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

NCT ID: NCT05405166

Last Updated: 2025-11-14

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

PHASE3

Total Enrollment

531 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-06-23

Study Completion Date

2027-03-23

Brief Summary

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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.

Detailed Description

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Two study arms will be treated in 4-week cycles until disease progression, unacceptable adverse events (AEs), participant request to discontinue therapy or any other reason, whichever comes first.

Conditions

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Plasma Cell Myeloma Recurrent

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Isatuximab Subcutaneous (SC)

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.

Group Type EXPERIMENTAL

Isatuximab SC

Intervention Type DRUG

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

Dexamethasone

Intervention Type DRUG

Pharmaceutical form: Tablet; Route of administration: Oral

Pomalidomide

Intervention Type DRUG

Pharmaceutical form: hard capsules; Route of administration: Oral

Dexamethasone

Intervention Type DRUG

Pharmaceutical form: As per local commercial product; Route of administration: Oral; Auxiliary Medicinal Product (AxMP) i.e., background treatment; ATC code: H02AB02

Montelukast

Intervention Type DRUG

Pharmaceutical form: As per local commercial product; Route of administration: Oral; AxMP i.e., background treatment; ATC code: R03DC03

Paracetamol / Acetaminophen

Intervention Type DRUG

Pharmaceutical form: As per local commercial product; Route of administration: Oral; AxMP i.e., background treatment; ATC code: N02BE01

Diphenhydramine

Intervention Type DRUG

Pharmaceutical form: As per local commercial product; Route of administration: As premedication- oral; for management of infusion reactions-IV (or oral equivalent); AxMP i.e., background treatment and rescue medication (in case of infusion reactions); ATC code: R06AA02

Methylprednisolone

Intervention Type DRUG

Pharmaceutical form: As per local commercial product; Route of administration: As premedication-IV; for management of infusion reactions- IV (or oral equivalent); AxMP i.e., background treatment and rescue medication (in case of infusion reactions); ATC code: H02AB04

Isatuximab Intravenous (IV)

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.

Group Type ACTIVE_COMPARATOR

Isatuximab IV

Intervention Type DRUG

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

Dexamethasone

Intervention Type DRUG

Pharmaceutical form: Tablet; Route of administration: Oral

Pomalidomide

Intervention Type DRUG

Pharmaceutical form: hard capsules; Route of administration: Oral

Dexamethasone

Intervention Type DRUG

Pharmaceutical form: As per local commercial product; Route of administration: Oral; Auxiliary Medicinal Product (AxMP) i.e., background treatment; ATC code: H02AB02

Montelukast

Intervention Type DRUG

Pharmaceutical form: As per local commercial product; Route of administration: Oral; AxMP i.e., background treatment; ATC code: R03DC03

Paracetamol / Acetaminophen

Intervention Type DRUG

Pharmaceutical form: As per local commercial product; Route of administration: Oral; AxMP i.e., background treatment; ATC code: N02BE01

Diphenhydramine

Intervention Type DRUG

Pharmaceutical form: As per local commercial product; Route of administration: As premedication- oral; for management of infusion reactions-IV (or oral equivalent); AxMP i.e., background treatment and rescue medication (in case of infusion reactions); ATC code: R06AA02

Methylprednisolone

Intervention Type DRUG

Pharmaceutical form: As per local commercial product; Route of administration: As premedication-IV; for management of infusion reactions- IV (or oral equivalent); AxMP i.e., background treatment and rescue medication (in case of infusion reactions); ATC code: H02AB04

Interventions

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Isatuximab IV

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

Intervention Type DRUG

Isatuximab SC

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

Intervention Type DRUG

Dexamethasone

Pharmaceutical form: Tablet; Route of administration: Oral

Intervention Type DRUG

Pomalidomide

Pharmaceutical form: hard capsules; Route of administration: Oral

Intervention Type DRUG

Dexamethasone

Pharmaceutical form: As per local commercial product; Route of administration: Oral; Auxiliary Medicinal Product (AxMP) i.e., background treatment; ATC code: H02AB02

Intervention Type DRUG

Montelukast

Pharmaceutical form: As per local commercial product; Route of administration: Oral; AxMP i.e., background treatment; ATC code: R03DC03

Intervention Type DRUG

Paracetamol / Acetaminophen

Pharmaceutical form: As per local commercial product; Route of administration: Oral; AxMP i.e., background treatment; ATC code: N02BE01

