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Investigational Site Number : 2760006 23538 Lübeck (Schleswig-Holstein) GermanyRekrutierend» Google-MapsInvestigational Site Number : 2760007 90419 Nürnberg (Bayern) GermanyRekrutierend» Google-MapsMohtaseb Cancer Center and Blood Disorders Site Number : 8400028 86442 Bullhead City United StatesRekrutierend» Google-MapsArizona Oncology Associates, PC - HAL Site Number : 8400015 86314 Prescott Valley United StatesRekrutierend» Google-MapsRocky Mountain Cancer Centers, LLP Site Number : 8400021 80012 Aurora United StatesRekrutierend» Google-MapsMayo Clinic Site Number : 8400008 32224 Jacksonville United StatesRekrutierend» Google-MapsBRCR Medical Center Inc Site Number : 8400030 33322 Plantation United StatesRekrutierend» Google-MapsCentre for Cancer and Blood Disorders Site Number : 8400026 20817 Bethesda United StatesRekrutierend» Google-MapsHattiesburg Clinic Site Number : 8400006 39401 Hattiesburg United StatesRekrutierend» Google-MapsComprehensive Cancer Centers of Nevada Site Number : 8400019 89169 Las Vegas United StatesRekrutierend» Google-MapsAtlantic Health System Site Number : 8400005 07960 Morristown United StatesRekrutierend» Google-MapsNew York Oncology Hematology, P.C. Site Number : 8400017 12206 Albany United StatesRekrutierend» Google-MapsNovant Health Site Number : 8400014 28207 Charlotte United StatesRekrutierend» Google-MapsNovant Health Forsyth Medical Center Site Number : 8400114 27103 Winston-Salem United StatesRekrutierend» Google-MapsGabrail Cancer Center Site Number : 8400027 44718 Canton United StatesRekrutierend» Google-MapsOncology_Hematology Care Clinical Trials, LLC Site Number : 8400016 45236 Cincinnati United StatesRekrutierend» Google-MapsOncology Associates Of Oregon, P.C. Site Number : 8400018 97401 Eugene United StatesRekrutierend» Google-MapsSpoknwrd Clinical Trials Inc. Site Number : 8400023 18045 Easton United StatesRekrutierend» Google-MapsGibbs Cancer Center-Spartanburg Medical Center Site Number : 8400002 29303 Spartanburg United StatesRekrutierend» Google-MapsTexas Oncology Baylor Sammons Site Number : 8400022 75246 Dallas United StatesRekrutierend» Google-MapsLumi Research Site Number : 8400029 77339 Kingwood United StatesRekrutierend» Google-MapsTexas Oncology - San Antonio Site Number : 8400020 78240 San Antonio United StatesRekrutierend» Google-MapsGeorge E. Wahlen Salt Lake City VA Medical Center Site Number : 8400011 84148 Salt Lake City United StatesRekrutierend» Google-MapsUW Cancer Center at ProHealth Care Site Number : 8400001 53188 Waukesha United StatesRekrutierend» Google-MapsInvestigational Site Number : 0320007 1280 Caba ArgentinaRekrutierend» Google-MapsInvestigational Site Number : 0320001 1430 Caba ArgentinaRekrutierend» Google-MapsInvestigational Site Number : 0320002 C1181ACH Ciudad Autonoma de Buenos Aires ArgentinaRekrutierend» Google-MapsInvestigational Site Number : 0320006 1900 La Plata ArgentinaRekrutierend» Google-MapsInvestigational Site Number : 0320003 1417 Caba ArgentinaRekrutierend» Google-MapsInvestigational Site Number : 0320008 C1180 Caba ArgentinaRekrutierend» Google-MapsInvestigational Site Number : 0320005 C1425ASG Caba ArgentinaRekrutierend» Google-MapsInvestigational Site Number : 0320010 X5008HHW Cordoba ArgentinaRekrutierend» Google-MapsInvestigational Site Number : 0320004 1426ANZ Buenos Aires ArgentinaRekrutierend» Google-MapsInvestigational Site Number : 0320009 M5501 Mendoza ArgentinaRekrutierend» Google-MapsInvestigational Site Number : 0360007 2170 Liverpool AustraliaRekrutierend» Google-MapsInvestigational Site Number : 0360004 2298 Waratah AustraliaRekrutierend» Google-MapsInvestigational Site Number : 0360003 2500 Wollongong AustraliaRekrutierend» Google-MapsInvestigational Site Number : 0360008 5000 Adelaide AustraliaRekrutierend» Google-MapsInvestigational Site Number : 0360009 3065 Fitzroy AustraliaRekrutierend» Google-MapsInvestigational Site Number : 0360006 3004 Melbourne AustraliaRekrutierend» Google-MapsInvestigational Site Number : 0360001 3121 Richmond AustraliaRekrutierend» Google-MapsNOHC - Nucleo de Oncologia e Hematologia do Ceara Site Number : 0760006 60115-281 