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Multiple MyelomaPhase 2BOREALISNCT05272826

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

A Phase 2 study testing Iberdomide, Bortezomib and Dexamethasone in people with Multiple Myeloma, run by Canadian Myeloma Research Group at 7 sites in Canada.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 65 years and older
Conditions the study is for
Multiple Myeloma
What is being tested?
Iberdomide, Bortezomib and Dexamethasone
How many people
75 participants
Where
7 sitesCanada
Study dates
12 Dec 2024to Mar 2031
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 65 years and older
  • All sexes
  • No healthy volunteers
  • Older adult

Who may be able to join

  • Must understand and voluntarily sign informed consent form
  • Age ≥ 65 years at the time of signing consent
  • Must be able to adhere to the study visit schedule and other protocol requirements.
  • Previously untreated, transplant ineligible, symptomatic multiple myeloma as defined by the criteria below.
  • Both criteria a and b must be met:
  • Clonal bone marrow plasma cells ≥10% or biopsy-proven bony or extramedullary plasmacytoma
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  • Any one or more of the following myeloma defining events (MDE):
  • Evidence of end organ damage that can be attributed to the underlying plasma cell proliferative disorder, specifically: i.Hypercalcemia: serum calcium >0.25 mmol/L (>1 mg/dL) higher than the upper limit of normal or >2.75 mmol/L (>11 mg/dL) ii. Renal insufficiency: creatinine clearance 177 μmol/L (>2 mg/dL) iii. Anemia: hemoglobin value of >2 g/dL below the lower limit of normal, or a hemoglobin value <10g/dL iv. Bone lesions: one or more osteolytic lesions on skeletal radiography, computed tomography (CT), or positron emission tomography-CT (PET-CT)
  • Biomarker criteria or MDE:
  • Clonal bone marrow plasma cell percentage ≥ 60% ii. Involved: uninvolved serum free light chain (FLC) ratio ≥100 (involved FLC level must be ≥100 mg/L) iii. > 1 focal lesions on magnetic resonance imaging (MRI) studies (at least 5 mm in size)
  • Must have Eastern Cooperative Oncology Group (ECOG) performance status score of 0, 1, or 2.
  • Females of child-bearing potential (FCBP) must have a negative serum test and follow the guidelines in the pregnancy prevention program. FCBP and males must either commit to continued abstinence from heterosexual intercourse or must abide by birth control requirements as described in Appendix 9 for the pregnancy prevention program.
  • Men must practice complete abstinence or agree to use a condom during sexual contact with a pregnant female or a female of childbearing potential while participating in the study, during dose interruptions and for at least 28 days following study drug discontinuation, even if he has undergone a successful vasectomy as described in Appendix 9 of the pregnancy prevention program.
  • Life expectancy of ≥ 3 months.
  • Able to take oral medications.
  • The following laboratory results must be met within 10 days prior to first study drug administration:
  • Absolute neutrophil count (ANC) ≥ 1.0 x 109/L. Growth factors cannot be given within 10 days of study drug administration.
  • Serum AST and ALT ≤ 1.5 x upper limit of normal (ULN).
  • Creatinine clearance ≥ 30 mL/min either directly measured via 24-hour urine collection or calculated using MDRD (Appendix 1).
  • Platelet count ≥ 50 x 109/L. Platelet transfusions to help subjects meet eligibility criteria are not allowed within 10 days before study enrollment.
  • Hemoglobin ≥ 80 g/L.

Who cannot join

  • Previous treatment with anti-myeloma therapy (does not include radiotherapy, bisphosphonates, or a single short course of steroid [i.e. less than or equal to the equivalent of dexamethasone 40 mg/day for 4 days; such a short course of steroid treatment must not have been given within 14 days of treatment start]).
  • Any serious medical condition that places the patient at an unacceptable risk if he or she participates in this study. Examples of such a medical condition are, but are not limited to, patient with unstable cardiac disease as defined by: Cardiac events such as MI within the past 6 months, NYHA heart failure class III-IV, uncontrolled atrial fibrillation or hypertension; patients with conditions requiring chronic steroid or immunosuppressive treatment, such as rheumatoid arthritis, multiple sclerosis and lupus, that likely need additional steroid or immunosuppressive treatments in addition to the study treatment.
  • Pregnant or lactating females.
  • Renal failure requiring hemodialysis or peritoneal dialysis.
  • Prior history of malignancies, other than multiple myeloma, unless the patient has been free of the disease for ≥ 3 years. Exceptions include the following:
  • Basal cell carcinoma of the skin
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  • Squamous cell carcinoma of the skin
  • Carcinoma in situ of the cervix
  • Carcinoma in situ of the breast
  • Incidental histological finding of prostate cancer (TNM stage of T1a or T1b)
  • Patients who are unable or unwilling to undergo antithrombotic therapy.
  • Peripheral neuropathy of ≥ grade 2 severity.
  • Known HIV positivity or active infectious hepatitis, type A, B, or C.
  • Primary AL (immunoglobulin light chain) amyloidosis and myeloma complicated by amyloidosis.
  • Plasma Cell Leukemia
  • Evidence of cardiovascular risk including any of the following:
  • QTc interval ≥ 470 msecs. Note that the QT interval should be corrected for heart rate by Fridericia's formula (QTcF)
  • Evidence of current clinically significant uncontrolled arrhythmias; including clinically significant ECG abnormalities; including 2nd degree (Type II) or 3rd degree atrioventricular (AV) block.
  • History of myocardial infarction, acute coronary syndromes (including unstable angina), coronary angioplasty, or stenting or bypass grafting within six months of screening.
  • Class III or IV heart failure as defined by the New York Heart Association functional classification system (Appendix 2)
  • Uncontrolled hypertension
  • Patients with hypersensitivity to boron or any of its excipients or to the active substance of Iberdomide or its excipients
  • Patients requiring strong inhibitors or inducers of CYP3A4/5. See Appendix 10 for a list of these drugs
  • Any concurrent severe and/or uncontrolled medical condition or psychiatric disease that is likely to interfere with study procedures or results, or that in the opinion of the investigator would constitute a hazard for participating in this study or that confounds the ability to interpret data from the study.
  • Patients that have had severe acute respiratory syndrome coronavirus 2 infection within 14 days for mild or asymptomatic infections or 28 days for severe/critical illness prior to initiating study treatment.
  • Patients that have undergone major surgery (as defined by the investigator) within 28 days of initiating study treatment.
  • Active systemic infection that is likely to interfere with the study procedures or results or that, in the opinion of the investigator, would constitute a hazard for participating in this study.
  • Patients with a gastrointestinal disease that may significantly alter the absorption of iberdomide
  • Patients that have received a live vaccine within 3 months of initiating study treatment.

