SC Versus IV Isatuximab in Combination With Pomalidomide and Dexamethasone in RRMM

Ctrough at steady state was the observed plasma concentration collected on pre-dose at Cycle 6 Day 1 (equivalent to prior to Cycle 6 Day 1) of isatuximab administration dose.

Time frame: Pre-dose at Cycle 6 Day 1

Population: Per Protocol-Pharmacokinetic (PP-PK) population: all randomized participants who met following: at least 11 Isa dose from Cycle 1 Day 1 to Cycle 5 Day 15 (1 dose omission permitted at Cycle 1 only); Isa pre-dose plasma concentration results from PK samples on Cycle 6 Day 1 collected within PP defined time window with adequate documentation of dosing and sampling dates and times.

ORR by independent review committee (IRC) using 2016 international myeloma working group (IMWG) criteria:Percentage of participants with complete response (CR),stringent CR (sCR),very good partial response (VGPR) & partial response (PR).CR:negative immunofixation on serum and urine,disappearance of any soft tissue plasmacytomas (STP),\<5% plasma cells in bone marrow (BM) aspirates & a normal free light chain(FLC)ratio (0.26-1.65).sCR:CR plus no clonal cells in BM biopsy. VGPR:serum & urine M-protein detectable by immunofixation, not electrophoresis;\>=90% reduction in serum M-protein plus urine M-protein level\<100mg/24hour(h);\>=90% decrease in sum of maximal perpendicular diameter (SPD) compared to baseline in STP;FLC only:\>=90% decrease in difference between involved and uninvolved FLC levels.PR:\>=50% reduction of serum M-protein and reduction in 24h urine M-protein by \>=90% or to \<200mg/24h.In addition to above, if present at baseline,\>=50% reduction in size SPD of STPs also required.

Time frame: From first dose of study medication administration (Day 1) up to PCD (06-Nov-2024), approximately 28 months

Population: The intent-to-treat (ITT) population included all randomized population (all participants who had given their informed consent and for whom there was confirmation of successful allocation of a randomization number by the interactive response technology \[IRT\]). Percentages are rounded off to the tenth decimal place.

EORTC QLQ-C30 is a cancer specific 30-item instrument that provides a comprehensive assessment of the principal health related QoL dimensions: GHS/QoL (2 items), functional scales (physical \[5 items\], role \[2 items\], emotional \[4 items\], cognitive \[2 items\], social \[2 items\]), symptom scales (fatigue \[3 items\], nausea & vomiting \[2 items\], pain \[2 items\]) and symptom items- 1 item each (dyspnea, insomnia, appetite loss, constipation, diarrhea, financial difficulties). For symptom items: questions were rated on a 4-point scale (1: not at all to 4: very much). All of the scales and single-item measures range in score from 0 to 100; mean is presented here. A higher score for symptom items and a positive change from baseline represents a higher level of symptomatology. The baseline value was defined as the last non-missing value collected on or before the start date of study medication.

Time frame: Baseline (Cycle 1 Day 1) and Cycle 2 Day 1, Cycles 3 to 21 Day 15 and EOT visit (30 days after last study medication administration or before further anti myeloma therapy initiation, whichever occurred first, up to approximately 28 months)

Population: The ITT population included all randomized population. Only those participants with data collected at specified timepoints are reported.

EORTC QLQ-C30 is a cancer specific 30-item instrument that provides a comprehensive assessment of the principal health related QoL dimensions: GHS/QoL (2 items), functional scales (physical \[5 items\], role \[2 items\], emotional \[4 items\], cognitive \[2 items\], social \[2 items\]), symptom scales (fatigue \[3 items\], nausea & vomiting \[2 items\], pain \[2 items\]) and symptom items- 1 item each (dyspnea, insomnia, appetite loss, constipation, diarrhea, financial difficulties). For functional scales: questions were rated on a 4-point scale (1: not at all to 4: very much). All of the scales and single-item measures range in score from 0 to 100; mean is presented here. A higher score and a positive change from baseline represents a better level of cognitive functioning. The baseline value was defined as the last non-missing value collected on or before the start date of study medication.

Time frame: Baseline (Cycle 1 Day 1) and Cycle 2 Day 1, Cycles 3 to 21 Day 15 and EOT visit (30 days after last study medication administration or before further anti myeloma therapy initiation, whichever occurred first, up to approximately 28 months)

Population: The ITT population included all randomized population. Only those participants with data collected at specified timepoints are reported.

