NCT05405166|Active Not RecruitingPhase 3ResultsDMCFDA Drug

SC Versus IV Isatuximab in Combination With Pomalidomide and Dexamethasone in RRMM

IRAKLIA

A Randomized, Phase 3, Open Label Study Evaluating Subcutaneous Versus Intravenous Administration of Isatuximab in Combination With Pomalidomide and Dexamethasone in Adult Patients With Relapsed and/or Refractory Multiple Myeloma (RRMM)

Sanofi ClinicalTrials.gov

Compare

4 other identifiers

EFC15951U1111-1261-58462023-508869-322021-002485-41

Study Type

interventional

Target

531

Locations

21 countries

Sites

146

Timeline

RegisteredJun 2022

StartedJun 2022

CompletionMar 2027

Brief Summary

This is a randomized, multicenter, Phase 3, open-label study evaluating subcutaneous (SC) vs intravenous (IV) administration of isatuximab in combination with pomalidomide and dexamethasone (Pd) in RRMM patients (study participants) who have received at least 1 prior line of therapy including lenalidomide and a proteasome inhibitor (PI). Eligible participants will be randomized 1:1 into 1 of 2 study arms: Arm SC: Isatuximab SC + Pd Arm IV: Isatuximab IV + Pd Participants will be allowed to continue therapy until disease progression, unacceptable adverse events (AEs), participant request to discontinue therapy or any other reason, whichever comes first.

Trial Health

On Track

Trial Health Score

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

Strong global presence with extensive site network

Enrollment

531

participants targeted

Target at P75+ for phase_3

Timeline

11mo left

Started Jun 2022

Longer than P75 for phase_3

Geographic Reach

21 countries

146 active sites

Status

active not 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

4.8 years study duration

Study Progress82%

Jun 2022Mar 2027

First Submitted

Initial submission to the registry

May 31, 2022

Completed

6 days until next milestone

First Posted

Study publicly available on registry

June 6, 2022

Completed

17 days until next milestone

Study Start

First participant enrolled

June 23, 2022

Completed

2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 6, 2024

Completed

1 year until next milestone

Results Posted

Study results publicly available

November 14, 2025

Completed

1.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

March 23, 2027

Expected

Last Updated

November 14, 2025

Status Verified

November 1, 2025

Enrollment Period

2.4 years

First QC Date

May 31, 2022

Results QC Date

November 3, 2025

Last Update Submit

November 3, 2025

Conditions

Plasma Cell Myeloma Recurrent

Outcome Measures

Primary Outcomes (2)

Overall Response Rate (ORR)
ORR by independent review committee (IRC) using 2016 international myeloma working group (IMWG) criteria:Percentage of participants with complete response (CR),stringent CR (sCR),very good partial response (VGPR) \& partial response (PR).CR:negative immunofixation on serum and urine,disappearance of any soft tissue plasmacytomas (STP),\<5% plasma cells in bone marrow (BM) aspirates \& a normal free light chain(FLC)ratio (0.26-1.65).sCR:CR plus no clonal cells in BM biopsy. VGPR:serum \& urine M-protein detectable by immunofixation, not electrophoresis;\>=90% reduction in serum M-protein plus urine M-protein level\<100mg/24hour(h);\>=90% decrease in sum of maximal perpendicular diameter (SPD) compared to baseline in STP;FLC only:\>=90% decrease in difference between involved and uninvolved FLC levels.PR:\>=50% reduction of serum M-protein and reduction in 24h urine M-protein by \>=90% or to \<200mg/24h.In addition to above, if present at baseline,\>=50% reduction in size SPD of STPs also required.
From first dose of study medication administration (Day 1) up to PCD (06-Nov-2024), approximately 28 months
Observed Concentration Before Dosing (Ctrough) of Isatuximab at Steady State
Ctrough at steady state was the observed plasma concentration collected on pre-dose at Cycle 6 Day 1 (equivalent to prior to Cycle 6 Day 1) of isatuximab administration dose.
Pre-dose at Cycle 6 Day 1

Secondary Outcomes (55)

Very Good Partial Response or Better Rate
From first dose of study medication administration (Day 1) up to PCD (06-Nov-2024), approximately 28 months
Ctrough of Isatuximab at 4 Weeks (CT4W)
Pre-dose at Cycle 2 Day 1 (at 4 weeks)
Percentage of Participants With Infusion Reactions
From first dose of study medication (Day 1) up to 30 days after the last dose of study medication, approximately 28 months
Percentage of Participants Who Responded Very Satisfied and Satisfied to the 'Patient Experience and Satisfaction Questionnaire (PESQ-FU)': Satisfaction With Injection Method' (Item-8) at Cycle 5 Day 15
Cycle 5 Day 15
Duration of Response (DOR)
From first dose of study medication administration (Day 1) up to PCD (06-Nov-2024), approximately 28 months
+50 more secondary outcomes

Study Arms (2)

Isatuximab Subcutaneous (SC)

EXPERIMENTAL

Isatuximab dose will be administered SC weekly for 4 weeks during Cycle 1 (Days 1, 8, 15, and 22) and Day 1 and 15 of subsequent cycles. Each cycle will be 28 days in duration. Pomalidomide dose will be taken orally on Day 1 to Day 21 of each cycle at the time that is the most convenient for the participants prior to or after isatuximab administration, preferably at the same time every day. Dexamethasone will be taken orally on Day 1, 8, 15 and 22 (to be repeated every 28 days). Participants may receive other treatments as background treatment and/or rescue medication.

Drug: Isatuximab SCDrug: DexamethasoneDrug: PomalidomideDrug: MontelukastDrug: Paracetamol / AcetaminophenDrug: DiphenhydramineDrug: Methylprednisolone

Isatuximab Intravenous (IV)

ACTIVE COMPARATOR

Isatuximab dose will be administered via IV infusion weekly for 4 weeks during Cycle 1 (Days 1, 8, 15, and 22) and Day 1 and 15 of subsequent cycles. Each cycle will be 28 days. Pomalidomide dose will be taken orally on Day 1 to Day 21 of each cycle at the time that is the most convenient for the participants prior to or after isatuximab administration, preferably at the same time every day. Dexamethasone will be taken orally on Day 1, 8, 15 and 22 (to be repeated every 28 days). Participants may receive other treatments as background treatment and/or rescue medication.

Drug: Isatuximab IVDrug: DexamethasoneDrug: PomalidomideDrug: MontelukastDrug: Paracetamol / AcetaminophenDrug: DiphenhydramineDrug: Methylprednisolone

Interventions

Isatuximab IVDRUG

Pharmaceutical form: Concentrate solution for IV infusion; Route of administration: Intravenous

Also known as: SAR650984, SARCLISA®

Isatuximab Intravenous (IV)

Isatuximab SCDRUG

Pharmaceutical form: Solution for subcutaneous administration; Route of administration: Subcutaneous (SC)

Also known as: SAR650984

Isatuximab Subcutaneous (SC)

DexamethasoneDRUG

Pharmaceutical form: Tablet; Route of administration: Oral