Intervention Type DRUG

Diphenhydramine

Pharmaceutical form: As per local commercial product; Route of administration: As premedication- oral; for management of infusion reactions-IV (or oral equivalent); AxMP i.e., background treatment and rescue medication (in case of infusion reactions); ATC code: R06AA02

Intervention Type DRUG

Methylprednisolone

Pharmaceutical form: As per local commercial product; Route of administration: As premedication-IV; for management of infusion reactions- IV (or oral equivalent); AxMP i.e., background treatment and rescue medication (in case of infusion reactions); ATC code: H02AB04

Intervention Type DRUG

Other Intervention Names

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SAR650984 SARCLISA® SAR650984 Pomalyst or equivalent

Eligibility Criteria

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Inclusion Criteria

* Participants with multiple myeloma who have received at least one prior line of anti-myeloma therapy, which must include lenalidomide and a proteasome inhibitor given alone or in combination.
* Measurable serum M-protein (≥ 0.5 g/dL) and/or urine M-protein (≥ 200 mg/24 hours) and/or serum free light chain (FLC) assay (Involved FLC assay ≥10 mg/dL and abnormal serum FLC ratio (\<0.26 or \>1.65)).

Exclusion Criteria

* Primary refractory multiple myeloma participants
* Participants with prior anti-CD38 treatment: (a) administered less than 9 months before randomization or, (b) intolerant to the anti-CD38 previously received
* Prior therapy with pomalidomide
* Participants with inadequate biological tests.
* Significant cardiac dysfunction
* Participants diagnosed or treated for another malignancy within 3 years prior to randomization with the exception of complete resection of basal cell carcinoma or squamous cell carcinoma of the skin, and in situ malignancy, or low risk prostate cancer after curative therapy
* Concomitant plasma cell leukemia
* Active primary amyloid light -chain amyloidosis
* Known acquired immunodeficiency syndrome (AIDS)-related illness or known human immunodeficiency virus (HIV) disease requiring antiviral treatment
* Know active Hepatitis A infection. Current active or chronic hepatitis B (HBV) or hepatitis C (HCV) infection. Participants with chronic HBV or HCV disease that is controlled under antiviral therapy are allowed.
* Women of childbearing potential or male participant with women of childbearing potential who do not agree to use highly effective method of birth control

The above information is not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Sanofi

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Clinical Sciences & Operations

Role: STUDY_DIRECTOR

Sanofi

Locations

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Mohtaseb Cancer Center and Blood Disorders Site Number : 8400028