EORTC QLQ-C30 is a cancer specific 30-item instrument that provides a comprehensive assessment of the principal health related QoL dimensions: GHS/QoL (2 items), functional scales (physical \[5 items\], role \[2 items\], emotional \[4 items\], cognitive \[2 items\], social \[2 items\]), symptom scales (fatigue \[3 items\], nausea & vomiting \[2 items\], pain \[2 items\]) and symptom items- 1 item each (dyspnea, insomnia, appetite loss, constipation, diarrhea, financial difficulties). For symptom items: questions were rated on a 4-point scale (1: not at all to 4: very much). All of the scales and single-item measures range in score from 0 to 100; mean is presented here. A higher score for symptom items and a positive change from baseline represents a higher level of symptomatology. The baseline value was defined as the last non-missing value collected on or before the start date of study medication.

Time frame: Baseline (Cycle 1 Day 1) and Cycle 2 Day 1, Cycles 3 to 21 Day 15 and EOT visit (30 days after last study medication administration or before further anti myeloma therapy initiation, whichever occurred first, up to approximately 28 months)

Population: The ITT population included all randomized population. Only those participants with data collected at specified timepoints are reported.

EORTC QLQ-C30 is a cancer specific 30-item instrument that provides a comprehensive assessment of the principal health related QoL dimensions: GHS/QoL (2 items), functional scales (physical \[5 items\], role \[2 items\], emotional \[4 items\], cognitive \[2 items\], social \[2 items\]), symptom scales (fatigue \[3 items\], nausea & vomiting \[2 items\], pain \[2 items\]) and symptom items- 1 item each (dyspnea, insomnia, appetite loss, constipation, diarrhea, financial difficulties). For symptom items: questions were rated on a 4-point scale (1: not at all to 4: very much). All of the scales and single-item measures range in score from 0 to 100; mean is presented here. A higher score for symptom items and a positive change from baseline represents a higher level of symptomatology. The baseline value was defined as the last non-missing value collected on or before the start date of study medication.

Time frame: Baseline (Cycle 1 Day 1) and Cycle 2 Day 1, Cycles 3 to 21 Day 15 and EOT visit (30 days after last study medication administration or before further anti myeloma therapy initiation, whichever occurred first, up to approximately 28 months)

Population: The ITT population included all randomized population. Only those participants with data collected at specified timepoints are reported.

EORTC QLQ-C30 is a cancer specific 30-item instrument that provides a comprehensive assessment of the principal health related QoL dimensions: GHS/QoL (2 items), functional scales (physical \[5 items\], role \[2 items\], emotional \[4 items\], cognitive \[2 items\], social \[2 items\]), symptom scales (fatigue \[3 items\], nausea & vomiting \[2 items\], pain \[2 items\]) and symptom items- 1 item each (dyspnea, insomnia, appetite loss, constipation, diarrhea, financial difficulties). For symptom items: questions were rated on a 4-point scale (1: not at all to 4: very much). All of the scales and single-item measures range in score from 0 to 100; mean is presented here. A higher score for symptom items and a positive change from baseline represents a higher level of symptomatology. The baseline value was defined as the last non-missing value collected on or before the start date of study medication.

Time frame: Baseline (Cycle 1 Day 1) and Cycle 2 Day 1, Cycles 3 to 21 Day 15 and EOT visit (30 days after last study medication administration or before further anti myeloma therapy initiation, whichever occurred first, up to approximately 28 months)

Population: The ITT population included all randomized population. Only those participants with data collected at specified timepoints are reported.

EORTC QLQ-C30 is a cancer specific 30-item instrument that provides a comprehensive assessment of the principal health related QoL dimensions: GHS/QoL (2 items), functional scales (physical \[5 items\], role \[2 items\], emotional \[4 items\], cognitive \[2 items\], social \[2 items\]), symptom scales (fatigue \[3 items\], nausea & vomiting \[2 items\], pain \[2 items\]) and symptom items- 1 item each (dyspnea, insomnia, appetite loss, constipation, diarrhea, financial difficulties). For functional scales: questions were rated on a 4-point scale (1: not at all to 4: very much). All of the scales and single-item measures range in score from 0 to 100; mean is presented here. A higher score and a positive change from baseline represents a better level of emotional functioning. The baseline value was defined as the last non-missing value collected on or before the start date of study medication.