Fortaleza BrazilRekrutierend» Google-MapsOC ONCOCLINICAS MULTIHEMO ILHA DO LEITE Site Number : 0760007 50070-460 Recife BrazilRekrutierend» Google-MapsCHN - Complexo Hospitalar de Niteroi Site Number : 0760008 24020-096 Niteroi BrazilRekrutierend» Google-MapsHospital Mae de Deus Site Number : 0760003 90110-270 Porto Alegre BrazilRekrutierend» Google-MapsA Beneficencia Portuguesa de Sao Paulo - Hospital Beneficencia Portuguesa - BP Mirante Site Number : 0760002 01321-001 Sao Paulo BrazilRekrutierend» Google-MapsClínica São Germano Site Number : 0760001 04537-081 Sao Paulo BrazilRekrutierend» Google-MapsInstituto COI de Educacao e Pesquisa Site Number : 0760004 22775-002 Rio De Janeiro BrazilRekrutierend» Google-MapsInvestigational Site Number : 1240001 M5G 2M9 Toronto CanadaRekrutierend» Google-MapsInvestigational Site Number : 1240004 J4V 2H1 Greenfield Park CanadaRekrutierend» Google-MapsInvestigational Site Number : 1240003 H1T 2M4 Montreal CanadaRekrutierend» Google-MapsInvestigational Site Number : 1520002 7500653 Santiago ChileRekrutierend» Google-MapsInvestigational Site Number : 1520003 7500921 Santiago ChileRekrutierend» Google-MapsInvestigational Site Number : 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: 1560017 200092 Shanghai ChinaRekrutierend» Google-MapsInvestigational Site Number : 1560013 110022 Shenyang ChinaRekrutierend» Google-MapsInvestigational Site Number : 1560021 518035 Shenzhen ChinaRekrutierend» Google-MapsInvestigational Site Number : 1560007 300020 Tianjin ChinaRekrutierend» Google-MapsInvestigational Site Number : 1560009 300032 Tianjin ChinaRekrutierend» Google-MapsInvestigational Site Number : 1560018 300060 Tianjin ChinaRekrutierend» Google-MapsInvestigational Site Number : 1560003 430022 Wuhan ChinaRekrutierend» Google-MapsInvestigational Site Number : 1560008 430030 Wuhan ChinaRekrutierend» Google-MapsInvestigational Site Number : 1560004 450008 Zhengzhou ChinaRekrutierend» Google-MapsInvestigational Site Number : 2030005 62500 Brno CzechiaRekrutierend» Google-MapsInvestigational Site Number : 2030003 77900 Olomouc CzechiaRekrutierend» Google-MapsInvestigational Site Number : 2030006 70852 Ostrava - Poruba CzechiaRekrutierend» Google-MapsInvestigational Site Number : 2030004 12808 Praha 2 CzechiaRekrutierend» Google-MapsInvestigational Site Number : 2500006 69373 Lyon FranceRekrutierend» Google-MapsInvestigational Site Number : 2500002 44093 Nantes FranceRekrutierend» Google-MapsInvestigational Site Number : 2500005 75012 Paris FranceRekrutierend» Google-MapsInvestigational Site Number : 2500008 24000 Perigueux FranceRekrutierend» Google-MapsInvestigational Site Number : 2500004 69495 Pierre Benite FranceRekrutierend» Google-MapsInvestigational Site Number : 2500001 86021 Poitiers FranceRekrutierend» Google-MapsInvestigational Site Number : 2500009 42055 Saint-Etienne Cedex 2 FranceRekrutierend» Google-MapsInvestigational Site Number : 2500003 31059 TOULOUSE Cedex 9 FranceRekrutierend» Google-MapsInvestigational Site Number : 2500007 37044 Tours FranceRekrutierend» Google-MapsInvestigational Site Number : 3000002 10676 Athens GreeceRekrutierend» Google-MapsInvestigational Site Number : 3000001 11528 Athens GreeceRekrutierend» Google-MapsInvestigational Site Number : 3000005 45500 Ioannina GreeceRekrutierend» Google-MapsInvestigational Site Number : 3000003 26500 Patra GreeceRekrutierend» Google-MapsInvestigational Site Number : 3000004 57010 Thessaloniki GreeceRekrutierend» Google-MapsInvestigational Site Number : 3480002 1083 Budapest HungaryRekrutierend» Google-MapsInvestigational Site Number : 3480004 1097 Budapest HungaryRekrutierend» Google-MapsInvestigational Site Number : 3480003 7400 Kaposvár HungaryRekrutierend» Google-MapsInvestigational Site Number : 3480008 7624 Pécs HungaryRekrutierend» Google-MapsInvestigational Site Number : 3480005 8000 Szekesfehervar HungaryRekrutierend» Google-MapsInvestigational Site Number : 3480006 9700 Szombathely HungaryRekrutierend» Google-MapsInvestigational Site Number : 3800001 47014 Meldola ItalyRekrutierend» Google-MapsInvestigational Site Number : 3800004 60126 Ancona ItalyRekrutierend» Google-MapsInvestigational Site Number : 