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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT04270409




Registration number
NCT04270409
Ethics application status
Date submitted
13/02/2020
Date registered
17/02/2020

Titles & IDs
Public title
Isatuximab in Combination With Lenalidomide and Dexamethasone in High-risk Smoldering Multiple Myeloma
Scientific 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
Secondary ID [1] 0 0
U1111-1222-7068
Secondary ID [2] 0 0
EFC15992
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Plasma Cell Myeloma 0 0
Condition category
Condition code
Cancer 0 0 0 0
Other cancer types
Cancer 0 0 0 0
Myeloma

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Isatuximab SAR650984
Treatment: Drugs - Lenalidomide
Treatment: Drugs - Dexamethasone
Treatment: Drugs - Montelukast or equivalent
Treatment: Drugs - Acetaminophen
Treatment: Drugs - Diphenhydramine or equivalent
Treatment: Drugs - Methylprednisolone or equivalent

Experimental: Isatuximab, lenalidomide, and dexamethasone (ILd) - Participants 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.

Active comparator: Lenalidomide and dexamethasone (Ld) - Lenalidomide \[PO administration\] in combination with dexamethasone \[PO administration\] for 24 cycles. 1 cycle = 28 days


Treatment: Drugs: Isatuximab SAR650984
Pharmaceutical for: Solution for infusion Route of administration: Intravenous

Treatment: Drugs: Lenalidomide
Pharmaceutical form: Capsules Route of administration: Oral

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

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

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

Treatment: Drugs: Diphenhydramine or equivalent
AxMP/pre-medication ATC code: R06AA02 Pharmaceutical form: ampule; Route of administration: Intravenous