Time frame: Baseline (Cycle 1 Day 1) and Cycle 2 Day 1, Cycles 3 to 21 Day 15 and EOT visit (30 days after last study medication administration or before further anti myeloma therapy initiation, whichever occurred first, up to approximately 28 months)

Population: The ITT population included all randomized population. Only those participants with data collected at specified timepoints are reported.

EORTC QLQ-C30 is a cancer specific 30-item instrument that provides a comprehensive assessment of the principal health related QoL dimensions: GHS/QoL (2 items), functional scales (physical \[5 items\], role \[2 items\], emotional \[4 items\], cognitive \[2 items\], social \[2 items\]), symptom scales (fatigue \[3 items\], nausea & vomiting \[2 items\], pain \[2 items\]) and symptom items- 1 item each (dyspnea, insomnia, appetite loss, constipation, diarrhea, financial difficulties). For symptom scales: questions were rated on a 4-point scale (1: not at all to 4: very much). All of the scales and single-item measures range in score from 0 to 100; mean is presented here. A higher score for symptoms and a positive change from baseline represents a higher level of symptomatology. The baseline value was defined as the last non-missing value collected on or before the start date of study medication.

Time frame: Baseline (Cycle 1 Day 1) and Cycle 2 Day 1, Cycles 3 to 21 Day 15 and EOT visit (30 days after last study medication administration or before further anti myeloma therapy initiation, whichever occurred first, up to approximately 28 months)

Population: The ITT population included all randomized population. Only those participants with data collected at specified timepoints are reported.

EORTC QLQ-C30 is a cancer specific 30-item instrument that provides a comprehensive assessment of the principal health related QoL dimensions: GHS/QoL (2 items), functional scales (physical \[5 items\], role \[2 items\], emotional \[4 items\], cognitive \[2 items\], social \[2 items\]), symptom scales (fatigue \[3 items\], nausea & vomiting \[2 items\], pain \[2 items\]) and symptom items- 1 item each (dyspnea, insomnia, appetite loss, constipation, diarrhea, financial difficulties). For symptom items: questions were rated on a 4-point scale (1: not at all to 4: very much). All of the scales and single-item measures range in score from 0 to 100; mean is presented here. A higher score for symptom items and a positive change from baseline represents a higher level of financial difficulties. The baseline value was defined as the last non-missing value collected on or before the start date of study medication.

Time frame: Baseline (Cycle 1 Day 1) and Cycle 2 Day 1, Cycles 3 to 21 Day 15 and EOT visit (30 days after last study medication administration or before further anti myeloma therapy initiation, whichever occurred first, up to approximately 28 months)

Population: The ITT population included all randomized population. Only those participants with data collected at specified timepoints are reported.

EORTC QLQ-C30 is a cancer specific 30-item instrument that provides a comprehensive assessment of the principal health related QoL dimensions: GHS/QoL (2 items), functional scales (physical \[5 items\], role \[2 items\], emotional \[4 items\], cognitive \[2 items\], social \[2 items\]), symptom scales (fatigue \[3 items\], nausea & vomiting \[2 items\], pain \[2 items\]) and symptom items- 1 item each (dyspnea, insomnia, appetite loss, constipation, diarrhea, financial difficulties). For symptom items: questions were rated on a 4-point scale (1: not at all to 4: very much). All of the scales and single-item measures range in score from 0 to 100; mean is presented here. A higher score for symptom items and a positive change from baseline represents a higher level of symptomatology. The baseline value was defined as the last non-missing value collected on or before the start date of study medication.

Time frame: Baseline (Cycle 1 Day 1) and Cycle 2 Day 1, Cycles 3 to 21 Day 15 and EOT visit (30 days after last study medication administration or before further anti myeloma therapy initiation, whichever occurred first, up to approximately 28 months)

Population: The ITT population included all randomized population. Only those participants with data collected at specified timepoints are reported.

EORTC QLQ-C30 is a cancer specific 30-item instrument that provides a comprehensive assessment of the principal health related QoL dimensions: GHS/QoL (2 items), functional scales (physical \[5 items\], role \[2 items\], emotional \[4 items\], cognitive \[2 items\], social \[2 items\]), symptom scales (fatigue \[3 items\], nausea & vomiting \[2 items\], pain \[2 items\]) and symptom items- 1 item each (dyspnea, insomnia, appetite loss, constipation, diarrhea, financial difficulties). For symptom scales: questions were rated on a 4-point scale (1: not at all to 4: very much). All of the scales and single-item measures range in score from 0 to 100; mean is presented here. A higher score for symptoms and a positive change from baseline represents a higher level of symptomatology. The baseline value was defined as the last non-missing value collected on or before the start date of study medication.

