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)

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Plasma Cell Myeloma Recurrent
• Intervention / Treatment: Drug: Isatuximab SC; Drug: Dexamethasone; Drug: Pomalidomide; Drug: Isatuximab IV; Drug: Dexamethasone; Drug: Montelukast; Drug: Paracetamol / Acetaminophen; Drug: Diphenhydramine; Drug: Methylprednisolone

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 531
• Phase: Phase 3

Contacts and Locations

Study Locations

• Argentina
  • Buenos Aires, Argentina, 1426ANZ
    • Investigational Site Number : 0320004
  • Mendoza, Argentina, M5501
    • Investigational Site Number : 0320009
  • Buenos Aires
    • CABA, Buenos Aires, Argentina, 1280
      • Investigational Site Number : 0320007
    • CABA, Buenos Aires, Argentina, 1430
      • Investigational Site Number : 0320001
    • Ciudad Autonoma Buenos Aires, Buenos Aires, Argentina, 1199
      • Investigational Site Number : 0320002
    • La Plata, Buenos Aires, Argentina, 1900
      • Investigational Site Number : 0320006
  • Buenos Aires F.D.
    • CABA, Buenos Aires F.D., Argentina, 1417
      • Investigational Site Number : 0320003
    • CABA, Buenos Aires F.D., Argentina, C1180
      • Investigational Site Number : 0320008
    • CABA, Buenos Aires F.D., Argentina, C1425ASG
      • Investigational Site Number : 0320005
  • Córdoba Province
    • Córdoba, Córdoba Province, Argentina, X5008HHW
      • Investigational Site Number : 0320010
• Australia
  • New South Wales
    • Liverpool, New South Wales, Australia, 2170
      • Investigational Site Number : 0360007
    • Waratah, New South Wales, Australia, 2298
      • Investigational Site Number : 0360004
    • Wollongong, New South Wales, Australia, 2500
      • Investigational Site Number : 0360003
  • South Australia
    • Adelaide, South Australia, Australia, 5000
      • Investigational Site Number : 0360008
  • Victoria
    • Fitzroy, Victoria, Australia, 3065
      • Investigational Site Number : 0360009
    • Melbourne, Victoria, Australia, 3004
      • Investigational Site Number : 0360006
    • Richmond, Victoria, Australia, 3121
      • Investigational Site Number : 0360001
• Brazil
  • Rio de Janeiro, Brazil, 22775-002
    • Instituto COI de Educacao e Pesquisa- Site Number : 0760004
  • Ceará
    • Fortaleza, Ceará, Brazil, 60115-281
      • NOHC - Nucleo de Oncologia e Hematologia do Ceara- Site Number : 0760006
  • Pernambuco
    • Recife, Pernambuco, Brazil, 50070-460
      • OC ONCOCLINICAS MULTIHEMO ILHA DO LEITE Site Number : 0760007
  • Rio Grande do Sul
    • Porto Alegre, Rio Grande do Sul, Brazil, 90110-270
      • Hospital Mae de Deus Site Number : 0760003
  • Rio de Janeiro
    • Niterói, Rio de Janeiro, Brazil, 24020-096
      • CHN - Complexo Hospitalar de Niteroi Site Number : 0760008
  • São Paulo
    • São Paulo, São Paulo, Brazil, 04537-081
      • Clínica São Germano- Site Number : 0760001
• Canada
  • Ontario
    • Toronto, Ontario, Canada, M5G 2M9
      • Investigational Site Number : 1240001
  • Quebec
    • Greenfield Park, Quebec, Canada, J4V 2H1
      • Investigational Site Number : 1240004
    • Montreal, Quebec, Canada, H1T 2M4
      • Investigational Site Number : 1240003
• Chile
  • Santiago, Chile, 8380455
    • Investigational Site Number : 1520004
  • Temuco, Chile, 4800827
    • Investigational Site Number : 1520001
  • Reg Metropolitana de Santiago
    • Santiago, Reg Metropolitana de Santiago, Chile, 7580206
      • Investigational Site Number : 1520002
    • Santiago, Reg Metropolitana de Santiago, Chile, 7500921
      • Investigational Site Number : 1520003
    • Santiago, Reg Metropolitana de Santiago, Chile, 7620157
      • Investigational Site Number : 1520006
  • Región de Valparaíso
    • Viña del Mar, Región de Valparaíso, Chile
      • Investigational Site Number : 1520005
• China
  • Beijing, China, 100044
    • Investigational Site Number : 1560001
  • Beijing, China, 100191
    • Investigational Site Number : 1560022
  • Changsha, China, 410013
    • Investigational Site Number : 1560010
  • Guangzhou, China, 510060
    • Investigational Site Number : 1560006
  • Hangzhou, China, 310003
    • Investigational Site Number : 1560002
  • Nanchang, China, 330006
    • Investigational Site Number : 1560020
  • Nanning, China, 530000
    • Investigational Site Number : 1560019
  • Qingdao, China, 266000
    • Investigational Site Number : 1560011
  • Shenyang, China, 110022
    • Investigational Site Number : 1560013
  • Tianjin, China, 300020
    • Investigational Site Number : 1560007
  • Tianjin, China, 300032
    • Investigational Site Number : 1560009
  • Tianjin, China, 300060
    • Investigational Site Number : 1560018
  • Wuhan, China, 430022
    • Investigational Site Number : 1560003
  • Wuhan, China, 430030
    • Investigational Site Number : 1560008
  • Zhengzhou, China, 450008
    • Investigational Site Number : 1560004
• Czechia
  • Brno, Czechia, 62500
    • Investigational Site Number : 2030005
  • Olomouc, Czechia, 77900
    • Investigational Site Number : 2030003
  • Ostrava - Poruba, Czechia, 70852
    • Investigational Site Number : 2030006
  • Prague, Czechia, 12808
    • Investigational Site Number : 2030004
• France
  • Nantes, France, 44093
    • Investigational Site Number : 2500002
  • Paris, France, 75012
    • Investigational Site Number : 2500005
  • Poitiers, France, 86021
    • Investigational Site Number : 2500001
  • Périgueux, France, 24000
    • Investigational Site Number : 2500008
  • Saint-Etienne, France, 42055
    • Investigational Site Number : 2500009
  • Toulouse, France, 31059
    • Investigational Site Number : 2500003
  • Tours, France, 37044
    • Investigational Site Number : 2500007
• Germany
  • Dresden, Germany, 01307
    • Investigational Site Number : 2760005
  • Hamburg, Germany, 22763
    • Investigational Site Number : 2760001
  • Heidelberg, Germany, 69120
    • Investigational Site Number : 2760003
  • Lübeck, Germany, 23538
    • Investigational Site Number : 2760006
  • Nuremberg, Germany, 90419
    • Investigational Site Number : 2760007
• Greece
  • Athens, Greece, 10676
    • Investigational Site Number : 3000002
  • Athens, Greece, 11528
    • Investigational Site Number : 3000001
  • Ioannina, Greece, 45500
    • Investigational Site Number : 3000005
  • Pátrai, Greece, 26500
    • Investigational Site Number : 3000003
  • Thessaloniki, Greece, 57010
    • Investigational Site Number : 3000004
• Hungary
  • Budapest, Hungary, 1083
    • Investigational Site Number : 3480002
  • Budapest, Hungary, 1097
    • Investigational Site Number : 3480004
  • Kaposvár, Hungary, 7400
    • Investigational Site Number : 3480003
  • Pécs, Hungary, 7624
    • Investigational Site Number : 3480008
  • Szombathely, Hungary, 9700
    • Investigational Site Number : 3480006
  • Székesfehérvár, Hungary, 8000
    • Investigational Site Number : 3480005
• Italy
  • Ancona, Italy, 60126
    • Investigational Site Number : 3800004
  • Bologna, Italy, 40138
    • Investigational Site Number : 3800002