Bullhead City, Arizona, United States

Site Status

Arizona Oncology Associates, PC - HAL- Site Number : 8400015

Prescott Valley, Arizona, United States

Site Status

Rocky Mountain Cancer Centers, LLP- Site Number : 8400021

Aurora, Colorado, United States

Site Status

Mayo Clinic- Site Number : 8400008

Jacksonville, Florida, United States

Site Status

BRCR Medical Center Inc Site Number : 8400030

Plantation, Florida, United States

Site Status

Centre for Cancer and Blood Disorders- Site Number : 8400026

Bethesda, Maryland, United States

Site Status

Hattiesburg Clinic Site Number : 8400006

Hattiesburg, Mississippi, United States

Site Status

Comprehensive Cancer Centers of Nevada- Site Number : 8400019

Las Vegas, Nevada, United States

Site Status

Atlantic Health System Site Number : 8400005

Morristown, New Jersey, United States

Site Status

New York Oncology Hematology, P.C.- Site Number : 8400017

Albany, New York, United States

Site Status

Novant Health- Site Number : 8400014

Charlotte, North Carolina, United States

Site Status

Novant Health Forsyth Medical Center Site Number : 8400114

Winston-Salem, North Carolina, United States

Site Status

Gabrail Cancer Center Site Number : 8400027

Canton, Ohio, United States

Site Status

Oncology_Hematology Care Clinical Trials, LLC- Site Number : 8400016

Cincinnati, Ohio, United States

Site Status

Oncology Associates Of Oregon, P.C.- Site Number : 8400018

Eugene, Oregon, United States

Site Status

Spoknwrd Clinical Trials Inc. Site Number : 8400023

Easton, Pennsylvania, United States

Site Status

Gibbs Cancer Center-Spartanburg Medical Center- Site Number : 8400002

Spartanburg, South Carolina, United States

Site Status

Texas Oncology Baylor Sammons- Site Number : 8400022

Dallas, Texas, United States

Site Status

University of Texas Southwestern- Site Number : 8400024

Dallas, Texas, United States

Site Status

Lumi Research- Site Number : 8400029

Kingwood, Texas, United States

Site Status

Texas Oncology - San Antonio- Site Number : 8400020

San Antonio, Texas, United States

Site Status

George E. Wahlen Salt Lake City VA Medical Center- Site Number : 8400011

Salt Lake City, Utah, United States

Site Status

UW Cancer Center at ProHealth Care Site Number : 8400001

Waukesha, Wisconsin, United States

Site Status

Investigational Site Number : 0320007

CABA, Buenos Aires, Argentina

Site Status

Investigational Site Number : 0320001

CABA, Buenos Aires, Argentina

Site Status

Investigational Site Number : 0320002

Ciudad Autonoma Buenos Aires, Buenos Aires, Argentina

Site Status

Investigational Site Number : 0320006

La Plata, Buenos Aires, Argentina

Site Status

Investigational Site Number : 0320003

CABA, Buenos Aires F.D., Argentina

Site Status

Investigational Site Number : 0320008

CABA, Buenos Aires F.D., Argentina

Site Status

Investigational Site Number : 0320005

CABA, Buenos Aires F.D., Argentina

Site Status

Investigational Site Number : 0320010

Córdoba, Córdoba Province, Argentina

Site Status

Investigational Site Number : 0320004

Buenos Aires, , Argentina

Site Status

Investigational Site Number : 0320009

Mendoza, , Argentina

Site Status

Investigational Site Number : 0360007

Liverpool, New South Wales, Australia

Site Status

Investigational Site Number : 0360004

Waratah, New South Wales, Australia

Site Status

Investigational Site Number : 0360003

Wollongong, New South Wales, Australia

Site Status

Investigational Site Number : 0360008

Adelaide, South Australia, Australia

Site Status

Investigational Site Number : 0360009

Fitzroy, Victoria, Australia

Site Status

Investigational Site Number : 0360006

Melbourne, Victoria, Australia

Site Status

Investigational Site Number : 0360001

Richmond, Victoria, Australia

Site Status

NOHC - Nucleo de Oncologia e Hematologia do Ceara- Site Number : 0760006

Fortaleza, Ceará, Brazil

Site Status

OC ONCOCLINICAS MULTIHEMO ILHA DO LEITE Site Number : 0760007

Recife, Pernambuco, Brazil

Site Status

CHN - Complexo Hospitalar de Niteroi Site Number : 0760008

Niterói, Rio de Janeiro, Brazil

Site Status

Hospital Mae de Deus Site Number : 0760003

Porto Alegre, Rio Grande do Sul, Brazil

Site Status

Clínica São Germano- Site Number : 0760001

São Paulo, São Paulo, Brazil

Site Status

Instituto COI de Educacao e Pesquisa- Site Number : 0760004

Rio de Janeiro, , Brazil

Site Status

Investigational Site Number : 1240001

Toronto, Ontario, Canada

Site Status

Investigational Site Number : 1240004

Greenfield Park, Quebec, Canada

Site Status