Time frame: Baseline (Cycle 1 Day 1) and Cycle 2 Day 1, Cycles 3 to 21 Day 15 and EOT visit (30 days after last study medication administration or before further anti myeloma therapy initiation, whichever occurred first, up to approximately 28 months)

Population: The ITT population included all randomized population. Only those participants with data collected at specified timepoints are reported.

EORTC QLQ-C30 is a cancer specific 30-item instrument that provides a comprehensive assessment of the principal health related QoL dimensions: GHS/QoL (2 items), functional scales (physical \[5 items\], role \[2 items\], emotional \[4 items\], cognitive \[2 items\], social \[2 items\]), symptom scales (fatigue \[3 items\], nausea & vomiting \[2 items\], pain \[2 items\]) and symptom items- 1 item each (dyspnea, insomnia, appetite loss, constipation, diarrhea, financial difficulties). For symptom scales: questions were rated on a 4-point scale (1: not at all to 4: very much). All of the scales and single-item measures range in score from 0 to 100; mean is presented here. A higher score for symptoms and a positive change from baseline represents a higher level of symptomatology. The baseline value was defined as the last non-missing value collected on or before the start date of study medication.

Time frame: Baseline (Cycle 1 Day 1) and Cycle 2 Day 1, Cycles 3 to 21 Day 15 and EOT visit (30 days after last study medication administration or before further anti myeloma therapy initiation, whichever occurred first, up to approximately 28 months)

Population: The ITT population included all randomized population. Only those participants with data collected at specified timepoints are reported.

EORTC QLQ-C30 is a cancer specific 30-item instrument that provides a comprehensive assessment of the principal health related QoL dimensions: GHS/QoL (2 items), functional scales (physical \[5 items\], role \[2 items\], emotional \[4 items\], cognitive \[2 items\], social \[2 items\]), symptom scales (fatigue \[3 items\], nausea & vomiting \[2 items\], pain \[2 items\]) and symptom items- 1 item each (dyspnea, insomnia, appetite loss, constipation, diarrhea, financial difficulties). For functional scales: questions were rated on a 4-point scale (1: not at all to 4: very much). All of the scales and single-item measures range in score from 0 to 100; mean is presented here. A higher score and a positive change from baseline represents a better level of physical functioning. The baseline value was defined as the last non-missing value collected on or before the start date of study medication.

Time frame: Baseline (Cycle 1 Day 1) and Cycle 2 Day 1, Cycles 3 to 21 Day 15 and EOT visit (30 days after last study medication administration or before further anti myeloma therapy initiation, whichever occurred first, up to approximately 28 months)

Population: The ITT population included all randomized population. Only those participants with data collected at specified timepoints are reported.

EORTC QLQ-C30 is a cancer specific 30-item instrument that provides a comprehensive assessment of the principal health related QoL dimensions: GHS/QoL (2 items), functional scales (physical \[5 items\], role \[2 items\], emotional \[4 items\], cognitive \[2 items\], social \[2 items\]), symptom scales (fatigue \[3 items\], nausea & vomiting \[2 items\], pain \[2 items\]) and symptom items- 1 item each (dyspnea, insomnia, appetite loss, constipation, diarrhea, financial difficulties). For functional scales: questions were rated on a 4-point scale (1: not at all to 4: very much). All of the scales and single-item measures range in score from 0 to 100; mean is presented here. A higher score and a positive change from baseline represents a better level of role functioning. The baseline value was defined as the last non-missing value collected on or before the start date of study medication.

Time frame: Baseline (Cycle 1 Day 1) and Cycle 2 Day 1, Cycles 3 to 21 Day 15 and EOT visit (30 days after last study medication administration or before further anti myeloma therapy initiation, whichever occurred first, up to approximately 28 months)

Population: The ITT population included all randomized population. Only those participants with data collected at specified timepoints are reported.

EORTC QLQ-C30 is a cancer specific 30-item instrument that provides a comprehensive assessment of the principal health related QoL dimensions: GHS/QoL (2 items), functional scales (physical \[5 items\], role \[2 items\], emotional \[4 items\], cognitive \[2 items\], social \[2 items\]), symptom scales (fatigue \[3 items\], nausea & vomiting \[2 items\], pain \[2 items\]) and symptom items- 1 item each (dyspnea, insomnia, appetite loss, constipation, diarrhea, financial difficulties). For functional scales: questions were rated on a 4-point scale (1: not at all to 4: very much). All of the scales and single-item measures range in score from 0 to 100; mean is presented here. A higher score and a positive change from baseline represents a better level of social functioning. The baseline value was defined as the last non-missing value collected on or before the start date of study medication.

