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Plasma Cell MyelomaPhase 3NCT04270409

Isatuximab in Combination With Lenalidomide and Dexamethasone in High-risk Smoldering Multiple Myeloma

A Phase 3 study testing Isatuximab SAR650984, Lenalidomide and Dexamethasone in people with Plasma Cell Myeloma, run by Sanofi at 105 sites in 24 countries.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

Primary Objectives: Safety run-in Part: To confirm the recommended dose of isatuximab when combined with lenalidomide and dexamethasone in participants with high-risk smoldering multiple myeloma (SMM) Randomized Phase 3 Part: To demonstrate the clinical benefit of isatuximab in combination with lenalidomide and… Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Plasma Cell Myeloma
What is being tested?
Isatuximab SAR650984, Lenalidomide and Dexamethasone
Could I receive a placebo?
No, everyone receives an active treatment
How many people
337 participants
Where
105 sitesin 24 countries
Study dates
16 Jun 2020to 21 Oct 2033
Phase
Phase 3
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Participants who are diagnosed within 5 years with SMM (per International Myeloma Working Group [IMWG] criteria), defined as serum M-protein ≥30 g/L or urinary M-protein ≥500 mg per 24 hour or both, and/or clonal bone marrow plasma cells (BMPCs) 10% to <60%, and absence of myeloma defining events or other related conditions and with high-risk SMM
  • Eastern Cooperative Oncology Group (ECOG) Performance Status 0 or 1 or 2
  • Capable of giving voluntary written informed consent
  • Absolute neutrophil count (ANC) ≥1000/µL (1 × 10^9/L)
  • Platelets ≥50,000/µL (50 × 10^9/L)
  • Total bilirubin ≤3 mg/dL (except Gilbert syndrome, in which direct bilirubin should be -≤5 mg/dL).
  • Alanine aminotransferase ≤3× upper limit of normal (ULN), aspartate aminotransferase ≤ 3 × ULN.

