days, followed by a weekly treatment phase.
The University Hospital of Toulouse was the first centre in France to offer outpatient dose escalation for this innovative treatment. This form of treatment depends on clinical and logistical feasibility. Where appropriate, patients are treated in a conventional unit. An analysis carried out at Toulouse University Hospital suggests a response to treatment, with no increased risk of complications in the outpatient setting. Patients' quality of life may also be unaffected. In addition, given the increasing demand for care in a context of finite resources, the economic evaluation of healthcare initiatives is becoming essential if we are to maintain a high-quality healthcare system that is accessible to all.
The study has two arms: patients treated in the outpatient unit and patients treated in the conventional unit. The prospective data collection is based on quality of life at three time points during the dose escalation phase. The following questionnaires will be used: EQ-5D-5L for utility analysis, QLQ-C30 validated in cancer patients and QLQ MY20 validated in multiple myeloma patients. Clinical data will be collected as well as economic data related to hospital stays.
3,632 studies on the registry are indexed under Multiple Myeloma; 745 are open to participants now.
This study's planned enrollment of 40 is below the median of 140 across 468 observational studies indexed under Multiple Myeloma.
Browse Multiple Myeloma studies →University Hospital, Toulouse is the lead sponsor of 794 studies on the registry; 214 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Study proposed during haematology consultation at the IUCT-Oncopole, detailing the care plan.
Exclusion Criteria:
Patients treated on an outpatient procedure if it's clinically feasible (good condition general, no rapid progression or major tumor burden, no current infection) and logistics (lived within 30 minutes from the IUCT Oncopole for 48 hours after each step-up dose)
Patients who do not meet the conditions for outpatient care and justify hospitalization in a conventional unit for dose escalation
Efficiency
Cost of the procedure for health system and quality-adjusted life year calculated from the generic EQ-5D-5L questionnaire
Time frame: 30 days
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University Hospital, Toulouse