Time frame: Baseline (Cycle 1 Day 1) and Cycle 2 Day 1, Cycles 3 to 21 Day 15 and EOT visit (30 days after last study medication administration or before further anti myeloma therapy initiation, whichever occurred first, up to approximately 28 months)

Population: The ITT population included all randomized population. Only those participants with data collected at specified timepoints are reported.

The EORTC QLQ-MY20 was used in conjunction with the EORTC QLQ-C30 to assess symptoms and side effects due to the treatment or the disease which impacts health related QoL in participants with MM. It contains 20 items, 4 independent subscales covering 2 functional domains: symptom scales which include disease symptoms (6 items) and side-effects of treatment (10 items) and function scale which include future perspective (3 items) and body image (1 item). Scores for each subscale are based on the 4-point Likert scale ranging from (1: not at all to 4: very much) and transformed from raw scores to linear scales ranging from 0 to 100; mean is presented here. A higher score for body image and a positive change from baseline represents better outcomes, better QoL. The baseline value was defined as the last non-missing value collected on or before the start date of study medication.

Time frame: Baseline (Cycle 1 Day 1) and Cycle 2 Day 1, Cycles 3 to 21 Day 15 and EOT visit (30 days after last study medication administration or before further anti myeloma therapy initiation, whichever occurred first, up to approximately 28 months)

Population: The ITT population included all randomized population. Only those participants with data collected at specified timepoints are reported.

The EORTC QLQ-MY20 was used in conjunction with the EORTC QLQ-C30 to assess symptoms and side effects due to the treatment or the disease which impacts health related QoL in participants with MM. It contains 20 items, 4 independent subscales covering 2 functional domains: symptom scales which include disease symptoms (6 items) and side-effects of treatment (10 items) and function scale which include future perspective (3 items) and body image (1 item). Scores for each subscale are based on the 4-point Likert scale ranging from (1: not at all to 4: very much) and transformed from raw scores to linear scales ranging from 0 to 100; mean is presented here. A higher score for future perspectives and a positive change from baseline represents better outcomes, better QoL. The baseline value was defined as the last non-missing value collected on or before the start date of study medication.

Time frame: Baseline (Cycle 1 Day 1) and Cycle 2 Day 1, Cycles 3 to 21 Day 15 and EOT visit (30 days after last study medication administration or before further anti myeloma therapy initiation, whichever occurred first, up to approximately 28 months)

Population: The ITT population included all randomized population. Only those participants with data collected at specified timepoints are reported.

The EORTC QLQ-MY20 was used in conjunction with the EORTC QLQ-C30 to assess symptoms and side effects due to the treatment or the disease which impacts health related QoL in participants with MM. It contains 20 items, 4 independent subscales covering 2 functional domains: symptom scales which include disease symptoms (6 items) and side-effects of treatment (10 items) and function scale which include future perspective (3 items) and body image (1 item). Scores for each subscale are based on the 4-point Likert scale ranging from (1: not at all to 4: very much) and transformed from raw scores to linear scales ranging from 0 to 100; mean is presented here. A higher score for side effects of treatment and a positive change from baseline represents more side effects, worse QoL. The baseline value was defined as the last non-missing value collected on or before the start date of study medication.

Time frame: Baseline (Cycle 1 Day 1) and Cycle 2 Day 1, Cycles 3 to 21 Day 15 and EOT visit (30 days after last study medication administration or before further anti myeloma therapy initiation, whichever occurred first, up to approximately 28 months)

Population: The ITT population included all randomized population. Only those participants with data collected at specified timepoints are reported.

The EORTC QLQ-MY20 was used in conjunction with the EORTC QLQ-C30 to assess symptoms and side effects due to the treatment or the disease which impacts health related QoL in participants with MM. It contains 20 items, 4 independent subscales covering 2 functional domains: symptom scales which include disease symptoms (6 items) and side-effects of treatment (10 items) and function scale which include future perspective (3 items) and body image (1 item). Scores for each subscale are based on the 4-point Likert scale ranging from (1: not at all to 4: very much) and transformed from raw scores to linear scales ranging from 0 to 100; mean is presented here. A higher score for disease symptoms and a positive change from baseline represents more symptoms, worse QoL. The baseline value was defined as the last non-missing value collected on or before the start date of study medication.

