Trial Outcomes & Findings for Multinational Clinical Study Comparing Isatuximab, Carfilzomib And Dexamethasone To Carfilzomib And Dexamethasone In Relapse And/Or Refractory Multiple Myeloma Patients (NCT NCT03275285)

Last Updated: 2026-02-09

Results Overview

Time (in months) from randomization to date of 1st documentation of progressive disease (PD)/date of death from any cause, whichever comes 1st. If PD \& death are not observed before cut-off date/date of initiation of further anti-myeloma treatment, PFS was censored at date of last valid disease assessment not showing PD performed prior to initiation of further anti-myeloma treatment/cut-off date, whichever comes 1st. PD(IMWG criteria):any 1 of following:Increase(inc) of \>=25% in serum M-component from nadir; serum M component inc \>=1 g/dL in 2 consecutive assessment, if starting M component \>=5 g/dL; and/or inc of \>=25% in urine M-component from nadir and/or development of new bone lesion/soft tissue extramedullary disease/inc \>=50% from nadir in sum of perpendicular diameters of existing soft tissue extramedullary disease lesion if \>1 lesion/ \>=50% increase in longest diameter of previous soft tissue extramedullary disease lesion \>1 cm in short axis. Estimated by Kaplan-Meier method.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

302 participants

Primary outcome timeframe

From randomization until the primary analysis data cut-off date of 7 Feb 2020 (median duration of follow-up was 20.73 months)

Results posted on

2026-02-09

Participant Flow

Study was conducted at 69 active centers in 16 countries. A total of 341 participants were screened between 25 October 2017 and 21 March 2019, of which 39 participants were screen failure due to not meeting eligibility criteria. Randomization was stratified by number of prior lines (1 versus \>1) \& revised international staging system (R-ISS) I or II versus III versus not classified. Reason for not completed = Reason for definitive treatment discontinuation.

First result analysis (A) reported was for a data cut-off date of 7 Feb 2020 for efficacy outcomes, 14 Jan 2022 for CR, MRD and PFS2. PFS data was reported at both cut-off dates: 7 Feb 2020 \& 14 Jan 2022. Primary A of PFS refers to planned interim A conducted at 103 events (death/PD) with cut-off date 7 Feb 2020 \& Final A of PFS conducted at 159 events with cut-off date 14 Jan 2022. Data cut-off for overall survival and LPLV was 7 Feb 2023 and 3 Jan 2025, respectively.

Participant milestones

Participant milestones
Measure	Carfilzomib + Dexamethasone (Kd) Participants received carfilzomib 20 milligrams per meter square (mg/m\^2), intravenous (IV) infusion on Days 1, and 2 in Cycle 1, and then escalated to 56 mg/m\^2 on Days 8, 9, 15 and 16 of Cycle 1 and then on Days 1, 2, 8, 9, 15 and 16 of each subsequent 28-day treatment cycle along with dexamethasone 20 milligrams (mg), orally (PO) or IV on Days 1, 2, 8, 9, 15, 16, 22 and 23 of each 28-day treatment cycle until disease progression or unacceptable adverse event or participant's decision to discontinue the study treatment or any other reason, whichever comes first (maximum exposure: 349 weeks).	Isatuximab + Carfilzomib + Dexamethasone (IKd) Participants received isatuximab 10 milligrams per kilogram (mg/kg), IV infusion on Days 1, 8, 15 and 22 in Cycle 1, and then on Days 1 and 15 of each 28-day treatment cycle plus carfilzomib 20 mg/m\^2, IV on Days 1, and 2 in Cycle 1, and then escalated to 56 mg/m\^2 on Days 8, 9, 15 and 16 of Cycle 1 and then on Days 1, 2, 8, 9, 15 and 16 of each subsequent 28-day treatment cycle and dexamethasone 20 mg, PO or IV on Day 1, 2, 8, 9, 15, 16, 22 and 23 of each 28-day treatment cycle until disease progression or unacceptable adverse event or participant's decision to discontinue the study treatment or any other reason, whichever comes first (maximum exposure: 356 weeks).
Overall Study STARTED	123	179
Overall Study Treated	122	177
Overall Study COMPLETED	0	0
Overall Study NOT COMPLETED	123	179

Reasons for withdrawal

Reasons for withdrawal
Measure	Carfilzomib + Dexamethasone (Kd) Participants received carfilzomib 20 milligrams per meter square (mg/m\^2), intravenous (IV) infusion on Days 1, and 2 in Cycle 1, and then escalated to 56 mg/m\^2 on Days 8, 9, 15 and 16 of Cycle 1 and then on Days 1, 2, 8, 9, 15 and 16 of each subsequent 28-day treatment cycle along with dexamethasone 20 milligrams (mg), orally (PO) or IV on Days 1, 2, 8, 9, 15, 16, 22 and 23 of each 28-day treatment cycle until disease progression or unacceptable adverse event or participant's decision to discontinue the study treatment or any other reason, whichever comes first (maximum exposure: 349 weeks).	Isatuximab + Carfilzomib + Dexamethasone (IKd) Participants received isatuximab 10 milligrams per kilogram (mg/kg), IV infusion on Days 1, 8, 15 and 22 in Cycle 1, and then on Days 1 and 15 of each 28-day treatment cycle plus carfilzomib 20 mg/m\^2, IV on Days 1, and 2 in Cycle 1, and then escalated to 56 mg/m\^2 on Days 8, 9, 15 and 16 of Cycle 1 and then on Days 1, 2, 8, 9, 15 and 16 of each subsequent 28-day treatment cycle and dexamethasone 20 mg, PO or IV on Day 1, 2, 8, 9, 15, 16, 22 and 23 of each 28-day treatment cycle until disease progression or unacceptable adverse event or participant's decision to discontinue the study treatment or any other reason, whichever comes first (maximum exposure: 356 weeks).
Overall Study Adverse Event	24	29
Overall Study Progressive disease	68	86
Overall Study Withdrawal by Subject	18	21
Overall Study Treatment extension study	1	24
Overall Study Randomized and not treated	1	2
Overall Study Study discontinuation	1	5
Overall Study Others	10	12

Baseline Characteristics

Multinational Clinical Study Comparing Isatuximab, Carfilzomib And Dexamethasone To Carfilzomib And Dexamethasone In Relapse And/Or Refractory Multiple Myeloma Patients

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Carfilzomib + Dexamethasone (Kd) n=123 Participants Participants received carfilzomib 20 mg/m\^2, IV infusion on Days 1, and 2 in Cycle 1, and then escalated to 56 mg/m\^2 on Days 8, 9, 15 and 16 of Cycle 1 and then on Days 1, 2, 8, 9, 15 and 16 of each subsequent 28-day treatment cycle along with dexamethasone 20 mg, PO or IV on Days 1, 2, 8, 9, 15, 16, 22 and 23 of each 28-day treatment cycle until disease progression or unacceptable adverse event or participant's decision to discontinue the study treatment or any other reason, whichever comes first (maximum exposure: 349 weeks).	Isatuximab + Carfilzomib + Dexamethasone (IKd) n=179 Participants Participants received isatuximab 10 mg/kg, IV infusion on Days 1, 8, 15 and 22 in Cycle 1, and then on Days 1 and 15 of each 28-day treatment cycle plus carfilzomib 20 mg/m\^2, IV on Days 1, and 2 in Cycle 1, and then escalated to 56 mg/m\^2 on Days 8, 9, 15 and 16 of Cycle 1 and then on Days 1, 2, 8, 9, 15 and 16 of each subsequent 28-day treatment cycle and dexamethasone 20 mg, PO or IV on Day 1, 2, 8, 9, 15, 16, 22 and 23 of each 28-day treatment cycle until disease progression or unacceptable adverse event or participant's decision to discontinue the study treatment or any other reason, whichever comes first (maximum exposure: 356 weeks).	Total n=302 Participants Total of all reporting groups
Age, Continuous	62.9 years STANDARD_DEVIATION 10.0 • n=362 Participants	63.3 years STANDARD_DEVIATION 9.8 • n=3 Participants	63.1 years STANDARD_DEVIATION 9.9 • n=7 Participants
Sex: Female, Male Female	55 Participants n=362 Participants	78 Participants n=3 Participants	133 Participants n=7 Participants
Sex: Female, Male Male	68 Participants n=362 Participants	101 Participants n=3 Participants	169 Participants n=7 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=362 Participants	0 Participants n=3 Participants	0 Participants n=7 Participants
Race (NIH/OMB) Asian	24 Participants n=362 Participants	26 Participants n=3 Participants	50 Participants n=7 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=362 Participants	0 Participants n=3 Participants	0 Participants n=7 Participants
Race (NIH/OMB) Black or African American	4 Participants n=362 Participants	5 Participants n=3 Participants	9 Participants n=7 Participants
Race (NIH/OMB) White	83 Participants n=362 Participants	131 Participants n=3 Participants	214 Participants n=7 Participants
Race (NIH/OMB) More than one race	0 Participants n=362 Participants	3 Participants n=3 Participants	3 Participants n=7 Participants
Race (NIH/OMB) Unknown or Not Reported	12 Participants n=362 Participants	14 Participants n=3 Participants	26 Participants n=7 Participants

PRIMARY outcome

Timeframe: From randomization until the primary analysis data cut-off date of 7 Feb 2020 (median duration of follow-up was 20.73 months)

Population: Analysis was performed on Intent to Treat (ITT) population that included all participants who gave their informed consent and for whom there was a confirmation of successful allocation of a randomization number by the interactive response technology (IRT).

Outcome measures

Outcome measures
Measure	Carfilzomib + Dexamethasone (Kd) n=123 Participants Participants received carfilzomib 20 mg/m\^2, IV infusion on Days 1, and 2 in Cycle 1, and then escalated to 56 mg/m\^2 on Days 8, 9, 15 and 16 of Cycle 1 and then on Days 1, 2, 8, 9, 15 and 16 of each subsequent 28-day treatment cycle along with dexamethasone 20 mg, PO or IV on Days 1, 2, 8, 9, 15, 16, 22 and 23 of each 28-day treatment cycle until disease progression or unacceptable adverse event or participant's decision to discontinue the study treatment or any other reason, whichever comes first (maximum exposure: 114 weeks).	Isatuximab + Carfilzomib + Dexamethasone (IKd) n=179 Participants Participants received isatuximab 10 mg/kg, IV infusion on Days 1, 8, 15 and 22 in Cycle 1, and then on Days 1 and Day 15 of each 28-day treatment cycle plus carfilzomib 20 mg/m\^2, IV on Days 1, and 2 in Cycle 1, and then escalated to 56 mg/m\^2 on Days 8, 9, 15 and 16 of Cycle 1 and then on Days 1, 2, 8, 9, 15 and 16 of each subsequent 28-day treatment cycle and dexamethasone 20 mg, PO or IV on Day 1, 2, 8, 9, 15, 16, 22 and 23 of each 28-day treatment cycle until disease progression or unacceptable adverse event or participant's decision to discontinue the study treatment or any other reason, whichever comes first (maximum exposure: 111 weeks).
Progression Free Survival (PFS) As Determined by Independent Response Committee (IRC): Primary Analysis	19.15 months Interval 15.77 to Upper limit of the confidence interval could not be reached due to less number of participants with the events.	NA months Median value and the upper and lower limit of the confidence interval could not be calculated because of less than 50% of the participants had PFS events.

PRIMARY outcome

Timeframe: From randomization until the primary analysis data cut-off date of 7 Feb 2020 (the median duration of follow-up was 20.73 months)

Population: Analysis was performed on the ITT. Analysis was performed by Kaplan-Meier method.

Time (in months) from randomization to date of 1st PD documentation/death date, whichever is 1st. If PD \& death not observed before cut-off date/date of further anti-myeloma treatment initiation, PFS censored at date of last valid disease assessment not showing PD performed prior to initiation of further anti-myeloma treatment/cut-off date, whichever was 1st. Progression/deaths occurring \>8 weeks after last disease assessment censored at earliest date of last disease assessment without evidence of progression before initiation of new anti-myeloma treatment \& cut-off date. PD (IMWG criteria): meeting any 1: Inc \>=25% in Serum M-component from nadir; serum M component inc \>=1 g/dL in 2 consecutive assessment, if starting M component \>=5 g/dL; and/or inc \>=25% in Urine M-component from nadir and/or development of new bone lesion/soft tissue extramedullary disease/inc \>=50% from nadir in sum of perpendicular diameters of existing soft tissue extramedullary disease lesion \>1 cm short axis.

Outcome measures

Outcome measures
Measure	Carfilzomib + Dexamethasone (Kd) n=123 Participants Participants received carfilzomib 20 mg/m\^2, IV infusion on Days 1, and 2 in Cycle 1, and then escalated to 56 mg/m\^2 on Days 8, 9, 15 and 16 of Cycle 1 and then on Days 1, 2, 8, 9, 15 and 16 of each subsequent 28-day treatment cycle along with dexamethasone 20 mg, PO or IV on Days 1, 2, 8, 9, 15, 16, 22 and 23 of each 28-day treatment cycle until disease progression or unacceptable adverse event or participant's decision to discontinue the study treatment or any other reason, whichever comes first (maximum exposure: 114 weeks).	Isatuximab + Carfilzomib + Dexamethasone (IKd) n=179 Participants Participants received isatuximab 10 mg/kg, IV infusion on Days 1, 8, 15 and 22 in Cycle 1, and then on Days 1 and Day 15 of each 28-day treatment cycle plus carfilzomib 20 mg/m\^2, IV on Days 1, and 2 in Cycle 1, and then escalated to 56 mg/m\^2 on Days 8, 9, 15 and 16 of Cycle 1 and then on Days 1, 2, 8, 9, 15 and 16 of each subsequent 28-day treatment cycle and dexamethasone 20 mg, PO or IV on Day 1, 2, 8, 9, 15, 16, 22 and 23 of each 28-day treatment cycle until disease progression or unacceptable adverse event or participant's decision to discontinue the study treatment or any other reason, whichever comes first (maximum exposure: 111 weeks).
Progression Free Survival as Determined by Independent Response Committee: [Event Censored if Occurred >8 Weeks From Last Disease Assessment]: Primary Analysis	20.27 months Interval 15.77 to Upper limit of the confidence interval could not be reached due to less number of participants with the events.	NA months Median value and the upper and lower limit of the confidence interval could not be calculated because of less than 50% of the participants had PFS events.

PRIMARY outcome

Timeframe: From randomization until the final analysis data cut-off date of 14 January 2022 (the median duration of follow-up was 43.96 months)

Population: Analysis was performed on ITT population.

PFS: time (in months) from randomization to date of first documentation of PD or date of death from any cause, whichever comes first. If PD and death are not observed before analysis cut-off date or date of initiation of further anti-myeloma treatment, PFS was censored at date of last valid disease assessment or analysis cut-off date, whichever comes first. PD as per IMWG criteria: any 1 of following: Inc of \>=25% in Serum M-component from nadir; serum M component increase \>=1 g/dL in 2 consecutive assessment, if starting M component was \>=5 g/dL; and/or inc of \>=25% in Urine M-component from nadir and/or development of new bone lesion/soft tissue extramedullary disease/inc \>=50% from nadir in sum of perpendicular diameters of existing soft tissue extramedullary disease lesion if \>1 lesion/ \>=50% inc in longest diameter of previous soft tissue extramedullary disease lesion \>1 cm in short axis. PFS estimated by Kaplan-Meier method.

Outcome measures

Outcome measures
Measure	Carfilzomib + Dexamethasone (Kd) n=123 Participants Participants received carfilzomib 20 mg/m\^2, IV infusion on Days 1, and 2 in Cycle 1, and then escalated to 56 mg/m\^2 on Days 8, 9, 15 and 16 of Cycle 1 and then on Days 1, 2, 8, 9, 15 and 16 of each subsequent 28-day treatment cycle along with dexamethasone 20 mg, PO or IV on Days 1, 2, 8, 9, 15, 16, 22 and 23 of each 28-day treatment cycle until disease progression or unacceptable adverse event or participant's decision to discontinue the study treatment or any other reason, whichever comes first (maximum exposure: 114 weeks).	Isatuximab + Carfilzomib + Dexamethasone (IKd) n=179 Participants Participants received isatuximab 10 mg/kg, IV infusion on Days 1, 8, 15 and 22 in Cycle 1, and then on Days 1 and Day 15 of each 28-day treatment cycle plus carfilzomib 20 mg/m\^2, IV on Days 1, and 2 in Cycle 1, and then escalated to 56 mg/m\^2 on Days 8, 9, 15 and 16 of Cycle 1 and then on Days 1, 2, 8, 9, 15 and 16 of each subsequent 28-day treatment cycle and dexamethasone 20 mg, PO or IV on Day 1, 2, 8, 9, 15, 16, 22 and 23 of each 28-day treatment cycle until disease progression or unacceptable adverse event or participant's decision to discontinue the study treatment or any other reason, whichever comes first (maximum exposure: 111 weeks).
Progression Free Survival as Determined by Independent Response Committee: Final Analysis	19.15 months Interval 15.77 to 25.035	35.65 months Interval 25.758 to 43.959

PRIMARY outcome

Timeframe: From randomization until the final analysis data cut-off date of 14 Jan 2022 (the median duration of follow-up was 43.96 months)

Population: Analysis was performed on the ITT population. Analysis was performed by Kaplan-Meier method.