Treatment: Drugs: Methylprednisolone or equivalent
AxMP/pre-medication; ATC code: H02AB04; Pharmaceutical form: vial; Route of administration: Intravenous
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Number of participants with Treatment-emergent adverse events (AEs) and serious adverse events- Safety Run-in Part
Timepoint [1] 0 0
Up to approximately 63 months
Primary outcome [2] 0 0
Plasma concentration of isatuximab during the treatment period - Safety Run-in Part
Timepoint [2] 0 0
After first infusion from Cycle 1 Day 1 to Day 28 in safety run-in part
Primary outcome [3] 0 0
Receptor density/receptor occupancy Safety Run-in Part
Timepoint [3] 0 0
Baseline to Cycle 2 Day 1 (each cycle is 28 days)
Primary outcome [4] 0 0
Progression-free survival (PFS) Randomized Phase 3 Part
Timepoint [4] 0 0
Up to approximately 114 months
Secondary outcome [1] 0 0
Overall Response Rate (ORR)- Safety Run-in Part
Timepoint [1] 0 0
Up to approximately 63 months
Secondary outcome [2] 0 0
Duration of Response (DOR) - Safety Run-in Part
Timepoint [2] 0 0
Up to approximately 63 months
Secondary outcome [3] 0 0
Minimal residual disease (MRD) negativity -Safety Run-in Part
Timepoint [3] 0 0
Up to approximately 36 months
Secondary outcome [4] 0 0
Time to diagnostic (SLiM CRAB) progression or death - Safety Run-in Part
Timepoint [4] 0 0
Up to approximately 63 months
Secondary outcome [5] 0 0
Time to first-line treatment for multiple myeloma (MM) - Safety Run-in Part
Timepoint [5] 0 0
Up to approximately 63 months
Secondary outcome [6] 0 0
Number of participants with anti-drug antibodies (ADA) against isatuximab- Safety Run-in Part
Timepoint [6] 0 0
Up to approximately 63 months
Secondary outcome [7] 0 0
PFS in participants with chromosomal abnormalities - Safety Run-In Part
Timepoint [7] 0 0
Up to approximately 63 months
Secondary outcome [8] 0 0
Overall Survival (OS) in participants with chromosomal abnormalities - Safety Run-In Part
Timepoint [8] 0 0
Up to approximately 63 months
Secondary outcome [9] 0 0
Minimal residual disease (MRD) negativity - Randomized Phase 3 Part
Timepoint [9] 0 0
Up to approximately 36 months
Secondary outcome [10] 0 0
Sustained MRD negativity - Randomized Phase 3 Part
Timepoint [10] 0 0
Up to approximately 36 months
Secondary outcome [11] 0 0
Second PFS (PFS2) - Randomized Phase 3 Part
Timepoint [11] 0 0
Up to approximately 144 months
Secondary outcome [12] 0 0
OS - Randomized Phase 3 Part
Timepoint [12] 0 0
Up to approximately 114 months
Secondary outcome [13] 0 0
Complete response (CR) rate - Randomized Phase 3 Part
Timepoint [13] 0 0
Up to approximately 114 months
Secondary outcome [14] 0 0
Overall Response Rate (ORR) - Randomized Phase 3 Part
Timepoint [14] 0 0
Up to approximately 114 months
Secondary outcome [15] 0 0
Duration of response (DOR) - Randomized Phase 3 Part
Timepoint [15] 0 0
Up to approximately 114 months
Secondary outcome [16] 0 0
Time to diagnostic (SLiM CRAB) progression - Randomized Phase 3 Part
Timepoint [16] 0 0
Up to approximately 114 months
Secondary outcome [17] 0 0
Time to biochemical progression - Randomized Phase 3 Part
Timepoint [17] 0 0
Up to approximately 114 months
Secondary outcome [18] 0 0
Time to first-line treatment for MM- Randomized Phase 3 Part
Timepoint [18] 0 0
Up to approximately 144 months
Secondary outcome [19] 0 0
PFS in participants with chromosomal abnormalities - Randomized Phase 3 Part
Timepoint [19] 0 0
Up to approximately 114 months
Secondary outcome [20] 0 0
OS in participants with chromosomal abnormalities - Randomized Phase 3 Part
Timepoint [20] 0 0
Up to approximately 144 months
Secondary outcome [21] 0 0
Number of participants with Treatment-emergent adverse events (AEs) and serious adverse events - Randomized Phase 3 Part
Timepoint [21] 0 0
Up to approximately 144 months
Secondary outcome [22] 0 0
Plasma concentration of isatuximab (Ctrough)- Safety Run-in and Randomized Phase 3 Part
Timepoint [22] 0 0
Baseline to Cycle 2 Day 1 (each cycle is 28 days)
Secondary outcome [23] 0 0
Concentration observed at the end of intravenous infusion.(Ceoi)- Safety Run-in Part
Timepoint [23] 0 0
Day 1 of Cycle 1 to 4
Secondary outcome [24] 0 0
Number of participants with Incidence of anti-drug antibodies (ADA) against isatuximab- Randomized Phase 3 Part
Timepoint [24] 0 0
Up to approximately 144 months
Secondary outcome [25] 0 0
European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 - Randomized Phase 3 Part
Timepoint [25] 0 0
Baseline to follow-up (up to approximately 114 months)
Secondary outcome [26] 0 0
EORTC QLQ-MY20 - Randomized Phase 3 Part
Timepoint [26] 0 0
Baseline to follow-up (up to approximately 114 months)
Secondary outcome [27] 0 0
EQ-5D-5L - Randomized Phase 3 Part
Timepoint [27] 0 0
Baseline to follow-up (up to approximately 114 months)
Secondary outcome [28] 0 0
Randomized Phase 3: HRUPQ - Randomized Phase 3 Part
Timepoint [28] 0 0
Baseline to follow-up (up to approximately 114 months)
Secondary outcome [29] 0 0
Patient's Qualitative Assessment of Treatment Version 2 (PQAT-v2) - Randomized Phase 3 Part
Timepoint [29] 0 0
End of treatment (up to approximately 3 year)

Eligibility
Key inclusion criteria
Inclusion criteria:

* 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.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Exclusion criteria:

