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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT05405166




Registration number
NCT05405166
Ethics application status
Date submitted
31/05/2022
Date registered
6/06/2022

Titles & IDs
Public title
SC Versus IV Isatuximab in Combination With Pomalidomide and Dexamethasone in RRMM
Scientific title
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)
Secondary ID [1] 0 0
U1111-1261-5846
Secondary ID [2] 0 0
EFC15951
Universal Trial Number (UTN)
Trial acronym
IRAKLIA
Linked study record

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

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Isatuximab IV
Treatment: Drugs - Isatuximab SC
Treatment: Drugs - Dexamethasone
Treatment: Drugs - Pomalidomide
Treatment: Drugs - Dexamethasone
Treatment: Drugs - Montelukast
Treatment: Drugs - Paracetamol / Acetaminophen
Treatment: Drugs - Diphenhydramine
Treatment: Drugs - Methylprednisolone

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.

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.


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

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

Treatment: Drugs: Dexamethasone
Pharmaceutical form: Tablet; Route of administration: Oral

Treatment: Drugs: Pomalidomide
Pharmaceutical form: hard capsules; Route of administration: Oral

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

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

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

Treatment: Drugs: 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

Treatment: Drugs: Methylprednisolone
Pharmaceutical form: As per local commercial product; Route of administration: As premedication-IV; for management of infusion reactions- IV (or oral equivalent); AxMP i.e., background treatment and rescue medication (in case of infusion reactions); ATC code: H02AB04
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Overall response rate (ORR)
Timepoint [1] 0 0
Up to approximately 2 years
Primary outcome [2] 0 0
Observed concentration before dosing (Cthrough) at steady state
Timepoint [2] 0 0
Predose at Cycle 6 Day 1 (duration of each cycle is 28 days)
Secondary outcome [1] 0 0
Very Good Partial Response or better rate (VGPR)
Timepoint [1] 0 0
Up to approximately 2 years
Secondary outcome [2] 0 0
Observed concentration before dosing (Ctrough)
Timepoint [2] 0 0
At 4 weeks i.e., predose at Cycle 2 Day 1 (duration of each cycle is 28 days)
Secondary outcome [3] 0 0
Incidence rate of infusion-reactions
Timepoint [3] 0 0
Up to approximately 4 years
Secondary outcome [4] 0 0
Percentage of participants satisfied or very satisfied with the injection method used to administer study medication
Timepoint [4] 0 0
At Cycle 5 Day 15
Secondary outcome [5] 0 0
Duration of response (DOR)
Timepoint [5] 0 0
Up to approximately 2 years
Secondary outcome [6] 0 0
Time to first response (TT1R)
Timepoint [6] 0 0
Up to approximately 2 years
Secondary outcome [7] 0 0
Time to best response (TTBR)
Timepoint [7] 0 0
Up to approximately 2 years
Secondary outcome [8] 0 0
Progression free survival (PFS)
Timepoint [8] 0 0
Up to approximately 4 years
Secondary outcome [9] 0 0
Overall survival (OS)
Timepoint [9] 0 0
Up to approximately 4 years
Secondary outcome [10] 0 0
Progression free survival 2 (PFS2)
Timepoint [10] 0 0
Up to approximately 4 years
Secondary outcome [11] 0 0
Number of participants with treatment-emergent adverse events (TEAEs)/serious adverse events (SAEs).
Timepoint [11] 0 0
Up to approximately 4 years
Secondary outcome [12] 0 0
Pharmacokinetic (PK) parameter
Timepoint [12] 0 0
Up to approximately 4 years
Secondary outcome [13] 0 0
PK parameter
Timepoint [13] 0 0
Up to approximately 4 years
Secondary outcome [14] 0 0
Successful injection rate
Timepoint [14] 0 0
Up to approximately 4 years
Secondary outcome [15] 0 0
Percentage of participants with anti-drug antibodies (ADA) against isatuximab
Timepoint [15] 0 0
Up to approximately 4 years
Secondary outcome [16] 0 0
Participant expectation questionnaire-baseline (PEQ-BL) score
Timepoint [16] 0 0
Cycle 1 Day 1 ((duration of each cycle is 28 days)
Secondary outcome [17] 0 0
Patient experience and satisfaction questionnaire- follow up (PESQ-FU) score
Timepoint [17] 0 0
Up to approximately 4 years
Secondary outcome [18] 0 0
Patient experience and satisfaction questionnaire-end of treatment (PESQ-EOT) score
Timepoint [18] 0 0
Up to approximately 4 years
Secondary outcome [19] 0 0
Patient's Assessment of Treatment (PAT) questionnaire score
Timepoint [19] 0 0
Up to approximately 4 years
Secondary outcome [20] 0 0
Change from baseline in the Health Resource Utilization and Productivity Questionnaire (HRUPQ) scores
Timepoint [20] 0 0
Baseline; up to approximately 4 years
Secondary outcome [21] 0 0
Change from baseline in European Organization for Research and Treatment of Cancer core quality of life questionnaire (EORTC QLQ-C30) score
Timepoint [21] 0 0
Baseline; up to approximately 4 years
Secondary outcome [22] 0 0
Change from baseline in European Organization for Research and Treatment of Cancer quality of life myeloma module (EORTC QLQ-MY20)
Timepoint [22] 0 0
Baseline; up to approximately 4 years
Secondary outcome [23] 0 0
Change from baseline in the European Quality of Life Group questionnaire with 5 dimensions and 5 levels per dimension (EQ-5D-5L) scores
Timepoint [23] 0 0
Baseline; up to approximately 4 years
Secondary outcome [24] 0 0
Number of participants with chromosomal abnormalities
Timepoint [24] 0 0
Up to approximately 4 years