Time (in months) from randomization to date of 1st documentation of PD/date of death from any cause, whichever comes 1st. If PD \& death are not observed before cut-off date/date of initiation of further anti-myeloma treatment, PFS was censored at date of last valid disease assessment not showing PD/cut-off date, whichever comes 1st. Progressions/deaths occurring \>8 weeks after last disease assessment were censored at earliest date of last valid disease assessment not showing PD before initiation of further anti-myeloma treatment \& cut-off date. PD (per IMWG criteria): meeting any 1 criteria: Inc of \>=25% in serum M-component from nadir; serum M component inc \>=1 g/dL in 2 consecutive assessment, if starting M component was \>=5 g/dL; and/or inc of \>=25% in urine M-component from nadir and/or development of new bone lesion/soft tissue extramedullary disease/inc \>=50% from nadir in sum of perpendicular diameters of existing soft tissue extramedullary disease lesion \>1 cm in short axis.

Outcome measures

Outcome measures
Measure	Carfilzomib + Dexamethasone (Kd) n=123 Participants Participants received carfilzomib 20 mg/m\^2, IV infusion on Days 1, and 2 in Cycle 1, and then escalated to 56 mg/m\^2 on Days 8, 9, 15 and 16 of Cycle 1 and then on Days 1, 2, 8, 9, 15 and 16 of each subsequent 28-day treatment cycle along with dexamethasone 20 mg, PO or IV on Days 1, 2, 8, 9, 15, 16, 22 and 23 of each 28-day treatment cycle until disease progression or unacceptable adverse event or participant's decision to discontinue the study treatment or any other reason, whichever comes first (maximum exposure: 114 weeks).	Isatuximab + Carfilzomib + Dexamethasone (IKd) n=179 Participants Participants received isatuximab 10 mg/kg, IV infusion on Days 1, 8, 15 and 22 in Cycle 1, and then on Days 1 and Day 15 of each 28-day treatment cycle plus carfilzomib 20 mg/m\^2, IV on Days 1, and 2 in Cycle 1, and then escalated to 56 mg/m\^2 on Days 8, 9, 15 and 16 of Cycle 1 and then on Days 1, 2, 8, 9, 15 and 16 of each subsequent 28-day treatment cycle and dexamethasone 20 mg, PO or IV on Day 1, 2, 8, 9, 15, 16, 22 and 23 of each 28-day treatment cycle until disease progression or unacceptable adverse event or participant's decision to discontinue the study treatment or any other reason, whichever comes first (maximum exposure: 111 weeks).
Progression Free Survival as Determined by Independent Response Committee [Event Censored if Occurred >8 Weeks From Last Disease Assessment]: Final Analysis	20.76 months Interval 16.164 to 28.189	41.66 months Interval 27.138 to Upper limit of the confidence interval could not be reached due to less number of participants with the events.

SECONDARY outcome

Timeframe: From randomization until the primary analysis data cut-off date of 7 Feb 2020 (the median duration of follow-up was 20.73 months)

Population: Analysis was performed on ITT population.

OR: participants with sCR, CR, VGPR \& partial response (PR) as best overall response assessed by IRC using IMWG response criteria (from start of treatment until disease progression, death, initiation of further anti-myeloma treatment/cutoff date, whichever occurs 1st). sCR: negative immunofixation on serum \& urine, disappearance of soft tissue plasmacytoma, \<5% plasma cells in bone marrow aspirate (BMA) + normal FLC ratio (0.26-1.65), absence of clonal cells in bone marrow biopsy. CR: negative immunofixation on serum \& urine, disappearance of soft tissue plasmacytoma, \<5% plasma cells in BMA. VGPR: serum \& urine M-protein detectable by immunofixation, not on electrophoresis/,\>=90% reduction in serum M-protein + urine M-protein level \<100mg/24h/,\>=90% decrease in SPD compared to baseline in soft tissue plasmacytoma. PR:\>=50% reduction of serum M-protein \& decrease in 24h urinary M-protein by \>=90%/\<200mg/24h, if present at baseline,\>=50% decrease in SPD of soft tissue plasmacytoma.

Outcome measures

Outcome measures
Measure	Carfilzomib + Dexamethasone (Kd) n=123 Participants Participants received carfilzomib 20 mg/m\^2, IV infusion on Days 1, and 2 in Cycle 1, and then escalated to 56 mg/m\^2 on Days 8, 9, 15 and 16 of Cycle 1 and then on Days 1, 2, 8, 9, 15 and 16 of each subsequent 28-day treatment cycle along with dexamethasone 20 mg, PO or IV on Days 1, 2, 8, 9, 15, 16, 22 and 23 of each 28-day treatment cycle until disease progression or unacceptable adverse event or participant's decision to discontinue the study treatment or any other reason, whichever comes first (maximum exposure: 114 weeks).	Isatuximab + Carfilzomib + Dexamethasone (IKd) n=179 Participants Participants received isatuximab 10 mg/kg, IV infusion on Days 1, 8, 15 and 22 in Cycle 1, and then on Days 1 and Day 15 of each 28-day treatment cycle plus carfilzomib 20 mg/m\^2, IV on Days 1, and 2 in Cycle 1, and then escalated to 56 mg/m\^2 on Days 8, 9, 15 and 16 of Cycle 1 and then on Days 1, 2, 8, 9, 15 and 16 of each subsequent 28-day treatment cycle and dexamethasone 20 mg, PO or IV on Day 1, 2, 8, 9, 15, 16, 22 and 23 of each 28-day treatment cycle until disease progression or unacceptable adverse event or participant's decision to discontinue the study treatment or any other reason, whichever comes first (maximum exposure: 111 weeks).
Percentage of Participants With Overall Response (OR) as Determined by Independent Response Committee: Primary Analysis	82.9 percentage of participants	86.6 percentage of participants

SECONDARY outcome

Timeframe: From randomization until the primary analysis data cut-off date of 7 Feb 2020 (the median duration of follow-up was 20.73 months)

Population: Analysis was performed on ITT population.

VGPR or better: defined as participants with sCR, CR and VGPR as the best overall response (defined as best response from start of treatment until disease progression, death, initiation of further anti-myeloma treatment or cut-off date whichever occurs first) as per IRC. As per IMWG response criteria: sCR: negative immunofixation on serum and urine, disappearance of any soft tissue plasmacytomas, \<5% plasma cells in BMAs plus normal FLC ratio (0.26-1.65), absence of clonal cells in bone marrow biopsy. CR: negative immunofixation on serum and urine, disappearance of any soft tissue plasmacytomas, \<5% plasma cells in BMAs. VGPR: serum and urine M-protein detectable by immunofixation, not on electrophoresis/,\>=90% reduction in serum M-protein plus urine M-protein level \<100mg/24h/,\>=90% decrease in SPD compared to baseline in soft tissue plasmacytoma.

Outcome measures

Outcome measures
Measure	Carfilzomib + Dexamethasone (Kd) n=123 Participants Participants received carfilzomib 20 mg/m\^2, IV infusion on Days 1, and 2 in Cycle 1, and then escalated to 56 mg/m\^2 on Days 8, 9, 15 and 16 of Cycle 1 and then on Days 1, 2, 8, 9, 15 and 16 of each subsequent 28-day treatment cycle along with dexamethasone 20 mg, PO or IV on Days 1, 2, 8, 9, 15, 16, 22 and 23 of each 28-day treatment cycle until disease progression or unacceptable adverse event or participant's decision to discontinue the study treatment or any other reason, whichever comes first (maximum exposure: 114 weeks).	Isatuximab + Carfilzomib + Dexamethasone (IKd) n=179 Participants Participants received isatuximab 10 mg/kg, IV infusion on Days 1, 8, 15 and 22 in Cycle 1, and then on Days 1 and Day 15 of each 28-day treatment cycle plus carfilzomib 20 mg/m\^2, IV on Days 1, and 2 in Cycle 1, and then escalated to 56 mg/m\^2 on Days 8, 9, 15 and 16 of Cycle 1 and then on Days 1, 2, 8, 9, 15 and 16 of each subsequent 28-day treatment cycle and dexamethasone 20 mg, PO or IV on Day 1, 2, 8, 9, 15, 16, 22 and 23 of each 28-day treatment cycle until disease progression or unacceptable adverse event or participant's decision to discontinue the study treatment or any other reason, whichever comes first (maximum exposure: 111 weeks).
Percentage of Participants With Very Good Partial Response (VGPR) or Better as Determined by Independent Response Committee: Primary Analysis	56.1 percentage of participants	72.6 percentage of participants

SECONDARY outcome

Timeframe: From randomization until the primary analysis data cut-off date of 7 Feb 2020 (the median duration of follow-up was 20.73 months)

Population: Analysis was performed on ITT population.

Percentage of participants with sCR, CR and VGPR for whom MRD assessed by sequencing was negative at any time after first dose of study treatment. MRD was assessed centrally by next-generation sequencing in bone marrow aspiration samples from participants who achieve VGPR or better, to determine depth of response at molecular level. VGPR or better: percentage of participants with sCR, CR and VGPR. sCR: negative immunofixation on serum and urine, disappearance of any soft tissue plasmacytomas, \<5% plasma cells in BMAs plus normal FLC ratio (0.26-1.65), absence of clonal cells in bone marrow biopsy. CR: negative immunofixation on serum and urine, disappearance of any soft tissue plasmacytomas, \<5% plasma cells in BMAs. VGPR: serum and urine M-protein detectable by immunofixation, not on electrophoresis/,\>=90% reduction in serum M-protein plus urine M-protein level \<100mg/24h/,\>=90% decrease in SPD compared to baseline in soft tissue plasmacytoma.

Outcome measures

Outcome measures
Measure	Carfilzomib + Dexamethasone (Kd) n=123 Participants Participants received carfilzomib 20 mg/m\^2, IV infusion on Days 1, and 2 in Cycle 1, and then escalated to 56 mg/m\^2 on Days 8, 9, 15 and 16 of Cycle 1 and then on Days 1, 2, 8, 9, 15 and 16 of each subsequent 28-day treatment cycle along with dexamethasone 20 mg, PO or IV on Days 1, 2, 8, 9, 15, 16, 22 and 23 of each 28-day treatment cycle until disease progression or unacceptable adverse event or participant's decision to discontinue the study treatment or any other reason, whichever comes first (maximum exposure: 114 weeks).	Isatuximab + Carfilzomib + Dexamethasone (IKd) n=179 Participants Participants received isatuximab 10 mg/kg, IV infusion on Days 1, 8, 15 and 22 in Cycle 1, and then on Days 1 and Day 15 of each 28-day treatment cycle plus carfilzomib 20 mg/m\^2, IV on Days 1, and 2 in Cycle 1, and then escalated to 56 mg/m\^2 on Days 8, 9, 15 and 16 of Cycle 1 and then on Days 1, 2, 8, 9, 15 and 16 of each subsequent 28-day treatment cycle and dexamethasone 20 mg, PO or IV on Day 1, 2, 8, 9, 15, 16, 22 and 23 of each 28-day treatment cycle until disease progression or unacceptable adverse event or participant's decision to discontinue the study treatment or any other reason, whichever comes first (maximum exposure: 111 weeks).
Percentage of Participants With VGPR or Better With Minimal Residual Disease (MRD) Negativity: Primary Analysis	13.0 percentage of participants	29.6 percentage of participants

SECONDARY outcome

Timeframe: From randomization until the final analysis data cut-off date of 14 Jan 2022 (the median duration of follow-up was 43.96 months)

Population: Analysis was performed on ITT population.

Percentage of participants with sCR, CR and VGPR for whom MRD assessed by sequencing was negative at any time after first dose of study treatment. MRD was assessed centrally by next-generation sequencing in BM aspiration samples from participants who achieve VGPR or better, to determine depth of response at molecular level. VGPR or better: percentage of participants with sCR, CR and VGPR. sCR: negative immunofixation on serum and urine, disappearance of any soft tissue plasmacytomas, \<5% plasma cells in bone marrow aspirates plus normal FLC ratio, absence of clonal cells in bone marrow biopsy. CR: negative immunofixation on serum and urine, disappearance of any soft tissue plasmacytomas, \<5% plasma cells in bone marrow aspirates. VGPR: serum and urine M-protein detectable by immunofixation, not on electrophoresis/,\>=90% reduction in serum M-protein plus urine M-protein level \<100mg/24h/,\>=90% decrease in SPD compared to baseline in soft tissue plasmacytoma.

Outcome measures

Outcome measures
Measure	Carfilzomib + Dexamethasone (Kd) n=123 Participants Participants received carfilzomib 20 mg/m\^2, IV infusion on Days 1, and 2 in Cycle 1, and then escalated to 56 mg/m\^2 on Days 8, 9, 15 and 16 of Cycle 1 and then on Days 1, 2, 8, 9, 15 and 16 of each subsequent 28-day treatment cycle along with dexamethasone 20 mg, PO or IV on Days 1, 2, 8, 9, 15, 16, 22 and 23 of each 28-day treatment cycle until disease progression or unacceptable adverse event or participant's decision to discontinue the study treatment or any other reason, whichever comes first (maximum exposure: 114 weeks).	Isatuximab + Carfilzomib + Dexamethasone (IKd) n=179 Participants Participants received isatuximab 10 mg/kg, IV infusion on Days 1, 8, 15 and 22 in Cycle 1, and then on Days 1 and Day 15 of each 28-day treatment cycle plus carfilzomib 20 mg/m\^2, IV on Days 1, and 2 in Cycle 1, and then escalated to 56 mg/m\^2 on Days 8, 9, 15 and 16 of Cycle 1 and then on Days 1, 2, 8, 9, 15 and 16 of each subsequent 28-day treatment cycle and dexamethasone 20 mg, PO or IV on Day 1, 2, 8, 9, 15, 16, 22 and 23 of each 28-day treatment cycle until disease progression or unacceptable adverse event or participant's decision to discontinue the study treatment or any other reason, whichever comes first (maximum exposure: 111 weeks).
Percentage of Participants With VGPR or Better With Minimal Residual Disease (MRD) Negativity: Final Analysis	13.8 percentage of participants	33.5 percentage of participants

SECONDARY outcome

Timeframe: From randomization until the final analysis data cut-off date of 14 Jan 2022 (the median duration of follow-up was 43.96 months)

Population: Analysis was performed on ITT population.

Complete response was defined as the participants with sCR and CR. IMWG response criteria for sCR: negative immunofixation on serum and urine, disappearance of any soft tissue plasmacytomas, \<5% plasma cells in bone marrow aspirates plus normal free light chain (FLC) ratio (0.26-1.65), absence of clonal cells in bone marrow biopsy. CR: negative immunofixation on serum and urine, disappearance of any soft tissue plasmacytomas, \<5% plasma cells in bone marrow aspirates. Complete response at the time of the final analysis was assessed with hydrashift isatuximab immunofixation electrophoresis (IFE) assay, which separated immunoglobulin G (IgG) isatuximab from IgG M protein.

Outcome measures

Outcome measures
Measure	Carfilzomib + Dexamethasone (Kd) n=123 Participants Participants received carfilzomib 20 mg/m\^2, IV infusion on Days 1, and 2 in Cycle 1, and then escalated to 56 mg/m\^2 on Days 8, 9, 15 and 16 of Cycle 1 and then on Days 1, 2, 8, 9, 15 and 16 of each subsequent 28-day treatment cycle along with dexamethasone 20 mg, PO or IV on Days 1, 2, 8, 9, 15, 16, 22 and 23 of each 28-day treatment cycle until disease progression or unacceptable adverse event or participant's decision to discontinue the study treatment or any other reason, whichever comes first (maximum exposure: 114 weeks).	Isatuximab + Carfilzomib + Dexamethasone (IKd) n=179 Participants Participants received isatuximab 10 mg/kg, IV infusion on Days 1, 8, 15 and 22 in Cycle 1, and then on Days 1 and Day 15 of each 28-day treatment cycle plus carfilzomib 20 mg/m\^2, IV on Days 1, and 2 in Cycle 1, and then escalated to 56 mg/m\^2 on Days 8, 9, 15 and 16 of Cycle 1 and then on Days 1, 2, 8, 9, 15 and 16 of each subsequent 28-day treatment cycle and dexamethasone 20 mg, PO or IV on Day 1, 2, 8, 9, 15, 16, 22 and 23 of each 28-day treatment cycle until disease progression or unacceptable adverse event or participant's decision to discontinue the study treatment or any other reason, whichever comes first (maximum exposure: 111 weeks).
Percentage of Participants With Complete Response (CR) as Per Independent Response Committee: Final Analysis	28.5 percentage of participants	44.1 percentage of participants

SECONDARY outcome

Timeframe: From randomization until the final analysis data cut-off date of 14 Jan 2022 (the median duration of follow-up was 43.96 months)

Population: Analysis was performed on ITT population.

