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Rapid-infusion Isatuximab in Relapsed/Refractory Multiple Myeloma

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ClinicalTrials.gov Identifier: NCT04802031
Recruitment Status : Not yet recruiting
First Posted : March 17, 2021
Last Update Posted : March 17, 2021
Sponsor:
Information provided by (Responsible Party):
Thomas Martin, MD, University of California, San Francisco

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:

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 10 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
Estimated Study Start Date : April 1, 2021
Estimated Primary Completion Date : October 31, 2022
Estimated Study Completion Date : November 30, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Multiple Myeloma
Drug Information available for: Isatuximab

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




Primary Outcome Measures :
  1. Number of participants with reported grade 2 or higher infusion-related reactions (IRR) [ Time Frame: 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 :
  1. Mean per-participant infusion duration [ Time Frame: 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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04802031


Contacts
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Contact: Charlie Aoun (415) 502-1564 Jenai.Wilmoth@ucsf.edu
Contact: Jenai Wilmoth, RN Jenai.Wilmoth@ucsf.edu

Locations
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United States, California
University of California San Francisco
San Francisco, California, United States, 94143
Contact: Charlie Aoun    415-502-1564    Charlie.Aoun@ucsf.edu   
Contact: Jenai Wilmoth, RN       Jenai.Wilmoth@ucsf.edu   
Principal Investigator: Thomas G. Martin, MD         
Sub-Investigator: Rahul Banerjee, MD         
Sponsors and Collaborators
Thomas Martin, MD
Investigators
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Principal Investigator: Thomas Martin, MD University of California, San Francisco
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Responsible Party: Thomas Martin, MD, Principal Investigator, University of California, San Francisco
ClinicalTrials.gov Identifier: NCT04802031    
Other Study ID Numbers: 202530
NCI-2021-01226 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
First Posted: March 17, 2021    Key Record Dates
Last Update Posted: March 17, 2021
Last Verified: March 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Thomas Martin, MD, University of California, San Francisco:
Isatuximab Infusion
Additional relevant MeSH terms:
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Multiple Myeloma
Neoplasms, Plasma Cell
Neoplasms by Histologic Type
Neoplasms
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Paraproteinemias
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Lymphoproliferative Disorders
Immunoproliferative Disorders
Immune System Diseases
Antibodies, Monoclonal
Immunologic Factors
Physiological Effects of Drugs