  • Brescia, Italy, 25123
    • Investigational Site Number : 3800005
  • Napoli, Italy, 80131
    • Investigational Site Number : 3800007
  • Palermo, Italy, 90127
    • Investigational Site Number : 3800008
  • Pavia, Italy, 27100
    • Investigational Site Number : 3800003
  • Forlì-Cesena
    • Meldola, Forlì-Cesena, Italy, 47014
      • Investigational Site Number : 3800001
  • Roma
    • Rome, Roma, Italy, 00168
      • Investigational Site Number : 3800006
• Japan
  • Yamagata, Japan, 990-9585
    • Investigational Site Number : 3920009
  • Aichi-ken
    • Nagoya, Aichi-ken, Japan, 467-8602
      • Investigational Site Number : 3920001
  • Chiba
    • Kamogawa-shi, Chiba, Japan, 296-8602
      • Investigational Site Number : 3920007
  • Ibaraki
    • Higashiibaraki-gun, Ibaraki, Japan, 311-3193
      • Investigational Site Number : 3920005
  • Iwate
    • Shiwa-gun, Iwate, Japan, 028-3695
      • Investigational Site Number : 3920010
  • Kanagawa
    • Kamakura-shi, Kanagawa, Japan, 247-0072
      • Investigational Site Number : 3920012
  • Kyoto
    • Kyoto, Kyoto, Japan, 603-8151
      • Investigational Site Number : 3920003
  • Miyagi
    • Natori-shi, Miyagi, Japan, 981-1293
      • Investigational Site Number : 3920006
  • Okayama-ken
    • Okayama, Okayama-ken, Japan, 701-1192
      • Investigational Site Number : 3920002
  • Osaka
    • Osaka, Osaka, Japan, 530-8480
      • Investigational Site Number : 3920011
  • Shizuoka
    • Sunto-gun, Shizuoka, Japan, 411-8777
      • Investigational Site Number : 3920008
  • Tokyo
    • Shibuya-ku, Tokyo, Japan, 150-8935
      • Investigational Site Number : 3920004
• Norway
  • Oslo, Norway, 0450
    • Investigational Site Number : 5780001
  • Ålesund, Norway, 6026
    • Investigational Site Number : 5780002
• Poland
  • Lublin, Poland, 20,081
    • Investigational Site Number : 6160001
  • Lesser Poland Voivodeship
    • Krakow, Lesser Poland Voivodeship, Poland, 30-688
      • Investigational Site Number : 6160005
  • Lower Silesian Voivodeship
    • Wroclaw, Lower Silesian Voivodeship, Poland, 50-367
      • Investigational Site Number : 6160004
• Spain
  • Madrid, Spain, 28034
    • Investigational Site Number : 7240005
  • Murcia, Spain, 30120
    • Investigational Site Number : 7240006
  • Salamanca, Spain, 37007
    • Investigational Site Number : 7240002
  • Cantabria
    • Santander, Cantabria, Spain, 39008
      • Investigational Site Number : 7240003
  • Catalunya [Cataluña]
    • Badalona, Catalunya [Cataluña], Spain, 08916
      • Investigational Site Number : 7240004
  • Madrid, Comunidad de
    • Madrid, Madrid, Comunidad de, Spain, 28046
      • Investigational Site Number : 7240007
  • Navarre
    • Pamplona, Navarre, Spain, 31008
      • Investigational Site Number : 7240001
• Sweden
  • Borås, Sweden, 50182
    • Investigational Site Number : 7520001
  • Stockholm, Sweden, 14186
    • Investigational Site Number : 7520003
• Taiwan
  • Kaohsiung City, Taiwan, 83301
    • Investigational Site Number : 1580001
  • Tainan, Taiwan, 704
    • Investigational Site Number : 1580005
  • Taipei, Taiwan, 10002
    • Investigational Site Number : 1580002
• Turkey (Türkiye)
  • Ankara, Turkey (Türkiye), 06010
    • Investigational Site Number : 7920007
  • Ankara, Turkey (Türkiye), 06200
    • Investigational Site Number : 7920009
  • Bornova, Turkey (Türkiye), 35100
    • Investigational Site Number : 7920004
  • Istanbul, Turkey (Türkiye), 34093
    • Investigational Site Number : 7920003
  • Istanbul, Turkey (Türkiye), 34098
    • Investigational Site Number : 7920005
  • Istanbul, Turkey (Türkiye), 34214
    • Investigational Site Number : 7920008
  • Istanbul, Turkey (Türkiye), 34381
    • Investigational Site Number : 7920001
• United Kingdom
  • Birmingham, United Kingdom, B15 2GW
    • Investigational Site Number : 8260004
  • Derby, United Kingdom, DE223NE
    • Investigational Site Number : 8260003
  • Leicestershire
    • Leicester, Leicestershire, United Kingdom, LE1 5WW
      • Investigational Site Number : 8260002
  • London, City of
    • London, London, City of, United Kingdom, W12 0HS
      • Investigational Site Number : 8260005
  • Norfolk
    • Norwich, Norfolk, United Kingdom, NR4 7UY
      • Investigational Site Number : 8260001
• United States
  • Arizona
    • Bullhead City, Arizona, United States, 86442
      • Mohtaseb Cancer Center and Blood Disorders Site Number : 8400028
    • Prescott Valley, Arizona, United States, 86314
      • Arizona Oncology Associates, PC - HAL- Site Number : 8400015
  • Colorado
    • Aurora, Colorado, United States, 80012
      • Rocky Mountain Cancer Centers, LLP- Site Number : 8400021
  • Florida
    • Jacksonville, Florida, United States, 32224
      • Mayo Clinic- Site Number : 8400008
    • Plantation, Florida, United States, 33322
      • BRCR Medical Center Inc Site Number : 8400030
  • Maryland
    • Bethesda, Maryland, United States, 20817
      • Centre for Cancer and Blood Disorders- Site Number : 8400026
  • Mississippi
    • Hattiesburg, Mississippi, United States, 39401
      • Hattiesburg Clinic Site Number : 8400006
  • Nevada
    • Las Vegas, Nevada, United States, 89169
      • Comprehensive Cancer Centers of Nevada- Site Number : 8400019
  • New Jersey
    • Morristown, New Jersey, United States, 07960
      • Atlantic Health System Site Number : 8400005
  • New York
    • Albany, New York, United States, 12206
      • New York Oncology Hematology, P.C.- Site Number : 8400017
  • North Carolina
    • Charlotte, North Carolina, United States, 28207
      • Novant Health- Site Number : 8400014
    • Winston-Salem, North Carolina, United States, 27103
      • Novant Health Forsyth Medical Center Site Number : 8400114
  • Ohio
    • Canton, Ohio, United States, 44718
      • Gabrail Cancer Center Site Number : 8400027
    • Cincinnati, Ohio, United States, 45236
      • Oncology_Hematology Care Clinical Trials, LLC- Site Number : 8400016
  • Oregon
    • Eugene, Oregon, United States, 97401
      • Oncology Associates Of Oregon, P.C.- Site Number : 8400018
  • Pennsylvania
    • Easton, Pennsylvania, United States, 18045
      • Spoknwrd Clinical Trials Inc. Site Number : 8400023
  • South Carolina
    • Spartanburg, South Carolina, United States, 29303
      • Gibbs Cancer Center-Spartanburg Medical Center- Site Number : 8400002
  • Texas
    • Dallas, Texas, United States, 75246
      • Texas Oncology Baylor Sammons- Site Number : 8400022
    • Dallas, Texas, United States, 75390
      • University of Texas Southwestern- Site Number : 8400024
    • Kingwood, Texas, United States, 77339
      • Lumi Research- Site Number : 8400029
    • San Antonio, Texas, United States, 78240
      • Texas Oncology - San Antonio- Site Number : 8400020
  • Utah
    • Salt Lake City, Utah, United States, 84148
      • George E. Wahlen Salt Lake City VA Medical Center- Site Number : 8400011
  • Wisconsin
    • Waukesha, Wisconsin, United States, 53188
      • UW Cancer Center at ProHealth Care Site Number : 8400001