Eligibility
Key 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)).
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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 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
23/06/2022
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
23/03/2027
Actual
Sample size
Target
Accrual to date
Final
531
Recruitment in Australia
Recruitment state(s)
NSW,SA,VIC
Recruitment hospital [1] 0 0
Investigational Site Number : 0360007 - Liverpool
Recruitment hospital [2] 0 0
Investigational Site Number : 0360004 - Waratah
Recruitment hospital [3] 0 0
Investigational Site Number : 0360003 - Wollongong
Recruitment hospital [4] 0 0
Investigational Site Number : 0360008 - Adelaide
Recruitment hospital [5] 0 0
Investigational Site Number : 0360009 - Fitzroy
Recruitment hospital [6] 0 0
Investigational Site Number : 0360006 - Melbourne
Recruitment hospital [7] 0 0
Investigational Site Number : 0360001 - Richmond
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
5000 - Adelaide
Recruitment postcode(s) [5] 0 0
3065 - Fitzroy
Recruitment postcode(s) [6] 0 0
3004 - Melbourne
Recruitment postcode(s) [7] 0 0
3121 - Richmond
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Arizona
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
Maryland
Country [5] 0 0
United States of America
State/province [5] 0 0
Mississippi
Country [6] 0 0
United States of America
State/province [6] 0 0
Nevada
Country [7] 0 0
United States of America
State/province [7] 0 0
New Jersey
Country [8] 0 0
United States of America
State/province [8] 0 0
New York
Country [9] 0 0
United States of America
State/province [9] 0 0
North Carolina
Country [10] 0 0
United States of America
State/province [10] 0 0
Ohio
Country [11] 0 0
United States of America
State/province [11] 0 0
Oregon
Country [12] 0 0
United States of America
State/province [12] 0 0
Pennsylvania
Country [13] 0 0
United States of America
State/province [13] 0 0
South Carolina
Country [14] 0 0
United States of America
State/province [14] 0 0
Texas
Country [15] 0 0
United States of America
State/province [15] 0 0
Utah
Country [16] 0 0
United States of America
State/province [16] 0 0
Wisconsin
Country [17] 0 0
Argentina
State/province [17] 0 0
Buenos Aires
Country [18] 0 0
Argentina
State/province [18] 0 0
Ciudad De Buenos Aires
Country [19] 0 0
Argentina
State/province [19] 0 0
Córdoba
Country [20] 0 0
Argentina
State/province [20] 0 0
Mendoza
Country [21] 0 0
Brazil
State/province [21] 0 0
Ceará
Country [22] 0 0
Brazil
State/province [22] 0 0
Pernambuco
Country [23] 0 0
Brazil
State/province [23] 0 0
Rio De Janeiro
Country [24] 0 0
Brazil
State/province [24] 0 0
