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Eligible patients will initially receive six 28-day cycles of isatuximab, pomalidomide, and low-dose dexamethasone. Patients will be allowed to continue treatment until disease progression, death, unacceptable AEs, lost to follow-up, or consent withdrawal.

Isatuximab will be given at a dose of 10 mg/kg QW by IV infusion.

Pomalidomide will be given at 4 mg orally(PO) on Days 1-21 of each cycle.

Dexamethasone will be given at 40 mg (20 mg for ≥75 years old) PO, or IV on days 1, 8, 15, and 22 in each cycle.

Acetaminophen (paracetamol) will be given at 650-1000 mg PO 15-30 minutes (but no longer than 60 minutes) before isatuximab infusion.

Ranitidine or equivalent will be given at 50 mg 15-30 minutes (but no longer than 60 minutes) before isatuximab infusion.

Diphenhydramine or equivalent will be given at 25-50 mg 15-30 minutes (but no longer than 60 minutes) before isatuximab infusion.

Intravenous (IV) infusion. Dose regimen: Isatuximab will be given at a dose of 10 mg/kg QW by IV infusion on Days 1, 8, 15, and 22 in Cycle 1 and Days 1 and 15 in subsequent cycles. In patients with ≥VGPR who will be randomized to receive isatuximab once monthly from Cycle 7, isatuximab will be given on day 1 of each cycle.

Isatuximab

Route of administration: Oral (PO). Dose regimen: Pomalidomide will be given at 4 mg orally (PO) will be given on Days 1-21 of each cycle.

Route of administration: PO or IV. Dose regimen: Dexamethasone will be given at 40 mg (20 mg for ≥75 years old) PO, or IV will be given on days 1, 8, 15, and 22 in each cycle.

Route of administration: PO. Dose regimen: Acetaminophen (paracetamol) will be given at 650-1000 mg PO 15-30 minutes (but no longer than 60 minutes) before isatuximab infusion

Acetaminophen (paracetamol)

Route of administration: IV. Dose regimen: Ranitidine or equivalent will be given at 50 mg 15-30 minutes (but no longer than 60 minutes) before isatuximab infusion.

Ranitidine (or equivalent)

Route of administration: IV. Dose regimen: Diphenhydramine or equivalent will be given at 25-50 mg 15-30 minutes (but no longer than 60 minutes) before isatuximab infusion.

Diphenhydramine (or equivalent)

Maria Pagoni, Prof

Evangelos Terpos, Prof

This is an investigator-initiated (IIS), phase 2, prospective, open-label, multinational study, designed to be conducted in approximately 14 sites. Eligible patients will initially receive six 28-day cycles of isatuximab, pomalidomide, and low-dose dexamethasone.

Following this phase:

Patients who achieve ≥VGPR will be randomized in a 1:1 ratio to receive isatuximab, given either Q2W or once monthly, plus pomalidomide and low-dose dexamethasone.

Patients with \<VGPR will continue treatment with isatuximab Q2W, pomalidomide, and low-dose dexamethasone.

The study will last for 42 months (recruitment and follow-up period), starting from the date of the first patient in (FPI) to the date of the last patient last visit (LPLV).

Core study procedures consist of baseline and post-baseline safety and disease evaluations, including physical examination, hematologic/clinical chemistry tests, radiologic assessments, bone marrow evaluations, and blood/urine M-protein assessments.

Patients will be allowed to continue treatment until disease progression, death, unacceptable AEs, lost to follow-up, or consent withdrawal.

A Phase 2 Study of Isatuximab in Combination With Pomalidomide and Dexamethasone in MM Patients Who Received One Prior Line of Therapy Containing Lenalidomide and a Proteasome Inhibitor

The primary endpoint is the ORR after six months of treatment with isatuximab in combination with pomalidomide, and low-dose dexamethasone. ORR is defined as the proportion of patients with stringent complete response (sCR), complete response (CR), VGPR, and partial response (PR), as assessed by the Investigator using the IMWG response criteria.

Defined as the time from study treatment initiation (Cycle 1 Day 1) to the date of first documentation of progressive disease (PD), as assessed by the Investigator using the IMWG response criteria, or the date of death from any cause, or the initiation of further anti-myeloma treatment, or data cut-off, whichever occurs first.

Defined as the time from study treatment initiation (Cycle 1 Day 1) to the date of death from any cause. OS will be assessed throughout the treatment period and post EOT during long term follow-up until the end of the study.

Defined as the proportion of patients achieving MRD-negative status, assessed at CR.

Defined as the time from study treatment initiation (Cycle 1, Day 1) to the date of the first objective response of PR or better.

Defined as the time from the date of the first response, as determined by the Investigator, to the date of the first PD (based on the International Myeloma Working Group \[IMWG\] response criteria) or death, whichever occurs first. DoR will be determined only for patients who have achieved ≥PR.

i.e. Adverse Events (AEs), Treatment-Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs).

Sanofi

Hellenic Society of Hematology

Spots Global Cancer Trial Database for diphenhydramine (or equivalent)