Actively Recruiting

Phase 2
Age: 65Years +
All Genders
NCT05272826

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

Age: 65Years +
All Genders

Eligibility Criteria

Eligible

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
Not Eligible

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

1
2
3
+1

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

Loading map...

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

Not the Right Trial for You?

Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.

Already have an account? Log in here