Please note that the copy function is not enabled for this field.
If you wish to
modify
existing outcomes, please copy and paste the current outcome text into the Update field.
LOGIN
CREATE ACCOUNT
MY TRIALS
LOGIN
CREATE ACCOUNT
MY TRIALS
REGISTER TRIAL
FAQs
HINTS AND TIPS
DEFINITIONS
Register a trial
The ANZCTR website will be unavailable from 1pm until 3pm (AEDT) on Wednesday the 30th of October for website maintenance. Please be sure to log out of the system in order to avoid any loss of data.
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this
information for consumers
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
Query!
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)
Query!
Secondary ID [1]
0
0
U1111-1261-5846
Query!
Secondary ID [2]
0
0
EFC15951
Query!
Universal Trial Number (UTN)
Query!
Trial acronym
IRAKLIA
Query!
Linked study record
Query!
Health condition
Health condition(s) or problem(s) studied:
Plasma Cell Myeloma Recurrent
0
0
Query!
Condition category
Condition code
Cancer
0
0
0
0
Query!
Other cancer types
Query!
Intervention/exposure
Study type
Interventional
Query!
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
Query!
Intervention code [1]
0
0
Treatment: Drugs
Query!
Comparator / control treatment
Query!
Control group
Query!
Outcomes
Primary outcome [1]
0
0
Overall response rate (ORR)
Query!
Assessment method [1]
0
0
ORR defined as the proportion of participants with stringent complete response (sCR), complete response (CR), very good partial response (VGPR), and partial response (PR) according to the 2016 IMWG criteria assessed by Independent Review Committee (IRC).
Query!
Timepoint [1]
0
0
Up to approximately 2 years
Query!
Primary outcome [2]
0
0
Observed concentration before dosing (Cthrough) at steady state
Query!
Assessment method [2]
0
0
Observed Isatuximab plasma concentration
Query!
Timepoint [2]
0
0
Predose at Cycle 6 Day 1 (duration of each cycle is 28 days)
Query!
Secondary outcome [1]
0
0
Very Good Partial Response or better rate (VGPR)
Query!
Assessment method [1]
0
0
Very Good Partial Response or better rate defined as the proportion of participants with stringent complete response (sCR), complete response (CR) and very good partial response (VGPR) according to the 2016 International Myeloma Working Group (IMWG) criteria assessed by Independent Review Committee (IRC).
Query!
Timepoint [1]
0
0
Up to approximately 2 years
Query!
Secondary outcome [2]
0
0
Observed concentration before dosing (Ctrough)
Query!
Assessment method [2]
0
0
Observed Isatuximab plasma concentration
Query!
Timepoint [2]
0
0
At 4 weeks i.e., predose at Cycle 2 Day 1 (duration of each cycle is 28 days)
Query!
Secondary outcome [3]
0
0
Incidence rate of infusion-reactions
Query!
Assessment method [3]
0
0
Proportion of participants with infusion-reactions related events
Query!
Timepoint [3]
0
0
Up to approximately 4 years
Query!
Secondary outcome [4]
0
0
Percentage of participants satisfied or very satisfied with the injection method used to administer study medication
Query!
Assessment method [4]
0
0
Participant's satisfaction with isatuximab subcutaneous (SC) and intravenous (IV) will be assessed based on the Patient Experience and Satisfaction Questionnaires (PESQ) questionnaire.
Query!
Timepoint [4]
0
0
At Cycle 5 Day 15
Query!
Secondary outcome [5]
0
0
Duration of response (DOR)
Query!
Assessment method [5]
0
0
DOR, defined as the time from the date of the first confirmed response to the date of first occurrence of progressive disease (PD) as determined by IRC or death, whichever happens first. DOR is determined only for participants who have achieved a response (PR or better). In the absence of PD or death before the analysis cut-off date, the DOR will be censored at the date of the last valid disease assessment performed prior to initiation of a further anti-myeloma treatment or the analysis cut-off date, whichever is earlier. Participants with two or more consecutive missed assessments prior to PD or death will be censored at the last valid disease assessment.