Rio Grande Do Sul
Country [25] 0 0
Brazil
State/province [25] 0 0
São Paulo
Country [26] 0 0
Canada
State/province [26] 0 0
Ontario
Country [27] 0 0
Canada
State/province [27] 0 0
Quebec
Country [28] 0 0
Chile
State/province [28] 0 0
Reg Metropolitana De Santiago
Country [29] 0 0
Chile
State/province [29] 0 0
Valparaíso
Country [30] 0 0
Chile
State/province [30] 0 0
Santiago
Country [31] 0 0
Chile
State/province [31] 0 0
Temuco
Country [32] 0 0
China
State/province [32] 0 0
Beijing
Country [33] 0 0
China
State/province [33] 0 0
Changsha
Country [34] 0 0
China
State/province [34] 0 0
Guangzhou
Country [35] 0 0
China
State/province [35] 0 0
Hangzhou
Country [36] 0 0
China
State/province [36] 0 0
Nanchang
Country [37] 0 0
China
State/province [37] 0 0
Nanning
Country [38] 0 0
China
State/province [38] 0 0
Qingdao
Country [39] 0 0
China
State/province [39] 0 0
Shenyang
Country [40] 0 0
China
State/province [40] 0 0
Tianjin
Country [41] 0 0
China
State/province [41] 0 0
Wuhan
Country [42] 0 0
China
State/province [42] 0 0
Zhengzhou
Country [43] 0 0
Czechia
State/province [43] 0 0
Brno
Country [44] 0 0
Czechia
State/province [44] 0 0
Olomouc
Country [45] 0 0
Czechia
State/province [45] 0 0
Ostrava - Poruba
Country [46] 0 0
Czechia
State/province [46] 0 0
Praha 2
Country [47] 0 0
France
State/province [47] 0 0
Nantes
Country [48] 0 0
France
State/province [48] 0 0
Paris
Country [49] 0 0
France
State/province [49] 0 0
Perigueux
Country [50] 0 0
France
State/province [50] 0 0
Poitiers
Country [51] 0 0
France
State/province [51] 0 0
Saint-Etienne Cedex 2
Country [52] 0 0
France
State/province [52] 0 0
TOULOUSE Cedex 9
Country [53] 0 0
France
State/province [53] 0 0
Tours
Country [54] 0 0
Germany
State/province [54] 0 0
Dresden
Country [55] 0 0
Germany
State/province [55] 0 0
Hamburg
Country [56] 0 0
Germany
State/province [56] 0 0
Heidelberg
Country [57] 0 0
Germany
State/province [57] 0 0
Lübeck
Country [58] 0 0
Germany
State/province [58] 0 0
Nürnberg
Country [59] 0 0
Greece
State/province [59] 0 0
Athens
Country [60] 0 0
Greece
State/province [60] 0 0
Ioannina
Country [61] 0 0
Greece
State/province [61] 0 0
Patra
Country [62] 0 0
Greece
State/province [62] 0 0
Thessaloniki
Country [63] 0 0
Hungary
State/province [63] 0 0
Budapest
Country [64] 0 0
Hungary
State/province [64] 0 0
Kaposvár
Country [65] 0 0
Hungary
State/province [65] 0 0
Pécs
Country [66] 0 0
Hungary
State/province [66] 0 0
Szekesfehervar
Country [67] 0 0
Hungary
State/province [67] 0 0
Szombathely
Country [68] 0 0
Italy
State/province [68] 0 0
Forlì-Cesena
Country [69] 0 0
Italy
State/province [69] 0 0
Roma
Country [70] 0 0
Italy
State/province [70] 0 0
Ancona
Country [71] 0 0
Italy