* 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%
* 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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
16/06/2020
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
21/10/2033
Actual
Sample size
Target
Accrual to date
Final
337
Recruitment in Australia
Recruitment state(s)
NSW,VIC,WA
Recruitment hospital [1] 0 0
Investigational Site Number :0360008 - Liverpool
Recruitment hospital [2] 0 0
Investigational Site Number :0360005 - Waratah
Recruitment hospital [3] 0 0
Investigational Site Number :0360001 - Wollongong
Recruitment hospital [4] 0 0
Investigational Site Number :0360002 - Fitzroy
Recruitment hospital [5] 0 0
Investigational Site Number :0360007 - Heidelberg West
Recruitment hospital [6] 0 0
Investigational Site Number :0360004 - Richmond
Recruitment hospital [7] 0 0
Investigational Site Number :0360006 - Nedlands
Recruitment postcode(s) [1] 0 0
2170 - Liverpool
Recruitment postcode(s) [2] 0 0
2298 - Waratah
Recruitment postcode(s) [3] 0 0
2500 - Wollongong
Recruitment postcode(s) [4] 0 0
3065 - Fitzroy
Recruitment postcode(s) [5] 0 0
3081 - Heidelberg West
Recruitment postcode(s) [6] 0 0
3121 - Richmond
Recruitment postcode(s) [7] 0 0
6009 - Nedlands
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California
Country [2] 0 0
United States of America
State/province [2] 0 0
Colorado
Country [3] 0 0
United States of America
State/province [3] 0 0
Florida
Country [4] 0 0
United States of America
State/province [4] 0 0
Massachusetts
Country [5] 0 0
United States of America
State/province [5] 0 0
North Carolina
Country [6] 0 0
United States of America
State/province [6] 0 0
Tennessee
Country [7] 0 0
United States of America
State/province [7] 0 0
Texas
Country [8] 0 0
Brazil
State/province [8] 0 0
São Paulo
Country [9] 0 0
Canada
State/province [9] 0 0
Alberta
Country [10] 0 0
Canada
State/province [10] 0 0
New Brunswick
Country [11] 0 0
Canada
State/province [11] 0 0
Quebec
Country [12] 0 0
China
State/province [12] 0 0
Hangzhou
Country [13] 0 0
China
State/province [13] 0 0
Nanchang
Country [14] 0 0
China
State/province [14] 0 0
Shanghai
Country [15] 0 0
China
State/province [15] 0 0
Shenyang
Country [16] 0 0
China
State/province [16] 0 0
Tianjin
Country [17] 0 0
Czechia
State/province [17] 0 0
Brno
Country [18] 0 0
Czechia
State/province [18] 0 0
Hradec Kralove
Country [19] 0 0
Czechia
State/province [19] 0 0
Olomouc
Country [20] 0 0
Czechia
State/province [20] 0 0
Ostrava - Poruba
Country [21] 0 0
Czechia
State/province [21] 0 0
Praha 2
Country [22] 0 0
Denmark
State/province [22] 0 0
Aalborg
Country [23] 0 0
Denmark
State/province [23] 0 0
Aarhus N
Country [24] 0 0
Denmark
State/province [24] 0 0
Copenhagen
Country [25] 0 0
Denmark
State/province [25] 0 0
Roskilde
Country [26] 0 0
France
State/province [26] 0 0
Ars-Laquenexy
Country [27] 0 0
France
State/province [27] 0 0
Bayonne
Country [28] 0 0
France
State/province [28] 0 0
GRENOBLE Cedex 9
Country [29] 0 0
France
State/province [29] 0 0
La Roche sur Yon
Country [30] 0 0
France
State/province [30] 0 0
Lille
Country [31] 0 0
France
State/province [31] 0 0
Paris
Country [32] 0 0
France
State/province [32] 0 0
Poitiers Cedex
Country [33] 0 0
France
State/province [33] 0 0
RENNES Cedex 09
Country [34] 0 0
Germany
State/province [34] 0 0
Hamburg
Country [35] 0 0
Germany
State/province [35] 0 0
