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

NCT05272826 | Recruiting Phase 2 DMC

• 1 other identifier: CMRG 010
• Study Type: interventional
• Target: 75
• Locations: 1 country
• Sites: 7

Brief 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.

Conditions

Multiple Myeloma

Outcome Measures

Primary Outcomes (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.

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

Secondary Outcomes (1)

• Evaluate Objective Response

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

Interventions

Dexamethasone DRUG

Administered as oral medication

Also known as: Decadron

Iberdomide DRUG

Available as formulated capsules and administered as oral medication

Also known as: CC-220

Bortezomib DRUG

Administered as subcutaneous injection

Also known as: Velcade

Isatuximab DRUG

Administered as subcutaneous injection

Also known as: Sarclisa

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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
• Any one or more of the following myeloma defining events (MDE):
• I. 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)
• II. Biomarker criteria or MDE:
• i. 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.

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Canadian Myeloma Research Group: lead

Study Sites (7)

Cross Cancer Institute

Edmonton, Alberta, T6G 1Z2, Canada

RECRUITING

NL Health Services

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

RECRUITING

QEII Health Science Centre

Halifax, Nova Scotia, Canada

RECRUITING

London Health Sciences Centre

London, Ontario, Canada

RECRUITING

Princess Margaret Hospital

Toronto, Ontario, Canada

RECRUITING

Hôpital Maisonneuve-Rosemont

Montreal, Quebec, Canada

RECRUITING

McGill University Health Centre

Montreal, Quebec, Canada

RECRUITING

MeSH Terms

Conditions

Multiple Myeloma

Interventions

iberdomide; Bortezomib; Dexamethasone; Calcium Dobesilate; isatuximab

Condition Hierarchy (Ancestors)

Neoplasms, Plasma Cell; Neoplasms by Histologic Type; Neoplasms; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Paraproteinemias; Blood Protein Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemorrhagic Disorders; Lymphoproliferative Disorders; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

Boronic Acids; Acids, Noncarboxylic; Acids; Inorganic Chemicals; Boron Compounds; Organic Chemicals; Pyrazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated; Benzenesulfonates; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Arylsulfonates; Arylsulfonic Acids; Sulfonic Acids; Sulfur Acids; Sulfur Compounds

Study Officials

• Martha Louzada, MD, MSc

  London Health Sciences Centre

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Vanessa Huntley

CONTACT

4164779849; cmrg@cmrg.ca

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 14, 2022
• First Posted: March 9, 2022
• Study Start: December 12, 2024
• Primary Completion (Estimated): March 1, 2028
• Study Completion (Estimated): March 1, 2031
• Last Updated: March 18, 2026

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

CA (7)