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.
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
Drug | Synonyms | Arms |
---|
Rapid Infusion Isatuximab | Hu 38SB19, ISATUXIMAB, Isatuximab-irfc, SAR 650984, SAR650984, Sarclisa | Treatment (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
Name | Type | Description | Interventions |
---|
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. | - 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
Last Updated
June 1, 2021