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

NCT06846905 | Recruiting

• 1 other identifier: RC31/24/0480
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Multiple Myeloma in Relapse

Keywords

Multiple myeloma; Neoplasms; Plasma Cell; Antineoplastic Agents; Antibodies Bispecific; Outpatient Care

Outcome Measures

Primary Outcomes (1)

• Efficiency

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

  30 days

Study Arms (2)

Outpatient step-up dose procedure

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)

Conventional procedure

Patients who do not meet the conditions for outpatient care and justify hospitalization in a conventional unit for dose escalation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Study proposed during haematology consultation at the IUCT-Oncopole, detailing the care plan.

You may qualify if:

• 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

You may not qualify if:

• Illiterate subjects or those with a language barrier

Sponsors & Collaborators

• University Hospital, Toulouse: lead

Study Sites (1)

CHU de Toulouse

Toulouse, 31100, France

RECRUITING

MeSH Terms

Conditions

Multiple Myeloma; Neoplasms

Condition Hierarchy (Ancestors)

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

Central Study Contacts

Aurore PERROT, Md, PhD

CONTACT

0531155050; perrot.aurore@iuct-oncopole.fr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 20, 2025
• First Posted: February 26, 2025
• Study Start: January 20, 2025
• Primary Completion (Estimated): September 30, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: February 26, 2025

Record last verified: 2025-02

Locations

FR (1)