NCT05298683

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

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 108 (estimated)
• Sponsor: Hellenic Society of Hematology · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Multiple Myeloma
• Renal Impairment
• Neoplasms, Plasma Cell
• Neoplasms by Histologic Type
• Neoplasms
• Paraproteinemias
• Blood Protein Disorders
• Hematologic Diseases

Interventions

Type	Name	Description
DRUG	Isatuximab	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.
DRUG	Pomalidomide	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.
DRUG	Dexamethasone	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.
DRUG	Acetaminophen (paracetamol)	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
DRUG	Ranitidine (or equivalent)	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.
DRUG	Diphenhydramine (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.

Timeline

• Start date: 2022-05-01
• Primary completion: 2025-11-01
• Completion: 2026-01-01
• First posted: 2022-03-28
• Last updated: 2022-03-28

Locations

6 sites across 1 country: Greece