Study of Iberdomide, Bortezomib, Dexamethasone With Isatuximab Added on Demand for ND-NTE
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.
| Condition(s) | Multiple Myeloma |
|---|---|
| Status | Recruiting |
| Phase | Phase 2 |
| Study type | Interventional |
| 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. |
| Who can participate | Inclusion Criteria: 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: 1. Clonal bone marrow plasma cells ≥10% or biopsy-proven bony or extramedullary plasmacytoma 2. 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: cre |
| Ages | 65 Years |
| Sex | All |
| Lead sponsor | Canadian Myeloma Research Group |
| Locations | Edmonton, Alberta, Canada; St. John's, Newfoundland and Labrador, Canada; Halifax, Nova Scotia, Canada; London, Ontario, Canada; Toronto, Ontario, Canada; Montreal, Quebec, Canada (+1 more sites) |
| Start date | 2024-12-12 |
| NCT ID | NCT05272826 |
| Official listing | https://clinicaltrials.gov/study/NCT05272826 |