Who cannot join

  • Evidence of any of the following calcium, renal failure, anemia, bone lesions (CRAB) criteria or Myeloma Defining Events (SLiM CRAB) detailed below (attributable to the participants SMM involvement):
  • Increased calcium levels: Corrected serum calcium >1 mg/dL above the ULN or >11 mg/dL
  • Renal insufficiency: Determined by glomerular filtration rate (GFR) <40 mL/min/1.73 m² (Modification of Diet in Renal Disease [MDRD] Formula) or serum creatinine >2 mg/dL
  • Anemia (hemoglobin 2 g/dL below lower limit of normal or <10 g/dL or both) transfusion support or concurrent treatment with erythropoietin stimulating agents is not permitted
  • ≥ 1 bone lytic lesion
  • BMPCs ≥60%
Show all 28Show fewer
  • Serum involved/uninvolved FLC ratio ≥100 and an involved FLC ≥100mg/L
  • Whole body magnetic resonance imaging (WB-MRI) or positron emission tomography-computed tomography (PET-CT) with more than 1 bone focal lesion (≥5 mm in diameter by MRI)
  • Primary systemic amyloid light-chain (AL) amyloidosis, monoclonal gammopathy of undetermined significance (MGUS), standard risk smoldering myeloma, soft tissue plasmacytoma, symptomatic myeloma
  • Uncontrolled infection within 28 days prior to randomization in Phase 3 or first study intervention administration in safety run-in
  • Clinically significant cardiac or vascular disease within 3 months prior to randomization, e.g. Myocardial Infarction; Unstable Angina; Coronary (e.g. Coronary Artery Bypass Graft, Percutaneous Coronary Intervention) or peripheral artery revascularization, Left Ventricular Ejection Fraction <40%, Heart Failure NYHA III-IV, Stroke, Transient Ischemic Attack, Pulmonary Embolism, other thromboembolic event, cardiac arrhythmia (Grade 3 or higher by NCI-CTCAE Version 5.0)
  • Known acquired immunodeficiency syndrome (AIDS)-related illness or known human immunodeficiency virus (HIV) disease requiring antiviral treatment or active hepatitis A (defined as positive hepatitis A antigen or positive IgM). HIV serology at screening will be tested for German participants and any other country where required as per local regulations and serology hepatitis B and C at screening will be tested for all participants
  • Uncontrolled or active hepatitis B virus (HBV) infection: Patients with positive Hepatitis B surface antigen (HBsAg) and/or HBV Deoxyribonucleic acid (DNA)
  • Of note:
  • Patient can be eligible if anti-HBc Immunoglobulin G (IgG) positive (with or without positive anti-HBs) but HBsAg and HBV DNA are negative. If anti-HBV therapy in relation with prior infection was started before initiation of IMP, the anti-HBV therapy and monitoring should continue throughout the study treatment period.
  • Patients with negative HBsAg and positive HBV DNA observed during screening period will be evaluated by a specialist for start of anti-viral treatment: study treatment could be proposed if HBV DNA becomes negative and all the other study criteria are still met.
  • Active hepatitis C virus (HCV) infection: positive HCV ribonucleic acid (RNA) and negative anti-HCV
  • Of note:
  • Patients with antiviral therapy for HCV started before initiation of IMP and positive HCV antibodies are eligible. The antiviral therapy for HCV should continue throughout the treatment period until seroconversion.
  • Patients with positive anti-HCV and undetectable HCV RNA without antiviral therapy for HCV are eligible
  • Malabsorption syndrome or any condition that can significantly impact the absorption of lenalidomide
  • Any of the following within 3 months prior to randomization (or first study intervention administration in safety run-in cohort): treatment resistant peptic ulcer disease, erosive esophagitis or gastritis, infectious or inflammatory bowel disease, diverticulitis, pulmonary embolism, or other uncontrolled thromboembolic event
  • Received treatment (eg surgery, radiotherapy, medication) for a malignancy within 3 years of randomization (or first study intervention administration in safety run-in cohort)
  • Prior exposure to approved or investigational treatments for SMM or multiple myeloma (MM) (including but not limited to conventional chemotherapies, immunomodulatory imid drugs, or Proteasome inhibitors); concurrent use of bisphosphonates or receptor activator of nuclear factor kappa-B ligand (RANKL) inhibitor denosumab is not permitted; however, prior bisphosphonates or once-a-year intravenous bisphosphonate given for the treatment of osteoporosis is permitted
  • Ongoing treatment with corticosteroids with a dose >10 mg prednisone or equivalent per day at the time of randomization (or first study intervention administration in safety run-in cohort)
  • Women of childbearing potential or male participant with women of childbearing potential who do not agree to use a highly effective method of birth control
  • Vaccination with a live vaccine 4 weeks before the start of the study drug. Seasonal flu vaccines that do not contain live virus are permitted
  • The above information is not intended to contain all considerations relevant to a potential participation in a clinical trial.

Trial locations and contacts

105 sites in 24 countries.

