A randomized, Phase 2, open label study evaluating subcutaneous administration of isatuximab in combination with carfilzomib and dexamethasone in adult participants with relapsed and/or refractory multiple myeloma (RRMM)

Conditions

Cancer - Relapsed/refractory multiple myeloma

Brief summary

Overall response rate (ORR) – Cohorts 1 to 3, Maximum observed concentration (Cmax) over Cycle 1- Cohorts 4 to 5, Cumulative area under the curve over the first 4 weeks (AUC4weeks) of isatuximab treatment- Cohorts 4 to 5

Detailed description

Proportion of participants preferring OBDS over manual administration of isatuximab SC at Day 15 of Cycle 6, Incidence rate of infusion reactions (IRs), Number of participants with treatment-emergent adverse events (TEAEs), serious adverse events (SAEs), and changes in laboratory parameters, Incidence rate of injection site reactions (ISRs), PK concentration: trough plasma concentration (Ctrough), Overall response rate (ORR), Duration of response (DOR), Time to first response (TT1R), Time to best response (TTBR), Progression free survival (PFS), Overall survival (OS), Incidence of participants with anti-drug antibodies (ADA) against isatuximab, Patient Expectations Questionnaire at Baseline (PEQ-BL v2) with isatuximab administered subcutaneously, Patient experience and satisfaction questionnaires (PESQ v2) with isatuximab administered subcutaneously, Health state utility assessed using Health Resource Utilization and Productivity Questionnaire (HRUPQ), Health Related Quality of Life (HRQL), European Quality of Life Group questionnaire with 5 dimensions and 5 levels per dimension (EQ-5D-5L)

Related papers

No related papers found yet.

Interventions

DRUGMONTELUKAST

DRUGIsatuximab

DRUGDIPHENHYDRAMINE

DRUGKyprolis 60 mg powder for solution for infusion

DRUGPARACETAMOL

DRUGDexamethason 4 mg JENAPHARM®

DRUGMETHYLPREDNISOLONE

DRUGDexaGalen® 8 mg injekt Injektionslösung

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Overall response rate (ORR) – Cohorts 1 to 3, Maximum observed concentration (Cmax) over Cycle 1- Cohorts 4 to 5, Cumulative area under the curve over the first 4 weeks (AUC4weeks) of isatuximab treatment- Cohorts 4 to 5	—

Secondary

Measure	Time frame
Proportion of participants preferring OBDS over manual administration of isatuximab SC at Day 15 of Cycle 6, Incidence rate of infusion reactions (IRs), Number of participants with treatment-emergent adverse events (TEAEs), serious adverse events (SAEs), and changes in laboratory parameters, Incidence rate of injection site reactions (ISRs), PK concentration: trough plasma concentration (Ctrough), Overall response rate (ORR), Duration of response (DOR), Time to first response (TT1R), Time to best response (TTBR), Progression free survival (PFS), Overall survival (OS), Incidence of participants with anti-drug antibodies (ADA) against isatuximab, Patient Expectations Questionnaire at Baseline (PEQ-BL v2) with isatuximab administered subcutaneously, Patient experience and satisfaction questionnaires (PESQ v2) with isatuximab administered subcutaneously, Health state utility assessed using Health Resource Utilization and Productivity Questionnaire (HRUPQ), Health Related Quali	—

Measure

Time frame

Proportion of participants preferring OBDS over manual administration of isatuximab SC at Day 15 of Cycle 6, Incidence rate of infusion reactions (IRs), Number of participants with treatment-emergent adverse events (TEAEs), serious adverse events (SAEs), and changes in laboratory parameters, Incidence rate of injection site reactions (ISRs), PK concentration: trough plasma concentration (Ctrough), Overall response rate (ORR), Duration of response (DOR), Time to first response (TT1R), Time to best response (TTBR), Progression free survival (PFS), Overall survival (OS), Incidence of participants with anti-drug antibodies (ADA) against isatuximab, Patient Expectations Questionnaire at Baseline (PEQ-BL v2) with isatuximab administered subcutaneously, Patient experience and satisfaction questionnaires (PESQ v2) with isatuximab administered subcutaneously, Health state utility assessed using Health Resource Utilization and Productivity Questionnaire (HRUPQ), Health Related Quali

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Countries

Czechia, Greece, Portugal

Outcome results

None listed