State/province [71] 0 0
Bologna
Country [72] 0 0
Italy
State/province [72] 0 0
Brescia
Country [73] 0 0
Italy
State/province [73] 0 0
Napoli
Country [74] 0 0
Italy
State/province [74] 0 0
Palermo
Country [75] 0 0
Italy
State/province [75] 0 0
Pavia
Country [76] 0 0
Japan
State/province [76] 0 0
Aichi
Country [77] 0 0
Japan
State/province [77] 0 0
Chiba
Country [78] 0 0
Japan
State/province [78] 0 0
Ibaraki
Country [79] 0 0
Japan
State/province [79] 0 0
Iwate
Country [80] 0 0
Japan
State/province [80] 0 0
Kanagawa
Country [81] 0 0
Japan
State/province [81] 0 0
Kyoto
Country [82] 0 0
Japan
State/province [82] 0 0
Miyagi
Country [83] 0 0
Japan
State/province [83] 0 0
Okayama
Country [84] 0 0
Japan
State/province [84] 0 0
Osaka
Country [85] 0 0
Japan
State/province [85] 0 0
Shizuoka
Country [86] 0 0
Japan
State/province [86] 0 0
Tokyo
Country [87] 0 0
Japan
State/province [87] 0 0
Yamagata-shi
Country [88] 0 0
Norway
State/province [88] 0 0
Oslo
Country [89] 0 0
Norway
State/province [89] 0 0
Ålesund
Country [90] 0 0
Poland
State/province [90] 0 0
Dolnoslaskie
Country [91] 0 0
Poland
State/province [91] 0 0
Malopolskie
Country [92] 0 0
Poland
State/province [92] 0 0
Lublin
Country [93] 0 0
Spain
State/province [93] 0 0
Cantabria
Country [94] 0 0
Spain
State/province [94] 0 0
Catalunya [Cataluña]
Country [95] 0 0
Spain
State/province [95] 0 0
Madrid, Comunidad De
Country [96] 0 0
Spain
State/province [96] 0 0
Navarra
Country [97] 0 0
Spain
State/province [97] 0 0
Madrid
Country [98] 0 0
Spain
State/province [98] 0 0
Murcia
Country [99] 0 0
Spain
State/province [99] 0 0
Salamanca
Country [100] 0 0
Sweden
State/province [100] 0 0
Borås
Country [101] 0 0
Sweden
State/province [101] 0 0
Stockholm
Country [102] 0 0
Taiwan
State/province [102] 0 0
Kaohsiung
Country [103] 0 0
Taiwan
State/province [103] 0 0
Tainan
Country [104] 0 0
Taiwan
State/province [104] 0 0
Taipei
Country [105] 0 0
Turkey
State/province [105] 0 0
Ankara
Country [106] 0 0
Turkey
State/province [106] 0 0
Bornova
Country [107] 0 0
Turkey
State/province [107] 0 0
Istanbul
Country [108] 0 0
United Kingdom
State/province [108] 0 0
Leicestershire
Country [109] 0 0
United Kingdom
State/province [109] 0 0
London, City Of
Country [110] 0 0
United Kingdom
State/province [110] 0 0
Norfolk
Country [111] 0 0
United Kingdom
State/province [111] 0 0
Birmingham
Country [112] 0 0
United Kingdom
State/province [112] 0 0
Derby

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
Trial Transparency email recommended (Toll free for US & Canada)
Address 0 0
Country 0 0
Phone 0 0
800-633-1610
Fax 0 0
Email 0 0
Contact-US@sanofi.com
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/NCT05405166