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Drug: Isatuximab SC; Pharmaceutical form: Solution for subcutaneous administration; Route of administration: Subcutaneous (SC); Other Names: SAR650984; Drug: Dexamethasone; Pharmaceutical form: Tablet; Route of administration: Oral; Drug: Pomalidomide; Pharmaceutical form: hard capsules; Route of administration: Oral; Other Names: Pomalyst or equivalent; Drug: Dexamethasone; Pharmaceutical form: As per local commercial product; Route of administration: Oral; Auxiliary Medicinal Product (AxMP) i.e., background treatment; ATC code: H02AB02; Drug: Montelukast; Pharmaceutical form: As per local commercial product; Route of administration: Oral; AxMP i.e., background treatment; ATC code: R03DC03; Drug: Paracetamol / Acetaminophen; Pharmaceutical form: As per local commercial product; Route of administration: Oral; AxMP i.e., background treatment; ATC code: N02BE01; 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; 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
Active Comparator: 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.	Drug: Dexamethasone; Pharmaceutical form: Tablet; Route of administration: Oral; Drug: Pomalidomide; Pharmaceutical form: hard capsules; Route of administration: Oral; Other Names: Pomalyst or equivalent; Drug: Isatuximab IV; Pharmaceutical form: Concentrate solution for IV infusion; Route of administration: Intravenous; Other Names: SAR650984; SARCLISA®; Drug: Dexamethasone; Pharmaceutical form: As per local commercial product; Route of administration: Oral; Auxiliary Medicinal Product (AxMP) i.e., background treatment; ATC code: H02AB02; Drug: Montelukast; Pharmaceutical form: As per local commercial product; Route of administration: Oral; AxMP i.e., background treatment; ATC code: R03DC03; Drug: Paracetamol / Acetaminophen; Pharmaceutical form: As per local commercial product; Route of administration: Oral; AxMP i.e., background treatment; ATC code: N02BE01; 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; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Very Good Partial Response or Better Rate	VGPR or better rate by IRC using 2016 IMWG criteria: Percentage of participants with sCR, CR, and VGPR. CR: negative immunofixation on serum and urine, disappearance of any STP, <5% plasma cells in BM aspirates & normal FLC ratio (0.26-1.65). sCR: CR plus no clonal cells in BM biopsy. VGPR: serum and urine M-protein detectable by immunofixation, not electrophoresis;>=90% reduction in serum M-protein plus urine M-protein level<100mg/24h;>=90% decrease in SPD compared to baseline in STP; FLC only:>=90% decrease in difference between involved and uninvolved FLC levels. Percentages are rounded off to the tenth decimal place.	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)	The CT4W was the observed plasma concentrations collected on pre-dose at Cycle 2 Day 1 (equivalent to prior to Cycle 2 Day 1) of isatuximab administration dose.	Pre-dose at Cycle 2 Day 1 (at 4 weeks)
Percentage of Participants With Infusion Reactions	Infusion reactions were graded using National Cancer Institute-Common Terminology Criteria for AE (NCI-CTCAE) version (v)5.0 criteria: Grade 1: mild transient reaction; infusion interruption not indicated; intervention not indicated. Grade 2: moderate reaction; therapy or infusion interruption indicated but responds promptly to symptomatic treatment; prophylactic medications indicated for <=24 hours. Grade 3/4: severe or life-threatening reaction (Grade 3: prolonged [not rapidly responsive to symptomatic medication and/or brief interruption of infusion]; recurrence of symptoms following initial improvement; hospitalization indicated for clinical sequelae. Grade 4: life-threatening consequences; urgent intervention indicated). Percentage of participants who observed AE of infusion reactions were collected through the electronic case report form (eCRF) as assessed by investigators. Percentages are rounded off to the tenth decimal place.	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	The PESQ-FU consisting of 9 items has been designed to follow up on participant experience and satisfaction regarding the injection method (discomfort, pain, side effects, time saving and satisfaction) and study medication (side effects, worth taking, satisfaction and recommendation). This questionnaire has been adapted based on qualitative interviews with oncology participants. The responses to 'satisfaction with injection method' were recorded as 'very satisfied, satisfied, neither satisfied nor dissatisfied, dissatisfied and very dissatisfied' at specified timepoints. The total percentage of participants who were very satisfied and satisfied with the injection method (item-8) at Cycle 5 Day 15 is reported here. Percentages are rounded off to the tenth decimal place.	Cycle 5 Day 15
Duration of Response (DOR)	DOR: Time from the date of first response to the date of first occurrence of progressive disease (PD) determined by IRC or death from any cause, whichever occurred first.DOR was determined only for participants who achieved a response (PR or better).If PD/death not observed, participant was censored at date of last valid disease assessment performed prior to initiating further anti-myeloma treatment or analysis cut-off date, whichever occurred first. As per IMWG criteria: PD: increase of >=25% from lowest confirmed value in any 1 of following: serum M-protein (absolute increase>=0.5 gram/deciliter[g/dL]),serum M-protein increase>=1g/dL if lowest M-component >=5g/dL, urine M-component (absolute increase >=200mg/24h), appearance of new lesion(s),>=50% increase from nadir in SPD of >1 lesion or >=50% increase in longest diameter of a previous lesion >1 centimeter (cm) in short axis. PR: as defined in OM1.	From first dose of study medication administration (Day 1) up to PCD (06-Nov-2024), approximately 28 months
Time to First Response (TT1R)	TT1R was defined as the time from randomization to the date of first IRC determined response (PR or better) that was subsequently confirmed. PR as per IMWG criteria was defined as >=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 the size SPD of STPs was also required.	From first dose of study medication administration (Day 1) up to PCD (06-Nov-2024), approximately 28 months
Time to Best Response (TTBR)	TTBR was defined as the time from randomization to the date of first occurrence of IRC determined best overall response (PR or better) that was subsequently confirmed. PR as per IMWG criteria was defined as >=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 the size SPD of STPs was also required.	From first dose of study medication administration (Day 1) up to PCD (06-Nov-2024), approximately 28 months
Progression Free Survival (PFS)	PFS is defined as the time from the date of randomization to the date of first documentation of PD as determined by IRC or the date of death from any cause, whichever came first. Responses will be determined according to IMWG criteria. PFS will be censored at the date of the last valid disease assessment not showing PD performed prior to initiation of a further anti-myeloma treatment (if any) or the analysis cut-off date, whichever comes first.	From first dose of study medication administration (Day 1) up to a maximum of 57 months
Overall Survival (OS)	OS is defined as the time from the date of randomization to death from any cause. Participants without death prior to the analysis cut-off date will be censored at the last date the participant was known to be alive or the cut-off date, whichever is first.	From first dose of study medication administration (Day 1) up to a maximum of 57 months
Progression Free Survival 2 (PFS2)	PFS2 is defined as time from the date of randomization to the date of first documentation of PD (as assessed by Investigator) after initiation of further anti-myeloma treatment or death from any cause, whichever happens first. Same censoring rule applies as in the PFS endpoint.	From first dose of study medication administration (Day 1) up to a maximum of 57 months
Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs)	An AE was defined as any untoward medical occurrence in a participant or clinical study participant, temporally associated with the use of study medication, whether or not considered related to the study medication. SAEs were any untoward medical occurrence that at any dose: resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect or was a medically important event. TEAEs were defined as AEs that developed, worsened or became serious during the TE period.	From first dose of study medication administration (Day 1) up to 30 days after the last dose of study medication, approximately 28 months
Isa-SC + Pd: Number of Participants With Injection Site Reactions (ISRs)	The ISRs are defined as AEs related to medication administration with onset typically within 24 hours from the start of the infusion and are graded using NCI-CTCAE v5.0 criteria: Grade 1: tenderness with or without associated symptoms (warmth, erythema, itching). Grade 2: pain; lipodystrophy; edema; phlebitis. Grade 3: ulceration or necrosis severe tissue damage operative intervention indicated. Grade 4: life-threatening consequences; urgent intervention indicated. ISRs were collected through the eCRF. Number of participants with at least 1 ISR is reported. ISRs were applicable only for the SC administration.	From first dose of study medication administration (Day 1) up to 30 days after the last dose of study medication, approximately 28 months
Ctrough of Isatuximab	Plasma samples were collected at specified timepoints for the assessment of Ctrough.	Pre-dose on Cycle 1 Days 8, 15 and 22, Cycles 2 to 5 Days 1 and 15, Cycles 6, 7, 8, 9, 12, 15, 18, 21, 24 and 27 Day 1
Isa-SC + Pd: Percentage of Successful Injections With Isatuximab Injector Device	Percentage of successful injections with investigational isatuximab injector device was defined as completion of administration per provided instructions for use with no use errors or technical issues divided by the total number of injections x 100. Delivery performance of the device was analyzed based on the successful injection rate in the Isa-SC + Pd arm as the investigational isatuximab injector device was used only for SC administration.	From first dose of study medication administration (Day 1) up to PCD (06-Nov-2024), approximately 28 months
