NCT05272826

Study of Iberdomide, Bortezomib, Dexamethasone With Isatuximab Added on Demand for ND-NTE MM Patients

A Single Arm, Response-adapted, Open Label Study of Iberdomide, Weekly Bortezomib and Dexamethasone (IberBd) With Isatuximab Added on Demand for Transplant-ineligible, Newly Diagnosed Multiple Myeloma Patients: the BOREALIS Trial

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 75 (estimated)
• Sponsor: Canadian Myeloma Research Group · Academic / Other
• Sex: All
• Age: 65 Years
• Healthy volunteers: Not accepted

Summary

This study will evaluate efficacy and tolerability of iberdomide, bortezomib, dexamethasone and isatuximab on demand administered in combination for newly diagnosed transplant-ineligible multiple myeloma patients.

Detailed description

This is a phase II, multicenter, single arm, response adapted, open label study of iberdomide, weekly bortezomib and dexamethasone (IberBd) for upfront treatment of transplant ineligible patients with Multiple Myeloma. Isatuximab will be added to treatment regimen for those who do not attain VGPR after 4 cycles of IberBd, or MRD negativity after 8 cycles of IberBd. This study will have an induction phase (cycle 1-4), an intensification phase (cycle 5-8), and a maintenance phase (cycle 9 onwards).

Conditions

• Multiple Myeloma

Interventions

Type	Name	Description
DRUG	Iberdomide	Available as formulated capsules and administered as oral medication
DRUG	Bortezomib	Administered as subcutaneous injection
DRUG	Dexamethasone	Administered as oral medication
DRUG	Isatuximab	Administered as subcutaneous injection

Timeline

• Start date: 2024-12-12
• Primary completion: 2028-03-01
• Completion: 2031-03-01
• First posted: 2022-03-09
• Last updated: 2026-03-18

Locations

7 sites across 1 country: Canada