Time frame: Baseline (Cycle 1 Day 1) and Cycle 2 Day 1, Cycles 3 to 21 Day 15 and EOT visit (30 days after last study medication administration or before further anti myeloma therapy initiation, whichever occurred first, up to approximately 28 months)

Population: The ITT population included all randomized population. Only those participants with data collected at specified timepoints are reported.

EORTC QLQ-C30 is a cancer specific 30-item instrument that provides a comprehensive assessment of the principal health related QoL dimensions: GHS/QoL (2 items), functional scales (physical \[5 items\], role \[2 items\], emotional \[4 items\], cognitive \[2 items\], social \[2 items\]), symptom scales (fatigue \[3 items\], nausea & vomiting \[2 items\], pain \[2 items\]) and symptom items- 1 item each (dyspnea, insomnia, appetite loss, constipation, diarrhea, financial difficulties). For GHS/QoL: overall health and quality of life were assessed, rated on a 7-point scale (1: very poor to 7: excellent). All of the scales and single-item measures range in score from 0 to 100; mean is presented here. A higher score for GHS/QoL and a positive change from baseline represents a healthy/better level of QoL. The baseline value was defined as the last non-missing value collected on or before the start date of study medication.

Time frame: Baseline (Cycle 1 Day 1) and Cycle 2 Day 1, Cycles 3 to 21 Day 15 and EOT visit (30 days after last study medication administration or before further anti myeloma therapy initiation, whichever occurred first, up to approximately 28 months)

Population: The ITT population included all randomized population. Only those participants with data collected at specified timepoints are reported.

The EQ-5D-5L is a standardized measure of health status that provides a simple, generic measure of health utility, and consists of 2 sections: descriptive and a VAS. The descriptive system consists of 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems, and extreme problems. The VAS records the respondent's self-rated health on a 20-cm vertical scale ranging from 0: the worst health you can imagine to 100: the best health you can imagine. Change from baseline in VAS is reported here. A higher score in VAS and positive change from baseline represents a better level of QoL. The baseline value was defined as the last non-missing value collected on or before the start date of study medication.

Time frame: Baseline (Cycle 1 Day 1) and Cycle 2 Day 1, Cycles 3 to 21 Day 15 and EOT visit (30 days after last study medication administration or before further anti myeloma therapy initiation, whichever occurred first, up to approximately 28 months)

Population: The ITT population included all randomized population. Only those participants with data collected at specified timepoints are reported.

Plasma samples were collected at specified timepoints for the assessment of Ctrough.

Time frame: Pre-dose on Cycle 1 Days 8, 15 and 22, Cycles 2 to 5 Days 1 and 15, Cycles 6, 7, 8, 9, 12, 15, 18, 21, 24 and 27 Day 1

Population: The PK population included all participants with at least 1 available isatuximab concentration post-baseline (whatever the cycle and even if dosing was incomplete) with adequate documentation of dosing and sampling dates and times. Only those participants with data collected at specified timepoints are reported.

The CT4W was the observed plasma concentrations collected on pre-dose at Cycle 2 Day 1 (equivalent to prior to Cycle 2 Day 1) of isatuximab administration dose.

Time frame: Pre-dose at Cycle 2 Day 1 (at 4 weeks)

Population: The CT4W-PK population: all randomized participants who met following: all 4 Isa doses for Cycle 1 administered; Isa pre-dose plasma concentration results from PK samples on Cycle 2 Day 1 collected within PP defined time window with adequate documentation of dosing and sampling dates and times.

Medical resource utilization was collected through HRUPQ. Participants were asked to indicate the duration of their hospital visit (from arrival to departure) and the duration of post-treatment monitoring based on their most recent isatuximab administration. The median duration across all visits (starting from Cycle 2) was calculated and reported here.

Time frame: From Cycle 2 Day 1 up to EOT visit (30 days after last study medication administration or before further anti myeloma therapy initiation, whichever occurred first, up to approximately 28 months)

Population: The ITT population included all randomized population.