Query!
Timepoint [5]
0
0
Up to approximately 2 years
Query!
Secondary outcome [6]
0
0
Time to first response (TT1R)
Query!
Assessment method [6]
0
0
TT1R, defined as the time from randomization to the date of first IRC determined response (PR or better) that is subsequently confirmed. Same censoring rule applies as in the DOR endpoint.
Query!
Timepoint [6]
0
0
Up to approximately 2 years
Query!
Secondary outcome [7]
0
0
Time to best response (TTBR)
Query!
Assessment method [7]
0
0
TTBR, defined as the time from randomization to the date of first occurrence of IRC determined best overall response (PR or better) that is subsequently confirmed. Same censoring rule applies as in the DOR endpoint
Query!
Timepoint [7]
0
0
Up to approximately 2 years
Query!
Secondary outcome [8]
0
0
Progression free survival (PFS)
Query!
Assessment method [8]
0
0
PFS, defined as the time from the date of randomization to the date of first documentation of progressive disease as determined by IRC or the date of death from any cause, whichever comes first. Responses will be determined according to IMWG criteria. Progression based on paraprotein will be confirmed based on two consecutive assessments. PFS will be censored at the date of the last valid disease assessment not showing disease progression performed prior to initiation of a further anti-myeloma treatment (if any) or the analysis cut-off date, whichever comes first. Participants with two or more consecutive missed assessments prior to PD or death will be censored at the last valid disease assessment.
Query!
Timepoint [8]
0
0
Up to approximately 4 years
Query!
Secondary outcome [9]
0
0
Overall survival (OS)
Query!
Assessment method [9]
0
0
OS, 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.
Query!
Timepoint [9]
0
0
Up to approximately 4 years
Query!
Secondary outcome [10]
0
0
Progression free survival 2 (PFS2)
Query!
Assessment method [10]
0
0
PFS2, 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.
Query!
Timepoint [10]
0
0
Up to approximately 4 years
Query!
Secondary outcome [11]
0
0
Number of participants with treatment-emergent adverse events (TEAEs)/serious adverse events (SAEs).
Query!
Assessment method [11]
0
0
Treatment-emergent adverse events (AEs) are defined as AEs that develop, worsen (according to the Investigator opinion), or become serious during the treatment period. The treatment period is defined as the time from first dose of study treatment up to 30 days after last dose of study treatment.
Query!
Timepoint [11]
0
0
Up to approximately 4 years
Query!
Secondary outcome [12]
0
0
Pharmacokinetic (PK) parameter
Query!
Assessment method [12]
0
0
Maximum plasma concentration (Cmax)
Query!
Timepoint [12]
0
0
Up to approximately 4 years
Query!
Secondary outcome [13]
0
0
PK parameter
Query!
Assessment method [13]
0
0
Area under the plasma concentration time curve over the dosing period (AUC)
Query!
Timepoint [13]
0
0
Up to approximately 4 years
Query!
Secondary outcome [14]
0
0
Successful injection rate
Query!
Assessment method [14]
0
0
Number of successful injections with (investigational) isatuximab injector device divided by total number of actual injections
Query!
Timepoint [14]
0
0
Up to approximately 4 years
Query!
Secondary outcome [15]
0
0
Percentage of participants with anti-drug antibodies (ADA) against isatuximab
Query!
Assessment method [15]
0
0
An ADA positive patient was defined as a subject either having treatment-induced ADA response (no positive ADA response at baseline and any positive response in the post baseline period, including the follow-up visit) or a treatment-boosted ADA response (a positive ADA response at baseline and a =4-fold increase in titer in the post baseline period including the follow-up visit).
Query!
Timepoint [15]
0
0
Up to approximately 4 years
Query!
