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Isatuximab -OBDS

Phase 2

Plasma Cell Myeloma Refractory | Small molecule | Oncology |Sanofi|Last Updated: Feb 23, 2026

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
UNCONTROLLEDBiomarker
Total Trials1
Total Enrollment64
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT06356571A Study to Investigate Subcutaneous Isatuximab in Combination With Weekly Carfilzomib and Dexamethasone in Adult Participants With Relapsed and/or Refractory Multiple MyelomaPHASE2 RECRUITING 64 — — Mar 17, 2025Jul 15, 2027Feb 23, 202634 United States
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Study Endpoints
Primary Endpoints
Overall response rate (ORR)
6 months after the Last Participant In (LPI) i.e., approximately 32 months

ORR, defined as the proportion of participants with stringent complete response (sCR), complete response (CR), very good partial response (VGPR), and partial response (PR), according to IMWG criteria assessed by investigator.

Secondary Endpoints
Number of participants with infusion reactions (IRs)
From the signing of informed consent to 30 days after the date of the last study treatment administration i.e., approximately 38 months
Number of participants with treatment-emergent adverse events (TEAEs), serious adverse events (SAEs), and laboratory abnormalities (per NCI-CTCAE grade or PCSA if NCI-CTCAE scale is not applicable)
From the signing of informed consent to 30 days after the date of the last study treatment administration i.e., approximately 38 months
Number of participants with injection site reactions (ISRs)
From the signing of informed consent to 30 days after the date of the last study treatment administration i.e., approximately 38 months
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Study Design & Arms
AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Isatuximab in combination with weekly carfilzomib and dexamethasoneEXPERIMENTALParticipants will receive isatuximab via SC-OBDS administration in combination with weekly carfilzomib and dexamethasone. Isatuximab will be administered on days 1, 8, 15 and 22 for Cycle 1 and then on days 1, 15 for subsequent cycles. Carfilzomib will be administered intravenously (IV) at a starting dose on Day 1 of Cycle 1 and then escalated dose on Days 8 and 15 of Cycle 1, followed by Days 1, 8 and 15 of subsequent cycles. Dexamethasone will be given on Days 1, 8, 15, and 22 of Cycle 1 and then on Days 1, 8 and 15 of subsequent cycles. Dexamethasone will be administered IV on Cycle 1 Day 1, and IV or PO in the subsequent administrations. 1 cycle = 28 days.
Interventions
NameTypeDescription
Isatuximab SC-OBDSDRUGPharmaceutical form:Solution for SC-OBDS administration-Route of administration:SC-OBDS
MontelukastDRUGPharmaceutical form:As per local commercial product-Route of administration:Oral
DexamethasoneDRUGPharmaceutical form:As per local commercial product-Route of administration:Oral or IV
AcetaminophenDRUGPharmaceutical form:As per local commercial product-Route of administration:Oral or IV
DiphenhydramineDRUGPharmaceutical form:As per local commercial product-Route of administration:Oral (as premedication) or IV/oral equivalent (for management of infusion reaction)
MethylprednisoloneDRUGPharmaceutical form:As per local commercial product-Route of administration:IV
CarfilzomibDRUGPharmaceutical form:As per local commercial product-Route of administration:IV
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites34

Inclusion Criteria: * Participants must have a documented diagnosis of MM. * Participants with measurable disease defined as at least one of the following: * Serum M-protein ≥0.5 g/dL measured using serum protein immunoelectrophoresis and/or * Urine M-protein ≥200 mg/24 hours measured using ur...

Countries:United States
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Recent Changes (Last 90 Days)
LOWMay 26, 2026NCT06356571primaryCompletionDate: changed
LOWMay 24, 2026NCT06356571studyFirstPostDate: changed