Number of Participants With Treatment-emergent Anti-drug Antibodies (ADA) Against Isatuximab	A participant with treatment-emergent ADA was a participant with at least 1 treatment induced or treatment boosted ADA at any time during the treatment or follow-up observation period. Treatment-induced ADA was defined as ADAs developed de novo (seroconversion) following administration of the biotherapeutic (ie, formation of ADAs any time after the initial study medication administration in a participant without pre-existing ADAs). Treatment-boosted ADA was defined as pre-existing ADAs that were boosted to a higher level following administration of biotherapeutic (ie, any time after the initial study medication administration) the ADA titer was significantly higher than the baseline titer. Number of participants with treatment-emergent ADAs is presented.	From first dose of study medication administration (Day 1) up to PCD (06-Nov-2024), approximately 28 months
Percentage of Participants With Response to 'Patient Expectation Questionnaire at Baseline (PEQ-BL)'	Percentage of participants who responded that they strongly agree or agree at baseline with expectations of pain, discomfort and side effects from the injection method, the injection method would save time, study medication may result in side effects and would be worth taking are reported. PEQ-BL consisted of 7 items. Percentage of participants who ever received medication through IV and/or SC administration are also reported. Percentages are rounded off to the tenth decimal place. The baseline value was defined as the last non-missing value collected on or before the start date of study medication.	Baseline (Cycle 1 Day 1)
Percentage of Participants Who Disagreed and Strongly Disagreed to 'PESQ-FU: Discomfort With Injection Method'	The PESQ-FU consisting of 9 items has been designed to follow up on participant experience and satisfaction regarding the injection method (discomfort, pain, side effects, time saving and satisfaction) and study medication (side effects, worth taking, satisfaction and recommendation). This questionnaire has been adapted based on qualitative interviews with oncology participants. The responses to 'discomfort with injection method' were recorded as 'strongly agree, agree, neither agree nor disagree, disagree and strongly disagree' at specified timepoints. Percentage of participants who disagreed and strongly disagreed that they experienced any discomfort with the injection method are reported here. Percentages are rounded off to the tenth decimal place.	Cycle 1 Days 8, 15, 22, Cycle 2 Days 1 and 15, Cycles 3 and 4 Day 1, Cycles 5 to 29 Day 15
Percentage of Participants Who Disagreed and Strongly Disagreed to 'PESQ-FU: Pain With Injection Method'	The PESQ-FU consisting of 9 items has been designed to follow up on participant experience and satisfaction regarding the injection method (discomfort, pain, side effects, time saving and satisfaction) and study medication (side effects, worth taking, satisfaction and recommendation). This questionnaire has been adapted based on qualitative interviews with oncology participants. The responses to 'pain with injection method' were recorded as 'strongly agree, agree, neither agree nor disagree, disagree and strongly disagree' at specified timepoints. Percentage of participants who disagreed and strongly disagreed that they experienced any pain with the injection method are reported here. Percentages are rounded off to the tenth decimal place.	Cycle 1 Days 8, 15, 22, Cycle 2 Days 1 and 15, Cycles 3 and 4 Day 1, Cycles 5 to 29 Day 15
Percentage of Participants Who Disagreed and Strongly Disagreed to 'PESQ-FU: Side Effects With Injection Method'	The PESQ-FU consisting of 9 items has been designed to follow up on participant experience and satisfaction regarding the injection method (discomfort, pain, side effects, time saving and satisfaction) and study medication (side effects, worth taking, satisfaction and recommendation). This questionnaire has been adapted based on qualitative interviews with oncology participants. The responses to 'side effects with injection method' were recorded as 'strongly agree, agree, neither agree nor disagree, disagree and strongly disagree' at specified timepoints. Percentage of participants who disagreed and strongly disagreed that they experienced any side effects with the injection method are reported here. Percentages are rounded off to the tenth decimal place.	Cycle 1 Days 8, 15, 22, Cycle 2 Days 1 and 15, Cycles 3 and 4 Day 1, Cycles 5 to 29 Day 15
Percentage of Participants Who Strongly Agreed and Agreed to 'PESQ-FU: Time Saving With Injection Method'	The PESQ-FU consisting of 9 items has been designed to follow up on participant experience and satisfaction regarding the injection method (discomfort, pain, side effects, time saving and satisfaction) and study medication (side effects, worth taking, satisfaction and recommendation). This questionnaire has been adapted based on qualitative interviews with oncology participants. The responses to 'time saving with injection method' were recorded as 'strongly agree, agree, neither agree nor disagree, disagree and strongly disagree' at specified timepoints. Percentage of participants who strongly agreed and agreed that they experienced time saving with the injection method are reported here. Percentages are rounded off to the tenth decimal place.	Cycle 1 Days 8, 15, 22, Cycle 2 Days 1 and 15, Cycles 3 and 4 Day 1, Cycles 5 to 29 Day 15
Percentage of Participants Who Responded Very Satisfied and Satisfied to 'PESQ-FU: Satisfaction With Injection Method'	The PESQ-FU consisting of 9 items has been designed to follow up on participant experience and satisfaction regarding the injection method (discomfort, pain, side effects, time saving and satisfaction) and study medication (side effects, worth taking, satisfaction and recommendation). This questionnaire has been adapted based on qualitative interviews with oncology participants. The responses to 'satisfaction with injection method' were recorded as 'very satisfied, satisfied, neither satisfied nor dissatisfied, dissatisfied and very dissatisfied' at specified timepoints. Percentage of participants who were very satisfied and satisfied with the injection method are reported here. Percentages are rounded off to the tenth decimal place.	Cycle 1 Days 8, 15, 22, Cycle 2 Days 1 and 15, Cycles 3 and 4 Day 1, Cycles 6 to 29 Day 15
Percentage of Participants Who Disagreed and Strongly Disagreed to 'PESQ-FU: Side Effects With Study Medication'	The PESQ-FU consisting of 9 items has been designed to follow up on participant experience and satisfaction regarding the injection method (discomfort, pain, side effects, time saving and satisfaction) and study medication (side effects, worth taking, satisfaction and recommendation). This questionnaire has been adapted based on qualitative interviews with oncology participants. The responses to 'side effects with study medication' were recorded as 'strongly agree, agree, neither agree nor disagree, disagree and strongly disagree' at specified timepoints. Percentage of participants who disagreed and strongly disagreed that they experienced any side effects with study medication are reported here. Percentages are rounded off to the tenth decimal place.	Cycle 1 Days 8, 15, 22, Cycle 2 Days 1 and 15, Cycles 3 and 4 Day 1, Cycles 5 to 29 Day 15
Percentage of Participants Who Strongly Agreed and Agreed to 'PESQ-FU: Study Medication Worth Taking'	The PESQ-FU consisting of 9 items has been designed to follow up on participant experience and satisfaction regarding the injection method (discomfort, pain, side effects, time saving and satisfaction) and study medication (side effects, worth taking, satisfaction and recommendation). This questionnaire has been adapted based on qualitative interviews with oncology participants. The responses to 'study medication worth taking' were recorded as 'strongly agree, agree, neither agree nor disagree, disagree and strongly disagree' at specified timepoints. Percentage of participants who strongly agreed and agreed that the study medication was worth taking are reported here. Percentages are rounded off to the tenth decimal place.	Cycle 1 Days 8, 15, 22, Cycle 2 Days 1 and 15, Cycles 3 and 4 Day 1, Cycles 5 to 29 Day 15
Percentage of Participants Who Responded Very Satisfied and Satisfied to 'PESQ-FU: Satisfaction With Study Medication'	The PESQ-FU consisting of 9 items has been designed to follow up on participant experience and satisfaction regarding the injection method (discomfort, pain, side effects, time saving and satisfaction) and study medication (side effects, worth taking, satisfaction and recommendation). This questionnaire has been adapted based on qualitative interviews with oncology participants. The responses to satisfaction with study medication were recorded as 'very satisfied, satisfied, neither satisfied nor dissatisfied, dissatisfied and very dissatisfied' at specified timepoints. Percentage of participants who were very satisfied and satisfied with the study medication are reported here. Percentages are rounded off to the tenth decimal place.	Cycle 1 Days 8, 15, 22, Cycle 2 Days 1 and 15, Cycles 3 and 4 Day 1, Cycles 5 to 29 Day 15
Percentage of Participants Who Responded Definitely Yes and Probably Yes to 'PESQ-FU: Recommendation of Study Medication'	The PESQ-FU consisting of 9 items has been designed to follow up on participant experience and satisfaction regarding the injection method (discomfort, pain, side effects, time saving and satisfaction) and study medication (side effects, worth taking, satisfaction and recommendation). This questionnaire has been adapted based on qualitative interviews with oncology participants. The responses to 'recommendation of the study medication' were recorded as 'definitely yes, probably yes, unsure, probably not and definitely not' at specified timepoints. Percentage of participants who responded definitely yes and probably yes to the recommendation of study medication are reported here. Percentages are rounded off to the tenth decimal place.	Cycle 1 Days 8, 15, 22, Cycle 2 Days 1 and 15, Cycles 3 and 4 Day 1, Cycles 5 to 29 Day 15
