Actively Recruiting
Study of Iberdomide, Bortezomib, Dexamethasone With Isatuximab Added on Demand for ND-NTE MM Patients
Led by Canadian Myeloma Research Group · Updated on 2026-03-18
75
Participants Needed
7
Research Sites
324 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Study of Iberdomide, Bortezomib, Dexamethasone With Isatuximab Added on Demand for ND-NTE MM Patients
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Must understand and voluntarily sign informed consent form
- Age 65 years or older at time of signing consent
- Able to follow study visit schedule and protocol requirements
- Previously untreated, transplant-ineligible, symptomatic multiple myeloma with clonal bone marrow plasma cells 10% or biopsy-proven plasmacytoma
- Must have one or more myeloma defining events such as hypercalcemia, renal insufficiency, anemia, or bone lesions
- Eastern Cooperative Oncology Group performance status of 0, 1, or 2
- Females of child-bearing potential must have negative pregnancy test and follow pregnancy prevention guidelines
- Men must agree to use contraception or abstain during study and for 28 days after
- Life expectancy of 3 months or more
- Able to take oral medications
- Laboratory requirements within 10 days prior to first study drug: ANC ≥ 1.0 x 10^9/L, AST and ALT ≤ 1.5 x ULN, creatinine clearance ≥ 30 mL/min, platelet count ≥ 50 x 10^9/L, hemoglobin ≥ 80 g/L
You will not qualify if you...
- Prior treatment with anti-myeloma therapy except limited short steroid use or radiotherapy
- Serious medical conditions posing unacceptable risk such as unstable cardiac disease or conditions needing chronic immunosuppressive treatment
- Pregnant or breastfeeding females
- Renal failure requiring dialysis
- History of other malignancies unless disease-free for 3 or more years, with exceptions for certain skin and cervical cancers
- Unable or unwilling to use antithrombotic therapy
- Peripheral neuropathy grade 2 or higher
- Known HIV positivity or active hepatitis A, B, or C infection
- Primary AL amyloidosis or myeloma complicated by amyloidosis
- Plasma cell leukemia
- Cardiovascular risks including prolonged QTc interval, arrhythmias, recent major cardiac events, severe heart failure, or uncontrolled hypertension
- Allergies to boron, iberdomide, or their components
- Use of strong CYP3A4/5 inhibitors or inducers
- Severe or uncontrolled medical or psychiatric conditions interfering with study
- Recent COVID-19 infection or major surgery within 28 days prior to treatment
- Active systemic infection
- Gastrointestinal disease affecting iberdomide absorption
- Receipt of live vaccine within 3 months before starting treatment
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 7 locations
1
Cross Cancer Institute
Edmonton, Alberta, Canada, T6G 1Z2
Actively Recruiting
2
NL Health Services
St. John's, Newfoundland and Labrador, Canada, A1B 3V6
Actively Recruiting
3
QEII Health Science Centre
Halifax, Nova Scotia, Canada
Actively Recruiting
4
London Health Sciences Centre
London, Ontario, Canada
Actively Recruiting
5
Princess Margaret Hospital
Toronto, Ontario, Canada
Actively Recruiting
6
Hôpital Maisonneuve-Rosemont
Montreal, Quebec, Canada
Actively Recruiting
7
McGill University Health Centre
Montreal, Quebec, Canada
Actively Recruiting
Research Team
V
Vanessa Huntley
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
0
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