NCT06356571

A Study to Investigate Subcutaneous Isatuximab in Combination With Weekly Carfilzomib and Dexamethasone in Adult Participants With Relapsed and/or Refractory Multiple Myeloma

A Single-arm, Open-label, Phase 2 Study Evaluating Subcutaneous Administration of Isatuximab, Administered by an On Body Delivery System, in Combination With Weekly Carfilzomib and Dexamethasone in Adult Participants With Relapsed and/or Refractory Multiple Myeloma (RRMM)

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 64 (estimated)
• Sponsor: Sanofi · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The primary purpose of this study is to assess the efficacy (overall response rate) of subcutaneous (SC) via on body delivery system (SC-OBDS) isatuximab in combination with weekly carfilzomib and dexamethasone (Kd) in adult participants with RRMM having received 1 to 3 prior lines of therapy.

Detailed description

The duration of the study for a participant will include a period for screening of up to 28 days, a study treatment period of 12 months (except early discontinuation), the end-of-treatment (EOT) visit about 30 days after the last dose of study treatment, and a study follow-up period until death or the final study cut-off date. A cycle duration is 28 days. After study treatment discontinuation, participants will return to the study site 30 days after the last dose of study treatment for the EOT visit or before further anti-myeloma therapy initiation, whichever comes first.

Conditions

• Plasma Cell Myeloma Refractory

Interventions

Type	Name	Description
DRUG	Isatuximab SC-OBDS	Pharmaceutical form:Solution for SC-OBDS administration-Route of administration:SC-OBDS
DRUG	Montelukast	Pharmaceutical form:As per local commercial product-Route of administration:Oral
DRUG	Dexamethasone	Pharmaceutical form:As per local commercial product-Route of administration:Oral or IV
DRUG	Acetaminophen	Pharmaceutical form:As per local commercial product-Route of administration:Oral or IV
DRUG	Diphenhydramine	Pharmaceutical form:As per local commercial product-Route of administration:Oral (as premedication) or IV/oral equivalent (for management of infusion reaction)
DRUG	Methylprednisolone	Pharmaceutical form:As per local commercial product-Route of administration:IV
DRUG	Carfilzomib	Pharmaceutical form:As per local commercial product-Route of administration:IV

Timeline

• Start date: 2025-03-17
• Primary completion: 2027-01-08
• Completion: 2027-07-15
• First posted: 2024-04-10
• Last updated: 2026-02-23

Locations

34 sites across 1 country: United States

Regulatory

• FDA-regulated drug study