Percentage of Participants With Response to 'Patient Experience and Satisfaction End of Treatment Questionnaire (PESQ-EOT)'	The PESQ-EOT consisting of 17 items assessed participant experience and satisfaction regarding the injection method (discomfort, pain, side effects, time saving and satisfaction) and study medication (side effects, worth taking, satisfaction and recommendation) and has been adapted based on qualitative interviews with oncology participants. In addition to the above, this questionnaire also includes additional items to assess whether participants received oncology medications in the past 2 years and if a participant received both IV and SC in the past 2 years, then participant preference on injection method (whether SC or IV). Percentage of participants with response to these additional items (received oncology medications in the past 2 years via IV/SC/both and if received both IV and SC; then the participant preference on injection method) are reported here. Percentages are rounded off to the tenth decimal place.	EOT visit (30 days after last study medication administration or before further anti myeloma therapy initiation, whichever occurred first, up to approximately 28 months)
Participant Responses to Patient's Assessment of Treatment (PAT) Questionnaire	The 4-item PAT is an internally developed non-disease specific and self-administered assessment which has been debriefed with oncology patients during qualitative interviews. It provided participant insights on the benefits and disadvantages of treatment. Benefits and disadvantages were respectively rated on a 0-10 scale wherein 0=none (not beneficial at all or no disadvantages at all) and 10=maximum (extremely beneficial or extremely disadvantageous). Disadvantages vs benefits were rated on a scale of -3 to 3 wherein -3=disadvantages significantly outweigh the benefits, 0=equal benefits and disadvantages and 3=benefits significantly outweigh the disadvantages. Mean of benefits, disadvantages and disadvantages vs benefits is presented here.	EOT visit (30 days after last study medication administration or before further anti myeloma therapy initiation, whichever occurred first, up to approximately 28 months)
Health Resource Utilization and Productivity Questionnaire (HRUPQ): Baseline Healthcare Utilization: Number of Times in the Past 6 Months a Participant Received Care	Healthcare utilization at baseline before study medication administration was collected via HRUPQ. The mean number of times in the past 6 months a participant received care in a clinic or hospital emergency room for any health issue including MM or due to MM and at-home care from a nurse or other health professional for any health issue including MM or due to MM is presented. The baseline value was defined as the last non-missing value collected on or before the start date of study medication.	Baseline (Cycle 1 Day 1)
HRUPQ: Baseline Healthcare Utilization: Number of Nights in the Past 6 Months a Participant Stayed in Hospital	Healthcare utilization at baseline before study medication administration was collected via HRUPQ. The mean number of nights in the past 6 month a participant stayed in hospital for any health issue including MM or due to MM and stayed in intensive care unit (ICU) for any health issue including MM or due to MM is presented. The baseline value was defined as the last non-missing value collected on or before the start date of study medication.	Baseline (Cycle 1 Day 1)
HRUPQ: Baseline Healthcare Utilization: Number of Times in the Past 6 Months a Participant Consulted a Healthcare Professional (HCP)	Healthcare utilization at baseline before study medication administration was collected via HRUPQ. The mean number of times in the past 6 months a participant consulted (had seen or talked to) following healthcare professionals: general doctor or primary care clinician (PCC) who treats a variety of illnesses for any health issue including MM or related to MM, physical or occupational therapist for any health issue including MM or related to MM, mental health professional (e.g. psychiatrist, psychologist, psychiatric nurse) for any health issue including MM or related to MM, medical doctor or clinician who specializes in particular medical disease or issue (specialist) for any health issue including MM or related to MM is presented. The baseline value was defined as the last non-missing value collected on or before the start date of study medication.	Baseline (Cycle 1 Day 1)
Duration of Hospital Visits for Treatment Administration and Duration of Post-Treatment Monitoring Based on HRUPQ	Medical resource utilization was collected through HRUPQ. Participants were asked to indicate the duration of their hospital visit (from arrival to departure) and the duration of post-treatment monitoring based on their most recent isatuximab administration. The median duration across all visits (starting from Cycle 2) was calculated and reported here.	From Cycle 2 Day 1 up to EOT visit (30 days after last study medication administration or before further anti myeloma therapy initiation, whichever occurred first, up to approximately 28 months)
Percentage of Participants Who Visited Healthcare Professional for Non-trial-related Health Issues Based on HRUPQ	Medical resource utilization was collected through HRUPQ. Percentage of participants with healthcare professional visit not required by clinical trial since last isatuximab administration was recorded. Percentages are rounded off to the tenth decimal place.	Cycle 1 Days 8, 15 and 22, Cycle 2 Day 1, Cycles 3 to 29 Day 15 and EOT visit (30 days after last study medication administration or before further anti myeloma therapy initiation, whichever occurred first, up to approximately 28 months)
Percentage of Participants Who Ever Retired During the Study Based on HRUPQ	Employment status was assessed via HRUPQ. Percentage of participants who ever retired during the study are reported. Percentages are rounded off to the tenth decimal place.	From first dose of study medication administration (Day 1) up to PCD (06-Nov-2024), approximately 28 months
Percentage of Participants Who Retired Early Due to MM Based on HRUPQ	Employment status was assessed via HRUPQ. Percentage of participants who retired early due to MM are reported. Percentages are rounded off to the tenth decimal place.	From first dose of study medication administration (Day 1) up to PCD (06-Nov-2024), approximately 28 months
Change From Baseline in European Organization for Research and Treatment of Cancer Core Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30): Global Health Status (GHS)/Quality of Life (QoL)	EORTC QLQ-C30 is a cancer specific 30-item instrument that provides a comprehensive assessment of the principal health related QoL dimensions: GHS/QoL (2 items), functional scales (physical [5 items], role [2 items], emotional [4 items], cognitive [2 items], social [2 items]), symptom scales (fatigue [3 items], nausea & vomiting [2 items], pain [2 items]) and symptom items- 1 item each (dyspnea, insomnia, appetite loss, constipation, diarrhea, financial difficulties). For GHS/QoL: overall health and quality of life were assessed, rated on a 7-point scale (1: very poor to 7: excellent). All of the scales and single-item measures range in score from 0 to 100; mean is presented here. A higher score for GHS/QoL and a positive change from baseline represents a healthy/better level of QoL. The baseline value was defined as the last non-missing value collected on or before the start date of study medication.	Baseline (Cycle 1 Day 1) and Cycle 2 Day 1, Cycles 3 to 21 Day 15 and EOT visit (30 days after last study medication administration or before further anti myeloma therapy initiation, whichever occurred first, up to approximately 28 months)
Change From Baseline in EORTC QLQ-C30: Physical Functioning	EORTC QLQ-C30 is a cancer specific 30-item instrument that provides a comprehensive assessment of the principal health related QoL dimensions: GHS/QoL (2 items), functional scales (physical [5 items], role [2 items], emotional [4 items], cognitive [2 items], social [2 items]), symptom scales (fatigue [3 items], nausea & vomiting [2 items], pain [2 items]) and symptom items- 1 item each (dyspnea, insomnia, appetite loss, constipation, diarrhea, financial difficulties). For functional scales: questions were rated on a 4-point scale (1: not at all to 4: very much). All of the scales and single-item measures range in score from 0 to 100; mean is presented here. A higher score and a positive change from baseline represents a better level of physical functioning. The baseline value was defined as the last non-missing value collected on or before the start date of study medication.	Baseline (Cycle 1 Day 1) and Cycle 2 Day 1, Cycles 3 to 21 Day 15 and EOT visit (30 days after last study medication administration or before further anti myeloma therapy initiation, whichever occurred first, up to approximately 28 months)
Change From Baseline in EORTC QLQ-C30: Role Functioning	EORTC QLQ-C30 is a cancer specific 30-item instrument that provides a comprehensive assessment of the principal health related QoL dimensions: GHS/QoL (2 items), functional scales (physical [5 items], role [2 items], emotional [4 items], cognitive [2 items], social [2 items]), symptom scales (fatigue [3 items], nausea & vomiting [2 items], pain [2 items]) and symptom items- 1 item each (dyspnea, insomnia, appetite loss, constipation, diarrhea, financial difficulties). For functional scales: questions were rated on a 4-point scale (1: not at all to 4: very much). All of the scales and single-item measures range in score from 0 to 100; mean is presented here. A higher score and a positive change from baseline represents a better level of role functioning. The baseline value was defined as the last non-missing value collected on or before the start date of study medication.	Baseline (Cycle 1 Day 1) and Cycle 2 Day 1, Cycles 3 to 21 Day 15 and EOT visit (30 days after last study medication administration or before further anti myeloma therapy initiation, whichever occurred first, up to approximately 28 months)
