NCT06356571|RecruitingPhase 2FDA Drug

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

SubQSA

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)

Sanofi ClinicalTrials.gov

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2 other identifiers

LPS18183U1111-1298-7348

Study Type

interventional

Target

Locations

1 country

Sites

Timeline

RegisteredApr 2024

StartedMar 2025

CompletionJul 2027

Brief 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.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

participants targeted

Target at P50-P75 for phase_2

Timeline

14mo left

Started Mar 2025

Geographic Reach

1 country

34 active sites

Status

recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

2.3 years study duration

Study Progress49%

Mar 2025Jul 2027

First Submitted

Initial submission to the registry

April 5, 2024

Completed

5 days until next milestone

First Posted

Study publicly available on registry

April 10, 2024

Completed

11 months until next milestone

Study Start

First participant enrolled

March 17, 2025

Completed

1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 8, 2027

Expected

6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 15, 2027

Last Updated

February 23, 2026

Status Verified

February 1, 2026

Enrollment Period

1.8 years

First QC Date

April 5, 2024

Last Update Submit

February 20, 2026

Conditions

Plasma Cell Myeloma Refractory

Keywords

Anti CD38 monoclonal antibodySARCLISA

Outcome Measures

Primary Outcomes (1)

Overall response rate (ORR)
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.
6 months after the Last Participant In (LPI) i.e., approximately 32 months

Secondary Outcomes (12)

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
CR or better
12 months after the Last Participant In (LPI) i.e., approximately 38 months
VGPR or better
12 months after the Last Participant In (LPI) i.e., approximately 38 months
+7 more secondary outcomes

Study Arms (1)

Isatuximab in combination with weekly carfilzomib and dexamethasone

EXPERIMENTAL

Participants 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.

Drug: Isatuximab SC-OBDSDrug: MontelukastDrug: DexamethasoneDrug: AcetaminophenDrug: DiphenhydramineDrug: MethylprednisoloneDrug: Carfilzomib