3800002 40138 Bologna ItalyRekrutierend» Google-MapsInvestigational Site Number : 3800005 25123 Brescia ItalyRekrutierend» Google-MapsInvestigational Site Number : 3800007 80131 Napoli ItalyRekrutierend» Google-MapsInvestigational Site Number : 3800008 90127 Palermo ItalyRekrutierend» Google-MapsInvestigational Site Number : 3800003 27100 Pavia ItalyRekrutierend» Google-MapsInvestigational Site Number : 3920001 467-8602 Nagoya-shi JapanRekrutierend» Google-MapsInvestigational Site Number : 3920007 296-8602 Kamogawa-shi JapanRekrutierend» Google-MapsInvestigational Site Number : 3920005 311-3193 Higashiibaraki-gun JapanRekrutierend» Google-MapsInvestigational Site Number : 3920010 028-3695 Shiwa-gun JapanRekrutierend» Google-MapsInvestigational Site Number : 3920012 247-0072 Kamakura-shi JapanRekrutierend» Google-MapsInvestigational Site Number : 3920003 603-8151 Kyoto-shi JapanRekrutierend» Google-MapsInvestigational Site Number : 3920006 981-1293 Natori-shi JapanRekrutierend» Google-MapsInvestigational Site Number : 3920002 701-1192 Okayama-shi JapanRekrutierend» Google-MapsInvestigational Site Number : 3920011 530-8480 Osaka-shi JapanRekrutierend» Google-MapsInvestigational Site Number : 3920008 411-8777 Sunto-gun JapanRekrutierend» Google-MapsInvestigational Site Number : 3920004 150-8935 Shibuya-ku JapanRekrutierend» Google-MapsInvestigational Site Number : 3920009 990-9585 Yamagata-shi JapanRekrutierend» Google-MapsInvestigational Site Number : 5780001 0450 Oslo NorwayRekrutierend» Google-MapsInvestigational Site Number : 5780002 6026 Ålesund NorwayRekrutierend» Google-MapsInvestigational Site Number : 6160004 50-367 Wroclaw PolandRekrutierend» Google-MapsInvestigational Site Number : 6160005 30-688 Krakow PolandRekrutierend» Google-MapsInvestigational Site Number : 6160001 20,081 Lublin PolandRekrutierend» Google-MapsInvestigational Site Number : 6160003 53,439 Wroclaw PolandRekrutierend» Google-MapsInvestigational Site Number : 7240003 39008 Santander SpainRekrutierend» Google-MapsInvestigational Site Number : 7240004 08916 Badalona SpainRekrutierend» Google-MapsInvestigational Site Number : 7240007 28046 Madrid SpainRekrutierend» Google-MapsInvestigational Site Number : 7240001 31008 Pamplona SpainRekrutierend» Google-MapsInvestigational Site Number : 7240005 28034 Madrid SpainRekrutierend» Google-MapsInvestigational Site Number : 7240006 30120 Murcia SpainRekrutierend» Google-MapsInvestigational Site Number : 7240002 37007 Salamanca SpainRekrutierend» Google-MapsInvestigational Site Number : 7520001 50182 Borås SwedenRekrutierend» Google-MapsInvestigational Site Number : 7520002 118 83 Stockholm SwedenRekrutierend» Google-MapsInvestigational Site Number : 7520003 14186 Stockholm SwedenRekrutierend» Google-MapsInvestigational Site Number : 1580001 83301 Kaohsiung TaiwanRekrutierend» Google-MapsInvestigational Site Number : 1580005 704 Tainan TaiwanRekrutierend» Google-MapsInvestigational Site Number : 1580002 10002 Taipei TaiwanRekrutierend» Google-MapsInvestigational Site Number : 7920007 06010 Ankara TurkeyRekrutierend» Google-MapsInvestigational Site Number : 7920009 06200 Ankara TurkeyRekrutierend» Google-MapsInvestigational Site Number : 7920004 35100 Bornova TurkeyRekrutierend» Google-MapsInvestigational Site Number : 7920003 34093 Istanbul TurkeyRekrutierend» Google-MapsInvestigational Site Number : 7920005 34098 Istanbul TurkeyRekrutierend» Google-MapsInvestigational Site Number : 7920008 34214 Istanbul TurkeyRekrutierend» Google-MapsInvestigational Site Number : 7920001 34381 Istanbul TurkeyRekrutierend» Google-MapsInvestigational Site Number : 8260002 LE1 5WW Leicester United KingdomRekrutierend» Google-MapsInvestigational Site Number : 8260005 W12 0HS London United KingdomRekrutierend» Google-MapsInvestigational Site Number : 8260001 NR4 7UY Norwich United KingdomRekrutierend» Google-MapsInvestigational Site Number : 8260004 B15 2GW Birmingham United KingdomRekrutierend» Google-MapsInvestigational Site Number : 8260003 DE223NE Derby United KingdomRekrutierend» Google-Maps
1. Overall response rate (ORR) (Time Frame - Up to approximately 2 years): 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).