Change From Baseline in EORTC QLQ-C30: Emotional Functioning	EORTC QLQ-C30 is a cancer specific 30-item instrument that provides a comprehensive assessment of the principal health related QoL dimensions: GHS/QoL (2 items), functional scales (physical [5 items], role [2 items], emotional [4 items], cognitive [2 items], social [2 items]), symptom scales (fatigue [3 items], nausea & vomiting [2 items], pain [2 items]) and symptom items- 1 item each (dyspnea, insomnia, appetite loss, constipation, diarrhea, financial difficulties). For functional scales: questions were rated on a 4-point scale (1: not at all to 4: very much). All of the scales and single-item measures range in score from 0 to 100; mean is presented here. A higher score and a positive change from baseline represents a better level of emotional functioning. The baseline value was defined as the last non-missing value collected on or before the start date of study medication.	Baseline (Cycle 1 Day 1) and Cycle 2 Day 1, Cycles 3 to 21 Day 15 and EOT visit (30 days after last study medication administration or before further anti myeloma therapy initiation, whichever occurred first, up to approximately 28 months)
Change From Baseline in EORTC QLQ-C30: Cognitive Functioning	EORTC QLQ-C30 is a cancer specific 30-item instrument that provides a comprehensive assessment of the principal health related QoL dimensions: GHS/QoL (2 items), functional scales (physical [5 items], role [2 items], emotional [4 items], cognitive [2 items], social [2 items]), symptom scales (fatigue [3 items], nausea & vomiting [2 items], pain [2 items]) and symptom items- 1 item each (dyspnea, insomnia, appetite loss, constipation, diarrhea, financial difficulties). For functional scales: questions were rated on a 4-point scale (1: not at all to 4: very much). All of the scales and single-item measures range in score from 0 to 100; mean is presented here. A higher score and a positive change from baseline represents a better level of cognitive functioning. The baseline value was defined as the last non-missing value collected on or before the start date of study medication.	Baseline (Cycle 1 Day 1) and Cycle 2 Day 1, Cycles 3 to 21 Day 15 and EOT visit (30 days after last study medication administration or before further anti myeloma therapy initiation, whichever occurred first, up to approximately 28 months)
Change From Baseline in EORTC QLQ-C30: Social Functioning	EORTC QLQ-C30 is a cancer specific 30-item instrument that provides a comprehensive assessment of the principal health related QoL dimensions: GHS/QoL (2 items), functional scales (physical [5 items], role [2 items], emotional [4 items], cognitive [2 items], social [2 items]), symptom scales (fatigue [3 items], nausea & vomiting [2 items], pain [2 items]) and symptom items- 1 item each (dyspnea, insomnia, appetite loss, constipation, diarrhea, financial difficulties). For functional scales: questions were rated on a 4-point scale (1: not at all to 4: very much). All of the scales and single-item measures range in score from 0 to 100; mean is presented here. A higher score and a positive change from baseline represents a better level of social functioning. The baseline value was defined as the last non-missing value collected on or before the start date of study medication.	Baseline (Cycle 1 Day 1) and Cycle 2 Day 1, Cycles 3 to 21 Day 15 and EOT visit (30 days after last study medication administration or before further anti myeloma therapy initiation, whichever occurred first, up to approximately 28 months)
Change From Baseline in EORTC QLQ-C30: Fatigue	EORTC QLQ-C30 is a cancer specific 30-item instrument that provides a comprehensive assessment of the principal health related QoL dimensions: GHS/QoL (2 items), functional scales (physical [5 items], role [2 items], emotional [4 items], cognitive [2 items], social [2 items]), symptom scales (fatigue [3 items], nausea & vomiting [2 items], pain [2 items]) and symptom items- 1 item each (dyspnea, insomnia, appetite loss, constipation, diarrhea, financial difficulties). For symptom scales: questions were rated on a 4-point scale (1: not at all to 4: very much). All of the scales and single-item measures range in score from 0 to 100; mean is presented here. A higher score for symptoms and a positive change from baseline represents a higher level of symptomatology. The baseline value was defined as the last non-missing value collected on or before the start date of study medication.	Baseline (Cycle 1 Day 1) and Cycle 2 Day 1, Cycles 3 to 21 Day 15 and EOT visit (30 days after last study medication administration or before further anti myeloma therapy initiation, whichever occurred first, up to approximately 28 months)
Change From Baseline in EORTC QLQ-C30: Nausea and Vomiting	EORTC QLQ-C30 is a cancer specific 30-item instrument that provides a comprehensive assessment of the principal health related QoL dimensions: GHS/QoL (2 items), functional scales (physical [5 items], role [2 items], emotional [4 items], cognitive [2 items], social [2 items]), symptom scales (fatigue [3 items], nausea & vomiting [2 items], pain [2 items]) and symptom items- 1 item each (dyspnea, insomnia, appetite loss, constipation, diarrhea, financial difficulties). For symptom scales: questions were rated on a 4-point scale (1: not at all to 4: very much). All of the scales and single-item measures range in score from 0 to 100; mean is presented here. A higher score for symptoms and a positive change from baseline represents a higher level of symptomatology. The baseline value was defined as the last non-missing value collected on or before the start date of study medication.	Baseline (Cycle 1 Day 1) and Cycle 2 Day 1, Cycles 3 to 21 Day 15 and EOT visit (30 days after last study medication administration or before further anti myeloma therapy initiation, whichever occurred first, up to approximately 28 months)
Change From Baseline in EORTC QLQ-C30: Pain	EORTC QLQ-C30 is a cancer specific 30-item instrument that provides a comprehensive assessment of the principal health related QoL dimensions: GHS/QoL (2 items), functional scales (physical [5 items], role [2 items], emotional [4 items], cognitive [2 items], social [2 items]), symptom scales (fatigue [3 items], nausea & vomiting [2 items], pain [2 items]) and symptom items- 1 item each (dyspnea, insomnia, appetite loss, constipation, diarrhea, financial difficulties). For symptom scales: questions were rated on a 4-point scale (1: not at all to 4: very much). All of the scales and single-item measures range in score from 0 to 100; mean is presented here. A higher score for symptoms and a positive change from baseline represents a higher level of symptomatology. The baseline value was defined as the last non-missing value collected on or before the start date of study medication.	Baseline (Cycle 1 Day 1) and Cycle 2 Day 1, Cycles 3 to 21 Day 15 and EOT visit (30 days after last study medication administration or before further anti myeloma therapy initiation, whichever occurred first, up to approximately 28 months)
Change From Baseline in EORTC QLQ-C30: Dyspnea	EORTC QLQ-C30 is a cancer specific 30-item instrument that provides a comprehensive assessment of the principal health related QoL dimensions: GHS/QoL (2 items), functional scales (physical [5 items], role [2 items], emotional [4 items], cognitive [2 items], social [2 items]), symptom scales (fatigue [3 items], nausea & vomiting [2 items], pain [2 items]) and symptom items- 1 item each (dyspnea, insomnia, appetite loss, constipation, diarrhea, financial difficulties). For symptom items: questions were rated on a 4-point scale (1: not at all to 4: very much). All of the scales and single-item measures range in score from 0 to 100; mean is presented here. A higher score for symptom items and a positive change from baseline represents a higher level of symptomatology. The baseline value was defined as the last non-missing value collected on or before the start date of study medication.	Baseline (Cycle 1 Day 1) and Cycle 2 Day 1, Cycles 3 to 21 Day 15 and EOT visit (30 days after last study medication administration or before further anti myeloma therapy initiation, whichever occurred first, up to approximately 28 months)
Change From Baseline in EORTC QLQ-C30: Insomnia	EORTC QLQ-C30 is a cancer specific 30-item instrument that provides a comprehensive assessment of the principal health related QoL dimensions: GHS/QoL (2 items), functional scales (physical [5 items], role [2 items], emotional [4 items], cognitive [2 items], social [2 items]), symptom scales (fatigue [3 items], nausea & vomiting [2 items], pain [2 items]) and symptom items- 1 item each (dyspnea, insomnia, appetite loss, constipation, diarrhea, financial difficulties). For symptom items: questions were rated on a 4-point scale (1: not at all to 4: very much). All of the scales and single-item measures range in score from 0 to 100; mean is presented here. A higher score for symptom items and a positive change from baseline represents a higher level of symptomatology. The baseline value was defined as the last non-missing value collected on or before the start date of study medication.	Baseline (Cycle 1 Day 1) and Cycle 2 Day 1, Cycles 3 to 21 Day 15 and EOT visit (30 days after last study medication administration or before further anti myeloma therapy initiation, whichever occurred first, up to approximately 28 months)
Change From Baseline in EORTC QLQ-C30: Appetite Loss	EORTC QLQ-C30 is a cancer specific 30-item instrument that provides a comprehensive assessment of the principal health related QoL dimensions: GHS/QoL (2 items), functional scales (physical [5 items], role [2 items], emotional [4 items], cognitive [2 items], social [2 items]), symptom scales (fatigue [3 items], nausea & vomiting [2 items], pain [2 items]) and symptom items- 1 item each (dyspnea, insomnia, appetite loss, constipation, diarrhea, financial difficulties). For symptom items: questions were rated on a 4-point scale (1: not at all to 4: very much). All of the scales and single-item measures range in score from 0 to 100; mean is presented here. A higher score for symptom items and a positive change from baseline represents a higher level of symptomatology. The baseline value was defined as the last non-missing value collected on or before the start date of study medication.	Baseline (Cycle 1 Day 1) and Cycle 2 Day 1, Cycles 3 to 21 Day 15 and EOT visit (30 days after last study medication administration or before further anti myeloma therapy initiation, whichever occurred first, up to approximately 28 months)