MRD negativity was defined as the percentage of participants for whom MRD was negative by next-generation sequencing at any timepoint after first dose of study treatment. Threshold for negativity is 10\^-5. MRD status in a participant was negative if at least one result of the assessment was negative in the participant otherwise MRD was considered as positive (MRD status reported as positive, missing or unevaluable). CR: participants with sCR and CR. IMWG response criteria for sCR: negative immunofixation on serum and urine, disappearance of any soft tissue plasmacytomas, \<5% plasma cells in bone marrow aspirates plus normal FLC ratio (0.26-1.65), absence of clonal cells in bone marrow biopsy. CR: negative immunofixation on serum and urine, disappearance of any soft tissue plasmacytomas, \<5% plasma cells in bone marrow aspirates. Complete response at the time of the final analysis was assessed with Hydrashift isatuximab IFE assay, which separated IgG isatuximab from IgG M protein.

Outcome measures

Outcome measures
Measure	Carfilzomib + Dexamethasone (Kd) n=123 Participants Participants received carfilzomib 20 mg/m\^2, IV infusion on Days 1, and 2 in Cycle 1, and then escalated to 56 mg/m\^2 on Days 8, 9, 15 and 16 of Cycle 1 and then on Days 1, 2, 8, 9, 15 and 16 of each subsequent 28-day treatment cycle along with dexamethasone 20 mg, PO or IV on Days 1, 2, 8, 9, 15, 16, 22 and 23 of each 28-day treatment cycle until disease progression or unacceptable adverse event or participant's decision to discontinue the study treatment or any other reason, whichever comes first (maximum exposure: 114 weeks).	Isatuximab + Carfilzomib + Dexamethasone (IKd) n=179 Participants Participants received isatuximab 10 mg/kg, IV infusion on Days 1, 8, 15 and 22 in Cycle 1, and then on Days 1 and Day 15 of each 28-day treatment cycle plus carfilzomib 20 mg/m\^2, IV on Days 1, and 2 in Cycle 1, and then escalated to 56 mg/m\^2 on Days 8, 9, 15 and 16 of Cycle 1 and then on Days 1, 2, 8, 9, 15 and 16 of each subsequent 28-day treatment cycle and dexamethasone 20 mg, PO or IV on Day 1, 2, 8, 9, 15, 16, 22 and 23 of each 28-day treatment cycle until disease progression or unacceptable adverse event or participant's decision to discontinue the study treatment or any other reason, whichever comes first (maximum exposure: 111 weeks).
Percentage of Participants With Complete Response With MRD Negativity: Final Analysis	12.2 percentage of participants	26.3 percentage of participants

SECONDARY outcome

Timeframe: From randomization until the final analysis data cut-off date of 7 Feb 2023 (the median duration of follow-up was 56.61 months)

Population: Analysis was performed on ITT population.

Overall survival, defined as the time from the date of randomization to death from any cause. The data reported is based on cut-off date of 7 Feb 2023.

Outcome measures

Outcome measures
Measure	Carfilzomib + Dexamethasone (Kd) n=123 Participants Participants received carfilzomib 20 mg/m\^2, IV infusion on Days 1, and 2 in Cycle 1, and then escalated to 56 mg/m\^2 on Days 8, 9, 15 and 16 of Cycle 1 and then on Days 1, 2, 8, 9, 15 and 16 of each subsequent 28-day treatment cycle along with dexamethasone 20 mg, PO or IV on Days 1, 2, 8, 9, 15, 16, 22 and 23 of each 28-day treatment cycle until disease progression or unacceptable adverse event or participant's decision to discontinue the study treatment or any other reason, whichever comes first (maximum exposure: 114 weeks).	Isatuximab + Carfilzomib + Dexamethasone (IKd) n=179 Participants Participants received isatuximab 10 mg/kg, IV infusion on Days 1, 8, 15 and 22 in Cycle 1, and then on Days 1 and Day 15 of each 28-day treatment cycle plus carfilzomib 20 mg/m\^2, IV on Days 1, and 2 in Cycle 1, and then escalated to 56 mg/m\^2 on Days 8, 9, 15 and 16 of Cycle 1 and then on Days 1, 2, 8, 9, 15 and 16 of each subsequent 28-day treatment cycle and dexamethasone 20 mg, PO or IV on Day 1, 2, 8, 9, 15, 16, 22 and 23 of each 28-day treatment cycle until disease progression or unacceptable adverse event or participant's decision to discontinue the study treatment or any other reason, whichever comes first (maximum exposure: 111 weeks).
Overall Survival (OS)	50.60 months Interval 38.932 to Upper limit of the confidence interval could not be reached due to less number of participants with the events.	NA months Interval 52.172 to Median value and the upper and lower limit of the confidence interval could not be calculated because of less than 50% of the participants had OS events.

SECONDARY outcome

Timeframe: From randomization until the primary analysis data cut-off date of 7 Feb 2020 (the median duration of follow-up was 20.73 months)

Population: Analysis was performed on the subset of participants with PR or better (defined as responders) in ITT population.

DOR: time (in months) from date of 1st IRC determined response for participants achieving PR/better to date of 1st documented PD determined by IRC/death, whichever happens 1st. If disease progression/death before analysis cut-off date was not observed, DOR was censored at date of last valid disease assessment performed prior to initiation of further anti-myeloma treatment/data cut-off date, whichever was 1st. PD (IMWG criteria): inc of \>=25% from lowest confirmed value in any 1 of following criteria: serum M-protein (absolute inc must be \>=0.5 g/dL), serum M-protein inc \>=1g/dL if lowest M component was \>=5g/dL; urine M-component (absolute inc must be \>=200mg/24 hour),appearance of new lesion(s), \>=50% inc from nadir in SPD of \>1 lesion, or \>=50% inc in the longest diameter of previous lesion \>1 cm in short axis. PR: \>=50% reduction of serum M-protein \& reduction in 24h urinary M-protein by \>=90%/\<200mg/24 h. Estimated by Kaplan Meier method.

Outcome measures

Outcome measures
Measure	Carfilzomib + Dexamethasone (Kd) n=102 Participants Participants received carfilzomib 20 mg/m\^2, IV infusion on Days 1, and 2 in Cycle 1, and then escalated to 56 mg/m\^2 on Days 8, 9, 15 and 16 of Cycle 1 and then on Days 1, 2, 8, 9, 15 and 16 of each subsequent 28-day treatment cycle along with dexamethasone 20 mg, PO or IV on Days 1, 2, 8, 9, 15, 16, 22 and 23 of each 28-day treatment cycle until disease progression or unacceptable adverse event or participant's decision to discontinue the study treatment or any other reason, whichever comes first (maximum exposure: 114 weeks).	Isatuximab + Carfilzomib + Dexamethasone (IKd) n=155 Participants Participants received isatuximab 10 mg/kg, IV infusion on Days 1, 8, 15 and 22 in Cycle 1, and then on Days 1 and Day 15 of each 28-day treatment cycle plus carfilzomib 20 mg/m\^2, IV on Days 1, and 2 in Cycle 1, and then escalated to 56 mg/m\^2 on Days 8, 9, 15 and 16 of Cycle 1 and then on Days 1, 2, 8, 9, 15 and 16 of each subsequent 28-day treatment cycle and dexamethasone 20 mg, PO or IV on Day 1, 2, 8, 9, 15, 16, 22 and 23 of each 28-day treatment cycle until disease progression or unacceptable adverse event or participant's decision to discontinue the study treatment or any other reason, whichever comes first (maximum exposure: 111 weeks).
Duration of Response (DOR): Primary Analysis	NA months Interval 14.752 to Median and upper limit of confidence interval could not be calculated because of less than 50% of the participants reaching PR or better with PFS events (PFS events includes progression and death without progression).	NA months Median and the upper and lower limit of confidence interval could not be calculated because of less than 50% of the participants reaching PR or better with PFS events (PFS events includes progression and death without progression).

SECONDARY outcome

Timeframe: From randomization until the primary analysis data cut-off date of 7 Feb 2020 (the median duration of follow-up was 20.73 months)

Population: Analysis was performed on ITT population. Analysis was performed by Kaplan-Meier method.

TTP was defined as time in months from randomization to the date of first documentation of PD (as determined by the IRC). If progression was not observed before the analysis cut-off date or the date of initiation of further anti-myeloma treatment, TTP was 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. As per IMWG criteria, PD was defined for participants with inc of \>= 25% from lowest confirmed value in any one of the following criteria: serum M-protein (the absolute inc must be \>= 0.5 g/dL), serum M-protein inc \>=1 g/dL if the lowest M component was \>=5 g/dL; urine M-component (the absolute inc must be \>=200 mg/24hour), appearance of new lesion(s), \>=50% inc from nadir in SPD of \>1 lesion, or \>=50% inc in the longest diameter of a previous lesion \>1 centimeter in short axis.

Outcome measures

Outcome measures
Measure	Carfilzomib + Dexamethasone (Kd) n=123 Participants Participants received carfilzomib 20 mg/m\^2, IV infusion on Days 1, and 2 in Cycle 1, and then escalated to 56 mg/m\^2 on Days 8, 9, 15 and 16 of Cycle 1 and then on Days 1, 2, 8, 9, 15 and 16 of each subsequent 28-day treatment cycle along with dexamethasone 20 mg, PO or IV on Days 1, 2, 8, 9, 15, 16, 22 and 23 of each 28-day treatment cycle until disease progression or unacceptable adverse event or participant's decision to discontinue the study treatment or any other reason, whichever comes first (maximum exposure: 114 weeks).	Isatuximab + Carfilzomib + Dexamethasone (IKd) n=179 Participants Participants received isatuximab 10 mg/kg, IV infusion on Days 1, 8, 15 and 22 in Cycle 1, and then on Days 1 and Day 15 of each 28-day treatment cycle plus carfilzomib 20 mg/m\^2, IV on Days 1, and 2 in Cycle 1, and then escalated to 56 mg/m\^2 on Days 8, 9, 15 and 16 of Cycle 1 and then on Days 1, 2, 8, 9, 15 and 16 of each subsequent 28-day treatment cycle and dexamethasone 20 mg, PO or IV on Day 1, 2, 8, 9, 15, 16, 22 and 23 of each 28-day treatment cycle until disease progression or unacceptable adverse event or participant's decision to discontinue the study treatment or any other reason, whichever comes first (maximum exposure: 111 weeks).
Time to Progression (TTP): Primary Analysis	20.27 months Interval 16.986 to Upper limit of the confidence interval could not be reached due to less number of participants with the progression event.	NA months Median and the upper and lower limit of confidence interval could not be calculated because of less than 50% of the participants with the progression event.

SECONDARY outcome

Timeframe: From randomization until the primary analysis data cut-off date of 7 Feb 2020 (the median duration of follow-up was 20.73 months)

Population: Analysis was performed on ITT population. Analysis was performed by Kaplan-Meier method.

Time to first response was defined as the time (in months) from randomization to the date of first IRC determined response (PR or better) that is subsequently confirmed. In the absence of response, participants were censored at the earliest of the date of the last valid disease assessment before disease progression or death, the date of the last valid disease assessment before initiation of a further anti-myeloma treatment (if any) or the analysis cut-off date, whichever comes first. PR per IMWG criteria was defined as \>=50% reduction of serum M-protein and reduction in 24 hours urinary M-protein by \>=90% or to \<200 mg/24 h. In addition to the above listed criteria, if present at baseline, a \>=50% reduction in the size (SPD) of soft tissue plasmacytomas was also required.

Outcome measures

Outcome measures
Measure	Carfilzomib + Dexamethasone (Kd) n=123 Participants Participants received carfilzomib 20 mg/m\^2, IV infusion on Days 1, and 2 in Cycle 1, and then escalated to 56 mg/m\^2 on Days 8, 9, 15 and 16 of Cycle 1 and then on Days 1, 2, 8, 9, 15 and 16 of each subsequent 28-day treatment cycle along with dexamethasone 20 mg, PO or IV on Days 1, 2, 8, 9, 15, 16, 22 and 23 of each 28-day treatment cycle until disease progression or unacceptable adverse event or participant's decision to discontinue the study treatment or any other reason, whichever comes first (maximum exposure: 114 weeks).	Isatuximab + Carfilzomib + Dexamethasone (IKd) n=179 Participants Participants received isatuximab 10 mg/kg, IV infusion on Days 1, 8, 15 and 22 in Cycle 1, and then on Days 1 and Day 15 of each 28-day treatment cycle plus carfilzomib 20 mg/m\^2, IV on Days 1, and 2 in Cycle 1, and then escalated to 56 mg/m\^2 on Days 8, 9, 15 and 16 of Cycle 1 and then on Days 1, 2, 8, 9, 15 and 16 of each subsequent 28-day treatment cycle and dexamethasone 20 mg, PO or IV on Day 1, 2, 8, 9, 15, 16, 22 and 23 of each 28-day treatment cycle until disease progression or unacceptable adverse event or participant's decision to discontinue the study treatment or any other reason, whichever comes first (maximum exposure: 111 weeks).
Time to First Response: Primary Analysis	1.12 months Interval 1.051 to 1.183	1.08 months Interval 1.051 to 1.117

SECONDARY outcome

Timeframe: From randomization until the primary analysis data cut-off date of 7 Feb 2020 (the median duration of follow-up was 20.73 months)

Population: Analysis was performed on ITT population. Analysis was performed by Kaplan-Meier method.

Time to best response was defined as time (in months) from randomization to the date of first occurrence of IRC determined as best overall response (PR or better) that is subsequently confirmed. In absence of response, participants were censored at earliest date of last valid disease assessment before disease progression/death, date of last valid disease assessment before initiation of further anti-myeloma treatment (if any)/ analysis cut-off date, whichever was 1st. PR (IMWG criteria) was defined as \>=50% reduction of serum M-protein and reduction in 24 hours urinary M-protein by \>=90% or to \<200 mg/24 h. In addition to above listed criteria, if present at baseline, a \>=50% reduction in the size (SPD) of soft tissue plasmacytomas was also required. Best Overall Response was defined as the best response, using the IRC's assessment of response, from start of treatment until disease progression, death, initiation of further anti-myeloma treatment or cut-off date, whichever occurs 1st.

Outcome measures

Outcome measures
Measure	Carfilzomib + Dexamethasone (Kd) n=123 Participants Participants received carfilzomib 20 mg/m\^2, IV infusion on Days 1, and 2 in Cycle 1, and then escalated to 56 mg/m\^2 on Days 8, 9, 15 and 16 of Cycle 1 and then on Days 1, 2, 8, 9, 15 and 16 of each subsequent 28-day treatment cycle along with dexamethasone 20 mg, PO or IV on Days 1, 2, 8, 9, 15, 16, 22 and 23 of each 28-day treatment cycle until disease progression or unacceptable adverse event or participant's decision to discontinue the study treatment or any other reason, whichever comes first (maximum exposure: 114 weeks).	Isatuximab + Carfilzomib + Dexamethasone (IKd) n=179 Participants Participants received isatuximab 10 mg/kg, IV infusion on Days 1, 8, 15 and 22 in Cycle 1, and then on Days 1 and Day 15 of each 28-day treatment cycle plus carfilzomib 20 mg/m\^2, IV on Days 1, and 2 in Cycle 1, and then escalated to 56 mg/m\^2 on Days 8, 9, 15 and 16 of Cycle 1 and then on Days 1, 2, 8, 9, 15 and 16 of each subsequent 28-day treatment cycle and dexamethasone 20 mg, PO or IV on Day 1, 2, 8, 9, 15, 16, 22 and 23 of each 28-day treatment cycle until disease progression or unacceptable adverse event or participant's decision to discontinue the study treatment or any other reason, whichever comes first (maximum exposure: 111 weeks).
Time to Best Response: Primary Analysis	3.78 months Interval 2.858 to 4.172	4.60 months Interval 3.811 to 5.257

SECONDARY outcome

Timeframe: From randomization until the final analysis data cut-off date of 14 Jan 2022 (the median duration of follow-up was 43.96 months)

Population: Analysis was performed on ITT population. Analysis was performed by Kaplan-Meier method.

PFS2 defined as time (in months) from date of randomization to date of 1st documentation of PD (as assessed by investigator) after initiation of further anti-myeloma treatment /death from any cause, whichever comes 1st. Participants alive without progression after initiation of further anti-myeloma treatment before analysis cut-off date, PFS2 censored at date of last follow-up visit not showing disease progression after initiation of further anti-myeloma treatment /analysis cut-off date, whichever comes 1st. As per IMWG criteria, PD: defined for participants with increase of \>= 25% from lowest confirmed value in any 1 of following criteria: serum M-protein (absolute increase must be \>= 0.5 g/dL), serum M-protein increase \>=1 g/dL if lowest M component was \>=5 g/dL; urine M-component (absolute increase must be \>=200 mg/24hour), appearance of new lesion(s), \>=50% increase from nadir in SPD of \>1 lesion, or \>=50% increase in longest diameter of previous lesion \>1 centimeter short axis.