105 sites in 24 countries

United States9 sites

  • Dana Farber Cancer Institute Site Number : 8400001

    Boston, Massachusetts, 02115

  • Presbyterian Hospital Site Number : 8400015

    Charlotte, North Carolina, 28204

  • Colorado Blood Cancer Institute Site Number : 8400007

    Denver, Colorado, 80218

  • ~University of Texas - MD Anderson Cancer Center Site Number : 8400002

    Houston, Texas, 77030

  • Cancer Specialist of North Florida Site Number : 8400011

    Jacksonville, Florida, 32256

  • UCLA Site Number : 8400010

    Los Angeles, California, 90024

  • University of Miami Site Number : 8400012

    Miami, Florida, 33136

  • Tennessee Oncology Site Number : 8400006

    Nashville, Tennessee, 37203

  • Novant Health Forsyth Medical Center Site Number : 8401015

    Winston-Salem, North Carolina, 27103

Other trials in United States

France9 sites

  • Investigational Site Number :2500009

    Ars-Laquenexy, 57085

  • Investigational Site Number :2500010

    Bayonne, 64109

  • Investigational Site Number :2500007

    Grenoble, 38043

  • Investigational Site Number :2500006

    La Roche-sur-Yon, 85925

  • Investigational Site Number :2500003

    Lille, 59037

  • Investigational Site Number :2500005

    Paris, 75012

  • Investigational Site Number :2500011

    Paris, 75013

  • Investigational Site Number :2500002

    Poitiers, 86021

  • Investigational Site Number :2500001

    Rennes, 35033

Other trials in France

Australia7 sites

  • Investigational Site Number :0360002

    Fitzroy, Victoria, 3065

  • Investigational Site Number :0360007

    Heidelberg West, Victoria, 3081

  • Investigational Site Number :0360008

    Liverpool, New South Wales, 2170

  • Investigational Site Number :0360006

    Nedlands, Western Australia, 6009

  • Investigational Site Number :0360004

    Richmond, Victoria, 3121

  • Investigational Site Number :0360005

    Waratah, New South Wales, 2298

  • Investigational Site Number :0360001

    Wollongong, New South Wales, 2500

Other trials in Australia

Japan7 sites

  • Investigational Site Number :3920005

    Higashiibaraki-gun, Ibaraki, 311-3193

  • Investigational Site Number :3920006

    Kamogawa-shi, Chiba, 296-8602

  • Investigational Site Number :3920008

    Maebashi, Gunma, 371-8511

  • Investigational Site Number :3920002

    Nagoya, Aichi-ken, 467-8602

  • Investigational Site Number :3920003

    Okayama, Okayama-ken, 701-1192

  • Investigational Site Number :3920001

    Shibuya-ku, Tokyo, 150-8935

  • Investigational Site Number :3920009

    Sunto-gun, Shizuoka, 411-8777

Other trials in Japan

Spain7 sites

  • Investigational Site Number :7240004

    Barcelona, Barcelona [Barcelona], 08036

  • Investigational Site Number :7240001

    Barcelona, Barcelona [Barcelona], 08041

  • Investigational Site Number :7240005

    Madrid, 28041

  • Investigational Site Number :7240006

    Pamplona, Navarre, 31008

  • Investigational Site Number :7240007

    Salamanca, 37007

  • Investigational Site Number :7240002

    Valencia, Valenciana, Comunidad, 46017

  • Investigational Site Number :7240003

    Zaragoza, 50009

Other trials in Spain

China6 sites

  • Investigational Site Number :1560002

    Hangzhou, 310003

  • Investigational Site Number :1560003

    Hangzhou, 310003

  • Investigational Site Number :1560006

    Nanchang, 330006

  • Investigational Site Number :1560004

    Shanghai, 200032

  • Investigational Site Number :1560005

    Shenyang, 110022

  • Investigational Site Number :1560001

    Tianjin, 300020

Other trials in China

Israel6 sites

  • Investigational Site Number :3760004

    Ashdod, 7747629

  • Investigational Site Number :3760001

    Jerusalem, 91031

  • Investigational Site Number :3760002

    Jerusalem, 91120

  • Investigational Site Number :3760005

    Petah Tikva, 49100

  • Investigational Site Number :3760006

    Ramat Gan, 5265601

  • Investigational Site Number :3760003

    Tel Aviv, 64239

Other trials in Israel

Czechia5 sites

  • Investigational Site Number : 2030004

    Brno, 62500

  • Investigational Site Number : 2030005

    Hradec Králové, 50005

  • Investigational Site Number : 2030002

    Olomouc, 77900

  • Investigational Site Number : 2030003

    Ostrava - Poruba, 70852

  • Investigational Site Number : 2030001

    Prague, 12808

Other trials in Czechia

Italy5 sites

  • Investigational Site Number :3800005

    Ancona, 60032

  • Investigational Site Number :3800003

    Bologna, 40138

  • Investigational Site Number :3800006

    Meldola, Forlì-Cesena, 47014

  • Investigational Site Number :3800001

    Rozzano, Milano, 20089

  • Investigational Site Number :3800002

    Terni, 05100

Other trials in Italy

Turkey (Türkiye)5 sites

  • Investigational Site Number : 7920005

    Ankara, 06010

  • Investigational Site Number : 7920001

    Ankara, 06620

  • Investigational Site Number : 7920004

    Istanbul, 34214

  • Investigational Site Number : 7920002

    Istanbul, 34390

  • Investigational Site Number : 7920003

    Izmir, 35040

Other trials in Turkey (Türkiye)