Secondary outcome [16]
0
0
Participant expectation questionnaire-baseline (PEQ-BL) score
Query!
Assessment method [16]
0
0
PEQ-BL is designed to assess the expectations of the participants regarding both the treatment (side effects, worth taking) and the administration method (confidence, comfortability, pain, side effects, potential time-savings), as well as to understand previous treatment experience from the participant (experience with injection methods for oncology medication).
Query!
Timepoint [16]
0
0
Cycle 1 Day 1 ((duration of each cycle is 28 days)
Query!
Secondary outcome [17]
0
0
Patient experience and satisfaction questionnaire- follow up (PESQ-FU) score
Query!
Assessment method [17]
0
0
PESQ-FU, a 9-item questionnaire is designed to follow up on participant experience and satisfaction regarding the treatment (side effects, worth taking and overall satisfaction) and the administration method (confidence, comfortability, pain, side effects, potential time-savings and overall satisfaction).
Query!
Timepoint [17]
0
0
Up to approximately 4 years
Query!
Secondary outcome [18]
0
0
Patient experience and satisfaction questionnaire-end of treatment (PESQ-EOT) score
Query!
Assessment method [18]
0
0
PESQ-EOT, a 17-item questionnaire is designed to assess participant experience and satisfaction regarding the treatment (side effects, worth taking and overall satisfaction) and the administration method (confidence, comfortability, pain, side effects, potential time-savings and overall satisfaction). This questionnaire includes also additional items to assess participant preference on injection method (subcutaneous or intravenous) and location of administration (at home or at clinic).
Query!
Timepoint [18]
0
0
Up to approximately 4 years
Query!
Secondary outcome [19]
0
0
Patient's Assessment of Treatment (PAT) questionnaire score
Query!
Assessment method [19]
0
0
The PAT provides patient insights on the benefits and disadvantages of treatment, including an overall Benefit/Disadvantage ratio using a final question that provides a quantitative assessment of the patient's perceived B/D. The 4-item PAT is an internally developed non-disease specific and self-administered assessment. This questionnaire contains 4 items and take approximately 2-3 minutes to complete.
Query!
Timepoint [19]
0
0
Up to approximately 4 years
Query!
Secondary outcome [20]
0
0
Change from baseline in the Health Resource Utilization and Productivity Questionnaire (HRUPQ) scores
Query!
Assessment method [20]
0
0
Medical resource utilization and participant productivity will be collected from participants through the HRUPQ questionnaire. The questions include number, nature (emergency or routine) and duration of hospitalizations; emergency room visits and outpatient medical encounters; and employment history. The HRUPQ contains 46 items.
Query!
Timepoint [20]
0
0
Baseline; up to approximately 4 years
Query!
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
Query!
Assessment method [21]
0
0
EORTC QLQ-C30 is a cancer-specific questionnaire that contains 30 items and provides a multidimensional assessment of Health Related Quality of Life (HRQL).
Query!
Timepoint [21]
0
0
Baseline; up to approximately 4 years
Query!
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)
Query!
Assessment method [22]
0
0
EORTC QLQ-MY20, a 20-item questionnaire is used to assess symptoms and side effects due to the treatment or the disease which impact HRQL in participants with multiple myeloma.
Query!
Timepoint [22]
0
0
Baseline; up to approximately 4 years
Query!
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
Query!
Assessment method [23]
0
0
EQ-5D-5L questionnaire is a measure of health status that provides a simple, generic measure of health utility, and consists of 2 sections: descriptive and visual analogue scale (VAS). The descriptive system consists of 5 dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. The VAS records the respondent's self-rated health on a 20 cm vertical, VAS with endpoints labelled 'the best health you can imagine' and 'the worst health you can imagine.'
Query!
Timepoint [23]
0
0
Baseline; up to approximately 4 years
Query!
Secondary outcome [24]
0
0
Number of participants with chromosomal abnormalities
Query!