DOR: Time from the date of first response to the date of first occurrence of progressive disease (PD) determined by IRC or death from any cause, whichever occurred first.DOR was determined only for participants who achieved a response (PR or better).If PD/death not observed, participant was censored at date of last valid disease assessment performed prior to initiating further anti-myeloma treatment or analysis cut-off date, whichever occurred first. As per IMWG criteria: PD: increase of \>=25% from lowest confirmed value in any 1 of following: serum M-protein (absolute increase\>=0.5 gram/deciliter\[g/dL\]),serum M-protein increase\>=1g/dL if lowest M-component \>=5g/dL, urine M-component (absolute increase \>=200mg/24h), appearance of new lesion(s),\>=50% increase from nadir in SPD of \>1 lesion or \>=50% increase in longest diameter of a previous lesion \>1 centimeter (cm) in short axis. PR: as defined in OM1.

Time frame: From first dose of study medication administration (Day 1) up to PCD (06-Nov-2024), approximately 28 months

Population: The ITT population included all randomized population. Only responders (participants who achieved a response of PR or better subsequently confirmed based on disease assessment by IRC) were included in the analysis.

Healthcare utilization at baseline before study medication administration was collected via HRUPQ. The mean number of times in the past 6 months a participant received care in a clinic or hospital emergency room for any health issue including MM or due to MM and at-home care from a nurse or other health professional for any health issue including MM or due to MM is presented. The baseline value was defined as the last non-missing value collected on or before the start date of study medication.

Time frame: Baseline (Cycle 1 Day 1)

Population: The ITT population included all randomized population. Only those participants with responses at Baseline are presented.

Healthcare utilization at baseline before study medication administration was collected via HRUPQ. The mean number of nights in the past 6 month a participant stayed in hospital for any health issue including MM or due to MM and stayed in intensive care unit (ICU) for any health issue including MM or due to MM is presented. The baseline value was defined as the last non-missing value collected on or before the start date of study medication.

Time frame: Baseline (Cycle 1 Day 1)

Population: The ITT population included all randomized population. Only those participants with responses at Baseline are presented.

Healthcare utilization at baseline before study medication administration was collected via HRUPQ. The mean number of times in the past 6 months a participant consulted (had seen or talked to) following healthcare professionals: general doctor or primary care clinician (PCC) who treats a variety of illnesses for any health issue including MM or related to MM, physical or occupational therapist for any health issue including MM or related to MM, mental health professional (e.g. psychiatrist, psychologist, psychiatric nurse) for any health issue including MM or related to MM, medical doctor or clinician who specializes in particular medical disease or issue (specialist) for any health issue including MM or related to MM is presented. The baseline value was defined as the last non-missing value collected on or before the start date of study medication.

Time frame: Baseline (Cycle 1 Day 1)

Population: The ITT population included all randomized population. Only those participants with responses at Baseline are presented.

The ISRs are defined as AEs related to medication administration with onset typically within 24 hours from the start of the infusion and are graded using NCI-CTCAE v5.0 criteria: Grade 1: tenderness with or without associated symptoms (warmth, erythema, itching). Grade 2: pain; lipodystrophy; edema; phlebitis. Grade 3: ulceration or necrosis severe tissue damage operative intervention indicated. Grade 4: life-threatening consequences; urgent intervention indicated. ISRs were collected through the eCRF. Number of participants with at least 1 ISR is reported. ISRs were applicable only for the SC administration.

Time frame: From first dose of study medication administration (Day 1) up to 30 days after the last dose of study medication, approximately 28 months

Population: The safety population included ITT participants who received at least 1 dose or a part of a dose of the study medication. As pre-specified in the protocol and statistical analysis plan (SAP), ISRs were evaluated only for Isa-SC + Pd arm.

Percentage of successful injections with investigational isatuximab injector device was defined as completion of administration per provided instructions for use with no use errors or technical issues divided by the total number of injections x 100. Delivery performance of the device was analyzed based on the successful injection rate in the Isa-SC + Pd arm as the investigational isatuximab injector device was used only for SC administration.

Time frame: From first dose of study medication administration (Day 1) up to PCD (06-Nov-2024), approximately 28 months

Population: The safety population included ITT participants who received at least 1 dose or a part of a dose of the study medication. Total number of actual injections is reported as type of units.

An AE was defined as any untoward medical occurrence in a participant or clinical study participant, temporally associated with the use of study medication, whether or not considered related to the study medication. SAEs were any untoward medical occurrence that at any dose: resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect or was a medically important event. TEAEs were defined as AEs that developed, worsened or became serious during the TE period.

Time frame: From first dose of study medication administration (Day 1) up to 30 days after the last dose of study medication, approximately 28 months

Population: The safety population included ITT participants who received at least 1 dose or a part of a dose of the study medication.

