Trial · NCT05405166
Registered outcomes57
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 20 of 57
Download this page as JSON| 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. |
| Secondary | Overall Survival (OS) | From first dose of study medication administration (Day 1) up to DCO date (29-Aug-2025), approximately 38 months | OS was defined as the time from the date of randomization to death from any cause. Participants without death prior to the analysis cut-off date were censored at the last date the participant was known to be alive or the cut-off date, whichever was first. |
| Secondary | Progression Free Survival 2 (PFS2) | From first dose of study medication administration (Day 1) up to DCO date (29-Aug-2025), approximately 38 months | PFS2 was defined as time from the date of randomization to the date of first documentation of PD (as assessed by Investigator) after initiation of further anti-myeloma treatment or death from any cause, whichever happened first. Same censoring rule applies as in the PFS endpoint. |
| Secondary | Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs) | From first dose of study medication (Day 1) up to 30 days after the last dose of study medication, approximately 38 months | 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. |
| Secondary | Isa-SC + Pd: Number of Participants With Injection Site Reactions (ISRs) | From first dose of study medication (Day 1) up to 30 days after the last dose of study medication, approximately 38 months | 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. |
| Secondary | Ctrough of Isatuximab | 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 | Plasma samples were collected at specified timepoints for the assessment of Ctrough. |
| Secondary | Isa-SC + Pd: Percentage of Successful Injections With Isatuximab Injector Device | From first dose of study medication administration (Day 1) up to DCO date (29-Aug-2025), approximately 38 months | 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. |
| Secondary | Number of Participants With Treatment-emergent Anti-drug Antibodies (ADA) Against Isatuximab | From first dose of study medication administration (Day 1) up to DCO date (29-Aug-2025), approximately 38 months | 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. |
| Secondary | Percentage of Participants With Response to 'Patient Expectation Questionnaire at Baseline (PEQ-BL)' | Baseline (Cycle 1 Day 1) | Percentage of participants who responded that they strongly agree or agree at baseline with expectations of pain, discomfort and side effects from the injection method, the injection method would save time, study medication may result in side effects and would be worth taking are reported. PEQ-BL consisted of 7 items. Percentage of participants who ever received medication through IV and/or SC administration are also reported. Percentages are rounded off to the tenth decimal place. The baseline value was defined as the last non-missing value collected on or before the start date of study medication. |
| Secondary | Percentage of Participants Who Disagreed and Strongly Disagreed to 'PESQ-FU: Discomfort With Injection Method' | Cycle 1 Days 8, 15, 22, Cycle 2 Days 1 and 15, Cycles 3 and 4 Day 1, Cycles 5 to 39 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 '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. |
| Secondary | Percentage of Participants Who Disagreed and Strongly Disagreed to 'PESQ-FU: Pain With Injection Method' | Cycle 1 Days 8, 15, 22, Cycle 2 Days 1 and 15, Cycles 3 and 4 Day 1, Cycles 5 to 39 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 '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. |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
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.
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