Heidelberg
Country [36] 0 0
Greece
State/province [36] 0 0
Athens
Country [37] 0 0
Greece
State/province [37] 0 0
Thessaloniki
Country [38] 0 0
Hungary
State/province [38] 0 0
Budapest
Country [39] 0 0
Hungary
State/province [39] 0 0
Debrecen
Country [40] 0 0
Hungary
State/province [40] 0 0
Kaposvár
Country [41] 0 0
Ireland
State/province [41] 0 0
Dublin
Country [42] 0 0
Israel
State/province [42] 0 0
Ashdod
Country [43] 0 0
Israel
State/province [43] 0 0
Jerusalem
Country [44] 0 0
Israel
State/province [44] 0 0
Petah-Tikva
Country [45] 0 0
Israel
State/province [45] 0 0
Ramat Gan
Country [46] 0 0
Israel
State/province [46] 0 0
Tel Aviv
Country [47] 0 0
Italy
State/province [47] 0 0
Forlì-Cesena
Country [48] 0 0
Italy
State/province [48] 0 0
Milano
Country [49] 0 0
Italy
State/province [49] 0 0
Ancona
Country [50] 0 0
Italy
State/province [50] 0 0
Bologna
Country [51] 0 0
Italy
State/province [51] 0 0
Terni
Country [52] 0 0
Japan
State/province [52] 0 0
Aichi
Country [53] 0 0
Japan
State/province [53] 0 0
Chiba
Country [54] 0 0
Japan
State/province [54] 0 0
Gunma
Country [55] 0 0
Japan
State/province [55] 0 0
Ibaraki
Country [56] 0 0
Japan
State/province [56] 0 0
Okayama
Country [57] 0 0
Japan
State/province [57] 0 0
Shizuoka
Country [58] 0 0
Japan
State/province [58] 0 0
Tokyo
Country [59] 0 0
Korea, Republic of
State/province [59] 0 0
Seoul-teukbyeolsi
Country [60] 0 0
Korea, Republic of
State/province [60] 0 0
Seoul
Country [61] 0 0
Lithuania
State/province [61] 0 0
Vilnius
Country [62] 0 0
New Zealand
State/province [62] 0 0
Canterbury
Country [63] 0 0
New Zealand
State/province [63] 0 0
Waikato
Country [64] 0 0
Norway
State/province [64] 0 0
Bergen
Country [65] 0 0
Norway
State/province [65] 0 0
Oslo
Country [66] 0 0
Poland
State/province [66] 0 0
Kujawsko-pomorskie
Country [67] 0 0
Poland
State/province [67] 0 0
Lódzkie
Country [68] 0 0
Poland
State/province [68] 0 0
Pomorskie
Country [69] 0 0
Poland
State/province [69] 0 0
Slaskie
Country [70] 0 0
Spain
State/province [70] 0 0
Barcelona [Barcelona]
Country [71] 0 0
Spain
State/province [71] 0 0
Navarra
Country [72] 0 0
Spain
State/province [72] 0 0
Valenciana, Comunidad
Country [73] 0 0
Spain
State/province [73] 0 0
Madrid
Country [74] 0 0
Spain
State/province [74] 0 0
Salamanca
Country [75] 0 0
Spain
State/province [75] 0 0
Zaragoza
Country [76] 0 0
Sweden
State/province [76] 0 0
Göteborg
Country [77] 0 0
Sweden
State/province [77] 0 0
Helsingborg
Country [78] 0 0
Turkey
State/province [78] 0 0
Ankara
Country [79] 0 0
Turkey
State/province [79] 0 0
Istanbul
Country [80] 0 0
Turkey
State/province [80] 0 0
Izmir
Country [81] 0 0
United Kingdom
State/province [81] 0 0
Hampshire
Country [82] 0 0
United Kingdom
State/province [82] 0 0
London, City Of
Country [83] 0 0
United Kingdom
State/province [83] 0 0
Leicester
Country [84] 0 0
United Kingdom
State/province [84] 0 0
Southampton

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Sanofi
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Clinical Sciences & Operations
Address 0 0
Sanofi
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
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
When will data be available (start and end dates)?
Available to whom?
Available for what types of analyses?
How or where can data be obtained?


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT04270409