A participant with treatment-emergent ADA was a participant with at least 1 treatment induced or treatment boosted ADA at any time during the treatment or follow-up observation period. Treatment-induced ADA was defined as ADAs developed de novo (seroconversion) following administration of the biotherapeutic (ie, formation of ADAs any time after the initial study medication administration in a participant without pre-existing ADAs). Treatment-boosted ADA was defined as pre-existing ADAs that were boosted to a higher level following administration of biotherapeutic (ie, any time after the initial study medication administration) the ADA titer was significantly higher than the baseline titer. Number of participants with treatment-emergent ADAs is presented.

Time frame: From first dose of study medication administration (Day 1) up to PCD (06-Nov-2024), approximately 28 months

Population: The ADA population included all participants from safety population with at least 1 ADA result (negative, positive or inconclusive) post-baseline.

BM aspirate was collected for fluorescent in situ hybridization for analysis of del\[17p\], t\[4;14\], t\[14;16\]) and 1q21+. ORR was also evaluated based on IRC assessment by disease characteristics. ORR for participants with at least 1 chromosomal abnormality i.e. \[del(17p)\] or \[1q21+ and t(4;14) or t(14;16)\] is presented. Percentages are rounded off to the tenth decimal place.

Time frame: From first dose of study medication administration (Day 1) up to PCD (06-Nov-2024), approximately 28 months

Population: The ITT population included all randomized population. Only participants with at least 1 chromosomal abnormality are included in the analysis.

OS is defined as the time from the date of randomization to death from any cause. Participants without death prior to the analysis cut-off date will be censored at the last date the participant was known to be alive or the cut-off date, whichever is first.

Time frame: From first dose of study medication administration (Day 1) up to a maximum of 57 months

The 4-item PAT is an internally developed non-disease specific and self-administered assessment which has been debriefed with oncology patients during qualitative interviews. It provided participant insights on the benefits and disadvantages of treatment. Benefits and disadvantages were respectively rated on a 0-10 scale wherein 0=none (not beneficial at all or no disadvantages at all) and 10=maximum (extremely beneficial or extremely disadvantageous). Disadvantages vs benefits were rated on a scale of -3 to 3 wherein -3=disadvantages significantly outweigh the benefits, 0=equal benefits and disadvantages and 3=benefits significantly outweigh the disadvantages. Mean of benefits, disadvantages and disadvantages vs benefits is presented here.

Time frame: EOT visit (30 days after last study medication administration or before further anti myeloma therapy initiation, whichever occurred first, up to approximately 28 months)

Population: The ITT population included all randomized population. Only those participants with data collected at EOT for this endpoint are reported.

The PESQ-FU consisting of 9 items has been designed to follow up on participant experience and satisfaction regarding the injection method (discomfort, pain, side effects, time saving and satisfaction) and study medication (side effects, worth taking, satisfaction and recommendation). This questionnaire has been adapted based on qualitative interviews with oncology participants. The responses to 'discomfort with injection method' were recorded as 'strongly agree, agree, neither agree nor disagree, disagree and strongly disagree' at specified timepoints. Percentage of participants who disagreed and strongly disagreed that they experienced any discomfort with the injection method are reported here. Percentages are rounded off to the tenth decimal place.

Time frame: Cycle 1 Days 8, 15, 22, Cycle 2 Days 1 and 15, Cycles 3 and 4 Day 1, Cycles 5 to 29 Day 15

Population: The ITT population included all randomized population. Only those participants with data collected at specified timepoints are reported.

The PESQ-FU consisting of 9 items has been designed to follow up on participant experience and satisfaction regarding the injection method (discomfort, pain, side effects, time saving and satisfaction) and study medication (side effects, worth taking, satisfaction and recommendation). This questionnaire has been adapted based on qualitative interviews with oncology participants. The responses to 'pain with injection method' were recorded as 'strongly agree, agree, neither agree nor disagree, disagree and strongly disagree' at specified timepoints. Percentage of participants who disagreed and strongly disagreed that they experienced any pain with the injection method are reported here. Percentages are rounded off to the tenth decimal place.

Time frame: Cycle 1 Days 8, 15, 22, Cycle 2 Days 1 and 15, Cycles 3 and 4 Day 1, Cycles 5 to 29 Day 15

Population: The ITT population included all randomized population. Only those participants with data collected at specified timepoints are reported.