Study of Iberdomide, Bortezomib, Dexamethasone With Isatuximab Added on Demand for ND-NTE MM Patients (NCT05272826)

🧪 Interventions in This Study

• Iberdomide (DRUG)
• Bortezomib (DRUG)
• Dexamethasone (DRUG)
• Isatuximab (DRUG)

Check every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).

1. Must understand and voluntarily sign informed consent form
2. Age ≥ 65 years at the time of signing consent
3. Must be able to adhere to the study visit schedule and other protocol requirements.
4. Previously untreated, transplant ineligible, symptomatic multiple myeloma as defined by the criteria below. Both criteria a and b must be met:
5. Clonal bone marrow plasma cells ≥10% or biopsy-proven bony or extramedullary plasmacytoma
6. 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)
7. Must have Eastern Cooperative Oncology Group (ECOG) performance status score of 0, 1, or 2.
8. 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.
9. 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.
10. Life expectancy of ≥ 3 months.
11. Able to take oral medications.
12. The following laboratory results must be met within 10 days prior to first study drug administration:

🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.

📍 All Participating Trial Locations (7 Sites)

• Cross Cancer Institute — Edmonton, Alberta
• NL Health Services — St. John's, Newfoundland and Labrador
• QEII Health Science Centre — Halifax, Nova Scotia
• London Health Sciences Centre — London, Ontario
• Princess Margaret Hospital — Toronto, Ontario
• Hôpital Maisonneuve-Rosemont — Montreal, Quebec
• McGill University Health Centre — Montreal, Quebec

📞 Contact the Study Coordinator

Phone: (416) 477-9849

Email: cmrg@cmrg.ca

Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.

💰 Cost, Insurance & Patient Rights

• 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
• Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
• Voluntary Participation: You may withdraw at any time without affecting your standard medical care.

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• A Study to Evaluate Preventive Treatments for GPRC5D-related Oral Events — San Francisco, California
• A Multicenter Prospective Observational Cohort Study Evaluating the Impact of Cancer-Directed Treatment and Medication Use, Including Cannabis Use, in Multiple Myeloma Patients — Goodyear, Arizona
• Teclistamab in Combination With Daratumumab for High-Risk Smoldering Myeloma: A Clinical and Correlative Phase 2 Immuno-Oncology Study (the REVIVE Study) — Miami, Florida
• Belantamab Mafodotin or Daratumumab With Bortezomib, Lenalidomide and Dexamethasone for Newly Diagnosed Multiple Myeloma — La Crosse, Wisconsin

Explore by condition: All Multiple Myeloma clinical trials

💡 How to Participate

1. Check the checklist above to see if you may qualify.
2. Contact the study coordinator using the phone/email above.
3. Ask about the visit schedule, what is covered at no cost, and any travel support.
4. Confirm with your own doctor before making a decision.