Change From Baseline in EORTC QLQ-C30: Constipation	EORTC QLQ-C30 is a cancer specific 30-item instrument that provides a comprehensive assessment of the principal health related QoL dimensions: GHS/QoL (2 items), functional scales (physical [5 items], role [2 items], emotional [4 items], cognitive [2 items], social [2 items]), symptom scales (fatigue [3 items], nausea & vomiting [2 items], pain [2 items]) and symptom items- 1 item each (dyspnea, insomnia, appetite loss, constipation, diarrhea, financial difficulties). For symptom items: questions were rated on a 4-point scale (1: not at all to 4: very much). All of the scales and single-item measures range in score from 0 to 100; mean is presented here. A higher score for symptom items and a positive change from baseline represents a higher level of symptomatology. The baseline value was defined as the last non-missing value collected on or before the start date of study medication.	Baseline (Cycle 1 Day 1) and Cycle 2 Day 1, Cycles 3 to 21 Day 15 and EOT visit (30 days after last study medication administration or before further anti myeloma therapy initiation, whichever occurred first, up to approximately 28 months)
Change From Baseline in EORTC QLQ-C30: Diarrhea	EORTC QLQ-C30 is a cancer specific 30-item instrument that provides a comprehensive assessment of the principal health related QoL dimensions: GHS/QoL (2 items), functional scales (physical [5 items], role [2 items], emotional [4 items], cognitive [2 items], social [2 items]), symptom scales (fatigue [3 items], nausea & vomiting [2 items], pain [2 items]) and symptom items- 1 item each (dyspnea, insomnia, appetite loss, constipation, diarrhea, financial difficulties). For symptom items: questions were rated on a 4-point scale (1: not at all to 4: very much). All of the scales and single-item measures range in score from 0 to 100; mean is presented here. A higher score for symptom items and a positive change from baseline represents a higher level of symptomatology. The baseline value was defined as the last non-missing value collected on or before the start date of study medication.	Baseline (Cycle 1 Day 1) and Cycle 2 Day 1, Cycles 3 to 21 Day 15 and EOT visit (30 days after last study medication administration or before further anti myeloma therapy initiation, whichever occurred first, up to approximately 28 months)
Change From Baseline in EORTC QLQ-C30: Financial Difficulties	EORTC QLQ-C30 is a cancer specific 30-item instrument that provides a comprehensive assessment of the principal health related QoL dimensions: GHS/QoL (2 items), functional scales (physical [5 items], role [2 items], emotional [4 items], cognitive [2 items], social [2 items]), symptom scales (fatigue [3 items], nausea & vomiting [2 items], pain [2 items]) and symptom items- 1 item each (dyspnea, insomnia, appetite loss, constipation, diarrhea, financial difficulties). For symptom items: questions were rated on a 4-point scale (1: not at all to 4: very much). All of the scales and single-item measures range in score from 0 to 100; mean is presented here. A higher score for symptom items and a positive change from baseline represents a higher level of financial difficulties. The baseline value was defined as the last non-missing value collected on or before the start date of study medication.	Baseline (Cycle 1 Day 1) and Cycle 2 Day 1, Cycles 3 to 21 Day 15 and EOT visit (30 days after last study medication administration or before further anti myeloma therapy initiation, whichever occurred first, up to approximately 28 months)
Change From Baseline in EORTC QLQ-Myeloma Module (MY20): Disease Symptoms	The EORTC QLQ-MY20 was used in conjunction with the EORTC QLQ-C30 to assess symptoms and side effects due to the treatment or the disease which impacts health related QoL in participants with MM. It contains 20 items, 4 independent subscales covering 2 functional domains: symptom scales which include disease symptoms (6 items) and side-effects of treatment (10 items) and function scale which include future perspective (3 items) and body image (1 item). Scores for each subscale are based on the 4-point Likert scale ranging from (1: not at all to 4: very much) and transformed from raw scores to linear scales ranging from 0 to 100; mean is presented here. A higher score for disease symptoms and a positive change from baseline represents more symptoms, worse QoL. The baseline value was defined as the last non-missing value collected on or before the start date of study medication.	Baseline (Cycle 1 Day 1) and Cycle 2 Day 1, Cycles 3 to 21 Day 15 and EOT visit (30 days after last study medication administration or before further anti myeloma therapy initiation, whichever occurred first, up to approximately 28 months)
Change From Baseline in EORTC QLQ-MY20: Side Effects of Treatment	The EORTC QLQ-MY20 was used in conjunction with the EORTC QLQ-C30 to assess symptoms and side effects due to the treatment or the disease which impacts health related QoL in participants with MM. It contains 20 items, 4 independent subscales covering 2 functional domains: symptom scales which include disease symptoms (6 items) and side-effects of treatment (10 items) and function scale which include future perspective (3 items) and body image (1 item). Scores for each subscale are based on the 4-point Likert scale ranging from (1: not at all to 4: very much) and transformed from raw scores to linear scales ranging from 0 to 100; mean is presented here. A higher score for side effects of treatment and a positive change from baseline represents more side effects, worse QoL. The baseline value was defined as the last non-missing value collected on or before the start date of study medication.	Baseline (Cycle 1 Day 1) and Cycle 2 Day 1, Cycles 3 to 21 Day 15 and EOT visit (30 days after last study medication administration or before further anti myeloma therapy initiation, whichever occurred first, up to approximately 28 months)
Change From Baseline in EORTC QLQ-MY20: Future Perspective	The EORTC QLQ-MY20 was used in conjunction with the EORTC QLQ-C30 to assess symptoms and side effects due to the treatment or the disease which impacts health related QoL in participants with MM. It contains 20 items, 4 independent subscales covering 2 functional domains: symptom scales which include disease symptoms (6 items) and side-effects of treatment (10 items) and function scale which include future perspective (3 items) and body image (1 item). Scores for each subscale are based on the 4-point Likert scale ranging from (1: not at all to 4: very much) and transformed from raw scores to linear scales ranging from 0 to 100; mean is presented here. A higher score for future perspectives and a positive change from baseline represents better outcomes, better QoL. The baseline value was defined as the last non-missing value collected on or before the start date of study medication.	Baseline (Cycle 1 Day 1) and Cycle 2 Day 1, Cycles 3 to 21 Day 15 and EOT visit (30 days after last study medication administration or before further anti myeloma therapy initiation, whichever occurred first, up to approximately 28 months)
Change From Baseline in EORTC QLQ-MY20: Body Image	The EORTC QLQ-MY20 was used in conjunction with the EORTC QLQ-C30 to assess symptoms and side effects due to the treatment or the disease which impacts health related QoL in participants with MM. It contains 20 items, 4 independent subscales covering 2 functional domains: symptom scales which include disease symptoms (6 items) and side-effects of treatment (10 items) and function scale which include future perspective (3 items) and body image (1 item). Scores for each subscale are based on the 4-point Likert scale ranging from (1: not at all to 4: very much) and transformed from raw scores to linear scales ranging from 0 to 100; mean is presented here. A higher score for body image and a positive change from baseline represents better outcomes, better QoL. The baseline value was defined as the last non-missing value collected on or before the start date of study medication.	Baseline (Cycle 1 Day 1) and Cycle 2 Day 1, Cycles 3 to 21 Day 15 and EOT visit (30 days after last study medication administration or before further anti myeloma therapy initiation, whichever occurred first, up to approximately 28 months)
Change From Baseline in European Quality of Life Group Measure With 5 Dimensions and 5 Levels Per Dimension (EQ-5D-5L): Visual Analogue Scale (VAS)	The EQ-5D-5L is a standardized measure of health status that provides a simple, generic measure of health utility, and consists of 2 sections: descriptive and a VAS. The descriptive system consists of 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems, and extreme problems. The VAS records the respondent's self-rated health on a 20-cm vertical scale ranging from 0: the worst health you can imagine to 100: the best health you can imagine. Change from baseline in VAS is reported here. A higher score in VAS and positive change from baseline represents a better level of QoL. The baseline value was defined as the last non-missing value collected on or before the start date of study medication.	Baseline (Cycle 1 Day 1) and Cycle 2 Day 1, Cycles 3 to 21 Day 15 and EOT visit (30 days after last study medication administration or before further anti myeloma therapy initiation, whichever occurred first, up to approximately 28 months)
ORR Based on at Least 1 Chromosomal Abnormality	BM aspirate was collected for fluorescent in situ hybridization for analysis of del[17p], t[4;14], t[14;16]) and 1q21+. ORR was also evaluated based on IRC assessment by disease characteristics. ORR for participants with at least 1 chromosomal abnormality i.e. [del(17p)] or [1q21+ and t(4;14) or t(14;16)] is presented. Percentages are rounded off to the tenth decimal place.	From first dose of study medication administration (Day 1) up to PCD (06-Nov-2024), approximately 28 months

