NCT04802031

Rapid-infusion Isatuximab in Relapsed/Refractory Multiple Myeloma

Safety of Rapid-Infusion Isatuximab in Patients With Relapsed/Refractory Multiple Myeloma

• Status: Withdrawn
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Thomas Martin, MD · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This phase II trial studies the effects of isatuximab given as a rapid-infusion in treating multiple myeloma that has come back (recurrent) or has not responded to treatment (refractory). Isatuximab, also known as Sarclisa, is an antibody (proteins that can protect the body from foreign organisms, such as bacteria and viruses) directed against cluster of differentiation 38 (CD38), a receptor antigen (a receptor or protein on the outside of blood cells that can be used as a target). Isatuximab may stop the growth of some blood cancers. Normally, the fastest that intravenous isatuximab can be given - for patients who have not had any reactions to their first two doses - is over 1 hour and 15 minutes. This study is designed to test whether intravenous isatuximab can be given over 30 minutes ("rapid infusion") among patients who have not developed any reactions to at least 2 prior doses of intravenous isatuximab at normal speeds. If shown to be safe, "rapid infusion" isatuximab may ultimately improve the patient experience while reducing the overall cost of the infusion.

Detailed description

PRIMARY OBJECTIVE: I. To evaluate the incidence of grade 2 or higher (Gr2+) infusion-related reactions (IRRs) with rapid-infusion (RI) isatuximab across 6 doses. SECONDARY OBJECTIVE: I. To estimate time savings with RI isatuximab (versus estimated standard of care \[SOC\] isatuximab duration lengths) across 6 doses of isatuximab. OUTLINE: Patients must have received standard of care isatuximab IV over for at least 2 doses without any Gr2+ IRRs reported. Patients will then receive a rapid infusion of isatuximab IV over 30 minutes. If a \>=Grade 2 iRR occurs, then participants will revert to a SOC infusion time and be taken off the study. If a Grade 1 or no IRR occurs, then participants will receive another rapid infusion of 30 minutes and assessed again for IRRs. Rapid infusions and IRR assessment after each RI will continue for up to at least 6 doses or until the patient experiences an Grade 2 or higher IRR.

Conditions

• Relapsed Multiple Myeloma
• Refractory Multiple Myeloma

Interventions

Type	Name	Description
BIOLOGICAL	Rapid Infusion Isatuximab	Given IV

Timeline

• Start date: 2021-05-28
• Primary completion: 2022-11-30
• Completion: 2022-12-31
• First posted: 2021-03-17
• Last updated: 2022-07-07

Regulatory

• FDA-regulated drug study