Denmark4 sites

  • Investigational Site Number :2080001

    Aalborg, 9000

  • Investigational Site Number :2080003

    Aarhus N, 8200

  • Investigational Site Number :2080005

    Copenhagen, 2100

  • Investigational Site Number :2080002

    Roskilde, 4000

Other trials in Denmark

Hungary4 sites

  • Investigational Site Number :3480003

    Budapest, 1083

  • Investigational Site Number :3480001

    Budapest, 1097

  • Investigational Site Number :3480002

    Debrecen, 4032

  • Investigational Site Number :3480004

    Kaposvár, 7400

Other trials in Hungary

Poland4 sites

  • Investigational Site Number :6160006

    Bydgoszcz, Kuyavian-Pomeranian Voivodeship, 85-168

  • Investigational Site Number :6160005

    Chorzów, Silesian Voivodeship, 41-500

  • Investigational Site Number :6160008

    Gdansk, Pomeranian Voivodeship, 80-214

  • Investigational Site Number :6160002

    Lodz, Lódzkie, 93-510

Other trials in Poland

South Korea4 sites

  • Investigational Site Number :4100004

    Gangnam-gu, Seoul-teukbyeolsi, 06351

  • Investigational Site Number :4100003

    Seoul, Seoul-teukbyeolsi, 03080

  • Investigational Site Number :4100001

    Seoul, Seoul-teukbyeolsi, 03722

  • Investigational Site Number :4100002

    Seoul, 06591

Other trials in South Korea

United Kingdom4 sites

  • Investigational Site Number :8260002

    Bournemouth, Hampshire, BH7 7DW

  • Investigational Site Number :8260001

    Leicester, LE15WW

  • Investigational Site Number :8260003

    London, London, City of, SE1 7EH

  • Investigational Site Number :8260004

    Southampton, SO16 6YD

Other trials in United Kingdom

Canada3 sites

  • Investigational Site Number :1240004

    Edmonton, Alberta, T6G 1Z2

  • Investigational Site Number :1240005

    Moncton, New Brunswick, E1C 6Z8

  • Investigational Site Number :1240001

    Montreal, Quebec, H1T 2M4

Other trials in Canada

Greece3 sites

  • Investigational Site Number :3000002

    Athens, 10676

  • Investigational Site Number :3000001

    Athens, 11528

  • Investigational Site Number :3000003

    Thessaloniki, PC 54007

Other trials in Greece

Ireland3 sites

  • Investigational Site Number :3720001

    Dublin, Dublin

  • Investigational Site Number :3720002

    Dublin, Dublin

  • Investigational Site Number :3720003

    Dublin, Dublin

Other trials in Ireland

Germany2 sites

  • Investigational Site Number :2760001

    Hamburg, 20246

  • Investigational Site Number :2760002

    Heidelberg, 69120

Other trials in Germany

New Zealand2 sites

  • Investigational Site Number :5540004

    Christchurch, Canterbury

  • Investigational Site Number :5540001

    Hamilton, Waikato Region, 3204

Other trials in New Zealand

Norway2 sites

  • Investigational Site Number :5780002

    Bergen, 5021

  • Investigational Site Number :5780001

    Oslo, 0450

Other trials in Norway

Sweden2 sites

  • Investigational Site Number :7520001

    Gothenburg, 413 45

  • Investigational Site Number :7520003

    Helsingborg, 251 87

Other trials in Sweden

Brazil1 site

  • Investigational Site Number :0760002

    São Paulo, São Paulo, 04537-081

Other trials in Brazil

Lithuania1 site

  • Investigational Site Number :4400001

    Vilnius, 08661

Other trials in Lithuania

About this study

Official title: A Phase 3 Randomized, Open-label, Multicenter Study of Isatuximab (SAR650984) in Combination With Lenalidomide and Dexamethasone Versus Lenalidomide and Dexamethasone in Patients With High-risk Smoldering Multiple Myeloma

Primary Objectives:

  • Safety run-in Part: To confirm the recommended dose of isatuximab when combined with lenalidomide and dexamethasone in participants with high-risk smoldering multiple myeloma (SMM)
  • Randomized Phase 3 Part: To demonstrate the clinical benefit of isatuximab in combination with lenalidomide and dexamethasone in the prolongation of progression-free survival when compared to lenalidomide and dexamethasone in subjects with high-risk SMM
Read more

Secondary Objectives:

Safety run-in Part:

