BridgeMD
New treatment option for Multiple Myeloma
Official title Study of Iberdomide, Bortezomib, Dexamethasone With Isatuximab Added on Demand for ND-NTE MM Patients
ClinicalTrials.gov ID: NCT05272826
What this study is testing
What is Iberdomide?
Iberdomide is an investigational medicine, given as an once-weekly pill taken by mouth, being studied as a potential treatment for multiple myeloma.
Also referred to as CC-220.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 65 and older
You may be able to join 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
You likely can't join if
- Previous treatment with anti-myeloma therapy (does not include radiotherapy, bisphosphonates, or a single short course of steroid [i.e. less than or...
- 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...
- 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...
- Basal cell carcinoma of the skin
See the full eligibility criteria
- 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...
- 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...
- 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...
- 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 people meet eligibility criteria are not allowed within 10 days before study enrollment.
- Hemoglobin ≥ 80 g/L.
- 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...
- 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...
- 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
- 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...
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Edmonton, Alberta, Canada
- St. John's, Newfoundland and Labrador, Canada
- Halifax, Nova Scotia, Canada
- London, Ontario, Canada
- Toronto, Ontario, Canada
- Montreal, Quebec, Canada
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Edmonton, Alberta, Canada; St. John's, Newfoundland and Labrador, Canada; Halifax, Nova Scotia, Canada; London, Ontario, Canada; Toronto, Ontario, Canada; Montreal, Quebec, Canada. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.