RecruitingPhase 2NCT05272826

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

Sponsor

Canadian Myeloma Research Group

Enrollment

75 participants

Start Date

Dec 12, 2024

Study Type

INTERVENTIONAL

Conditions

Multiple Myeloma

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.

Eligibility

Min Age: 65 Years

Plain Language Summary

Simplified for easier understanding

This study tests a new drug combination — iberdomide, bortezomib, and dexamethasone (with isatuximab added if needed) — as a first treatment for older patients with multiple myeloma who are not eligible for a stem cell transplant. **You may be eligible if...** - You are 65 or older with newly diagnosed, symptomatic multiple myeloma - You have not had any prior treatment for multiple myeloma - You are not eligible for a stem cell transplant - Your myeloma is causing organ damage (e.g., bone lesions, anemia, kidney problems, or high calcium) **You may NOT be eligible if...** - You have previously been treated for multiple myeloma - You are eligible for and wish to pursue a stem cell transplant - You have smoldering (inactive) myeloma - You have significant heart, kidney, or liver problems that would make treatment unsafe - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGIberdomide

Available as formulated capsules and administered as oral medication

DRUGBortezomib

Administered as subcutaneous injection

DRUGDexamethasone

Administered as oral medication

DRUGIsatuximab

Administered as subcutaneous injection

Locations(7)

Cross Cancer Institute

Edmonton, Alberta, Canada

NL Health Services

St. John's, Newfoundland and Labrador, Canada

QEII Health Science Centre

Halifax, Nova Scotia, Canada

London Health Sciences Centre

London, Ontario, Canada

Princess Margaret Hospital

Toronto, Ontario, Canada

Hôpital Maisonneuve-Rosemont

Montreal, Quebec, Canada

McGill University Health Centre

Montreal, Quebec, Canada

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

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NCT05272826

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