Rapid-infusion Isatuximab in Relapsed/Refractory Multiple Myeloma

Sponsor

Thomas Martin, MD (Other)

Overall Status

Withdrawn

CT.gov ID

NCT04802031

Collaborator

(none)

Enrollment

Arm

19.1

Anticipated Duration (Months)

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Relapsed Multiple Myeloma Refractory Multiple Myeloma	Biological: Rapid Infusion Isatuximab	Phase 2

Detailed Description

PRIMARY OBJECTIVE:

To evaluate the incidence of grade 2 or higher (Gr2+) infusion-related reactions (IRRs) with rapid-infusion (RI) isatuximab across 6 doses.

SECONDARY OBJECTIVE:

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

0 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

May 28, 2021

Anticipated Primary Completion Date :

Nov 30, 2022

Anticipated Study Completion Date :

Dec 31, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Treatment (isatuximab) 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 Given IV Other Names: Hu 38SB19 ISATUXIMAB Isatuximab-irfc SAR 650984 SAR650984 Sarclisa

Arm

Intervention/Treatment

Experimental: Treatment (isatuximab)

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

Given IV

Other Names:

Hu 38SB19

ISATUXIMAB

Isatuximab-irfc

SAR 650984

SAR650984

Sarclisa

Outcome Measures

Primary Outcome Measures

Number of participants with reported grade 2 or higher infusion-related reactions (IRR) [Up to 6 months]
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.

Secondary Outcome Measures

Mean per-participant infusion duration [9-12 weeks depending on isatuximab dosing interval]
Descriptive statistics for total infusion durations in minutes including mean, standard deviation, and 95% confidence interval will be reported across the first 6 doses of RI isatuximab.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

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

Exclusion Criteria:

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Thomas Martin, MD

Investigators

Principal Investigator: Thomas Martin, MD, University of California, San Francisco

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Thomas Martin, MD, Principal Investigator, University of California, San Francisco

ClinicalTrials.gov Identifier:

NCT04802031

Other Study ID Numbers:

202530
NCI-2021-01226

First Posted:

Mar 17, 2021

Last Update Posted:

Jul 7, 2022

Last Verified:

Jul 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Yes

Studies a U.S. FDA-regulated Device Product:

Product Manufactured in and Exported from the U.S.:

Keywords provided by Thomas Martin, MD, Principal Investigator, University of California, San Francisco

Isatuximab Infusion

Additional relevant MeSH terms:

Multiple Myeloma

Neoplasms, Plasma Cell

Antibodies, Monoclonal

Study Results

No Results Posted as of Jul 7, 2022