ISASOCUT-IFM2022-05-Multicenter phase 2 study of subcutaneous isatuximab plus bortezomib, lenalidomide and dexamethasone in the treatment of newly diagnosed transplant ineligible multiple myeloma

Conditions

Newly diagnosed transplant ineligible multiple myeloma

Brief summary

very good partial response rate (VGPR) will be assessed according to IMWG international criteria*

Detailed description

• To determine Survivals, Overall Survival (OS), Progression free survival (PFS), Time to Progression (TTP), Time to Next Therapy (TTNT) and Event Free survival (EFS), • To determine duration of response (DOR) and time to response (TTR), • To assess responses to the treatment according to IMWG*, ORR (Overall response rate) >=PR, >=CR (complete response), and best MRD 10-5 rate + sustained 12 and 24 months., • To assess the safety, including infusions reactions, device deficiencies, and local tolerability (injections site reactions) of SC isatuximab + VRd according to CTCAE 5.0., • Patient experience/satisfaction questionnaire with SC isatuximab using the patient experience and satisfaction questionnaire, • To assess of abilities and life quality of patients QLQ-C30, QLQ-MY20 and EQ-5D-5L, FOR MIBAPIX AND PK-ADA•To estimate isatuximab PK parameters and derived exposure by population PK modelling, FOR MIBAPIX AND PK-ADA• Incidence of participants with anti-drug antibodies (ADA) against isatuximab, FOR MIBAPIX AND PK-ADA• To determine apixaban plasma exposure with the area under the concentration curve in relation to time

Related papers

No related papers found yet.

Interventions

DRUGSARCLISA 20mg/mL concentrate for solution for infusion.

DRUGDEXAMETHASONE

DRUGRevlimid 25 mg hard capsules

DRUGVELCADE 3.5 mg powder for solution for injection

Eligibility

Sex/Gender

All

Age

65 Years to No maximum

Design outcomes

Primary

Measure	Time frame
very good partial response rate (VGPR) will be assessed according to IMWG international criteria*	—

Secondary

Measure	Time frame
• To determine Survivals, Overall Survival (OS), Progression free survival (PFS), Time to Progression (TTP), Time to Next Therapy (TTNT) and Event Free survival (EFS), • To determine duration of response (DOR) and time to response (TTR), • To assess responses to the treatment according to IMWG*, ORR (Overall response rate) >=PR, >=CR (complete response), and best MRD 10-5 rate + sustained 12 and 24 months., • To assess the safety, including infusions reactions, device deficiencies, and local tolerability (injections site reactions) of SC isatuximab + VRd according to CTCAE 5.0., • Patient experience/satisfaction questionnaire with SC isatuximab using the patient experience and satisfaction questionnaire, • To assess of abilities and life quality of patients QLQ-C30, QLQ-MY20 and EQ-5D-5L, FOR MIBAPIX AND PK-ADA•To estimate isatuximab PK parameters and derived exposure by population PK modelling, FOR MIBAPIX AND PK-ADA• Incidence of participants with anti-drug antibodies (ADA) against i	—

Measure

Time frame

• To determine Survivals, Overall Survival (OS), Progression free survival (PFS), Time to Progression (TTP), Time to Next Therapy (TTNT) and Event Free survival (EFS), • To determine duration of response (DOR) and time to response (TTR), • To assess responses to the treatment according to IMWG*, ORR (Overall response rate) >=PR, >=CR (complete response), and best MRD 10-5 rate + sustained 12 and 24 months., • To assess the safety, including infusions reactions, device deficiencies, and local tolerability (injections site reactions) of SC isatuximab + VRd according to CTCAE 5.0., • Patient experience/satisfaction questionnaire with SC isatuximab using the patient experience and satisfaction questionnaire, • To assess of abilities and life quality of patients QLQ-C30, QLQ-MY20 and EQ-5D-5L, FOR MIBAPIX AND PK-ADA•To estimate isatuximab PK parameters and derived exposure by population PK modelling, FOR MIBAPIX AND PK-ADA• Incidence of participants with anti-drug antibodies (ADA) against i

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Countries

France

Outcome results

None listed