Collaborators and Investigators

• Sponsor: Sanofi
• Investigators: Study Director: Clinical Sciences & Operations, Sanofi

Publications and helpful links

General Publications

• 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.

Helpful Links

• EFC15951 Relapsed/Refractory Multiple Myeloma USA website
• EFC15951 Plain Language Results Summary

Study record dates

Study Major Dates

• Study Start (Actual): June 23, 2022
• Primary Completion (Actual): November 6, 2024
• Study Completion (Estimated): March 23, 2027

Study Registration Dates

• First Submitted: May 31, 2022
• First Submitted That Met QC Criteria: May 31, 2022
• First Posted (Actual): June 6, 2022

Study Record Updates

• Last Update Posted (Estimated): November 14, 2025
• Last Update Submitted That Met QC Criteria: November 3, 2025
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Neoplasms; Immune System Diseases; Neoplasms by Histologic Type; Hematologic Diseases; Lymphoproliferative Disorders; Immunoproliferative Disorders; Hemostatic Disorders; Paraproteinemias; Blood Protein Disorders; Hemorrhagic Disorders; Multiple Myeloma; Neoplasms, Plasma Cell; Organic Chemicals; Hydrocarbons; Hydrocarbons, Cyclic; Hydrocarbons, Aromatic; Polycyclic Compounds; Anilides; Amides; Aniline Compounds; Amines; Acetanilides; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Steroids, Fluorinated; Benzene Derivatives; Pregnadienetriols; Ethylamines; Prednisolone; Benzhydryl Compounds; Dexamethasone; Acetaminophen; Methylprednisolone; Diphenhydramine; pomalidomide; isatuximab; montelukast
• Other Study ID Numbers: EFC15951; U1111-1261-5846 (Registry Identifier: ICTRP); 2021-002485-41 (EudraCT Number); 2023-508869-32 (Registry Identifier: CTIS)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No