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Monoclonal Antibodies
Rapid Infusion Isatuximab for Multiple Myeloma
Phase 2
Waitlist Available
Research Sponsored by Thomas Martin, MD
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 6 months
Awards & highlights
Study Summary
This study is evaluating whether a faster infusion of isatuximab may be safe for patients with multiple myeloma.
Eligible Conditions
- Multiple Myeloma
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 6 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 6 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Number of participants with reported grade 2 or higher infusion-related reactions (IRR)
Secondary outcome measures
Mean per-participant infusion duration
Trial Design
1Treatment groups
Experimental Treatment
Group I: Treatment (isatuximab)Experimental Treatment1 Intervention
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.
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Who is running the clinical trial?
Thomas Martin, MDLead Sponsor
3 Previous Clinical Trials
145 Total Patients Enrolled
3 Trials studying Multiple Myeloma
145 Patients Enrolled for Multiple Myeloma
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
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