A randomized, Phase 3, open label study evaluating subcutaneous versus intravenous administration of isatuximab in combination with pomalidomide and dexamethasone in adult patients with relapsed and/or refractory multiple myeloma (RRMM)

Conditions

Cancer - Plasma cell myeloma recurrent

Brief summary

Overall response rate (ORR), Observed concentration before dosing (Cthrough) at steady state

Detailed description

Very Good Partial Response or better rate (VGPR, Observed concentration before dosing (Ctrough), Incidence rate of infusion-reactions, Percentage of participants satisfied or very satisfied with the injection method used to administer study medication, Duration of response (DOR), Time to first response (TT1R), Time to best response (TTBR), Progression free survival (PFS), Overall survival (OS), Progression free survival 2 (PFS2), Number of participants with treatment-emergent adverse events (TEAEs)/serious adverse events (SAEs), Pharmacokinetic (PK) parameter: Maximum plasma concentration (Cmax), PK parameter: Area under the plasma concentration time curve over the dosing period (AUC), Successful injection rate, Percentage of participants with anti-drug antibodies (ADA) against isatuximab, Participant expectation questionnaire-baseline (PEQ-BL) score, Patient experience and satisfaction questionnaire- follow up (PESQ-FU) score, Patient experience and satisfaction questionnaire-end of treatment (PESQ-EOT) score, Patient’s Assessment of Treatment (PAT) questionnaire score, Change from baseline in the Health Resource Utilization and Productivity Questionnaire (HRUPQ) scores, Change from baseline in European Organization for Research and Treatment of Cancer core quality of life questionnaire (EORTC QLQ-C30) score, Change from baseline in European Organization for Research and Treatment of Cancer quality of life myeloma module (EORTC QLQ-MY20), Change from baseline in the European Quality of Life Group questionnaire with 5 dimensions and 5 levels per dimension (EQ-5D-5L) scores, Number of participants with chromosomal abnormalities

Related papers

No related papers found yet.

Interventions

DRUGImnovid 2 mg hard capsules

DRUGDexamethason 8 mg JENAPHARM®

DRUGImnovid 1 mg hard capsules

DRUGJAMP Pomalidomide

DRUGImnovid 3 mg hard capsules

DRUGMONTELUKAST

DRUGIsatuximab

DRUGImnovid 4 mg hard capsules

DRUGDexamethason 4 mg JENAPHARM®

DRUGDEXAMETHASONE

Eligibility

Sex/Gender

All

Age

65 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Overall response rate (ORR), Observed concentration before dosing (Cthrough) at steady state	—

Secondary

Measure	Time frame
Very Good Partial Response or better rate (VGPR, Observed concentration before dosing (Ctrough), Incidence rate of infusion-reactions, Percentage of participants satisfied or very satisfied with the injection method used to administer study medication, Duration of response (DOR), Time to first response (TT1R), Time to best response (TTBR), Progression free survival (PFS), Overall survival (OS), Progression free survival 2 (PFS2), Number of participants with treatment-emergent adverse events (TEAEs)/serious adverse events (SAEs), Pharmacokinetic (PK) parameter: Maximum plasma concentration (Cmax), PK parameter: Area under the plasma concentration time curve over the dosing period (AUC), Successful injection rate, Percentage of participants with anti-drug antibodies (ADA) against isatuximab, Participant expectation questionnaire-baseline (PEQ-BL) score, Patient experience and satisfaction questionnaire- follow up (PESQ-FU) score, Patient experience and satisfaction questionnai	—

Measure

Time frame

Very Good Partial Response or better rate (VGPR, Observed concentration before dosing (Ctrough), Incidence rate of infusion-reactions, Percentage of participants satisfied or very satisfied with the injection method used to administer study medication, Duration of response (DOR), Time to first response (TT1R), Time to best response (TTBR), Progression free survival (PFS), Overall survival (OS), Progression free survival 2 (PFS2), Number of participants with treatment-emergent adverse events (TEAEs)/serious adverse events (SAEs), Pharmacokinetic (PK) parameter: Maximum plasma concentration (Cmax), PK parameter: Area under the plasma concentration time curve over the dosing period (AUC), Successful injection rate, Percentage of participants with anti-drug antibodies (ADA) against isatuximab, Participant expectation questionnaire-baseline (PEQ-BL) score, Patient experience and satisfaction questionnaire- follow up (PESQ-FU) score, Patient experience and satisfaction questionnai

—

Countries

Czechia, France, Germany, Greece, Hungary, Italy, Norway, Poland, Spain, Sweden

Outcome results

None listed