Assessment method [24]
0
0
Explore chromosomal abnormalities (mainly but not limited to t(4;14), t(14;16), del(17p), and 1q21+)
Query!
Timepoint [24]
0
0
Up to approximately 4 years
Query!
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)).
Query!
Minimum age
18
Years
Query!
Query!
Maximum age
No limit
Query!
Query!
Sex
Both males and females
Query!
Can healthy volunteers participate?
No
Query!
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.
Query!
Study design
Purpose of the study
Treatment
Query!
Allocation to intervention
Randomised controlled trial
Query!
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Query!
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Query!
Masking / blinding
Open (masking not used)
Query!
Who is / are masked / blinded?
Query!
Query!
Query!
Query!
Intervention assignment
Parallel
Query!
Other design features
Query!
Phase
Phase 3
Query!
Type of endpoint/s
Query!
Statistical methods / analysis
Query!
Recruitment
Recruitment status
Active, not recruiting
Query!
Data analysis
Query!
Reason for early stopping/withdrawal
Query!
Other reasons
Query!
Date of first participant enrolment
Anticipated
Query!
Actual
23/06/2022
Query!
Date of last participant enrolment
Anticipated
Query!
Actual
Query!
Date of last data collection
Anticipated
23/03/2027
Query!
Actual
Query!
Sample size
Target
534
Query!
Accrual to date
Query!
Final
Query!
Recruitment in Australia
Recruitment state(s)
NSW,SA,VIC
Query!
Recruitment hospital [1]
0
0
Investigational Site Number : 0360007 - Liverpool
Query!
Recruitment hospital [2]
0
0
Investigational Site Number : 0360004 - Waratah
Query!
Recruitment hospital [3]
0
0
Investigational Site Number : 0360003 - Wollongong
Query!
Recruitment hospital [4]
0
0
Investigational Site Number : 0360008 - Adelaide
Query!
Recruitment hospital [5]
0
0
Investigational Site Number : 0360009 - Fitzroy
Query!
Recruitment hospital [6]
0
0
Investigational Site Number : 0360006 - Melbourne
Query!
Recruitment hospital [7]
0
0
Investigational Site Number : 0360001 - Richmond
Query!
Recruitment postcode(s) [1]
0
0
2170 - Liverpool
Query!
Recruitment postcode(s) [2]
0
0
2298 - Waratah
Query!
Recruitment postcode(s) [3]
0
0
2500 - Wollongong
Query!
Recruitment postcode(s) [4]
0
0
5000 - Adelaide
Query!
Recruitment postcode(s) [5]
0
0
3065 - Fitzroy
Query!
Recruitment postcode(s) [6]
0
0
3004 - Melbourne
Query!
Recruitment postcode(s) [7]
0
0
3121 - Richmond
Query!
Recruitment outside Australia
Country [1]
0
0
United States of America
Query!
State/province [1]
0
0
Arizona
Query!
Country [2]
0
0
United States of America
Query!
State/province [2]
0
0
Colorado
Query!
Country [3]
0
0
United States of America
Query!
State/province [3]
0
0
Florida
Query!
Country [4]
0
0
United States of America
Query!
State/province [4]
0
0
Maryland
Query!
Country [5]
0
0
United States of America
Query!
State/province [5]
0
0
Mississippi
Query!
Country [6]
0
0
United States of America
Query!
State/province [6]
0
0
Nevada
Query!
Country [7]
0
0
United States of America
Query!
State/province [7]
0
0
New Jersey
Query!
Country [8]
0
0
United States of America
Query!
State/province [8]
0
0
New York
Query!
Country [9]
0
0
United States of America
Query!
State/province [9]
0
0
North Carolina
Query!
Country [10]
0
0
United States of America
Query!
State/province [10]
0
0
Ohio
Query!
Country [11]
0
0
United States of America
Query!
State/province [11]
0
0
Oregon
Query!
