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
|Condition or disease||Intervention/treatment||Phase|
|Relapsed Multiple Myeloma Refractory Multiple Myeloma||Biological: Rapid Infusion Isatuximab||Phase 2|
I. To evaluate the incidence of grade 2 or higher (Gr2+) infusion-related reactions (IRRs) with rapid-infusion (RI) isatuximab across 6 doses.
I. To estimate time savings with RI isatuximab (versus estimated standard of care [SOC] isatuximab duration lengths) across 6 doses of isatuximab.
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 Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||10 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
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
- 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.
- 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.
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
|Contact: Charlie Aoun||(415) 502-1564||Jenai.Wilmoth@ucsf.edu|
|Contact: Jenai Wilmoth, RN||Jenai.Wilmoth@ucsf.edu|
|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|
|Principal Investigator:||Thomas Martin, MD||University of California, San Francisco|