Outcome measures

Outcome measures
Measure	Carfilzomib + Dexamethasone (Kd) n=123 Participants Participants received carfilzomib 20 mg/m\^2, IV infusion on Days 1, and 2 in Cycle 1, and then escalated to 56 mg/m\^2 on Days 8, 9, 15 and 16 of Cycle 1 and then on Days 1, 2, 8, 9, 15 and 16 of each subsequent 28-day treatment cycle along with dexamethasone 20 mg, PO or IV on Days 1, 2, 8, 9, 15, 16, 22 and 23 of each 28-day treatment cycle until disease progression or unacceptable adverse event or participant's decision to discontinue the study treatment or any other reason, whichever comes first (maximum exposure: 114 weeks).	Isatuximab + Carfilzomib + Dexamethasone (IKd) n=179 Participants Participants received isatuximab 10 mg/kg, IV infusion on Days 1, 8, 15 and 22 in Cycle 1, and then on Days 1 and Day 15 of each 28-day treatment cycle plus carfilzomib 20 mg/m\^2, IV on Days 1, and 2 in Cycle 1, and then escalated to 56 mg/m\^2 on Days 8, 9, 15 and 16 of Cycle 1 and then on Days 1, 2, 8, 9, 15 and 16 of each subsequent 28-day treatment cycle and dexamethasone 20 mg, PO or IV on Day 1, 2, 8, 9, 15, 16, 22 and 23 of each 28-day treatment cycle until disease progression or unacceptable adverse event or participant's decision to discontinue the study treatment or any other reason, whichever comes first (maximum exposure: 111 weeks).
Second Progression Free Survival (PFS2): Final Analysis - Data Cut-off Date of 14 Jan 2022	35.58 months Interval 24.049 to 40.509	47.18 months Interval 38.111 to Upper limit of confidence interval could not be calculated because not enough participants with PFS2 events.

SECONDARY outcome

Timeframe: From randomization until the overal survival analysis data cut-off date of 07 Feb 2023 (the median duration of follow-up was 56.61 months)

Population: Analysis was performed on ITT population. Analysis was performed by Kaplan-Meier method.

Outcome measures

Outcome measures
Measure	Carfilzomib + Dexamethasone (Kd) n=123 Participants Participants received carfilzomib 20 mg/m\^2, IV infusion on Days 1, and 2 in Cycle 1, and then escalated to 56 mg/m\^2 on Days 8, 9, 15 and 16 of Cycle 1 and then on Days 1, 2, 8, 9, 15 and 16 of each subsequent 28-day treatment cycle along with dexamethasone 20 mg, PO or IV on Days 1, 2, 8, 9, 15, 16, 22 and 23 of each 28-day treatment cycle until disease progression or unacceptable adverse event or participant's decision to discontinue the study treatment or any other reason, whichever comes first (maximum exposure: 114 weeks).	Isatuximab + Carfilzomib + Dexamethasone (IKd) n=179 Participants Participants received isatuximab 10 mg/kg, IV infusion on Days 1, 8, 15 and 22 in Cycle 1, and then on Days 1 and Day 15 of each 28-day treatment cycle plus carfilzomib 20 mg/m\^2, IV on Days 1, and 2 in Cycle 1, and then escalated to 56 mg/m\^2 on Days 8, 9, 15 and 16 of Cycle 1 and then on Days 1, 2, 8, 9, 15 and 16 of each subsequent 28-day treatment cycle and dexamethasone 20 mg, PO or IV on Day 1, 2, 8, 9, 15, 16, 22 and 23 of each 28-day treatment cycle until disease progression or unacceptable adverse event or participant's decision to discontinue the study treatment or any other reason, whichever comes first (maximum exposure: 111 weeks).
Second Progression Free Survival (PFS2): Overal Survival Analysis - Data Cut-off Date of 07 Feb 2023	32.36 months Interval 23.129 to 40.016	47.18 months Interval 38.965 to 57.922

SECONDARY outcome

Timeframe: From the first dose of study treatment to 30 days following the last administration of study treatment (maximum duration: up to 114 weeks)

Population: Analysis was performed on ITT population. Here, 'overall number of participants analyzed' = participants with available data for this outcome measure and 'Number analyzed' signifies participants with available data for each specified category. Here, "0" signifies that none of the participants were available for assessment at the specified timepoint.

RR comprises of complete RR (CR renal), partial RR (PR renal) \& minor RR (MR renal). CR renal was defined as an improvement in estimated glomerular filtration rate (eGFR) from \<50 mL/min/1.73m\^2 at Baseline to \>=60 mL/min/1.73m\^2 in at least 1 assessment during the treatment period (time from first dose of study treatment up to 30 days after last dose of study treatment); PR renal was defined as improvement in eGFR from \<15 mL/min/1.73m\^2 at baseline to at least 1 assessment in the range of 30 to 60 mL/min/1.73m\^2 during the on-treatment-period and MR renal was defined as an improvement in eGFR from \<15 mL/min/1.73m\^2 at Baseline to at least 1 assessment in the range of 15 to 30 mL/min/1.73m\^2 during the on-treatment-period or from 15 to 30 mL/min/1.73m\^2 at Baseline to at least 1 assessment in the range of 30 to 60 mL/min/1.73m\^2 during the on-treatment-period.

Outcome measures

Outcome measures
Measure	Carfilzomib + Dexamethasone (Kd) n=13 Participants Participants received carfilzomib 20 mg/m\^2, IV infusion on Days 1, and 2 in Cycle 1, and then escalated to 56 mg/m\^2 on Days 8, 9, 15 and 16 of Cycle 1 and then on Days 1, 2, 8, 9, 15 and 16 of each subsequent 28-day treatment cycle along with dexamethasone 20 mg, PO or IV on Days 1, 2, 8, 9, 15, 16, 22 and 23 of each 28-day treatment cycle until disease progression or unacceptable adverse event or participant's decision to discontinue the study treatment or any other reason, whichever comes first (maximum exposure: 114 weeks).	Isatuximab + Carfilzomib + Dexamethasone (IKd) n=25 Participants Participants received isatuximab 10 mg/kg, IV infusion on Days 1, 8, 15 and 22 in Cycle 1, and then on Days 1 and Day 15 of each 28-day treatment cycle plus carfilzomib 20 mg/m\^2, IV on Days 1, and 2 in Cycle 1, and then escalated to 56 mg/m\^2 on Days 8, 9, 15 and 16 of Cycle 1 and then on Days 1, 2, 8, 9, 15 and 16 of each subsequent 28-day treatment cycle and dexamethasone 20 mg, PO or IV on Day 1, 2, 8, 9, 15, 16, 22 and 23 of each 28-day treatment cycle until disease progression or unacceptable adverse event or participant's decision to discontinue the study treatment or any other reason, whichever comes first (maximum exposure: 111 weeks).
Number of Participants With Renal Response (RR): Primary Analysis MR Renal	1 Participants	4 Participants
Number of Participants With Renal Response (RR): Primary Analysis CR Renal	4 Participants	13 Participants

SECONDARY outcome

Timeframe: Baseline, Day 1 of each cycle (Cycle 2 to Cycle 25), at the End of Treatment visit (any day up to 114 weeks)

Population: Analysis was performed on ITT population. Here, 'Number analyzed' signifies participants with available data for each specified category.

EORTC QLQ-C30 is a cancer-specific instrument that contains 30 items \& provides multidimensional assessment of HRQL. EORTC QLQ-C30 includes global health status/quality of life (GHS/QOL), functional scales (physical, role, cognitive, emotional, social), symptom scales (fatigue, pain, nausea/vomiting), and 6 single items (dyspnea, appetite loss, insomnia, constipation, diarrhea, financial difficulties). Most questions from QLQ-C30 are 4-point scale (1/Not at All to 4/Very Much), except Items 29-30, which comprise GHS scale \& are 7-point scale (1/Very Poor to 7/Excellent). GHS total score is calculated as (\[{Q29+Q30}/2\]-1)/6\*100. Answers are converted into grading scale, with values between 0 (worse outcome) to100 (best outcome). High score represents a favorable outcome with best quality of life for participant. Results reported for primary analysis with data cut-off date 7-Feb-2020.

Outcome measures

Outcome measures
Measure	Carfilzomib + Dexamethasone (Kd) n=123 Participants Participants received carfilzomib 20 mg/m\^2, IV infusion on Days 1, and 2 in Cycle 1, and then escalated to 56 mg/m\^2 on Days 8, 9, 15 and 16 of Cycle 1 and then on Days 1, 2, 8, 9, 15 and 16 of each subsequent 28-day treatment cycle along with dexamethasone 20 mg, PO or IV on Days 1, 2, 8, 9, 15, 16, 22 and 23 of each 28-day treatment cycle until disease progression or unacceptable adverse event or participant's decision to discontinue the study treatment or any other reason, whichever comes first (maximum exposure: 114 weeks).	Isatuximab + Carfilzomib + Dexamethasone (IKd) n=179 Participants Participants received isatuximab 10 mg/kg, IV infusion on Days 1, 8, 15 and 22 in Cycle 1, and then on Days 1 and Day 15 of each 28-day treatment cycle plus carfilzomib 20 mg/m\^2, IV on Days 1, and 2 in Cycle 1, and then escalated to 56 mg/m\^2 on Days 8, 9, 15 and 16 of Cycle 1 and then on Days 1, 2, 8, 9, 15 and 16 of each subsequent 28-day treatment cycle and dexamethasone 20 mg, PO or IV on Day 1, 2, 8, 9, 15, 16, 22 and 23 of each 28-day treatment cycle until disease progression or unacceptable adverse event or participant's decision to discontinue the study treatment or any other reason, whichever comes first (maximum exposure: 111 weeks).
Health Related Quality of Life (HRQL): Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Cancer Specific Questionnaire With 30 Items (EORTC QLQ-C30): Global Health Status Score at Specified Timepoints Cycle 18 Day 1	8.70 score on a scale Standard Deviation 23.16	-0.36 score on a scale Standard Deviation 20.56
Health Related Quality of Life (HRQL): Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Cancer Specific Questionnaire With 30 Items (EORTC QLQ-C30): Global Health Status Score at Specified Timepoints Cycle 21 Day 1	12.50 score on a scale Standard Deviation 21.81	-1.85 score on a scale Standard Deviation 21.54
Health Related Quality of Life (HRQL): Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Cancer Specific Questionnaire With 30 Items (EORTC QLQ-C30): Global Health Status Score at Specified Timepoints Cycle 23 Day 1	15.56 score on a scale Standard Deviation 22.02	3.15 score on a scale Standard Deviation 20.73
Health Related Quality of Life (HRQL): Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Cancer Specific Questionnaire With 30 Items (EORTC QLQ-C30): Global Health Status Score at Specified Timepoints Cycle 25 Day 1	15.00 score on a scale Standard Deviation 28.50	3.13 score on a scale Standard Deviation 17.18
Health Related Quality of Life (HRQL): Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Cancer Specific Questionnaire With 30 Items (EORTC QLQ-C30): Global Health Status Score at Specified Timepoints End of Treatment	-6.14 score on a scale Standard Deviation 22.90	-11.90 score on a scale Standard Deviation 25.86
Health Related Quality of Life (HRQL): Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Cancer Specific Questionnaire With 30 Items (EORTC QLQ-C30): Global Health Status Score at Specified Timepoints Cycle 2 Day 1	1.52 score on a scale Standard Deviation 21.11	-1.60 score on a scale Standard Deviation 20.06
Health Related Quality of Life (HRQL): Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Cancer Specific Questionnaire With 30 Items (EORTC QLQ-C30): Global Health Status Score at Specified Timepoints Cycle 3 Day 1	4.17 score on a scale Standard Deviation 22.92	0.05 score on a scale Standard Deviation 20.29
Health Related Quality of Life (HRQL): Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Cancer Specific Questionnaire With 30 Items (EORTC QLQ-C30): Global Health Status Score at Specified Timepoints Cycle 4 Day 1	3.58 score on a scale Standard Deviation 21.20	-1.89 score on a scale Standard Deviation 23.71
Health Related Quality of Life (HRQL): Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Cancer Specific Questionnaire With 30 Items (EORTC QLQ-C30): Global Health Status Score at Specified Timepoints Cycle 5 Day 1	3.60 score on a scale Standard Deviation 21.80	-1.23 score on a scale Standard Deviation 23.12
Health Related Quality of Life (HRQL): Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Cancer Specific Questionnaire With 30 Items (EORTC QLQ-C30): Global Health Status Score at Specified Timepoints Cycle 6 Day 1	3.13 score on a scale Standard Deviation 20.50	-1.44 score on a scale Standard Deviation 22.12
Health Related Quality of Life (HRQL): Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Cancer Specific Questionnaire With 30 Items (EORTC QLQ-C30): Global Health Status Score at Specified Timepoints Cycle 7 Day 1	4.22 score on a scale Standard Deviation 22.55	-1.77 score on a scale Standard Deviation 22.38
Health Related Quality of Life (HRQL): Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Cancer Specific Questionnaire With 30 Items (EORTC QLQ-C30): Global Health Status Score at Specified Timepoints Cycle 8 Day 1	3.82 score on a scale Standard Deviation 21.71	-1.06 score on a scale Standard Deviation 20.78
Health Related Quality of Life (HRQL): Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Cancer Specific Questionnaire With 30 Items (EORTC QLQ-C30): Global Health Status Score at Specified Timepoints Cycle 9 Day 1	6.60 score on a scale Standard Deviation 19.28	-0.78 score on a scale Standard Deviation 22.17
Health Related Quality of Life (HRQL): Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Cancer Specific Questionnaire With 30 Items (EORTC QLQ-C30): Global Health Status Score at Specified Timepoints Cycle 10 Day 1	4.91 score on a scale Standard Deviation 21.55	-1.21 score on a scale Standard Deviation 20.35
Health Related Quality of Life (HRQL): Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Cancer Specific Questionnaire With 30 Items (EORTC QLQ-C30): Global Health Status Score at Specified Timepoints Cycle 11 Day 1	4.34 score on a scale Standard Deviation 20.06	-1.10 score on a scale Standard Deviation 20.18
Health Related Quality of Life (HRQL): Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Cancer Specific Questionnaire With 30 Items (EORTC QLQ-C30): Global Health Status Score at Specified Timepoints Cycle 12 Day 1	8.59 score on a scale Standard Deviation 22.37	0.84 score on a scale Standard Deviation 22.40
Health Related Quality of Life (HRQL): Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Cancer Specific Questionnaire With 30 Items (EORTC QLQ-C30): Global Health Status Score at Specified Timepoints Cycle 13 Day 1	7.08 score on a scale Standard Deviation 19.76	-1.26 score on a scale Standard Deviation 20.63
Health Related Quality of Life (HRQL): Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Cancer Specific Questionnaire With 30 Items (EORTC QLQ-C30): Global Health Status Score at Specified Timepoints Cycle 14 Day 1	9.75 score on a scale Standard Deviation 21.62	-0.98 score on a scale Standard Deviation 21.43
Health Related Quality of Life (HRQL): Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Cancer Specific Questionnaire With 30 Items (EORTC QLQ-C30): Global Health Status Score at Specified Timepoints Cycle 15 Day 1	5.26 score on a scale Standard Deviation 22.14	0.16 score on a scale Standard Deviation 20.51
Health Related Quality of Life (HRQL): Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Cancer Specific Questionnaire With 30 Items (EORTC QLQ-C30): Global Health Status Score at Specified Timepoints Cycle 16 Day 1	6.33 score on a scale Standard Deviation 20.73	-1.07 score on a scale Standard Deviation 20.94
Health Related Quality of Life (HRQL): Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Cancer Specific Questionnaire With 30 Items (EORTC QLQ-C30): Global Health Status Score at Specified Timepoints Cycle 17 Day 1	7.27 score on a scale Standard Deviation 21.04	0.00 score on a scale Standard Deviation 22.18
Health Related Quality of Life (HRQL): Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Cancer Specific Questionnaire With 30 Items (EORTC QLQ-C30): Global Health Status Score at Specified Timepoints Cycle 19 Day 1	12.40 score on a scale Standard Deviation 21.42	-1.23 score on a scale Standard Deviation 20.12
Health Related Quality of Life (HRQL): Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Cancer Specific Questionnaire With 30 Items (EORTC QLQ-C30): Global Health Status Score at Specified Timepoints Cycle 20 Day 1	10.78 score on a scale Standard Deviation 20.97	-1.05 score on a scale Standard Deviation 20.40
Health Related Quality of Life (HRQL): Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Cancer Specific Questionnaire With 30 Items (EORTC QLQ-C30): Global Health Status Score at Specified Timepoints Cycle 22 Day 1	17.98 score on a scale Standard Deviation 22.27	0.31 score on a scale Standard Deviation 21.24
Health Related Quality of Life (HRQL): Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Cancer Specific Questionnaire With 30 Items (EORTC QLQ-C30): Global Health Status Score at Specified Timepoints Cycle 24 Day 1	14.81 score on a scale Standard Deviation 26.28	0.38 score on a scale Standard Deviation 14.88

SECONDARY outcome

Timeframe: Baseline, Day 1 of each cycle (Cycle 2 to Cycle 25), at the End of Treatment visit (any day up to 114 weeks)

Population: Analysis was performed on ITT population. Here, 'Number analyzed' signifies participants with available data for each specified category.

