Trial · NCT05405166

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

NCT05405166, Phase 3, Active not recruiting, Sanofi; results first posted 2025-11-14

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. SC Versus IV Isatuximab in Combination With Pomalidomide and Dexamethasone in RRMM. Trials, record NCT05405166. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT05405166

On this page

Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: SC Versus IV Isatuximab in Combination With Pomalidomide and Dexamethasone in RRMM
NCT number: NCT05405166
Status: Active not recruiting
Phases: Phase 3
Enrollment: 531 participants, actual
Lead sponsor: Sanofi
Conditions: Plasma Cell Myeloma Recurrent
Interventions: Isatuximab IV, Isatuximab SC, Dexamethasone, Pomalidomide, Dexamethasone, Montelukast, Paracetamol / Acetaminophen, Diphenhydramine, Methylprednisolone
First posted: 2022-06-06
Last updated: 2026-09-02
Results first posted: 2025-11-14

Source ClinicalTrials.gov

Registered outcomes57

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Overall Response Rate (ORR)	From first dose of study medication administration (Day 1) up to PCD (06-Nov-2024), approximately 28 months	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.
Primary	Observed Concentration Before Dosing (Ctrough) of Isatuximab at Steady State	Pre-dose at Cycle 6 Day 1	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.
Secondary	Very Good Partial Response or Better Rate	From first dose of study medication administration (Day 1) up to DCO date (29-Aug-2025), approximately 38 months	VGPR or better rate by IRC using 2016 IMWG criteria: Percentage of participants with sCR, CR, and VGPR. CR: negative immunofixation on serum and urine, disappearance of any STP, \<5% plasma cells in BM aspirates \& normal FLC ratio (0.26-1.65). sCR: CR plus no clonal cells in BM biopsy. VGPR: serum and urine M-protein detectable by immunofixation, not electrophoresis;\>=90% reduction in serum M-protein plus urine M-protein level\<100mg/24h;\>=90% decrease in SPD compared to baseline in STP; FLC only:\>=90% decrease in difference between involved and uninvolved FLC levels. Percentages are rounded off to the tenth decimal place.
Secondary	Ctrough of Isatuximab at 4 Weeks (CT4W)	Pre-dose at Cycle 2 Day 1 (at 4 weeks)	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.
Secondary	Percentage of Participants With Infusion Reactions	From first dose of study medication (Day 1) up to 30 days after the last dose of study medication, approximately 38 months	Infusion reactions were graded using National Cancer Institute-Common Terminology Criteria for AE (NCI-CTCAE) version (v)5.0 criteria: Grade 1: mild transient reaction; infusion interruption not indicated; intervention not indicated. Grade 2: moderate reaction; therapy or infusion interruption indicated but responds promptly to symptomatic treatment; prophylactic medications indicated for \<=24 hours. Grade 3/4: severe or life-threatening reaction (Grade 3: prolonged \[not rapidly responsive to symptomatic medication and/or brief interruption of infusion\]; recurrence of symptoms following initial improvement; hospitalization indicated for clinical sequelae. Grade 4: life-threatening consequences; urgent intervention indicated). Percentage of participants who observed AE of infusion reactions were collected through the electronic case report form (eCRF) as assessed by investigators. Percentages are rounded off to the tenth decimal place.
Secondary	Percentage of Participants Who Responded Very Satisfied and Satisfied to the 'Patient Experience and Satisfaction Questionnaire (PESQ-FU)': Satisfaction With Injection Method' (Item-8) at Cycle 5 Day 15	Cycle 5 Day 15	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 'satisfaction with injection method' were recorded as 'very satisfied, satisfied, neither satisfied nor dissatisfied, dissatisfied and very dissatisfied' at specified timepoints. The total percentage of participants who were very satisfied and satisfied with the injection method (item-8) at Cycle 5 Day 15 is reported here. Percentages are rounded off to the tenth decimal place.
Secondary	Duration of Response (DOR)	From first dose of study medication administration (Day 1) up to DCO date (29-Aug-2025), approximately 38 months	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.
Secondary	Time to First Response (TT1R)	From first dose of study medication administration (Day 1) up to DCO date (29-Aug-2025), approximately 38 months	TT1R was defined as the time from randomization to the date of first IRC determined response (PR or better) that was subsequently confirmed. PR as per IMWG criteria was defined as \>=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 the size SPD of STPs was also required.
Secondary	Time to Best Response (TTBR)	From first dose of study medication administration (Day 1) up to DCO date (29-Aug-2025), approximately 38 months	TTBR was defined as the time from randomization to the date of first occurrence of IRC determined best overall response (PR or better) that was subsequently confirmed. PR as per IMWG criteria was defined as \>=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 the size SPD of STPs was also required.
Secondary	Progression-free Survival (PFS)	From first dose of study medication administration (Day 1) up to DCO date (29-Aug-2025), approximately 38 months	PFS was defined as the time from the date of randomization to the date of first documentation of PD as determined by IRC or the date of death from any cause, whichever came first. Responses were determined according to IMWG criteria. PFS was censored at the date of the last valid disease assessment not showing PD performed prior to initiation of a further anti-myeloma treatment (if any) or the analysis cut-off date, whichever came first.

