Clinical Trials /

Rapid-infusion Isatuximab in Relapsed/Refractory Multiple Myeloma

NCT04802031

Description:

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.

Related Conditions:
  • Multiple Myeloma
Recruiting Status:

Recruiting

Phase:

Phase 2

Trial Eligibility

Document

Title

  • Brief Title: Rapid-infusion Isatuximab in Relapsed/Refractory Multiple Myeloma
  • Official Title: Safety of Rapid-Infusion Isatuximab in Patients With Relapsed/Refractory Multiple Myeloma

Clinical Trial IDs

  • ORG STUDY ID: 202530
  • SECONDARY ID: NCI-2021-01226
  • NCT ID: NCT04802031

Conditions

  • Relapsed Multiple Myeloma
  • Refractory Multiple Myeloma

Interventions

DrugSynonymsArms
Rapid Infusion IsatuximabHu 38SB19, ISATUXIMAB, Isatuximab-irfc, SAR 650984, SAR650984, SarclisaTreatment (isatuximab)

Purpose

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.
    

Trial Arms

NameTypeDescriptionInterventions
Treatment (isatuximab)ExperimentalParticipants 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.
  • Rapid Infusion Isatuximab

Eligibility 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
      
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:Number of participants with reported grade 2 or higher infusion-related reactions (IRR)
Time Frame:Up to 6 months
Safety Issue:
Description: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

Measure:Mean per-participant infusion duration
Time Frame:9-12 weeks depending on isatuximab dosing interval
Safety Issue:
Description: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.

Details

Phase:Phase 2
Primary Purpose:Interventional
Overall Status:Recruiting
Lead Sponsor:Thomas Martin, MD

Trial Keywords

  • Isatuximab Infusion

Last Updated

June 1, 2021