EORTC QLQ-MY20 is a validated questionnaire to assess the overall quality of life in participants with multiple myeloma. It is used in conjunction with the EORTC QLQ-C30 to assess symptoms and side effects due to treatment or the disease. Disease symptoms domain is one of the four domain scores. Disease symptoms domain consist of 6 questions and the score uses 4-point scale (1 'Not at All' to 4 'Very Much'). Disease Symptoms Domain Score is calculated as (\[{Q31+Q32+Q33+Q34+Q35+Q36}/6\]-1)/3\*100. Scores are averaged, and transformed to 0-100 scale, where higher scores = more symptoms and lower HRQL.

Outcome measures

Outcome measures
Measure	Carfilzomib + Dexamethasone (Kd) n=123 Participants Participants received carfilzomib 20 mg/m\^2, IV infusion on Days 1, and 2 in Cycle 1, and then escalated to 56 mg/m\^2 on Days 8, 9, 15 and 16 of Cycle 1 and then on Days 1, 2, 8, 9, 15 and 16 of each subsequent 28-day treatment cycle along with dexamethasone 20 mg, PO or IV on Days 1, 2, 8, 9, 15, 16, 22 and 23 of each 28-day treatment cycle until disease progression or unacceptable adverse event or participant's decision to discontinue the study treatment or any other reason, whichever comes first (maximum exposure: 114 weeks).	Isatuximab + Carfilzomib + Dexamethasone (IKd) n=179 Participants Participants received isatuximab 10 mg/kg, IV infusion on Days 1, 8, 15 and 22 in Cycle 1, and then on Days 1 and Day 15 of each 28-day treatment cycle plus carfilzomib 20 mg/m\^2, IV on Days 1, and 2 in Cycle 1, and then escalated to 56 mg/m\^2 on Days 8, 9, 15 and 16 of Cycle 1 and then on Days 1, 2, 8, 9, 15 and 16 of each subsequent 28-day treatment cycle and dexamethasone 20 mg, PO or IV on Day 1, 2, 8, 9, 15, 16, 22 and 23 of each 28-day treatment cycle until disease progression or unacceptable adverse event or participant's decision to discontinue the study treatment or any other reason, whichever comes first (maximum exposure: 111 weeks).
HRQL: Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Cancer Specific Questionnaire With 20 Items (EORTC QLQ-MY20): Disease Symptoms Domain Score at Specified Timepoints: Primary Analysis Cycle 2 Day 1	-5.34 score on a scale Standard Deviation 15.75	-3.40 score on a scale Standard Deviation 19.58
HRQL: Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Cancer Specific Questionnaire With 20 Items (EORTC QLQ-MY20): Disease Symptoms Domain Score at Specified Timepoints: Primary Analysis Cycle 3 Day 1	-8.28 score on a scale Standard Deviation 15.33	-7.42 score on a scale Standard Deviation 18.15
HRQL: Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Cancer Specific Questionnaire With 20 Items (EORTC QLQ-MY20): Disease Symptoms Domain Score at Specified Timepoints: Primary Analysis Cycle 4 Day 1	-5.45 score on a scale Standard Deviation 17.48	-7.46 score on a scale Standard Deviation 17.99
HRQL: Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Cancer Specific Questionnaire With 20 Items (EORTC QLQ-MY20): Disease Symptoms Domain Score at Specified Timepoints: Primary Analysis Cycle 5 Day 1	-5.78 score on a scale Standard Deviation 17.01	-6.37 score on a scale Standard Deviation 18.32
HRQL: Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Cancer Specific Questionnaire With 20 Items (EORTC QLQ-MY20): Disease Symptoms Domain Score at Specified Timepoints: Primary Analysis Cycle 6 Day 1	-6.11 score on a scale Standard Deviation 18.07	-6.16 score on a scale Standard Deviation 19.88
HRQL: Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Cancer Specific Questionnaire With 20 Items (EORTC QLQ-MY20): Disease Symptoms Domain Score at Specified Timepoints: Primary Analysis Cycle 7 Day 1	-6.64 score on a scale Standard Deviation 17.44	-4.78 score on a scale Standard Deviation 20.77
HRQL: Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Cancer Specific Questionnaire With 20 Items (EORTC QLQ-MY20): Disease Symptoms Domain Score at Specified Timepoints: Primary Analysis Cycle 8 Day 1	-6.94 score on a scale Standard Deviation 17.76	-5.47 score on a scale Standard Deviation 19.96
HRQL: Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Cancer Specific Questionnaire With 20 Items (EORTC QLQ-MY20): Disease Symptoms Domain Score at Specified Timepoints: Primary Analysis Cycle 9 Day 1	-5.65 score on a scale Standard Deviation 18.00	-5.51 score on a scale Standard Deviation 17.86
HRQL: Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Cancer Specific Questionnaire With 20 Items (EORTC QLQ-MY20): Disease Symptoms Domain Score at Specified Timepoints: Primary Analysis Cycle 10 Day 1	-5.56 score on a scale Standard Deviation 18.48	-4.98 score on a scale Standard Deviation 17.24
HRQL: Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Cancer Specific Questionnaire With 20 Items (EORTC QLQ-MY20): Disease Symptoms Domain Score at Specified Timepoints: Primary Analysis Cycle 11 Day 1	-3.24 score on a scale Standard Deviation 17.78	-7.10 score on a scale Standard Deviation 17.57
HRQL: Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Cancer Specific Questionnaire With 20 Items (EORTC QLQ-MY20): Disease Symptoms Domain Score at Specified Timepoints: Primary Analysis Cycle 12 Day 1	-5.30 score on a scale Standard Deviation 16.27	-6.89 score on a scale Standard Deviation 17.58
HRQL: Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Cancer Specific Questionnaire With 20 Items (EORTC QLQ-MY20): Disease Symptoms Domain Score at Specified Timepoints: Primary Analysis Cycle 13 Day 1	-7.69 score on a scale Standard Deviation 17.06	-5.95 score on a scale Standard Deviation 16.44
HRQL: Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Cancer Specific Questionnaire With 20 Items (EORTC QLQ-MY20): Disease Symptoms Domain Score at Specified Timepoints: Primary Analysis Cycle 14 Day 1	-8.66 score on a scale Standard Deviation 16.35	-7.08 score on a scale Standard Deviation 17.98
HRQL: Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Cancer Specific Questionnaire With 20 Items (EORTC QLQ-MY20): Disease Symptoms Domain Score at Specified Timepoints: Primary Analysis Cycle 15 Day 1	-5.56 score on a scale Standard Deviation 17.69	-5.19 score on a scale Standard Deviation 17.84
HRQL: Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Cancer Specific Questionnaire With 20 Items (EORTC QLQ-MY20): Disease Symptoms Domain Score at Specified Timepoints: Primary Analysis Cycle 16 Day 1	-8.06 score on a scale Standard Deviation 18.27	-5.77 score on a scale Standard Deviation 18.66
HRQL: Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Cancer Specific Questionnaire With 20 Items (EORTC QLQ-MY20): Disease Symptoms Domain Score at Specified Timepoints: Primary Analysis Cycle 17 Day 1	-7.57 score on a scale Standard Deviation 19.01	-4.29 score on a scale Standard Deviation 19.73
HRQL: Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Cancer Specific Questionnaire With 20 Items (EORTC QLQ-MY20): Disease Symptoms Domain Score at Specified Timepoints: Primary Analysis Cycle 18 Day 1	-7.16 score on a scale Standard Deviation 17.67	-3.78 score on a scale Standard Deviation 17.93
HRQL: Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Cancer Specific Questionnaire With 20 Items (EORTC QLQ-MY20): Disease Symptoms Domain Score at Specified Timepoints: Primary Analysis Cycle 19 Day 1	-7.18 score on a scale Standard Deviation 19.57	-3.64 score on a scale Standard Deviation 16.70
HRQL: Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Cancer Specific Questionnaire With 20 Items (EORTC QLQ-MY20): Disease Symptoms Domain Score at Specified Timepoints: Primary Analysis Cycle 20 Day 1	-11.93 score on a scale Standard Deviation 17.09	-3.54 score on a scale Standard Deviation 21.63
HRQL: Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Cancer Specific Questionnaire With 20 Items (EORTC QLQ-MY20): Disease Symptoms Domain Score at Specified Timepoints: Primary Analysis Cycle 21 Day 1	-9.72 score on a scale Standard Deviation 16.74	-3.81 score on a scale Standard Deviation 19.70
HRQL: Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Cancer Specific Questionnaire With 20 Items (EORTC QLQ-MY20): Disease Symptoms Domain Score at Specified Timepoints: Primary Analysis Cycle 22 Day 1	-9.94 score on a scale Standard Deviation 18.76	-5.35 score on a scale Standard Deviation 22.48
HRQL: Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Cancer Specific Questionnaire With 20 Items (EORTC QLQ-MY20): Disease Symptoms Domain Score at Specified Timepoints: Primary Analysis Cycle 23 Day 1	-5.56 score on a scale Standard Deviation 25.11	-6.01 score on a scale Standard Deviation 19.53
HRQL: Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Cancer Specific Questionnaire With 20 Items (EORTC QLQ-MY20): Disease Symptoms Domain Score at Specified Timepoints: Primary Analysis Cycle 24 Day 1	-6.17 score on a scale Standard Deviation 29.97	-9.60 score on a scale Standard Deviation 18.16
HRQL: Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Cancer Specific Questionnaire With 20 Items (EORTC QLQ-MY20): Disease Symptoms Domain Score at Specified Timepoints: Primary Analysis Cycle 25 Day 1	-12.22 score on a scale Standard Deviation 28.97	-14.58 score on a scale Standard Deviation 21.65
HRQL: Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Cancer Specific Questionnaire With 20 Items (EORTC QLQ-MY20): Disease Symptoms Domain Score at Specified Timepoints: Primary Analysis End of Treatment	2.35 score on a scale Standard Deviation 23.10	1.75 score on a scale Standard Deviation 23.48

SECONDARY outcome

Timeframe: Baseline, Day 1 of each cycle (Cycle 2 to Cycle 25), at the End of Treatment visit (any day up to 114 weeks)

Population: Analysis was performed on ITT population. Here, 'Number analyzed' signifies participants with available data for each specified category.

EORTC QLQ-MY20 is a validated questionnaire to assess the overall quality of life in participants with multiple myeloma. Side effects of treatment domain is one of the four domain scores. Side effects of treatment domain consists of 10 questions and the score uses a 4-point scale (1 'Not at All' to 4 'Very Much'). Side Effects of Treatment Score (MYSE) is calculated as (\[{Q37+Q38+Q39+Q40+Q41+Q42+Q43+Q44+Q45+Q46}/10\]-1)/3\*100. Scores are averaged, and transformed to 0-100 scale, where higher scores = more side effects and lower HRQL and lower scores = less side effects and better HRQL.

Outcome measures

Outcome measures
Measure	Carfilzomib + Dexamethasone (Kd) n=123 Participants Participants received carfilzomib 20 mg/m\^2, IV infusion on Days 1, and 2 in Cycle 1, and then escalated to 56 mg/m\^2 on Days 8, 9, 15 and 16 of Cycle 1 and then on Days 1, 2, 8, 9, 15 and 16 of each subsequent 28-day treatment cycle along with dexamethasone 20 mg, PO or IV on Days 1, 2, 8, 9, 15, 16, 22 and 23 of each 28-day treatment cycle until disease progression or unacceptable adverse event or participant's decision to discontinue the study treatment or any other reason, whichever comes first (maximum exposure: 114 weeks).	Isatuximab + Carfilzomib + Dexamethasone (IKd) n=179 Participants Participants received isatuximab 10 mg/kg, IV infusion on Days 1, 8, 15 and 22 in Cycle 1, and then on Days 1 and Day 15 of each 28-day treatment cycle plus carfilzomib 20 mg/m\^2, IV on Days 1, and 2 in Cycle 1, and then escalated to 56 mg/m\^2 on Days 8, 9, 15 and 16 of Cycle 1 and then on Days 1, 2, 8, 9, 15 and 16 of each subsequent 28-day treatment cycle and dexamethasone 20 mg, PO or IV on Day 1, 2, 8, 9, 15, 16, 22 and 23 of each 28-day treatment cycle until disease progression or unacceptable adverse event or participant's decision to discontinue the study treatment or any other reason, whichever comes first (maximum exposure: 111 weeks).
HRQL: Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Cancer Specific Questionnaire With 20 Items (EORTC QLQ-MY20): Side Effects of Treatment at Specified Timepoints: Primary Analysis Cycle 4 Day 1	0.83 score on a scale Standard Deviation 11.38	0.99 score on a scale Standard Deviation 11.89
HRQL: Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Cancer Specific Questionnaire With 20 Items (EORTC QLQ-MY20): Side Effects of Treatment at Specified Timepoints: Primary Analysis Cycle 2 Day 1	1.23 score on a scale Standard Deviation 11.56	1.41 score on a scale Standard Deviation 11.71
HRQL: Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Cancer Specific Questionnaire With 20 Items (EORTC QLQ-MY20): Side Effects of Treatment at Specified Timepoints: Primary Analysis Cycle 3 Day 1	0.44 score on a scale Standard Deviation 10.11	0.84 score on a scale Standard Deviation 12.00
HRQL: Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Cancer Specific Questionnaire With 20 Items (EORTC QLQ-MY20): Side Effects of Treatment at Specified Timepoints: Primary Analysis Cycle 5 Day 1	1.91 score on a scale Standard Deviation 11.36	2.36 score on a scale Standard Deviation 11.94
HRQL: Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Cancer Specific Questionnaire With 20 Items (EORTC QLQ-MY20): Side Effects of Treatment at Specified Timepoints: Primary Analysis Cycle 6 Day 1	2.08 score on a scale Standard Deviation 11.81	1.61 score on a scale Standard Deviation 12.32
HRQL: Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Cancer Specific Questionnaire With 20 Items (EORTC QLQ-MY20): Side Effects of Treatment at Specified Timepoints: Primary Analysis Cycle 7 Day 1	1.47 score on a scale Standard Deviation 12.14	2.14 score on a scale Standard Deviation 10.76
HRQL: Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Cancer Specific Questionnaire With 20 Items (EORTC QLQ-MY20): Side Effects of Treatment at Specified Timepoints: Primary Analysis Cycle 8 Day 1	1.53 score on a scale Standard Deviation 12.07	2.86 score on a scale Standard Deviation 12.77
HRQL: Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Cancer Specific Questionnaire With 20 Items (EORTC QLQ-MY20): Side Effects of Treatment at Specified Timepoints: Primary Analysis Cycle 9 Day 1	1.68 score on a scale Standard Deviation 11.57	1.49 score on a scale Standard Deviation 11.96
HRQL: Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Cancer Specific Questionnaire With 20 Items (EORTC QLQ-MY20): Side Effects of Treatment at Specified Timepoints: Primary Analysis Cycle 10 Day 1	2.07 score on a scale Standard Deviation 11.62	2.68 score on a scale Standard Deviation 12.51
HRQL: Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Cancer Specific Questionnaire With 20 Items (EORTC QLQ-MY20): Side Effects of Treatment at Specified Timepoints: Primary Analysis Cycle 11 Day 1	3.38 score on a scale Standard Deviation 12.00	2.03 score on a scale Standard Deviation 12.16
HRQL: Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Cancer Specific Questionnaire With 20 Items (EORTC QLQ-MY20): Side Effects of Treatment at Specified Timepoints: Primary Analysis Cycle 12 Day 1	1.20 score on a scale Standard Deviation 10.52	3.04 score on a scale Standard Deviation 12.72
HRQL: Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Cancer Specific Questionnaire With 20 Items (EORTC QLQ-MY20): Side Effects of Treatment at Specified Timepoints: Primary Analysis Cycle 13 Day 1	0.82 score on a scale Standard Deviation 10.22	2.12 score on a scale Standard Deviation 12.33
HRQL: Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Cancer Specific Questionnaire With 20 Items (EORTC QLQ-MY20): Side Effects of Treatment at Specified Timepoints: Primary Analysis Cycle 14 Day 1	1.08 score on a scale Standard Deviation 10.56	1.71 score on a scale Standard Deviation 12.58
HRQL: Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Cancer Specific Questionnaire With 20 Items (EORTC QLQ-MY20): Side Effects of Treatment at Specified Timepoints: Primary Analysis Cycle 15 Day 1	1.85 score on a scale Standard Deviation 11.45	1.87 score on a scale Standard Deviation 11.80
HRQL: Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Cancer Specific Questionnaire With 20 Items (EORTC QLQ-MY20): Side Effects of Treatment at Specified Timepoints: Primary Analysis Cycle 16 Day 1	0.99 score on a scale Standard Deviation 10.54	2.58 score on a scale Standard Deviation 11.88
HRQL: Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Cancer Specific Questionnaire With 20 Items (EORTC QLQ-MY20): Side Effects of Treatment at Specified Timepoints: Primary Analysis Cycle 17 Day 1	2.74 score on a scale Standard Deviation 10.03	4.10 score on a scale Standard Deviation 12.77
HRQL: Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Cancer Specific Questionnaire With 20 Items (EORTC QLQ-MY20): Side Effects of Treatment at Specified Timepoints: Primary Analysis Cycle 18 Day 1	2.37 score on a scale Standard Deviation 10.51	2.95 score on a scale Standard Deviation 13.38
HRQL: Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Cancer Specific Questionnaire With 20 Items (EORTC QLQ-MY20): Side Effects of Treatment at Specified Timepoints: Primary Analysis Cycle 19 Day 1	2.76 score on a scale Standard Deviation 11.41	2.16 score on a scale Standard Deviation 11.56
HRQL: Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Cancer Specific Questionnaire With 20 Items (EORTC QLQ-MY20): Side Effects of Treatment at Specified Timepoints: Primary Analysis Cycle 20 Day 1	-0.17 score on a scale Standard Deviation 10.62	2.05 score on a scale Standard Deviation 13.03
HRQL: Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Cancer Specific Questionnaire With 20 Items (EORTC QLQ-MY20): Side Effects of Treatment at Specified Timepoints: Primary Analysis Cycle 21 Day 1	3.17 score on a scale Standard Deviation 10.61	2.74 score on a scale Standard Deviation 12.87
HRQL: Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Cancer Specific Questionnaire With 20 Items (EORTC QLQ-MY20): Side Effects of Treatment at Specified Timepoints: Primary Analysis Cycle 22 Day 1	3.55 score on a scale Standard Deviation 6.46	1.51 score on a scale Standard Deviation 12.51
HRQL: Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Cancer Specific Questionnaire With 20 Items (EORTC QLQ-MY20): Side Effects of Treatment at Specified Timepoints: Primary Analysis Cycle 23 Day 1	7.85 score on a scale Standard Deviation 9.93	-1.39 score on a scale Standard Deviation 12.02
HRQL: Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Cancer Specific Questionnaire With 20 Items (EORTC QLQ-MY20): Side Effects of Treatment at Specified Timepoints: Primary Analysis Cycle 24 Day 1	12.35 score on a scale Standard Deviation 7.17	-2.54 score on a scale Standard Deviation 11.33
HRQL: Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Cancer Specific Questionnaire With 20 Items (EORTC QLQ-MY20): Side Effects of Treatment at Specified Timepoints: Primary Analysis Cycle 25 Day 1	11.85 score on a scale Standard Deviation 4.06	-3.50 score on a scale Standard Deviation 12.83
HRQL: Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Cancer Specific Questionnaire With 20 Items (EORTC QLQ-MY20): Side Effects of Treatment at Specified Timepoints: Primary Analysis End of Treatment	4.63 score on a scale Standard Deviation 13.01	5.56 score on a scale Standard Deviation 16.22

