A Phase 1 interventional study of Isatuximab SAR650984 in Multiple Myeloma, sponsored by Sanofi. Completed at 3 sites in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-09-08.
Sponsored by Sanofi · Phase 1, Interventional, and Treatment
Primary Objective:
To evaluate the pharmacokinetics (PK) of isatuximab.
Secondary Objectives:
The duration of the study for an individual patient will include a screening period of up to 21 days, a treatment period of repeated 28-day cycles, and a follow-up period. End of treatment visit will be done at 30 (±7) days after last treatment.
3,632 studies on the registry are indexed under Multiple Myeloma; 745 are open to participants now.
This study's enrollment of 25 is below the median of 41 across 2,907 interventional studies indexed under Multiple Myeloma.
Browse Multiple Myeloma studies →Sanofi is the lead sponsor of 1,508 studies on the registry; 90 are open to participants now.
Of its 198 completed or terminated interventional studies of FDA-regulated products, 118 (60%) have results posted.
Counted across the registry records on this site, refreshed daily.
Measurable disease defined as at least 1 of the following:
Exclusion criteria:
The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Administered intravenously every week in Cycle 1 (4 weeks) followed by every 2 weeks (Q2W) in subsequent cycles.
Drug: Isatuximab SAR650984
Pharmaceutical form: Concentrate for solution Route of administration: Intravenous
Also known as: Sarclisa
Assessment of PK: Cmax
To evaluate the maximum observed concentration (Cmax)
Time frame: Cycle 1, up to 168 hours after start of infusion
Assessment of PK: tmax
To evaluate the time to reach Cmax (tmax)
Time frame: Cycle 1, up to 168 hours after start of infusion
Assessment of PK: AUC0-168h
To evaluate area under the plasma concentration versus time curve over the dosing interval (AUC0-168h)
Time frame: Cycle 1, up to 168 hours after start of infusion
Assessment of PK: Ceoi
To evaluate the concentration observed at the end of an IV infusion (Ceoi)
Time frame: Cycle 1 Day 1, Cycle 2 Day 1, Cycle 4 Day 1; Cycle duration is 28 days
Assessment of PK: Ctrough
To evaluate concentration observed just before investigational medicinal product (IMP) administration during repeated dosing (Ctrough)
Time frame: Up to approximately 40 weeks (Cycle 10)
Adverse Events
Treatment Emergent Adverse Events (TEAEs)/Serious Adverse Events (SAE) based on standard and systematic assessment including infusion associated reactions (IARs), laboratory test abnormalities, vital signs and ECOG performance status
Time frame: Up to 30 days after the last IMP administration
Anti-tumor activity: Overall response (ORR)
Proportion of patients achieving: stringent complete response (sCR), complete response (CR), very good partial response (VGPR), or partial response (PR) according to International Myeloma Working Group (IMWG 2016) criteria
Time frame: Up to 12 months after last patient treated
Anti-Tumor Activity: Duration of response (DOR)
Time from the date of the first determined response to the date of subsequent determined progressive disease or death, whichever happens earlier
Time frame: Up to 12 months after last patient treated
Anti-Tumor Activity: Time to progression (TTP)
Time interval from the date of first IMP administration to the date of the first assessed disease progression using IMWG criteria
Time frame: Up to 12 months after last patient treated
Anti-Tumor Activity: Progression free survival (PFS)
Time interval from the date of first IMP administration to the date of the first documentation of disease progression or death due to any cause, whichever comes first
Time frame: Up to 12 months after last patient treated
Anti-Tumor Activity: Overall survival (OS)
Time interval from the date of first IMP administration to death due to any cause
Time frame: Up to 12 months after last patient treated
Immunogenicity
To evaluate the presence of antidrug antibodies (ADA) to isatuximab
Time frame: Up to 13 months (10 cycles + 3 months) after last patient treated
Plan to share: Yes — Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org
No publications or documents are linked to this record.
This study is completed, as verified in Sep 2023. You cannot join it, but the record below documents what was studied.
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