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

NCT06356571 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 64

Last updated 2026-02-23

No results posted yet for this study

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.

Conditions

  • Plasma Cell Myeloma Refractory

Interventions

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

Sponsors & Collaborators

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-03-17
Primary Completion
2027-01-08
Completion
2027-07-15
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06356571 on ClinicalTrials.gov