Country [12]
0
0
United States of America
Query!
State/province [12]
0
0
Pennsylvania
Query!
Country [13]
0
0
United States of America
Query!
State/province [13]
0
0
South Carolina
Query!
Country [14]
0
0
United States of America
Query!
State/province [14]
0
0
Texas
Query!
Country [15]
0
0
United States of America
Query!
State/province [15]
0
0
Utah
Query!
Country [16]
0
0
United States of America
Query!
State/province [16]
0
0
Wisconsin
Query!
Country [17]
0
0
Argentina
Query!
State/province [17]
0
0
Buenos Aires
Query!
Country [18]
0
0
Argentina
Query!
State/province [18]
0
0
Ciudad De Buenos Aires
Query!
Country [19]
0
0
Argentina
Query!
State/province [19]
0
0
Córdoba
Query!
Country [20]
0
0
Argentina
Query!
State/province [20]
0
0
Mendoza
Query!
Country [21]
0
0
Brazil
Query!
State/province [21]
0
0
Ceará
Query!
Country [22]
0
0
Brazil
Query!
State/province [22]
0
0
Pernambuco
Query!
Country [23]
0
0
Brazil
Query!
State/province [23]
0
0
Rio De Janeiro
Query!
Country [24]
0
0
Brazil
Query!
State/province [24]
0
0
Rio Grande Do Sul
Query!
Country [25]
0
0
Brazil
Query!
State/province [25]
0
0
São Paulo
Query!
Country [26]
0
0
Canada
Query!
State/province [26]
0
0
Ontario
Query!
Country [27]
0
0
Canada
Query!
State/province [27]
0
0
Quebec
Query!
Country [28]
0
0
Chile
Query!
State/province [28]
0
0
Reg Metropolitana De Santiago
Query!
Country [29]
0
0
Chile
Query!
State/province [29]
0
0
Valparaíso
Query!
Country [30]
0
0
Chile
Query!
State/province [30]
0
0
Santiago
Query!
Country [31]
0
0
Chile
Query!
State/province [31]
0
0
Temuco
Query!
Country [32]
0
0
China
Query!
State/province [32]
0
0
Beijing
Query!
Country [33]
0
0
China
Query!
State/province [33]
0
0
Changsha
Query!
Country [34]
0
0
China
Query!
State/province [34]
0
0
Guangzhou
Query!
Country [35]
0
0
China
Query!
State/province [35]
0
0
Hangzhou
Query!
Country [36]
0
0
China
Query!
State/province [36]
0
0
Nanchang
Query!
Country [37]
0
0
China
Query!
State/province [37]
0
0
Nanning
Query!
Country [38]
0
0
China
Query!
State/province [38]
0
0
Qingdao
Query!
Country [39]
0
0
China
Query!
State/province [39]
0
0
Shanghai
Query!
Country [40]
0
0
China
Query!
State/province [40]
0
0
Shenyang
Query!
Country [41]
0
0
China
Query!
State/province [41]
0
0
Shenzhen
Query!
Country [42]
0
0
China
Query!
State/province [42]
0
0
Tianjin
Query!
Country [43]
0
0
China
Query!
State/province [43]
0
0
Wuhan
Query!
Country [44]
0
0
China
Query!
State/province [44]
0
0
Zhengzhou
Query!
Country [45]
0
0
Czechia
Query!
State/province [45]
0
0
Brno
Query!
Country [46]
0
0
Czechia
Query!
State/province [46]
0
0
Olomouc
Query!
Country [47]
0
0
Czechia
Query!
State/province [47]
0
0
Ostrava - Poruba
Query!
Country [48]
0
0
Czechia
Query!
State/province [48]
0
0
Praha 2
Query!
Country [49]
0
0
France
Query!
State/province [49]
0
0
Lyon
Query!
Country [50]
0
0
France
Query!
State/province [50]
0
0
Nantes
Query!