  • To assess overall response rate (ORR)
  • To assess duration of response (DOR)
  • To assess minimal residual disease (MRD) negativity in participants achieving very good partial response (VGPR) or complete response (CR)
  • To assess time to diagnostic (SLiM CRAB) progression or death
  • To assess time to first-line treatment for multiple myeloma (MM)
  • To assess the potential immunogenicity of isatuximab
  • Impact of abnormal chromosomal subtype on participant outcome

Randomized Phase 3 Part:

Key Secondary Objectives:

To compare between the arms

  • MRD negativity
  • Sustained MRD negativity
  • Second progression-free survival (PFS2)
  • Overall survival

Other Secondary Objectives:

To evaluate in both arms

  • CR rate
  • ORR
  • DOR
  • Time to diagnostic (SLiM CRAB) progression
  • Time to biochemical progression
  • Time to first-line treatment for MM
  • Impact of abnormal chromosomal subtype on participant outcome
  • Safety and tolerability
  • Pharmacokinetics (PK)
  • Potential of isatuximab immunogenicity
  • Clinical outcome assessments (COAs)
Read the detailed description

Study duration is expected to be approximately 12 years, including a 42-day screening period, followed by an up to 36-month treatment period, and a follow-up period of approximately 9 years.

Being tested
Isatuximab SAR650984, Lenalidomide, Dexamethasone, Montelukast or equivalent, Acetaminophen
Keywords
Anti-CD38 monoclonal antibody
Medical subject headings
Multiple Myeloma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Isatuximab SAR650984Drug

    Also called Sarclisa

    Pharmaceutical for: Solution for infusion Route of administration: Intravenous

  • LenalidomideDrug

    Pharmaceutical form: Capsules Route of administration: Oral

  • DexamethasoneDrug

    Pharmaceutical form: Tablets and solution for injection Route of administration: Oral and intravenous

  • Montelukast or equivalentDrug

    Auxiliary Medicinal Product (AxMP)/pre-medication; ATC code: R03DC03; Pharmaceutical form: tablet; Route of administration: Oral;

  • AcetaminophenDrug

    AxMP/pre-medication ATC code: N02BE01 Pharmaceutical form: tablet/ampule/capsule; Route of administration: Intravenous (IV) or per os (PO)

  • Diphenhydramine or equivalentDrug

    AxMP/pre-medication ATC code: R06AA02 Pharmaceutical form: ampule; Route of administration: Intravenous

  • Methylprednisolone or equivalentDrug

    AxMP/pre-medication; ATC code: H02AB04; Pharmaceutical form: vial; Route of administration: Intravenous

Study groups in NCT04270409
Study groupRoleWhat they receive
Isatuximab, lenalidomide, and dexamethasone (ILd)ExperimentalParticipants will receive isatuximab [intravenous (IV) administration] in combination with lenalidomide [per os (PO) administration] and dexamethasone [IV on Day 1 of Cycle 1 for participants receiving isatuximab IV only and PO otherwise for subsequent cycles] for 24 cycles followed by isatuximab monotherapy for 12 cycles for a total duration of 36 cycles. 1 cycle = 28 days. Participants may receive other treatments as pre-medication.
Receives: Drug: Isatuximab SAR650984; Drug: Lenalidomide; Drug: Dexamethasone; Drug: Montelukast or equivalent; Drug: Acetaminophen; Drug: Diphenhydramine or equivalent; Drug: Methylprednisolone or equivalent
Lenalidomide and dexamethasone (Ld)Active comparatorLenalidomide [PO administration] in combination with dexamethasone [PO administration] for 24 cycles. 1 cycle = 28 days
Receives: Drug: Lenalidomide; Drug: Dexamethasone

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of participants with Treatment-emergent adverse events (AEs) and serious adverse events- Safety Run-in Part

    Measured: Up to approximately 63 months

  2. Plasma concentration of isatuximab during the treatment period - Safety Run-in Part

    Measured: After first infusion from Cycle 1 Day 1 to Day 28 in safety run-in part

  3. Receptor density/receptor occupancy Safety Run-in Part

    Change in CD38 receptor occupancy from baseline

    Measured: Baseline to Cycle 2 Day 1 (each cycle is 28 days)

  4. Progression-free survival (PFS) Randomized Phase 3 Part

    PFS defined as the time from randomization to MM (SLiM CRAB criteria) or other related conditions based on independent review committee (IRC) assessment according to 2014 International Myeloma Working Group (IMWG) criteria or death from any cause, whichever happens first

    Measured: Up to approximately 114 months

Secondary outcomes (29)

  1. Overall Response Rate (ORR)- Safety Run-in Part

    ORR defined as the proportion of participants with best overall response (BOR) recorded as partial response (PR) or better according to 2016 IMWG criteria

    Measured: Up to approximately 63 months

  2. Duration of Response (DOR) - Safety Run-in Part

    DOR defined as the time from the date of the first response to date of first progressive disease (PD) or death, whichever happens first.