Trial locations and contacts

7 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Vanessa Huntley contact

4164779849 ext. 201

cmrg@cmrg.ca

7 sites in 1 country

Canada7 sites, 7 recruiting

  • Cross Cancer Institute

    Edmonton, Alberta, T6G 1Z2

    Farzana Khawaja, RN, 780 989-5970, Farzana.Khawaja@cancercarealberta.ca

    Swati Patel, swati.patel@cancercarealberta.ca

    Recruiting

  • QEII Health Science Centre

    Halifax, Nova Scotia

    (Grace) Yuen Yee Cheung, RN, 902-473-5231 ext. 5037, yuenyee.cheung@nshealth.ca

    Alfredo De la Torre, MD

    Recruiting

  • London Health Sciences Centre

    London, Ontario

    Swati Khalia, 519-685-8500, swati.khalia@lhsc.on.ca

    Mohammed Abouzeenni, mohamed.abouzeenni@lhsc.on.ca

    Recruiting

  • Hôpital Maisonneuve-Rosemont

    Montreal, Quebec

    Marie-Pier Lecours-Cyr, 514-252-3400 ext. 5037, mplecours-cyr.hmr@ssss.gouv.qc.ca

    Richard LeBlanc, MD

    Recruiting

  • McGill University Health Centre

    Montreal, Quebec

    Manuel Rocha, 514-934-1934 ext. 37405, manuel.rocha@muhc.mcgill.ca

    Micahel Sebag, MD

    Recruiting

  • NL Health Services

    St. John's, Newfoundland and Labrador, A1B 3V6

    Kelly Pittman, RN, 709-777-2951, kelly.pittman@easternhealth.ca

    Debra Bergstrom, MD

    Recruiting

  • Princess Margaret Hospital

    Toronto, Ontario

    Protus Wadu, 416-946-4501, protus.wadu@uhn.ca

    Guido Lancman, MD, MSc

    Recruiting

Other trials in Canada

About this study

Official title: 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

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.

Read the 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).

Being tested
Iberdomide, Bortezomib, Dexamethasone, Isatuximab
Medical subject headings
Multiple Myeloma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • IberdomideDrug

    Also called CC-220

    Available as formulated capsules and administered as oral medication

  • BortezomibDrug

    Also called Velcade

    Administered as subcutaneous injection

  • DexamethasoneDrug

    Also called Decadron

    Administered as oral medication

  • IsatuximabDrug

    Also called Sarclisa

    Administered as subcutaneous injection

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Evaluate Rate of Stringent Complete Response (sCR) transplant ineligible multiple myeloma patients.

    Evaluate the rate of stringent complete response (sCR) after 4 cycles of therapy of Iber+ weekly Bd in newly diagnosed transplant ineligible multiple myeloma patients.

    Measured: After 4 cycles of therapy (each cycle is 28 days)

Secondary outcomes (1)

  1. Evaluate Objective Response

    Evaluate objective response as per IMWG criteria: progressive disease, stable disease, partial response, very good partial response, complete response and stringent complete response according to IMWG criteria. Multiple measurements will be aggregated to arrive at one reported value (e.g., weight and height will be combined to report BMI in kg/m^2).

    Measured: After 4 cycles of therapy (each cycle is 28 days)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Mar 2022
  2. Study start12 Dec 2024
  3. Primary completionMar 2028 (estimated)
  4. Study completionMar 2031 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
75 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05272826
Sponsor's protocol ID
CMRG 010
Acronym
BOREALIS
Status last verified
Aug 2026
First submitted
14 Feb 2022
Last updated
31 Aug 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Iberdomide, Bortezomib and Dexamethasone in people with Multiple Myeloma, run by Canadian Myeloma Research Group at 7 sites in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 21 inclusion and 29 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 31 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 7 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Vanessa Huntley (4164779849 ext. 201, cmrg@cmrg.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Evaluate Rate of Stringent Complete Response (sCR) transplant ineligible multiple myeloma patients. (time frame: After 4 cycles of therapy (each cycle is 28 days)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05272826.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Aug 2026.

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BOREALIS Clinical Trial NCT05272826 | AzTrials