Country [51]
0
0
France
Query!
State/province [51]
0
0
Paris
Query!
Country [52]
0
0
France
Query!
State/province [52]
0
0
Perigueux
Query!
Country [53]
0
0
France
Query!
State/province [53]
0
0
Pierre Benite
Query!
Country [54]
0
0
France
Query!
State/province [54]
0
0
Poitiers
Query!
Country [55]
0
0
France
Query!
State/province [55]
0
0
Saint-Etienne Cedex 2
Query!
Country [56]
0
0
France
Query!
State/province [56]
0
0
TOULOUSE Cedex 9
Query!
Country [57]
0
0
France
Query!
State/province [57]
0
0
Tours
Query!
Country [58]
0
0
Germany
Query!
State/province [58]
0
0
Dresden
Query!
Country [59]
0
0
Germany
Query!
State/province [59]
0
0
Hamburg
Query!
Country [60]
0
0
Germany
Query!
State/province [60]
0
0
Heidelberg
Query!
Country [61]
0
0
Germany
Query!
State/province [61]
0
0
Lübeck
Query!
Country [62]
0
0
Germany
Query!
State/province [62]
0
0
Nürnberg
Query!
Country [63]
0
0
Greece
Query!
State/province [63]
0
0
Athens
Query!
Country [64]
0
0
Greece
Query!
State/province [64]
0
0
Ioannina
Query!
Country [65]
0
0
Greece
Query!
State/province [65]
0
0
Patra
Query!
Country [66]
0
0
Greece
Query!
State/province [66]
0
0
Thessaloniki
Query!
Country [67]
0
0
Hungary
Query!
State/province [67]
0
0
Budapest
Query!
Country [68]
0
0
Hungary
Query!
State/province [68]
0
0
Kaposvár
Query!
Country [69]
0
0
Hungary
Query!
State/province [69]
0
0
Pécs
Query!
Country [70]
0
0
Hungary
Query!
State/province [70]
0
0
Szekesfehervar
Query!
Country [71]
0
0
Hungary
Query!
State/province [71]
0
0
Szombathely
Query!
Country [72]
0
0
Italy
Query!
State/province [72]
0
0
Forlì-Cesena
Query!
Country [73]
0
0
Italy
Query!
State/province [73]
0
0
Lazio
Query!
Country [74]
0
0
Italy
Query!
State/province [74]
0
0
Ancona
Query!
Country [75]
0
0
Italy
Query!
State/province [75]
0
0
Bologna
Query!
Country [76]
0
0
Italy
Query!
State/province [76]
0
0
Brescia
Query!
Country [77]
0
0
Italy
Query!
State/province [77]
0
0
Napoli
Query!
Country [78]
0
0
Italy
Query!
State/province [78]
0
0
Palermo
Query!
Country [79]
0
0
Italy
Query!
State/province [79]
0
0
Pavia
Query!
Country [80]
0
0
Japan
Query!
State/province [80]
0
0
Aichi
Query!
Country [81]
0
0
Japan
Query!
State/province [81]
0
0
Chiba
Query!
Country [82]
0
0
Japan
Query!
State/province [82]
0
0
Ibaraki
Query!
Country [83]
0
0
Japan
Query!
State/province [83]
0
0
Iwate
Query!
Country [84]
0
0
Japan
Query!
State/province [84]
0
0
Kanagawa
Query!
Country [85]
0
0
Japan
Query!
State/province [85]
0
0
Kyoto
Query!
Country [86]
0
0
Japan
Query!
State/province [86]
0
0
Miyagi
Query!
Country [87]
0
0
Japan
Query!
State/province [87]
0
0
Okayama
Query!
Country [88]
0
0
Japan
Query!
State/province [88]
0
0
Osaka
Query!
Country [89]
0
0
Japan
Query!
State/province [89]
0
0
Shizuoka
Query!
Country [90]
0
0
Japan
Query!