SECONDARY outcome

Timeframe: Baseline, Day 1 of each cycle (Cycle 2 to Cycle 25), at the End of Treatment visit (any day up to 114 weeks)

Population: Analysis was performed on ITT population. Here, 'Number analyzed' signifies participants with available data for each specified category.

EORTC QLQ-MY20 is a validated questionnaire to assess the overall quality of life in participants with multiple myeloma. It is used in conjunction with the EORTC QLQ-C30 to assess symptoms and side effects due to treatment or the disease. It consists of one question and scores are based on the 4-point Likert scale ranging from "Not at all" to "Very much". Body image score is calculated as: (1 - \[Q47-1\]/3)\*100. Scores are averaged, and transformed to scale ranging from 0 to 100. A higher score represents a better quality of life.

Outcome measures

Outcome measures
Measure	Carfilzomib + Dexamethasone (Kd) n=123 Participants Participants received carfilzomib 20 mg/m\^2, IV infusion on Days 1, and 2 in Cycle 1, and then escalated to 56 mg/m\^2 on Days 8, 9, 15 and 16 of Cycle 1 and then on Days 1, 2, 8, 9, 15 and 16 of each subsequent 28-day treatment cycle along with dexamethasone 20 mg, PO or IV on Days 1, 2, 8, 9, 15, 16, 22 and 23 of each 28-day treatment cycle until disease progression or unacceptable adverse event or participant's decision to discontinue the study treatment or any other reason, whichever comes first (maximum exposure: 114 weeks).	Isatuximab + Carfilzomib + Dexamethasone (IKd) n=179 Participants Participants received isatuximab 10 mg/kg, IV infusion on Days 1, 8, 15 and 22 in Cycle 1, and then on Days 1 and Day 15 of each 28-day treatment cycle plus carfilzomib 20 mg/m\^2, IV on Days 1, and 2 in Cycle 1, and then escalated to 56 mg/m\^2 on Days 8, 9, 15 and 16 of Cycle 1 and then on Days 1, 2, 8, 9, 15 and 16 of each subsequent 28-day treatment cycle and dexamethasone 20 mg, PO or IV on Day 1, 2, 8, 9, 15, 16, 22 and 23 of each 28-day treatment cycle until disease progression or unacceptable adverse event or participant's decision to discontinue the study treatment or any other reason, whichever comes first (maximum exposure: 111 weeks).
HRQL: Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Cancer Specific Questionnaire With 20 Items (EORTC QLQ-MY20): Body Image Score at Specified Timepoints: Primary Analysis Cycle 2 Day 1	-1.29 score on a scale Standard Deviation 23.76	-1.27 score on a scale Standard Deviation 21.31
HRQL: Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Cancer Specific Questionnaire With 20 Items (EORTC QLQ-MY20): Body Image Score at Specified Timepoints: Primary Analysis Cycle 3 Day 1	1.98 score on a scale Standard Deviation 23.01	1.27 score on a scale Standard Deviation 26.84
HRQL: Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Cancer Specific Questionnaire With 20 Items (EORTC QLQ-MY20): Body Image Score at Specified Timepoints: Primary Analysis Cycle 4 Day 1	-1.65 score on a scale Standard Deviation 25.55	-1.10 score on a scale Standard Deviation 28.04
HRQL: Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Cancer Specific Questionnaire With 20 Items (EORTC QLQ-MY20): Body Image Score at Specified Timepoints: Primary Analysis Cycle 5 Day 1	-0.69 score on a scale Standard Deviation 26.34	-2.89 score on a scale Standard Deviation 27.29
HRQL: Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Cancer Specific Questionnaire With 20 Items (EORTC QLQ-MY20): Body Image Score at Specified Timepoints: Primary Analysis Cycle 6 Day 1	-1.83 score on a scale Standard Deviation 24.02	-1.60 score on a scale Standard Deviation 26.93
HRQL: Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Cancer Specific Questionnaire With 20 Items (EORTC QLQ-MY20): Body Image Score at Specified Timepoints: Primary Analysis Cycle 7 Day 1	-0.77 score on a scale Standard Deviation 27.83	-3.03 score on a scale Standard Deviation 24.36
HRQL: Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Cancer Specific Questionnaire With 20 Items (EORTC QLQ-MY20): Body Image Score at Specified Timepoints: Primary Analysis Cycle 8 Day 1	-5.16 score on a scale Standard Deviation 25.08	-0.25 score on a scale Standard Deviation 24.84
HRQL: Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Cancer Specific Questionnaire With 20 Items (EORTC QLQ-MY20): Body Image Score at Specified Timepoints: Primary Analysis Cycle 9 Day 1	-2.14 score on a scale Standard Deviation 24.82	-1.02 score on a scale Standard Deviation 25.80
HRQL: Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Cancer Specific Questionnaire With 20 Items (EORTC QLQ-MY20): Body Image Score at Specified Timepoints: Primary Analysis Cycle 10 Day 1	-1.80 score on a scale Standard Deviation 25.22	-1.33 score on a scale Standard Deviation 25.54
HRQL: Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Cancer Specific Questionnaire With 20 Items (EORTC QLQ-MY20): Body Image Score at Specified Timepoints: Primary Analysis Cycle 11 Day 1	-1.85 score on a scale Standard Deviation 29.01	-0.55 score on a scale Standard Deviation 23.47
HRQL: Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Cancer Specific Questionnaire With 20 Items (EORTC QLQ-MY20): Body Image Score at Specified Timepoints: Primary Analysis Cycle 12 Day 1	-2.05 score on a scale Standard Deviation 25.60	-0.55 score on a scale Standard Deviation 25.09
HRQL: Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Cancer Specific Questionnaire With 20 Items (EORTC QLQ-MY20): Body Image Score at Specified Timepoints: Primary Analysis Cycle 13 Day 1	-3.89 score on a scale Standard Deviation 26.10	-2.63 score on a scale Standard Deviation 21.79
HRQL: Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Cancer Specific Questionnaire With 20 Items (EORTC QLQ-MY20): Body Image Score at Specified Timepoints: Primary Analysis Cycle 14 Day 1	-4.52 score on a scale Standard Deviation 26.59	-3.24 score on a scale Standard Deviation 25.57
HRQL: Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Cancer Specific Questionnaire With 20 Items (EORTC QLQ-MY20): Body Image Score at Specified Timepoints: Primary Analysis Cycle 15 Day 1	0.00 score on a scale Standard Deviation 25.20	-2.22 score on a scale Standard Deviation 24.58
HRQL: Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Cancer Specific Questionnaire With 20 Items (EORTC QLQ-MY20): Body Image Score at Specified Timepoints: Primary Analysis Cycle 16 Day 1	-1.31 score on a scale Standard Deviation 27.46	-2.94 score on a scale Standard Deviation 22.55
HRQL: Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Cancer Specific Questionnaire With 20 Items (EORTC QLQ-MY20): Body Image Score at Specified Timepoints: Primary Analysis Cycle 17 Day 1	-1.42 score on a scale Standard Deviation 28.62	-1.98 score on a scale Standard Deviation 26.17
HRQL: Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Cancer Specific Questionnaire With 20 Items (EORTC QLQ-MY20): Body Image Score at Specified Timepoints: Primary Analysis Cycle 18 Day 1	1.48 score on a scale Standard Deviation 30.11	-1.77 score on a scale Standard Deviation 24.62
HRQL: Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Cancer Specific Questionnaire With 20 Items (EORTC QLQ-MY20): Body Image Score at Specified Timepoints: Primary Analysis Cycle 19 Day 1	0.00 score on a scale Standard Deviation 31.62	-3.70 score on a scale Standard Deviation 26.18
HRQL: Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Cancer Specific Questionnaire With 20 Items (EORTC QLQ-MY20): Body Image Score at Specified Timepoints: Primary Analysis Cycle 20 Day 1	0.00 score on a scale Standard Deviation 27.22	-0.76 score on a scale Standard Deviation 24.75
HRQL: Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Cancer Specific Questionnaire With 20 Items (EORTC QLQ-MY20): Body Image Score at Specified Timepoints: Primary Analysis Cycle 21 Day 1	-4.76 score on a scale Standard Deviation 34.80	-3.20 score on a scale Standard Deviation 26.74
HRQL: Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Cancer Specific Questionnaire With 20 Items (EORTC QLQ-MY20): Body Image Score at Specified Timepoints: Primary Analysis Cycle 22 Day 1	-8.77 score on a scale Standard Deviation 36.59	-1.85 score on a scale Standard Deviation 27.02
HRQL: Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Cancer Specific Questionnaire With 20 Items (EORTC QLQ-MY20): Body Image Score at Specified Timepoints: Primary Analysis Cycle 23 Day 1	-13.33 score on a scale Standard Deviation 30.34	-5.41 score on a scale Standard Deviation 24.23
HRQL: Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Cancer Specific Questionnaire With 20 Items (EORTC QLQ-MY20): Body Image Score at Specified Timepoints: Primary Analysis Cycle 24 Day 1	-25.93 score on a scale Standard Deviation 36.43	-3.03 score on a scale Standard Deviation 25.01
HRQL: Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Cancer Specific Questionnaire With 20 Items (EORTC QLQ-MY20): Body Image Score at Specified Timepoints: Primary Analysis Cycle 25 Day 1	-53.33 score on a scale Standard Deviation 18.26	-8.33 score on a scale Standard Deviation 25.82
HRQL: Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Cancer Specific Questionnaire With 20 Items (EORTC QLQ-MY20): Body Image Score at Specified Timepoints: Primary Analysis End of Treatment	-5.65 score on a scale Standard Deviation 21.58	-9.36 score on a scale Standard Deviation 27.28

SECONDARY outcome

Timeframe: Baseline, Day 1 of each cycle (Cycle 2 to Cycle 25), at the End of Treatment visit (any day up to 114 weeks)

Population: Analysis was performed on ITT population. Here, 'Number analyzed' signifies participants with available data for each specified category.

EORTC QLQ-MY20 is a validated questionnaire to assess the overall quality of life in participants with multiple myeloma. It is used in conjunction with the EORTC QLQ-C30 to assess symptoms and side effects due to treatment or the disease. It consists of three questions and the scores are based on the 4-point Likert scale ranging from "Not at all" to "Very much". Future Perspective score is calculated as (1 - (\[{Q48+Q49+Q50}/3\] -1)/3)\*100. Scores are averaged and transformed to scale ranging from 0 to 100. A higher score represents a better quality of life.

Outcome measures

Outcome measures
Measure	Carfilzomib + Dexamethasone (Kd) n=123 Participants Participants received carfilzomib 20 mg/m\^2, IV infusion on Days 1, and 2 in Cycle 1, and then escalated to 56 mg/m\^2 on Days 8, 9, 15 and 16 of Cycle 1 and then on Days 1, 2, 8, 9, 15 and 16 of each subsequent 28-day treatment cycle along with dexamethasone 20 mg, PO or IV on Days 1, 2, 8, 9, 15, 16, 22 and 23 of each 28-day treatment cycle until disease progression or unacceptable adverse event or participant's decision to discontinue the study treatment or any other reason, whichever comes first (maximum exposure: 114 weeks).	Isatuximab + Carfilzomib + Dexamethasone (IKd) n=179 Participants Participants received isatuximab 10 mg/kg, IV infusion on Days 1, 8, 15 and 22 in Cycle 1, and then on Days 1 and Day 15 of each 28-day treatment cycle plus carfilzomib 20 mg/m\^2, IV on Days 1, and 2 in Cycle 1, and then escalated to 56 mg/m\^2 on Days 8, 9, 15 and 16 of Cycle 1 and then on Days 1, 2, 8, 9, 15 and 16 of each subsequent 28-day treatment cycle and dexamethasone 20 mg, PO or IV on Day 1, 2, 8, 9, 15, 16, 22 and 23 of each 28-day treatment cycle until disease progression or unacceptable adverse event or participant's decision to discontinue the study treatment or any other reason, whichever comes first (maximum exposure: 111 weeks).
HRQL: Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Cancer Specific Questionnaire With 20 Items (EORTC QLQ-MY20): Future Perspective at Specified Timepoints: Primary Analysis Cycle 2 Day 1	0.54 score on a scale Standard Deviation 19.33	7.57 score on a scale Standard Deviation 26.48
HRQL: Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Cancer Specific Questionnaire With 20 Items (EORTC QLQ-MY20): Future Perspective at Specified Timepoints: Primary Analysis Cycle 3 Day 1	4.84 score on a scale Standard Deviation 22.08	9.70 score on a scale Standard Deviation 24.76
HRQL: Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Cancer Specific Questionnaire With 20 Items (EORTC QLQ-MY20): Future Perspective at Specified Timepoints: Primary Analysis Cycle 4 Day 1	6.60 score on a scale Standard Deviation 20.44	8.55 score on a scale Standard Deviation 26.62
HRQL: Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Cancer Specific Questionnaire With 20 Items (EORTC QLQ-MY20): Future Perspective at Specified Timepoints: Primary Analysis Cycle 5 Day 1	7.67 score on a scale Standard Deviation 22.64	7.56 score on a scale Standard Deviation 26.98
HRQL: Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Cancer Specific Questionnaire With 20 Items (EORTC QLQ-MY20): Future Perspective at Specified Timepoints: Primary Analysis Cycle 6 Day 1	8.42 score on a scale Standard Deviation 21.81	9.97 score on a scale Standard Deviation 25.70
HRQL: Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Cancer Specific Questionnaire With 20 Items (EORTC QLQ-MY20): Future Perspective at Specified Timepoints: Primary Analysis Cycle 7 Day 1	8.17 score on a scale Standard Deviation 21.93	8.47 score on a scale Standard Deviation 24.74
HRQL: Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Cancer Specific Questionnaire With 20 Items (EORTC QLQ-MY20): Future Perspective at Specified Timepoints: Primary Analysis Cycle 8 Day 1	7.41 score on a scale Standard Deviation 22.51	10.54 score on a scale Standard Deviation 24.50
HRQL: Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Cancer Specific Questionnaire With 20 Items (EORTC QLQ-MY20): Future Perspective at Specified Timepoints: Primary Analysis Cycle 9 Day 1	7.26 score on a scale Standard Deviation 21.10	8.57 score on a scale Standard Deviation 28.26
HRQL: Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Cancer Specific Questionnaire With 20 Items (EORTC QLQ-MY20): Future Perspective at Specified Timepoints: Primary Analysis Cycle 10 Day 1	8.56 score on a scale Standard Deviation 22.79	11.56 score on a scale Standard Deviation 24.82
HRQL: Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Cancer Specific Questionnaire With 20 Items (EORTC QLQ-MY20): Future Perspective at Specified Timepoints: Primary Analysis Cycle 11 Day 1	8.02 score on a scale Standard Deviation 21.69	12.02 score on a scale Standard Deviation 24.23
HRQL: Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Cancer Specific Questionnaire With 20 Items (EORTC QLQ-MY20): Future Perspective at Specified Timepoints: Primary Analysis Cycle 12 Day 1	6.84 score on a scale Standard Deviation 24.51	11.48 score on a scale Standard Deviation 22.90
HRQL: Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Cancer Specific Questionnaire With 20 Items (EORTC QLQ-MY20): Future Perspective at Specified Timepoints: Primary Analysis Cycle 13 Day 1	11.11 score on a scale Standard Deviation 20.04	10.72 score on a scale Standard Deviation 23.18
HRQL: Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Cancer Specific Questionnaire With 20 Items (EORTC QLQ-MY20): Future Perspective at Specified Timepoints: Primary Analysis Cycle 14 Day 1	8.85 score on a scale Standard Deviation 22.86	11.31 score on a scale Standard Deviation 23.29
HRQL: Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Cancer Specific Questionnaire With 20 Items (EORTC QLQ-MY20): Future Perspective at Specified Timepoints: Primary Analysis Cycle 15 Day 1	9.55 score on a scale Standard Deviation 24.16	12.28 score on a scale Standard Deviation 22.27
HRQL: Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Cancer Specific Questionnaire With 20 Items (EORTC QLQ-MY20): Future Perspective at Specified Timepoints: Primary Analysis Cycle 16 Day 1	12.42 score on a scale Standard Deviation 24.51	11.76 score on a scale Standard Deviation 25.20
HRQL: Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Cancer Specific Questionnaire With 20 Items (EORTC QLQ-MY20): Future Perspective at Specified Timepoints: Primary Analysis Cycle 17 Day 1	12.29 score on a scale Standard Deviation 21.64	10.89 score on a scale Standard Deviation 25.29
HRQL: Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Cancer Specific Questionnaire With 20 Items (EORTC QLQ-MY20): Future Perspective at Specified Timepoints: Primary Analysis Cycle 18 Day 1	11.36 score on a scale Standard Deviation 22.41	7.33 score on a scale Standard Deviation 23.25
HRQL: Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Cancer Specific Questionnaire With 20 Items (EORTC QLQ-MY20): Future Perspective at Specified Timepoints: Primary Analysis Cycle 19 Day 1	9.21 score on a scale Standard Deviation 24.96	8.40 score on a scale Standard Deviation 25.50
HRQL: Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Cancer Specific Questionnaire With 20 Items (EORTC QLQ-MY20): Future Perspective at Specified Timepoints: Primary Analysis Cycle 20 Day 1	10.13 score on a scale Standard Deviation 24.67	9.60 score on a scale Standard Deviation 25.34
HRQL: Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Cancer Specific Questionnaire With 20 Items (EORTC QLQ-MY20): Future Perspective at Specified Timepoints: Primary Analysis Cycle 21 Day 1	10.32 score on a scale Standard Deviation 22.41	10.65 score on a scale Standard Deviation 26.15
HRQL: Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Cancer Specific Questionnaire With 20 Items (EORTC QLQ-MY20): Future Perspective at Specified Timepoints: Primary Analysis Cycle 22 Day 1	8.77 score on a scale Standard Deviation 25.28	12.14 score on a scale Standard Deviation 22.35
HRQL: Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Cancer Specific Questionnaire With 20 Items (EORTC QLQ-MY20): Future Perspective at Specified Timepoints: Primary Analysis Cycle 23 Day 1	9.63 score on a scale Standard Deviation 27.81	12.61 score on a scale Standard Deviation 20.48
HRQL: Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Cancer Specific Questionnaire With 20 Items (EORTC QLQ-MY20): Future Perspective at Specified Timepoints: Primary Analysis Cycle 24 Day 1	1.23 score on a scale Standard Deviation 24.50	16.16 score on a scale Standard Deviation 18.70
HRQL: Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Cancer Specific Questionnaire With 20 Items (EORTC QLQ-MY20): Future Perspective at Specified Timepoints: Primary Analysis Cycle 25 Day 1	-4.44 score on a scale Standard Deviation 24.34	15.28 score on a scale Standard Deviation 16.67
HRQL: Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Cancer Specific Questionnaire With 20 Items (EORTC QLQ-MY20): Future Perspective at Specified Timepoints: Primary Analysis End of Treatment	-3.95 score on a scale Standard Deviation 22.86	-3.70 score on a scale Standard Deviation 31.45