Investigational Site Number : 1240003

Montreal, Quebec, Canada

Site Status

Investigational Site Number : 1520003

Santiago, Reg Metropolitana de Santiago, Chile

Site Status

Investigational Site Number : 1520002

Santiago, Reg Metropolitana de Santiago, Chile

Site Status

Investigational Site Number : 1520006

Santiago, Reg Metropolitana de Santiago, Chile

Site Status

Investigational Site Number : 1520005

Viña del Mar, Región de Valparaíso, Chile

Site Status

Investigational Site Number : 1520004

Santiago, , Chile

Site Status

Investigational Site Number : 1520001

Temuco, , Chile

Site Status

Investigational Site Number : 1560001

Beijing, , China

Site Status

Investigational Site Number : 1560022

Beijing, , China

Site Status

Investigational Site Number : 1560010

Changsha, , China

Site Status

Investigational Site Number : 1560006

Guangzhou, , China

Site Status

Investigational Site Number : 1560002

Hangzhou, , China

Site Status

Investigational Site Number : 1560020

Nanchang, , China

Site Status

Investigational Site Number : 1560019

Nanning, , China

Site Status

Investigational Site Number : 1560011

Qingdao, , China

Site Status

Investigational Site Number : 1560013

Shenyang, , China

Site Status

Investigational Site Number : 1560007

Tianjin, , China

Site Status

Investigational Site Number : 1560009

Tianjin, , China

Site Status

Investigational Site Number : 1560018

Tianjin, , China

Site Status

Investigational Site Number : 1560003

Wuhan, , China

Site Status

Investigational Site Number : 1560008

Wuhan, , China

Site Status

Investigational Site Number : 1560004

Zhengzhou, , China

Site Status

Investigational Site Number : 2030005

Brno, , Czechia

Site Status

Investigational Site Number : 2030003

Olomouc, , Czechia

Site Status

Investigational Site Number : 2030006

Ostrava - Poruba, , Czechia

Site Status

Investigational Site Number : 2030004

Prague, , Czechia

Site Status

Investigational Site Number : 2500002

Nantes, , France

Site Status

Investigational Site Number : 2500005

Paris, , France

Site Status

Investigational Site Number : 2500008

Périgueux, , France

Site Status

Investigational Site Number : 2500001

Poitiers, , France

Site Status

Investigational Site Number : 2500009

Saint-Etienne, , France

Site Status

Investigational Site Number : 2500003

Toulouse, , France

Site Status

Investigational Site Number : 2500007

Tours, , France

Site Status

Investigational Site Number : 2760005

Dresden, , Germany

Site Status

Investigational Site Number : 2760001

Hamburg, , Germany

Site Status

Investigational Site Number : 2760003

Heidelberg, , Germany

Site Status

Investigational Site Number : 2760006

Lübeck, , Germany

Site Status

Investigational Site Number : 2760007

Nuremberg, , Germany

Site Status

Investigational Site Number : 3000002

Athens, , Greece

Site Status

Investigational Site Number : 3000001

Athens, , Greece

Site Status

Investigational Site Number : 3000005

Ioannina, , Greece

Site Status

Investigational Site Number : 3000003

Pátrai, , Greece

Site Status

Investigational Site Number : 3000004

Thessaloniki, , Greece

Site Status

Investigational Site Number : 3480002

Budapest, , Hungary

Site Status

Investigational Site Number : 3480004

Budapest, , Hungary

Site Status

Investigational Site Number : 3480003

Kaposvár, , Hungary

Site Status

Investigational Site Number : 3480008

Pécs, , Hungary

Site Status

Investigational Site Number : 3480005

Székesfehérvár, , Hungary

Site Status

Investigational Site Number : 3480006

Szombathely, , Hungary

Site Status

Investigational Site Number : 3800001

Meldola, Forlì-Cesena, Italy

Site Status

Investigational Site Number : 3800006

Rome, Roma, Italy

Site Status

Investigational Site Number : 3800004

Ancona, , Italy

Site Status

Investigational Site Number : 3800002

Bologna, , Italy

Site Status

Investigational Site Number : 3800005

Brescia, , Italy

Site Status

Investigational Site Number : 3800007

Napoli, , Italy

Site Status

Investigational Site Number : 3800008

Palermo, , Italy

Site Status

Investigational Site Number : 3800003

Pavia, , Italy

Site Status

Investigational Site Number : 3920001

Nagoya, Aichi-ken, Japan

Site Status

Investigational Site Number : 3920007

Kamogawa-shi, Chiba, Japan

Site Status

Investigational Site Number : 3920005

Higashiibaraki-gun, Ibaraki, Japan

Site Status

Investigational Site Number : 3920010

Shiwa-gun, Iwate, Japan

Site Status

Investigational Site Number : 3920012

Kamakura-shi, Kanagawa, Japan