State/province [90]
0
0
Tokyo
Query!
Country [91]
0
0
Japan
Query!
State/province [91]
0
0
Yamagata-shi
Query!
Country [92]
0
0
Norway
Query!
State/province [92]
0
0
Oslo
Query!
Country [93]
0
0
Norway
Query!
State/province [93]
0
0
Ålesund
Query!
Country [94]
0
0
Poland
Query!
State/province [94]
0
0
Dolnoslaskie
Query!
Country [95]
0
0
Poland
Query!
State/province [95]
0
0
Malopolskie
Query!
Country [96]
0
0
Poland
Query!
State/province [96]
0
0
Lublin
Query!
Country [97]
0
0
Poland
Query!
State/province [97]
0
0
Wroclaw
Query!
Country [98]
0
0
Spain
Query!
State/province [98]
0
0
Cantabria
Query!
Country [99]
0
0
Spain
Query!
State/province [99]
0
0
Catalunya [Cataluña]
Query!
Country [100]
0
0
Spain
Query!
State/province [100]
0
0
Madrid, Comunidad De
Query!
Country [101]
0
0
Spain
Query!
State/province [101]
0
0
Navarra
Query!
Country [102]
0
0
Spain
Query!
State/province [102]
0
0
Madrid
Query!
Country [103]
0
0
Spain
Query!
State/province [103]
0
0
Murcia
Query!
Country [104]
0
0
Spain
Query!
State/province [104]
0
0
Salamanca
Query!
Country [105]
0
0
Sweden
Query!
State/province [105]
0
0
Borås
Query!
Country [106]
0
0
Sweden
Query!
State/province [106]
0
0
Stockholm
Query!
Country [107]
0
0
Taiwan
Query!
State/province [107]
0
0
Kaohsiung
Query!
Country [108]
0
0
Taiwan
Query!
State/province [108]
0
0
Tainan
Query!
Country [109]
0
0
Taiwan
Query!
State/province [109]
0
0
Taipei
Query!
Country [110]
0
0
Turkey
Query!
State/province [110]
0
0
Ankara
Query!
Country [111]
0
0
Turkey
Query!
State/province [111]
0
0
Bornova
Query!
Country [112]
0
0
Turkey
Query!
State/province [112]
0
0
Istanbul
Query!
Country [113]
0
0
United Kingdom
Query!
State/province [113]
0
0
Leicestershire
Query!
Country [114]
0
0
United Kingdom
Query!
State/province [114]
0
0
London, City Of
Query!
Country [115]
0
0
United Kingdom
Query!
State/province [115]
0
0
Norfolk
Query!
Country [116]
0
0
United Kingdom
Query!
State/province [116]
0
0
Birmingham
Query!
Country [117]
0
0
United Kingdom
Query!
State/province [117]
0
0
Derby
Query!
Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Query!
Name
Sanofi
Query!
Address
Query!
Country
Query!
Ethics approval
Ethics application status
Query!
Summary
Brief summary
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.
Query!
Trial website
https://clinicaltrials.gov/study/NCT05405166
Query!
Trial related presentations / publications
Query!
Public notes
Query!
Contacts
Principal investigator
Name
0
0
Clinical Sciences & Operations
Query!
Address
0
0
Sanofi
Query!
Country
0
0
Query!
Phone
0
0
Query!
Fax
0
0
Query!
Email
0
0
Query!
Contact person for public queries
Name
0
0
Trial Transparency email recommended (Toll free for US & Canada)
Query!
Address
0
0
Query!
Country
0
0
Query!
Phone
0
0
800-633-1610
Query!
Fax
0
0
Query!
Email
0
0
[email protected]
Query!
Contact person for scientific queries
Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
Query!
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.
Query!
When will data be available (start and end dates)?
Query!
Available to whom?
Query!
Available for what types of analyses?
Query!
How or where can data be obtained?
Query!
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