SECONDARY outcome

Timeframe: Baseline, Day 1 of each cycle (Cycle 2 to Cycle 25), at the End of Treatment visit (any day up to 114 weeks)

Population: Analysis was performed on ITT population. Here, 'Number analyzed' signifies participants with available data for each specified category.

The EQ-5D-5L is a standardized measure of health status that provides a general assessment of health utility and consist in 2 sections a descriptive system comprising 5 dimensions (mobility, self-care, usual activities, pain/discomfort and anxiety/depression) and Visual Analog Scale (VAS). Each dimension has a 5-level response: no problems, slight problems, moderate problems, severe problems, and extreme problems. Response options are measured with a 5-point Likert scale. The 5D-5L systems are converted into a single index utility score between 0 to 1, where higher score indicates a better health state and lower score indicate worse health state.

Outcome measures

Outcome measures
Measure	Carfilzomib + Dexamethasone (Kd) n=123 Participants Participants received carfilzomib 20 mg/m\^2, IV infusion on Days 1, and 2 in Cycle 1, and then escalated to 56 mg/m\^2 on Days 8, 9, 15 and 16 of Cycle 1 and then on Days 1, 2, 8, 9, 15 and 16 of each subsequent 28-day treatment cycle along with dexamethasone 20 mg, PO or IV on Days 1, 2, 8, 9, 15, 16, 22 and 23 of each 28-day treatment cycle until disease progression or unacceptable adverse event or participant's decision to discontinue the study treatment or any other reason, whichever comes first (maximum exposure: 114 weeks).	Isatuximab + Carfilzomib + Dexamethasone (IKd) n=179 Participants Participants received isatuximab 10 mg/kg, IV infusion on Days 1, 8, 15 and 22 in Cycle 1, and then on Days 1 and Day 15 of each 28-day treatment cycle plus carfilzomib 20 mg/m\^2, IV on Days 1, and 2 in Cycle 1, and then escalated to 56 mg/m\^2 on Days 8, 9, 15 and 16 of Cycle 1 and then on Days 1, 2, 8, 9, 15 and 16 of each subsequent 28-day treatment cycle and dexamethasone 20 mg, PO or IV on Day 1, 2, 8, 9, 15, 16, 22 and 23 of each 28-day treatment cycle until disease progression or unacceptable adverse event or participant's decision to discontinue the study treatment or any other reason, whichever comes first (maximum exposure: 111 weeks).
HRQL: Change From Baseline in European Quality of Life Group Questionnaire With 5 Dimensions and 5 Levels Per Dimension (EQ-5D-5L): Health State Utility Index Value at Specified Timepoints: Primary Analysis Cycle 2 Day 1	0.05 score on a scale Standard Deviation 0.17	0.04 score on a scale Standard Deviation 0.19
HRQL: Change From Baseline in European Quality of Life Group Questionnaire With 5 Dimensions and 5 Levels Per Dimension (EQ-5D-5L): Health State Utility Index Value at Specified Timepoints: Primary Analysis Cycle 3 Day 1	0.06 score on a scale Standard Deviation 0.21	0.05 score on a scale Standard Deviation 0.22
HRQL: Change From Baseline in European Quality of Life Group Questionnaire With 5 Dimensions and 5 Levels Per Dimension (EQ-5D-5L): Health State Utility Index Value at Specified Timepoints: Primary Analysis Cycle 4 Day 1	0.02 score on a scale Standard Deviation 0.21	0.05 score on a scale Standard Deviation 0.21
HRQL: Change From Baseline in European Quality of Life Group Questionnaire With 5 Dimensions and 5 Levels Per Dimension (EQ-5D-5L): Health State Utility Index Value at Specified Timepoints: Primary Analysis Cycle 5 Day 1	0.04 score on a scale Standard Deviation 0.20	0.04 score on a scale Standard Deviation 0.20
HRQL: Change From Baseline in European Quality of Life Group Questionnaire With 5 Dimensions and 5 Levels Per Dimension (EQ-5D-5L): Health State Utility Index Value at Specified Timepoints: Primary Analysis Cycle 6 Day 1	0.03 score on a scale Standard Deviation 0.19	0.05 score on a scale Standard Deviation 0.23
HRQL: Change From Baseline in European Quality of Life Group Questionnaire With 5 Dimensions and 5 Levels Per Dimension (EQ-5D-5L): Health State Utility Index Value at Specified Timepoints: Primary Analysis Cycle 7 Day 1	0.06 score on a scale Standard Deviation 0.19	0.04 score on a scale Standard Deviation 0.21
HRQL: Change From Baseline in European Quality of Life Group Questionnaire With 5 Dimensions and 5 Levels Per Dimension (EQ-5D-5L): Health State Utility Index Value at Specified Timepoints: Primary Analysis Cycle 8 Day 1	0.06 score on a scale Standard Deviation 0.19	0.05 score on a scale Standard Deviation 0.22
HRQL: Change From Baseline in European Quality of Life Group Questionnaire With 5 Dimensions and 5 Levels Per Dimension (EQ-5D-5L): Health State Utility Index Value at Specified Timepoints: Primary Analysis Cycle 9 Day 1	0.05 score on a scale Standard Deviation 0.20	0.04 score on a scale Standard Deviation 0.19
HRQL: Change From Baseline in European Quality of Life Group Questionnaire With 5 Dimensions and 5 Levels Per Dimension (EQ-5D-5L): Health State Utility Index Value at Specified Timepoints: Primary Analysis Cycle 10 Day 1	0.06 score on a scale Standard Deviation 0.22	0.03 score on a scale Standard Deviation 0.22
HRQL: Change From Baseline in European Quality of Life Group Questionnaire With 5 Dimensions and 5 Levels Per Dimension (EQ-5D-5L): Health State Utility Index Value at Specified Timepoints: Primary Analysis Cycle 11 Day 1	0.04 score on a scale Standard Deviation 0.23	0.05 score on a scale Standard Deviation 0.20
HRQL: Change From Baseline in European Quality of Life Group Questionnaire With 5 Dimensions and 5 Levels Per Dimension (EQ-5D-5L): Health State Utility Index Value at Specified Timepoints: Primary Analysis Cycle 12 Day 1	0.03 score on a scale Standard Deviation 0.16	0.02 score on a scale Standard Deviation 0.20
HRQL: Change From Baseline in European Quality of Life Group Questionnaire With 5 Dimensions and 5 Levels Per Dimension (EQ-5D-5L): Health State Utility Index Value at Specified Timepoints: Primary Analysis Cycle 13 Day 1	0.06 score on a scale Standard Deviation 0.16	0.03 score on a scale Standard Deviation 0.19
HRQL: Change From Baseline in European Quality of Life Group Questionnaire With 5 Dimensions and 5 Levels Per Dimension (EQ-5D-5L): Health State Utility Index Value at Specified Timepoints: Primary Analysis Cycle 14 Day 1	0.06 score on a scale Standard Deviation 0.24	0.04 score on a scale Standard Deviation 0.19
HRQL: Change From Baseline in European Quality of Life Group Questionnaire With 5 Dimensions and 5 Levels Per Dimension (EQ-5D-5L): Health State Utility Index Value at Specified Timepoints: Primary Analysis Cycle 15 Day 1	0.05 score on a scale Standard Deviation 0.18	0.05 score on a scale Standard Deviation 0.18
HRQL: Change From Baseline in European Quality of Life Group Questionnaire With 5 Dimensions and 5 Levels Per Dimension (EQ-5D-5L): Health State Utility Index Value at Specified Timepoints: Primary Analysis Cycle 16 Day 1	0.06 score on a scale Standard Deviation 0.16	0.04 score on a scale Standard Deviation 0.19
HRQL: Change From Baseline in European Quality of Life Group Questionnaire With 5 Dimensions and 5 Levels Per Dimension (EQ-5D-5L): Health State Utility Index Value at Specified Timepoints: Primary Analysis Cycle 17 Day 1	0.05 score on a scale Standard Deviation 0.15	0.03 score on a scale Standard Deviation 0.20
HRQL: Change From Baseline in European Quality of Life Group Questionnaire With 5 Dimensions and 5 Levels Per Dimension (EQ-5D-5L): Health State Utility Index Value at Specified Timepoints: Primary Analysis Cycle 18 Day 1	0.02 score on a scale Standard Deviation 0.15	0.04 score on a scale Standard Deviation 0.17
HRQL: Change From Baseline in European Quality of Life Group Questionnaire With 5 Dimensions and 5 Levels Per Dimension (EQ-5D-5L): Health State Utility Index Value at Specified Timepoints: Primary Analysis Cycle 19 Day 1	0.03 score on a scale Standard Deviation 0.20	0.03 score on a scale Standard Deviation 0.18
HRQL: Change From Baseline in European Quality of Life Group Questionnaire With 5 Dimensions and 5 Levels Per Dimension (EQ-5D-5L): Health State Utility Index Value at Specified Timepoints: Primary Analysis Cycle 20 Day 1	0.06 score on a scale Standard Deviation 0.17	0.03 score on a scale Standard Deviation 0.23
HRQL: Change From Baseline in European Quality of Life Group Questionnaire With 5 Dimensions and 5 Levels Per Dimension (EQ-5D-5L): Health State Utility Index Value at Specified Timepoints: Primary Analysis Cycle 21 Day 1	0.03 score on a scale Standard Deviation 0.15	0.02 score on a scale Standard Deviation 0.22
HRQL: Change From Baseline in European Quality of Life Group Questionnaire With 5 Dimensions and 5 Levels Per Dimension (EQ-5D-5L): Health State Utility Index Value at Specified Timepoints: Primary Analysis Cycle 22 Day 1	0.05 score on a scale Standard Deviation 0.19	0.02 score on a scale Standard Deviation 0.22
HRQL: Change From Baseline in European Quality of Life Group Questionnaire With 5 Dimensions and 5 Levels Per Dimension (EQ-5D-5L): Health State Utility Index Value at Specified Timepoints: Primary Analysis Cycle 23 Day 1	0.05 score on a scale Standard Deviation 0.18	0.00 score on a scale Standard Deviation 0.27
HRQL: Change From Baseline in European Quality of Life Group Questionnaire With 5 Dimensions and 5 Levels Per Dimension (EQ-5D-5L): Health State Utility Index Value at Specified Timepoints: Primary Analysis Cycle 24 Day 1	0.04 score on a scale Standard Deviation 0.24	0.03 score on a scale Standard Deviation 0.20
HRQL: Change From Baseline in European Quality of Life Group Questionnaire With 5 Dimensions and 5 Levels Per Dimension (EQ-5D-5L): Health State Utility Index Value at Specified Timepoints: Primary Analysis Cycle 25 Day 1	0.05 score on a scale Standard Deviation 0.38	0.04 score on a scale Standard Deviation 0.22
HRQL: Change From Baseline in European Quality of Life Group Questionnaire With 5 Dimensions and 5 Levels Per Dimension (EQ-5D-5L): Health State Utility Index Value at Specified Timepoints: Primary Analysis End of Treatment	-0.03 score on a scale Standard Deviation 0.25	-0.08 score on a scale Standard Deviation 0.27

SECONDARY outcome

Timeframe: Baseline, Day 1 of each cycle (Cycle 2 to Cycle 25), at the End of Treatment visit (any day up to 114 weeks)

Population: Analysis was performed on ITT population. Here, 'Number analyzed' signifies participants with available data for each specified category.

The EQ-5D-5L is a standardized measure of health status that provides a general assessment of health utility and consist of 2 sections; descriptive system comprises 5 dimensions (mobility, self-care, usual activities, pain/discomfort and anxiety/depression) and a VAS. The VAS records the respondent's self-rated health on a 20 centimeter (cm) vertical VAS; the scale went from 0 (worst imaginable health state) to 100 (best imaginable health state). This information can be used as a quantitative measure of health as judged by the individual respondents.