2. Observed concentration before dosing (Cthrough) at steady state (Time Frame - Predose at Cycle 6 Day 1 (duration of each cycle is 28 days)): Observed Isatuximab plasma concentration
Secondary outcome:
1. Very Good Partial Response or better rate (VGPR) (Time Frame - Up to approximately 2 years): 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).
2. Observed concentration before dosing (Ctrough) (Time Frame - At 4 weeks i.e., predose at Cycle 2 Day 1 (duration of each cycle is 28 days)): Observed Isatuximab plasma concentration
3. Incidence rate of infusion-reactions (Time Frame - Up to approximately 4 years): Proportion of participants with infusion-reactions related events
4. Percentage of participants satisfied or very satisfied with the injection method used to administer study medication (Time Frame - At Cycle 5 Day 15): Participant's satisfaction with isatuximab subcutaneous (SC) and intravenous (IV) will be assessed based on the Patient Experience and Satisfaction Questionnaires (PESQ) questionnaire.
5. Duration of response (DOR) (Time Frame - Up to approximately 2 years): 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.
6. Time to first response (TT1R) (Time Frame - Up to approximately 2 years): 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.
7. Time to best response (TTBR) (Time Frame - Up to approximately 2 years): 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
8. Progression free survival (PFS) (Time Frame - Up to approximately 4 years): 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.
9. Overall survival (OS) (Time Frame - Up to approximately 4 years): 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.
10. Progression free survival 2 (PFS2) (Time Frame - Up to approximately 4 years): 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.
11. Number of participants with treatment-emergent adverse events (TEAEs)/serious adverse events (SAEs). (Time Frame - Up to approximately 4 years): 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.
12. Pharmacokinetic (PK) parameter (Time Frame - Up to approximately 4 years): Maximum plasma concentration (Cmax)
13. PK parameter (Time Frame - Up to approximately 4 years): Area under the plasma concentration time curve over the dosing period (AUC)
14. Successful injection rate (Time Frame - Up to approximately 4 years): Number of successful injections with (investigational) isatuximab injector device divided by total number of actual injections
15. Percentage of participants with anti-drug antibodies (ADA) against isatuximab (Time Frame - Up to approximately 4 years): 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).
16. Participant expectation questionnaire-baseline (PEQ-BL) score (Time Frame - Cycle 1 Day 1 ((duration of each cycle is 28 days)): 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).
17. Patient experience and satisfaction questionnaire- follow up (PESQ-FU) score (Time Frame - Up to approximately 4 years): 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).
18. Patient experience and satisfaction questionnaire-end of treatment (PESQ-EOT) score (Time Frame - Up to approximately 4 years): 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).
19. Patient's Assessment of Treatment (PAT) questionnaire score (Time Frame - Up to approximately 4 years): 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.
20. Change from baseline in the Health Resource Utilization and Productivity Questionnaire (HRUPQ) scores (Time Frame - Baseline; up to approximately 4 years): 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.
21. Change from baseline in European Organization for Research and Treatment of Cancer core quality of life questionnaire (EORTC QLQ-C30) score (Time Frame - Baseline; up to approximately 4 years): EORTC QLQ-C30 is a cancer-specific questionnaire that contains 30 items and provides a multidimensional assessment of Health Related Quality of Life (HRQL).
22. Change from baseline in European Organization for Research and Treatment of Cancer quality of life myeloma module (EORTC QLQ-MY20) (Time Frame - Baseline; up to approximately 4 years): 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.
23. Change from baseline in the European Quality of Life Group questionnaire with 5 dimensions and 5 levels per dimension (EQ-5D-5L) scores (Time Frame - Baseline; up to approximately 4 years): 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.'
24. Number of participants with chromosomal abnormalities (Time Frame - Up to approximately 4 years): Explore chromosomal abnormalities (mainly but not limited to t(4;14), t(14;16), del(17p), and 1q21+)
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).
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).
