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

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.

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Key information

Conditions

Multiple Myeloma in Relapse Blood Protein Disorders Cardiovascular Diseases Hematologic Diseases Hemic and Lymphatic Diseases Hemorrhagic Disorders Hemostatic Disorders Immune System Diseases Immunoproliferative Disorders Lymphoproliferative Disorders Multiple Myeloma Neoplasms Neoplasms by Histologic Type Neoplasms, Plasma Cell Paraproteinemias Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

CHU de Toulouse

Toulouse, 31100, France

Location status: Recruiting

Location contact

Aurore PERROT, MD, PhD

CONTACT

[email protected]

0531155050 ext. 33

Aurore PERROT, Md, PhD

PRINCIPAL_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

Efficiency

Time frame: 30 days

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

Study contacts

Contact information is provided by the study sponsor or research team.

Aurore PERROT, Md, PhD

CONTACT

[email protected]

0531155050 ext. 33

Sponsors and collaborators

Lead sponsor

University Hospital, Toulouse

Other

Registry information

Acronym: AmbuSpé

Important dates

Study start: 2025
Primary completion: 2026
Study completion: 2026
First posted: Feb 26, 2025
Registry last updated: Feb 26, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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