Outcome measures

Outcome measures
Measure	Carfilzomib + Dexamethasone (Kd) n=123 Participants Participants received carfilzomib 20 mg/m\^2, IV infusion on Days 1, and 2 in Cycle 1, and then escalated to 56 mg/m\^2 on Days 8, 9, 15 and 16 of Cycle 1 and then on Days 1, 2, 8, 9, 15 and 16 of each subsequent 28-day treatment cycle along with dexamethasone 20 mg, PO or IV on Days 1, 2, 8, 9, 15, 16, 22 and 23 of each 28-day treatment cycle until disease progression or unacceptable adverse event or participant's decision to discontinue the study treatment or any other reason, whichever comes first (maximum exposure: 114 weeks).	Isatuximab + Carfilzomib + Dexamethasone (IKd) n=179 Participants Participants received isatuximab 10 mg/kg, IV infusion on Days 1, 8, 15 and 22 in Cycle 1, and then on Days 1 and Day 15 of each 28-day treatment cycle plus carfilzomib 20 mg/m\^2, IV on Days 1, and 2 in Cycle 1, and then escalated to 56 mg/m\^2 on Days 8, 9, 15 and 16 of Cycle 1 and then on Days 1, 2, 8, 9, 15 and 16 of each subsequent 28-day treatment cycle and dexamethasone 20 mg, PO or IV on Day 1, 2, 8, 9, 15, 16, 22 and 23 of each 28-day treatment cycle until disease progression or unacceptable adverse event or participant's decision to discontinue the study treatment or any other reason, whichever comes first (maximum exposure: 111 weeks).
HRQL: Change From Baseline in European Quality of Life Working Group Health Status Measure 5 Dimensions, 5 Levels (EQ-5D-5L) Score: Visual Analogic Scale (VAS) at Specified Timepoints: Primary Analysis Cycle 2 Day 1	2.42 score on a scale Standard Deviation 17.04	0.60 score on a scale Standard Deviation 15.23
HRQL: Change From Baseline in European Quality of Life Working Group Health Status Measure 5 Dimensions, 5 Levels (EQ-5D-5L) Score: Visual Analogic Scale (VAS) at Specified Timepoints: Primary Analysis Cycle 3 Day 1	4.70 score on a scale Standard Deviation 16.13	3.47 score on a scale Standard Deviation 17.80
HRQL: Change From Baseline in European Quality of Life Working Group Health Status Measure 5 Dimensions, 5 Levels (EQ-5D-5L) Score: Visual Analogic Scale (VAS) at Specified Timepoints: Primary Analysis Cycle 4 Day 1	6.03 score on a scale Standard Deviation 16.73	2.29 score on a scale Standard Deviation 18.69
HRQL: Change From Baseline in European Quality of Life Working Group Health Status Measure 5 Dimensions, 5 Levels (EQ-5D-5L) Score: Visual Analogic Scale (VAS) at Specified Timepoints: Primary Analysis Cycle 5 Day 1	3.40 score on a scale Standard Deviation 16.89	2.35 score on a scale Standard Deviation 19.73
HRQL: Change From Baseline in European Quality of Life Working Group Health Status Measure 5 Dimensions, 5 Levels (EQ-5D-5L) Score: Visual Analogic Scale (VAS) at Specified Timepoints: Primary Analysis Cycle 6 Day 1	2.80 score on a scale Standard Deviation 18.56	1.24 score on a scale Standard Deviation 19.11
HRQL: Change From Baseline in European Quality of Life Working Group Health Status Measure 5 Dimensions, 5 Levels (EQ-5D-5L) Score: Visual Analogic Scale (VAS) at Specified Timepoints: Primary Analysis Cycle 7 Day 1	0.64 score on a scale Standard Deviation 21.69	2.24 score on a scale Standard Deviation 18.85
HRQL: Change From Baseline in European Quality of Life Working Group Health Status Measure 5 Dimensions, 5 Levels (EQ-5D-5L) Score: Visual Analogic Scale (VAS) at Specified Timepoints: Primary Analysis Cycle 8 Day 1	1.48 score on a scale Standard Deviation 17.11	2.40 score on a scale Standard Deviation 18.87
HRQL: Change From Baseline in European Quality of Life Working Group Health Status Measure 5 Dimensions, 5 Levels (EQ-5D-5L) Score: Visual Analogic Scale (VAS) at Specified Timepoints: Primary Analysis Cycle 9 Day 1	-0.14 score on a scale Standard Deviation 17.46	2.93 score on a scale Standard Deviation 19.04
HRQL: Change From Baseline in European Quality of Life Working Group Health Status Measure 5 Dimensions, 5 Levels (EQ-5D-5L) Score: Visual Analogic Scale (VAS) at Specified Timepoints: Primary Analysis Cycle 10 Day 1	2.76 score on a scale Standard Deviation 17.41	2.82 score on a scale Standard Deviation 18.35
HRQL: Change From Baseline in European Quality of Life Working Group Health Status Measure 5 Dimensions, 5 Levels (EQ-5D-5L) Score: Visual Analogic Scale (VAS) at Specified Timepoints: Primary Analysis Cycle 11 Day 1	3.86 score on a scale Standard Deviation 20.07	3.77 score on a scale Standard Deviation 18.51
HRQL: Change From Baseline in European Quality of Life Working Group Health Status Measure 5 Dimensions, 5 Levels (EQ-5D-5L) Score: Visual Analogic Scale (VAS) at Specified Timepoints: Primary Analysis Cycle 12 Day 1	5.29 score on a scale Standard Deviation 18.51	3.63 score on a scale Standard Deviation 19.34
HRQL: Change From Baseline in European Quality of Life Working Group Health Status Measure 5 Dimensions, 5 Levels (EQ-5D-5L) Score: Visual Analogic Scale (VAS) at Specified Timepoints: Primary Analysis Cycle 13 Day 1	6.81 score on a scale Standard Deviation 19.57	4.94 score on a scale Standard Deviation 18.41
HRQL: Change From Baseline in European Quality of Life Working Group Health Status Measure 5 Dimensions, 5 Levels (EQ-5D-5L) Score: Visual Analogic Scale (VAS) at Specified Timepoints: Primary Analysis Cycle 14 Day 1	7.95 score on a scale Standard Deviation 18.12	4.72 score on a scale Standard Deviation 17.67
HRQL: Change From Baseline in European Quality of Life Working Group Health Status Measure 5 Dimensions, 5 Levels (EQ-5D-5L) Score: Visual Analogic Scale (VAS) at Specified Timepoints: Primary Analysis Cycle 15 Day 1	4.96 score on a scale Standard Deviation 18.92	3.23 score on a scale Standard Deviation 18.87
HRQL: Change From Baseline in European Quality of Life Working Group Health Status Measure 5 Dimensions, 5 Levels (EQ-5D-5L) Score: Visual Analogic Scale (VAS) at Specified Timepoints: Primary Analysis Cycle 16 Day 1	3.94 score on a scale Standard Deviation 18.78	4.56 score on a scale Standard Deviation 18.88
HRQL: Change From Baseline in European Quality of Life Working Group Health Status Measure 5 Dimensions, 5 Levels (EQ-5D-5L) Score: Visual Analogic Scale (VAS) at Specified Timepoints: Primary Analysis Cycle 17 Day 1	5.04 score on a scale Standard Deviation 17.93	4.97 score on a scale Standard Deviation 18.55
HRQL: Change From Baseline in European Quality of Life Working Group Health Status Measure 5 Dimensions, 5 Levels (EQ-5D-5L) Score: Visual Analogic Scale (VAS) at Specified Timepoints: Primary Analysis Cycle 18 Day 1	3.71 score on a scale Standard Deviation 19.08	3.83 score on a scale Standard Deviation 18.46
HRQL: Change From Baseline in European Quality of Life Working Group Health Status Measure 5 Dimensions, 5 Levels (EQ-5D-5L) Score: Visual Analogic Scale (VAS) at Specified Timepoints: Primary Analysis Cycle 19 Day 1	7.44 score on a scale Standard Deviation 18.73	3.69 score on a scale Standard Deviation 18.37
HRQL: Change From Baseline in European Quality of Life Working Group Health Status Measure 5 Dimensions, 5 Levels (EQ-5D-5L) Score: Visual Analogic Scale (VAS) at Specified Timepoints: Primary Analysis Cycle 20 Day 1	6.18 score on a scale Standard Deviation 18.43	4.20 score on a scale Standard Deviation 17.20
HRQL: Change From Baseline in European Quality of Life Working Group Health Status Measure 5 Dimensions, 5 Levels (EQ-5D-5L) Score: Visual Analogic Scale (VAS) at Specified Timepoints: Primary Analysis Cycle 21 Day 1	7.25 score on a scale Standard Deviation 23.46	3.26 score on a scale Standard Deviation 18.97
HRQL: Change From Baseline in European Quality of Life Working Group Health Status Measure 5 Dimensions, 5 Levels (EQ-5D-5L) Score: Visual Analogic Scale (VAS) at Specified Timepoints: Primary Analysis Cycle 22 Day 1	5.58 score on a scale Standard Deviation 24.06	2.35 score on a scale Standard Deviation 18.62
HRQL: Change From Baseline in European Quality of Life Working Group Health Status Measure 5 Dimensions, 5 Levels (EQ-5D-5L) Score: Visual Analogic Scale (VAS) at Specified Timepoints: Primary Analysis Cycle 23 Day 1	6.33 score on a scale Standard Deviation 18.73	6.44 score on a scale Standard Deviation 18.34
HRQL: Change From Baseline in European Quality of Life Working Group Health Status Measure 5 Dimensions, 5 Levels (EQ-5D-5L) Score: Visual Analogic Scale (VAS) at Specified Timepoints: Primary Analysis Cycle 24 Day 1	5.11 score on a scale Standard Deviation 17.93	4.50 score on a scale Standard Deviation 18.31
HRQL: Change From Baseline in European Quality of Life Working Group Health Status Measure 5 Dimensions, 5 Levels (EQ-5D-5L) Score: Visual Analogic Scale (VAS) at Specified Timepoints: Primary Analysis Cycle 25 Day 1	9.20 score on a scale Standard Deviation 21.48	5.00 score on a scale Standard Deviation 18.83
HRQL: Change From Baseline in European Quality of Life Working Group Health Status Measure 5 Dimensions, 5 Levels (EQ-5D-5L) Score: Visual Analogic Scale (VAS) at Specified Timepoints: Primary Analysis End of Treatment	-4.40 score on a scale Standard Deviation 18.66	-7.80 score on a scale Standard Deviation 21.08

SECONDARY outcome

Timeframe: End of infusion on Cycle 1 Day 1 and Cycle 1 Day 15; Cycle 2 Day 1

Population: Analysis was performed on pharmacokinetic (PK) population which included participants who received at least 1 dose of Isatuximab, with data for at least 1 PK parameter available. Data for this outcome measure (OM) was not planned to be collected and analyzed for Kd arm. Here, 'Number analyzed' signifies participants with available data for each specified category.

Ceoi is the plasma concentration observed at the end of intravenous infusion.

Outcome measures

Outcome measures
Measure	Carfilzomib + Dexamethasone (Kd) n=172 Participants Participants received carfilzomib 20 mg/m\^2, IV infusion on Days 1, and 2 in Cycle 1, and then escalated to 56 mg/m\^2 on Days 8, 9, 15 and 16 of Cycle 1 and then on Days 1, 2, 8, 9, 15 and 16 of each subsequent 28-day treatment cycle along with dexamethasone 20 mg, PO or IV on Days 1, 2, 8, 9, 15, 16, 22 and 23 of each 28-day treatment cycle until disease progression or unacceptable adverse event or participant's decision to discontinue the study treatment or any other reason, whichever comes first (maximum exposure: 114 weeks).	Isatuximab + Carfilzomib + Dexamethasone (IKd) Participants received isatuximab 10 mg/kg, IV infusion on Days 1, 8, 15 and 22 in Cycle 1, and then on Days 1 and Day 15 of each 28-day treatment cycle plus carfilzomib 20 mg/m\^2, IV on Days 1, and 2 in Cycle 1, and then escalated to 56 mg/m\^2 on Days 8, 9, 15 and 16 of Cycle 1 and then on Days 1, 2, 8, 9, 15 and 16 of each subsequent 28-day treatment cycle and dexamethasone 20 mg, PO or IV on Day 1, 2, 8, 9, 15, 16, 22 and 23 of each 28-day treatment cycle until disease progression or unacceptable adverse event or participant's decision to discontinue the study treatment or any other reason, whichever comes first (maximum exposure: 111 weeks).
Pharmacokinetics: Plasma Concentration at End of Infusion (Ceoi) of Isatuximab: Primary Analysis Cycle 1 Day 1	274.01 microgram/milliliter (mcg/mL) Standard Deviation 183.67	—
Pharmacokinetics: Plasma Concentration at End of Infusion (Ceoi) of Isatuximab: Primary Analysis Cycle 1 Day 15	380.28 microgram/milliliter (mcg/mL) Standard Deviation 85.70	—
Pharmacokinetics: Plasma Concentration at End of Infusion (Ceoi) of Isatuximab: Primary Analysis Cycle 2 Day 1	522.74 microgram/milliliter (mcg/mL) Standard Deviation 204.11	—

SECONDARY outcome

Timeframe: Pre-infusion on Cycle 1 Day 1, Day 8, Day 15 and Day 22, Cycle 2 Day 1, Cycle 3 Day 1, Cycle 4 Day 1, Cycle 5 Day 1, Cycle 6 Day 1, Cycle 7 Day 1, Cycle 8 Day 1, Cycle 9 Day 1 and Cycle 10 Day 1

Population: Analysis was performed on PK population. Data for this OM was not planned to be collected and analyzed for Kd arm. Here,'Number analyzed' signifies participants with available data for each specified category.

Ctrough was the plasma concentration observed just before treatment administration during repeated dosing.

Outcome measures

Outcome measures
Measure	Carfilzomib + Dexamethasone (Kd) n=172 Participants Participants received carfilzomib 20 mg/m\^2, IV infusion on Days 1, and 2 in Cycle 1, and then escalated to 56 mg/m\^2 on Days 8, 9, 15 and 16 of Cycle 1 and then on Days 1, 2, 8, 9, 15 and 16 of each subsequent 28-day treatment cycle along with dexamethasone 20 mg, PO or IV on Days 1, 2, 8, 9, 15, 16, 22 and 23 of each 28-day treatment cycle until disease progression or unacceptable adverse event or participant's decision to discontinue the study treatment or any other reason, whichever comes first (maximum exposure: 114 weeks).	Isatuximab + Carfilzomib + Dexamethasone (IKd) Participants received isatuximab 10 mg/kg, IV infusion on Days 1, 8, 15 and 22 in Cycle 1, and then on Days 1 and Day 15 of each 28-day treatment cycle plus carfilzomib 20 mg/m\^2, IV on Days 1, and 2 in Cycle 1, and then escalated to 56 mg/m\^2 on Days 8, 9, 15 and 16 of Cycle 1 and then on Days 1, 2, 8, 9, 15 and 16 of each subsequent 28-day treatment cycle and dexamethasone 20 mg, PO or IV on Day 1, 2, 8, 9, 15, 16, 22 and 23 of each 28-day treatment cycle until disease progression or unacceptable adverse event or participant's decision to discontinue the study treatment or any other reason, whichever comes first (maximum exposure: 111 weeks).
Pharmacokinetics: Plasma Concentration of Isatuximab at Ctrough: Primary Analysis Cycle 8 Day 1	490.51 mcg/mL Standard Deviation 198.17	—
Pharmacokinetics: Plasma Concentration of Isatuximab at Ctrough: Primary Analysis Cycle 9 Day 1	486.07 mcg/mL Standard Deviation 181.34	—
Pharmacokinetics: Plasma Concentration of Isatuximab at Ctrough: Primary Analysis Cycle 10 Day 1	490.08 mcg/mL Standard Deviation 206.53	—
Pharmacokinetics: Plasma Concentration of Isatuximab at Ctrough: Primary Analysis Cycle 1 Day 1	3.66 mcg/mL Standard Deviation 34.40	—
Pharmacokinetics: Plasma Concentration of Isatuximab at Ctrough: Primary Analysis Cycle 1 Day 8	82.14 mcg/mL Standard Deviation 43.87	—
Pharmacokinetics: Plasma Concentration of Isatuximab at Ctrough: Primary Analysis Cycle 1 Day 15	180.02 mcg/mL Standard Deviation 71.83	—
Pharmacokinetics: Plasma Concentration of Isatuximab at Ctrough: Primary Analysis Cycle 1 Day 22	252.63 mcg/mL Standard Deviation 100.16	—
Pharmacokinetics: Plasma Concentration of Isatuximab at Ctrough: Primary Analysis Cycle 2 Day 1	324.28 mcg/mL Standard Deviation 132.98	—
Pharmacokinetics: Plasma Concentration of Isatuximab at Ctrough: Primary Analysis Cycle 3 Day 1	295.78 mcg/mL Standard Deviation 146.11	—
Pharmacokinetics: Plasma Concentration of Isatuximab at Ctrough: Primary Analysis Cycle 4 Day 1	342.48 mcg/mL Standard Deviation 140.94	—
Pharmacokinetics: Plasma Concentration of Isatuximab at Ctrough: Primary Analysis Cycle 5 Day 1	389.25 mcg/mL Standard Deviation 172.11	—
Pharmacokinetics: Plasma Concentration of Isatuximab at Ctrough: Primary Analysis Cycle 6 Day 1	427.16 mcg/mL Standard Deviation 188.51	—
Pharmacokinetics: Plasma Concentration of Isatuximab at Ctrough: Primary Analysis Cycle 7 Day 1	433.22 mcg/mL Standard Deviation 177.11	—

SECONDARY outcome

Timeframe: Cycle 1: pre-dose (0 hour), 30 minutes (min), 35 min, 45 min, 60 min, 1 hour 30 min, 2 hours 30 min and 4 hours 30 min post-dose on Day 15

Population: Analysis was performed on PK population. Data for this OM was not planned to be collected and analyzed for Kd arm. Here, 'overall number of participants analyzed' = participants with available data for this outcome measure.

Cmax was defined as the maximum concentration observed after the first infusion calculated using the non-compartmental analysis after the intravenous infusion of carfilzomib with isatuximab.