This study aims to evaluate the stringent Complete Response (sCR) rate by the end of two cycles of induction treatment, defined as the proportion of patients who have achieved sCR, according to International Myeloma Working Group (IMWG) criteria, by the end of two cycles of induction treatment.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
54
Isatuximab (IV): 10 mg/kg on Days 1, 8, 15, 22, 29 in Cycle 1; from Cycle 2 onwards, it will be given on Days 1, 15, 29.
Bortezomib (SQ): 1.3 mg/m² on Days 1, 4, 8, 11, 22, 25, 29, and 32.
Lenalidomide (PO): 25 mg/day (10 mg/day for patients with creatinine clearance \[CrCl\] ≥30 to \<60 mL/min) from Day 1 to Day 14 and from Day 22 to Day 35 of each cycle.
Aarhus University Hospital
Aarhus, Denmark
Beaumont Hospital
Dublin, Ireland
Mater Misericordiae University Hospital
Dublin, Ireland
St James's Hospital
Dublin, Ireland
University Hospital Waterford
To evaluate the Very Good Partial Response (VGPR) or better rate by the end of two cycles of induction treatment
To evaluate the Very Good Partial Response (VGPR) or better rate by the end of two cycles of induction treatment, defined as the proportion of patients who have achieved VGPR, according to International Myeloma Working Group (IMWG) criteria, by the end of two cycles of induction treatment.
Time frame: 84 days
To evaluate complete response (CR) and sCR rate following one year and two years of maintenance therapy.
Time frame: 3.5 years
To evaluate overall response rate and rate of very good partial response (VGPR) or better following one year of maintenance therapy.
Time frame: 3.5 years
To evaluate time to VGPR or better.
Time frame: 3.5 years
To assess negative minimal residual disease (MRD) rate following ASCT and after 1 and 2 years of maintenance treatment.
Time frame: 3.5 years
To evaluate clinical outcomes including time to progression (TTP).
Time frame: 3.5 years
To evaluate clinical outcomes including progression-free survival (PFS).
Time frame: 3.5 years
To evaluate clinical outcomes including overall survival (OS).
Time frame: 3.5 years
To evaluate clinical outcomes including duration of response (DOR).
Time frame: 3.5 years
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Dexamethasone (IV on the days of Isatuximab and PO on other days): 20 mg/day on Days 1, 2, 4, 5, 8, 9, 11, 12, 15, 16, 22, 23, 25, 26, 29, 30, 32, and 33. If patients are ≥75 years old, dexamethasone will be administered on Days 1, 4, 8, 11, 15, 16, 22, 25, 29 and 32.
Waterford, Ireland
To assess the safety of the Isa-RVD treatment regime based on reported adverse events and toxicity.
Time frame: 3.5 years
To assess the tolerability of the Isa-RVD treatment regime based on reported adverse events and toxicity.
Time frame: 3.5 years
To evaluate stem cell yield after mobilization.
Time frame: 90 days