    Measured: Up to approximately 63 months

  3. Minimal residual disease (MRD) negativity -Safety Run-in Part

    MRD negativity defined as the proportion of participants for whom MRD is negative in participants achieving very good partial response (VGPR) or above.

    Measured: Up to approximately 36 months

  4. Time to diagnostic (SLiM CRAB) progression or death - Safety Run-in Part

    Time to diagnostic (SLiM CRAB) progression or death defined as the time from the date of the first study intervention administration to diagnosis of SLiM CRAB or other related conditions progression or death from any cause, whichever happens first.

    Measured: Up to approximately 63 months

  5. Time to first-line treatment for multiple myeloma (MM) - Safety Run-in Part

    Time to first-line treatment for MM defined as the time from the date of the first study intervention administration to first-line treatment for MM.

    Measured: Up to approximately 63 months

  6. Number of participants with anti-drug antibodies (ADA) against isatuximab- Safety Run-in Part

    Measured: Up to approximately 63 months

  7. PFS in participants with chromosomal abnormalities - Safety Run-In Part

    Association of chromosomal abnormalities with survival outcomes

    Measured: Up to approximately 63 months

  8. Overall Survival (OS) in participants with chromosomal abnormalities - Safety Run-In Part

    Association of chromosomal abnormalities with survival outcomes

    Measured: Up to approximately 63 months

  9. Minimal residual disease (MRD) negativity - Randomized Phase 3 Part

    MRD negativity defined as the proportion Number of participants for whom MRD is negative in participants achieving VGPR or above.

    Measured: Up to approximately 36 months

  10. Sustained MRD negativity - Randomized Phase 3 Part

    Sustained MRD negativity defined as the proportion of participants for whom MRD is negative during a minimum period of one year.

    Measured: Up to approximately 36 months

  11. Second PFS (PFS2) - Randomized Phase 3 Part

    PFS2 defined as the time from the date of randomization to the date of first documentation of PD (as reported by the Investigator) after initiation of further treatment for MM or the date of death from any cause, whichever happens first

    Measured: Up to approximately 144 months

  12. OS - Randomized Phase 3 Part

    OS defined as the time from date of randomization to death from any cause.

    Measured: Up to approximately 114 months

  13. Complete response (CR) rate - Randomized Phase 3 Part

    Percentage of participants with a CR (or better [stringent CR (sCR)]) as defined by 2016 IMWG response criteria, assessed by an IRC based on central laboratory values.

    Measured: Up to approximately 114 months

  14. Overall Response Rate (ORR) - Randomized Phase 3 Part

    ORR is defined as the proportion of participants with BOR recorded as PR or better according to the 2016 IMWG criteria, assessed by an IRC based on central laboratory values.

    Measured: Up to approximately 114 months

  15. Duration of response (DOR) - Randomized Phase 3 Part

    DOR is defined as the time from the date of the first IRC determined response to the date of first IRC PD, or death, whichever happens first.

    Measured: Up to approximately 114 months

  16. Time to diagnostic (SLiM CRAB) progression - Randomized Phase 3 Part

    Time to diagnostic (SLiM CRAB) progression defined as the time from randomization to the date of diagnosis of SLiM CRAB progression based on IRC assessment.

    Measured: Up to approximately 114 months

  17. Time to biochemical progression - Randomized Phase 3 Part

    Time to biochemical progression defined as the time from randomization to the date of biochemical progression based on IRC assessment.

    Measured: Up to approximately 114 months

  18. Time to first-line treatment for MM- Randomized Phase 3 Part

    Time to first-line treatment for MM defined as the time from randomization to first-line treatment for MM

    Measured: Up to approximately 144 months

  19. PFS in participants with chromosomal abnormalities - Randomized Phase 3 Part

    Association of chromosomal abnormalities with survival outcomes.