Site Status

Investigational Site Number : 3920003

Kyoto, Kyoto, Japan

Site Status

Investigational Site Number : 3920006

Natori-shi, Miyagi, Japan

Site Status

Investigational Site Number : 3920002

Okayama, Okayama-ken, Japan

Site Status

Investigational Site Number : 3920011

Osaka, Osaka, Japan

Site Status

Investigational Site Number : 3920008

Sunto-gun, Shizuoka, Japan

Site Status

Investigational Site Number : 3920004

Shibuya-ku, Tokyo, Japan

Site Status

Investigational Site Number : 3920009

Yamagata, , Japan

Site Status

Investigational Site Number : 5780002

Ålesund, , Norway

Site Status

Investigational Site Number : 5780001

Oslo, , Norway

Site Status

Investigational Site Number : 6160005

Krakow, Lesser Poland Voivodeship, Poland

Site Status

Investigational Site Number : 6160004

Wroclaw, Lower Silesian Voivodeship, Poland

Site Status

Investigational Site Number : 6160001

Lublin, , Poland

Site Status

Investigational Site Number : 7240003

Santander, Cantabria, Spain

Site Status

Investigational Site Number : 7240004

Badalona, Catalunya [Cataluña], Spain

Site Status

Investigational Site Number : 7240007

Madrid, Madrid, Comunidad de, Spain

Site Status

Investigational Site Number : 7240001

Pamplona, Navarre, Spain

Site Status

Investigational Site Number : 7240005

Madrid, , Spain

Site Status

Investigational Site Number : 7240006

Murcia, , Spain

Site Status

Investigational Site Number : 7240002

Salamanca, , Spain

Site Status

Investigational Site Number : 7520001

Borås, , Sweden

Site Status

Investigational Site Number : 7520003

Stockholm, , Sweden

Site Status

Investigational Site Number : 1580001

Kaohsiung City, , Taiwan

Site Status

Investigational Site Number : 1580005

Tainan, , Taiwan

Site Status

Investigational Site Number : 1580002

Taipei, , Taiwan

Site Status

Investigational Site Number : 7920007

Ankara, , Turkey (Türkiye)

Site Status

Investigational Site Number : 7920009

Ankara, , Turkey (Türkiye)

Site Status

Investigational Site Number : 7920004

Bornova, , Turkey (Türkiye)

Site Status

Investigational Site Number : 7920003

Istanbul, , Turkey (Türkiye)

Site Status

Investigational Site Number : 7920005

Istanbul, , Turkey (Türkiye)

Site Status

Investigational Site Number : 7920008

Istanbul, , Turkey (Türkiye)

Site Status

Investigational Site Number : 7920001

Istanbul, , Turkey (Türkiye)

Site Status

Investigational Site Number : 8260002

Leicester, Leicestershire, United Kingdom

Site Status

Investigational Site Number : 8260005

London, London, City of, United Kingdom

Site Status

Investigational Site Number : 8260001

Norwich, Norfolk, United Kingdom

Site Status

Investigational Site Number : 8260004

Birmingham, , United Kingdom

Site Status

Investigational Site Number : 8260003

Derby, , United Kingdom

Site Status

Countries

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United States Argentina Australia Brazil Canada Chile China Czechia France Germany Greece Hungary Italy Japan Norway Poland Spain Sweden Taiwan Turkey (Türkiye) United Kingdom

References

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Ailawadhi S, Spicka I, Spencer A, Lu J, Oriol A, Ling S, Schjesvold F, Berkovits A, Hus M, Li C, Dimopoulos MA, Rajnics P, Besisik SK, Hungria V, Custidiano MDR, Parmar G, Leleu X, Li F, Cerchione C, Gomez C, Ishida T, Mateos MV, Buck TT, LeBlanc R, Minarik J, Goldschmidt H, Zhang R, Semiond D, Suzan F, Stefanova-Urena M, Koch V, Moreau P. Isatuximab Subcutaneous by On-Body Injector Versus Isatuximab Intravenous Plus Pomalidomide and Dexamethasone in Relapsed/Refractory Multiple Myeloma: Phase III IRAKLIA Study. J Clin Oncol. 2025 Aug;43(22):2527-2537. doi: 10.1200/JCO-25-00744. Epub 2025 Jun 3.

Reference Type DERIVED
PMID: 40459178 (View on PubMed)

Provided Documents

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Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Related Links

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https://www.sanofistudies.com/S2PX/

EFC15951 Relapsed/Refractory Multiple Myeloma USA website

https://www.trialsummaries.com/Study/StudyDetails?id=25235&tenant=MT_SNY_9011

EFC15951 Plain Language Results Summary

Other Identifiers

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U1111-1261-5846

Identifier Type: REGISTRY

Identifier Source: secondary_id

2023-508869-32

Identifier Type: REGISTRY

Identifier Source: secondary_id

2021-002485-41

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

EFC15951

Identifier Type: -

Identifier Source: org_study_id