Status:
WITHDRAWN
Rapid-infusion Isatuximab in Relapsed/Refractory Multiple Myeloma
Lead Sponsor:
Thomas Martin, MD
Conditions:
Relapsed Multiple Myeloma
Refractory Multiple Myeloma
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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, ...
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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
May 28 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 31 2022
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT04802031
Start Date
May 28 2021
End Date
December 31 2022
Last Update
July 7 2022
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