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Clinical Trials in France / NCT06846905
Recruiting Observational

Cost-utility Analysis of Ambulatory Dose Escalation of Bispecific Antibodies in Multiple Myeloma.

NCT06846905 · tracked via the Priya Life Science France tracker
Sponsor
University Hospital, Toulouse
Phase
Observational
Started
2025-01-20
Last updated
2025-02-26

Condition(s) studied

Multiple Myeloma in Relapse

Study summary

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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: * Relapsed and/or refractory multiple myeloma * Treated with teclistamab, elranatamab ou talquetamab * More than 18 years old * Having received the information from the study and not having objected to participate * Day hospital care in case of clinical feasibility (good general condition, no rapid progression or major tumor burden, no current infection) and logistics (accommodated less than 30 minutes from the IUCT Oncopole for 48 hours after each dose escalation) or in conventional hospitalization at the IUCT Oncopole Exclusion Criteria: * Illiterate subjects or those with a language barrier

Primary outcome measure(s)

  • Efficiency — 30 days
    Cost of the procedure for health system and quality-adjusted life year calculated from the generic EQ-5D-5L questionnaire

Trial sites (1)

FacilityCityRegionStatus
CHU de Toulouse Toulouse France Recruiting

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Other trials for the same condition

Study of HPN217 in Participants With Relapsed/Refractory Multiple Myeloma MK-4002 (MK-4002-001) Active, not recruiting
Study Comparing Continuous Versus Fixed Duration Therapy With Daratumumab, Lenalidomide, and Dexamethasone for Relapsed Multiple Myeloma Active, not recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06846905 on ClinicalTrials.gov ↗ ← All trials in France