    Measured: Up to approximately 114 months

  20. OS in participants with chromosomal abnormalities - Randomized Phase 3 Part

    Association of chromosomal abnormalities with survival outcomes.

    Measured: Up to approximately 144 months

  21. Number of participants with Treatment-emergent adverse events (AEs) and serious adverse events - Randomized Phase 3 Part

    Measured: Up to approximately 144 months

  22. Plasma concentration of isatuximab (Ctrough)- Safety Run-in and Randomized Phase 3 Part

    Ctrough defined as concentration observed just before treatment administration during repeated dosing after IV administration

    Measured: Baseline to Cycle 2 Day 1 (each cycle is 28 days)

  23. Concentration observed at the end of intravenous infusion.(Ceoi)- Safety Run-in Part

    Measured: Day 1 of Cycle 1 to 4

  24. Number of participants with Incidence of anti-drug antibodies (ADA) against isatuximab- Randomized Phase 3 Part

    Measured: Up to approximately 144 months

  25. European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 - Randomized Phase 3 Part

    The EORTC Multiple Myeloma Module (QLQ-C30) will be used to assess cancer-specific health related quality of life (HRQL), disease and treatment related symptoms and impact of symptoms. Mean change from baseline scores will be assessed, with responses ranging from 1=not at all to 4=very much or 1=very poor to 7=excellent; higher scores represent a better level of physical functioning

    Measured: Baseline to follow-up (up to approximately 114 months)

  26. EORTC QLQ-MY20 - Randomized Phase 3 Part

    The EORTC Multiple Myeloma Module (QLQ-MY20) will be used to measure myeloma-specific HRQL, disease and treatment related symptoms and impact of symptoms. Mean change from baseline in scores will be assessed using a 4-point scale, with responses ranging from 1=not at all to 4=very much; higher scores represent better perspectives of the future and higher level of symptomatology

    Measured: Baseline to follow-up (up to approximately 114 months)

  27. EQ-5D-5L - Randomized Phase 3 Part

    The EQ-5D-5L will be used to assess health status and health utility. Mean change from baseline scores will be assessed from 5 items, with responses ranging from 'no' to 'extreme problems'; health state utility values (HSUVs) are generated by multiplying the item scores by country specific value sets; health status is assessed via a VAS; higher scores = higher HSUV/health status

    Measured: Baseline to follow-up (up to approximately 114 months)

  28. Randomized Phase 3: HRUPQ - Randomized Phase 3 Part

    Mean change from baseline in Health resource utilization and productivity questionnaire (HRUPQ) scores. HRUPQ will assess health care resource utilization of HRSM and the impact of high risk smoldering multiple myeloma (HRSMM) on employment/work; higher scores = greater impact on work/productivity, resources.

    Measured: Baseline to follow-up (up to approximately 114 months)

  29. Patient's Qualitative Assessment of Treatment Version 2 (PQAT-v2) - Randomized Phase 3 Part

    PQAT-v2 will be used to assess participant-perceived advantages and disadvantages of treatment. Patient's qualitative assessment of treatment will be assessed using a 10 point VAS/NRS scale with response anchors of 'not beneficial at all' to 'extremely beneficial'; higher scores represent greater patient-perceived benefits of treatment

    Measured: End of treatment (up to approximately 3 year)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Feb 2020
  2. Study start16 Jun 2020
  3. Primary completion14 Oct 2030 (estimated)
  4. Study completion21 Oct 2033 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
337 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04270409
Sponsor's protocol ID
EFC15992
Other IDs
U1111-1222-7068, 2023-507419-37, 2019-003139-47, 2019, 2023
Status last verified
Dec 2025
First submitted
13 Feb 2020
Last updated
12 Dec 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: 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

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Isatuximab SAR650984, Lenalidomide and Dexamethasone in people with Plasma Cell Myeloma, run by Sanofi at 105 sites in 24 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 28 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 12 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 105 sites in United States, France, Australia, Japan, Spain and 19 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of participants with Treatment-emergent adverse events (AEs) and serious adverse events- Safety Run-in Part (time frame: Up to approximately 63 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04270409.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Dec 2025.

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