Rapid-infusion Isatuximab in Relapsed/Refractory Multiple Myeloma

NCT04802031 | Withdrawn Phase 2 DMC FDA Drug

• 2 other identifiers: 202530NCI-2021-01226
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Relapsed Multiple Myeloma; Refractory Multiple Myeloma

Keywords

Isatuximab Infusion

Outcome Measures

Primary Outcomes (1)

• Number of participants with reported grade 2 or higher infusion-related reactions (IRR)

  The per-patient incidence of Grade 2 or higher IRRs with rapid infusion (RI) isatuximab will be calculated as the number of patients who developed \>= 1 Grade 2+ IRR with RI isatuximab divided by the total number of patients who receive \>= 1 dose of RI isatuximab.

  Up to 6 months

Secondary Outcomes (1)

• Mean per-participant infusion duration

  9-12 weeks depending on isatuximab dosing interval

Study Arms (1)

Treatment (isatuximab)

EXPERIMENTAL

Participants receive their first 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 removed from the study. If a Grade 1 or no IRR occurs, then participants will receive another rapid infusion of 30 minutes. Participants will continue to receive RI and IRR assessment after each dose up to at least 6 doses or until a grade 2 or higher IRR occurs.

Biological: Rapid Infusion Isatuximab

Interventions

Rapid Infusion Isatuximab BIOLOGICAL

Given IV

Also known as: Hu 38SB19, ISATUXIMAB, Isatuximab-irfc, SAR 650984, SAR650984, Sarclisa

Treatment (isatuximab)

Eligibility Criteria

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

You may qualify if:

• Histologically confirmed diagnosis of multiple myeloma (International Classification of Disease (ICD-10) code: C90.0)
• Previous exposure to at least one proteasome inhibitors (PI) and lenalidomide (or candidacy for isatuximab as per updated Food and Drug Administration (FDA) package insert information in the future)
• Planned or current isatuximab-containing therapy. Patients receiving isatuximab as part of a clinical trial are eligible for this study if allowed by the trial sponsor.
• For ease of registration, patients will be allowed to enroll at any point after the decision is made to initiate isatuximab (with the understanding that their initial doses will be standard of care (SOC), including the first 2 doses for all patients). However, rapid infusion (RI) isatuximab will only be administered to participants who have not had infusion-related reactions (iRRs) during \>= 2 consecutive prior doses of SOC isatuximab
• Ability to understand a written informed consent form (ICF) document, and the willingness to sign the ICF document

You may not qualify if:

• Age \< 18
• Body weight \> 70 kilograms (kg) at the time of any RI isatuximab dose
• Current pregnancy or (if of reproductive age) unwillingness to follow contraception requirements as per the FDA package insert
• New York Heart Association Stage IV heart disease, i.e. unable to carry on any physical activity without discomfort or symptoms of heart failure (as per study investigator)
• Any medical condition, including mental illness or substance abuse, deemed by the principal investigator to interfere with the ability to provide consent or cooperate with study procedures

Sponsors & Collaborators

• Thomas Martin, MD: lead

MeSH Terms

Conditions

Multiple Myeloma

Interventions

isatuximab

Condition Hierarchy (Ancestors)

Neoplasms, Plasma Cell; Neoplasms by Histologic Type; Neoplasms; 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

Study Officials

• Thomas Martin, MD

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: March 13, 2021
• First Posted: March 17, 2021
• Study Start: May 28, 2021
• Primary Completion: November 30, 2022
• Study Completion: December 31, 2022
• Last Updated: July 7, 2022

Record last verified: 2022-07

Data Sharing

• IPD Sharing: Will not share