1 to 10 of 57Source ClinicalTrials.gov

See all 57 registered outcomes

Outcomes57

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Overall Response Rate (ORR)	From first dose of study medication administration (Day 1) up to PCD (06-Nov-2024), approximately 28 months	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.	percentage of participants	NUMBER
PRIMARY	Observed Concentration Before Dosing (Ctrough) of Isatuximab at Steady State	Pre-dose at Cycle 6 Day 1	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.	microgram/milliliter (mcg/mL)	MEAN
SECONDARY	Very Good Partial Response or Better Rate	From first dose of study medication administration (Day 1) up to PCD (06-Nov-2024), approximately 28 months	The ITT population included all randomized population.	percentage of participants	NUMBER
SECONDARY	Ctrough of Isatuximab at 4 Weeks (CT4W)	Pre-dose at Cycle 2 Day 1 (at 4 weeks)	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.	mcg/mL	MEAN
SECONDARY	Percentage of Participants With Infusion Reactions	From first dose of study medication (Day 1) up to 30 days after the last dose of study medication, approximately 28 months	The safety population included ITT participants who received at least 1 dose or a part of a dose of the study medication.	percentage of participants	NUMBER
SECONDARY	Percentage of Participants Who Responded Very Satisfied and Satisfied to the 'Patient Experience and Satisfaction Questionnaire (PESQ-FU)': Satisfaction With Injection Method' (Item-8) at Cycle 5 Day 15	Cycle 5 Day 15	The ITT population included all randomized population.	percentage of participants	NUMBER
SECONDARY	Duration of Response (DOR)	From first dose of study medication administration (Day 1) up to PCD (06-Nov-2024), approximately 28 months	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.	months	MEDIAN
SECONDARY	Time to First Response (TT1R)	From first dose of study medication administration (Day 1) up to PCD (06-Nov-2024), approximately 28 months	The ITT population included all randomized population.	months	MEDIAN
SECONDARY	Time to Best Response (TTBR)	From first dose of study medication administration (Day 1) up to PCD (06-Nov-2024), approximately 28 months	The ITT population included all randomized population.	months	MEDIAN
SECONDARY	Progression Free Survival (PFS)	From first dose of study medication administration (Day 1) up to a maximum of 57 months

1 to 10 of 57Source ClinicalTrials.gov

See all 57 outcomes

Results by group2,170

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Value	Spread	Units
Overall Response Rate (ORR)	Isa-IV + Pd	70.5	0.6467 to 0.7591	percentage of participants
Overall Response Rate (ORR)	Isa-SC + Pd	71.1	0.6522 to 0.7651	percentage of participants
Observed Concentration Before Dosing (Ctrough) of Isatuximab at Steady State	Isa-IV + Pd	340	Standard Deviation 169	microgram/milliliter (mcg/mL)
Observed Concentration Before Dosing (Ctrough) of Isatuximab at Steady State	Isa-SC + Pd	499	Standard Deviation 259	microgram/milliliter (mcg/mL)
Very Good Partial Response or Better Rate	Isa-IV + Pd	45.9		percentage of participants
Very Good Partial Response or Better Rate	Isa-SC + Pd	46.4		percentage of participants
Ctrough of Isatuximab at 4 Weeks (CT4W)	Isa-IV + Pd	302	Standard Deviation 117	mcg/mL
Ctrough of Isatuximab at 4 Weeks (CT4W)	Isa-SC + Pd	421	Standard Deviation 215	mcg/mL
Percentage of Participants With Infusion Reactions	Isa-IV + Pd	25.0	95% Confidence Interval 19.89 to 30.68	percentage of participants
Percentage of Participants With Infusion Reactions	Isa-SC + Pd	1.5	95% Confidence Interval 0.42 to 3.85	percentage of participants

1 to 10 of 2,170Source ClinicalTrials.gov

See all 2,170 results by group

Participant flow8

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Isa-IV + Pd	268
Overall Study	STARTED	Isa-SC + Pd	263
Overall Study	Randomized and Treated	Isa-IV + Pd	264
Overall Study	Randomized and Treated	Isa-SC + Pd	263
Overall Study	COMPLETED	Isa-IV + Pd	0
Overall Study	COMPLETED	Isa-SC + Pd	0
Overall Study	NOT COMPLETED	Isa-IV + Pd	268
Overall Study	NOT COMPLETED	Isa-SC + Pd	263

Source ClinicalTrials.gov

Adverse events440

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk	Events
other	Bronchitis	Infections and infestations	Isa-IV + Pd	17	264	18
other	Bronchitis	Infections and infestations	Isa-SC + Pd	18	263	22
other	Covid-19	Infections and infestations	Isa-IV + Pd	33	264	35
other	Covid-19	Infections and infestations	Isa-SC + Pd	27	263	29
other	Influenza	Infections and infestations	Isa-IV + Pd	4	264	4
other	Influenza	Infections and infestations	Isa-SC + Pd	15	263	15
other	Nasopharyngitis	Infections and infestations	Isa-IV + Pd	17	264	22
other	Nasopharyngitis	Infections and infestations	Isa-SC + Pd	16	263	18
other	Pneumonia	Infections and infestations	Isa-IV + Pd	23	264	24
other	Pneumonia	Infections and infestations	Isa-SC + Pd	18	263	20

1 to 10 of 440Source ClinicalTrials.gov

See all 440 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Isa-IV + Pd	49	268
Total, all-cause mortality	Isa-SC + Pd	50	263
Total, other adverse events	Isa-IV + Pd	241	264
Total, other adverse events	Isa-SC + Pd	234	263
Total, serious adverse events	Isa-IV + Pd	127	264
Total, serious adverse events	Isa-SC + Pd	139	263

Source ClinicalTrials.gov

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as
40459178	DERIVED

Source PubMed

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons3

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

Comparison	Source
Isa-IV + Pd vs Isa-SC + Pd: Number of Participants With Treatment-emergent Anti-drug Antibodies (ADA) Against Isatuximab	Trial comparisons
Isa-IV + Pd vs Isa-SC + Pd: deaths from any cause	Trial comparisons
Isa-IV + Pd vs Isa-SC + Pd: serious adverse events	Trial comparisons

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT05405166

GET https://conductscience.org/api/trials/v1/NCT05405166/registered?page=2

API reference For AI assistants