Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Iberdomide · 1 trial · 1 indication
Rate of patients with treatment emergent adverse events (TEAEs) overall and per dose level
Evaluation of the rate of complete remission (CR) + stringent complete (sCR) remission for patients receiving 2-4 cycles of the combination of KID followed by ASCT in patients with newly diagnosed MM.
| Arm | Type | Description |
|---|---|---|
| Starting Dose -1 | EXPERIMENTAL | CC-220/Iberdomide: 1.1 mg \[CC-220 dosing schedule: daily for 21 days of each 28-day cycle\] Carfilzomib: 20 mg/m2 C1D1 56 mg/m2 thereafter \[Days 1, 8, 15 per 28-day cycle\] Dexamethasone: 40 mg (≤ 75 years) 20 mg (\> 75 years) \[Days 1, 8, 15, 22 per 28-day cycle\] Treatment will continue with carfilzomib, iberdomide, and dexamethasone for up to 4 cycles (28 days) at the physician's discretion followed by the Autologous Stem Cell Transplant. Patients will be followed every 3 months for up to 2 years, or until PD or the start of a new line of therapy. |
| Dose Level 1 | EXPERIMENTAL | CC-220/Iberdomide: 1.3 mg \[CC-220 dosing schedule: daily for 21 days of each 28-day cycle\] Carfilzomib: 20 mg/m2 C1D1 56 mg/m2 thereafter \[Days 1, 8, 15 per 28-day cycle\] CC-220 dose level 1 enrollment will occur following an independent safety review two months after the first 10 patients have completed at least 2 cycles of therapy at dose level -1. Dexamethasone: 40 mg (≤ 75 years) 20 mg (\> 75 years) \[Days 1, 8, 15, 22 per 28-day cycle\] Treatment will continue with carfilzomib, iberdomide, and dexamethasone for up to 4 cycles (28 days) at the physician's discretion followed by the Autologous Stem Cell Transplant. Patients will be followed every 3 months for up to 2 years, or until PD or the start of a new line of therapy. |
| Dose Level 2 | EXPERIMENTAL | CC-220/Iberdomide: 1.6 mg \[CC-220 dosing schedule: daily for 21 days of each 28-day cycle\] Carfilzomib: 20 mg/m2 C1D1 56 mg/m2 thereafter \[Days 1, 8, 15 per 28-day cycle\] CC-220 dose level 2 enrollment will occur following an independent safety review two months after the first 10 patients have completed at least 2 cycles of therapy at dose level 1. Dexamethasone: 40 mg (≤ 75 years) 20 mg (\> 75 years) \[Days 1, 8, 15, 22 per 28-day cycle\] Treatment will continue with carfilzomib, iberdomide, and dexamethasone for up to 4 cycles (28 days) at the physician's discretion followed by the Autologous Stem Cell Transplant. Patients will be followed every 3 months for up to 2 years, or until PD or the start of a new line of therapy. |
| Dose Level -2 | EXPERIMENTAL | CC-220/Iberdomide: 0.75 mg \[CC-220 dosing schedule: daily for 21 days of each 28-day cycle\] Carfilzomib: 20 mg/m2 C1D1 56 mg/m2 thereafter \[Days 1, 8, 15 per 28-day cycle\] Dexamethasone: 40 mg (≤ 75 years) 20 mg (\> 75 years) \[Days 1, 8, 15, 22 per 28-day cycle\] Treatment will continue with carfilzomib, iberdomide, and dexamethasone for up to 4 cycles (28 days) at the physician's discretion followed by the Autologous Stem Cell Transplant. Patients will be followed every 3 months for up to 2 years, or until PD or the start of a new line of therapy. |
| Name | Type | Description |
|---|---|---|
| Carfilzomib | DRUG | 20 mg/m2 C1D1; 56 mg/m2 thereafter |
| Iberdomide | DRUG | Oral CC-220 at dose specified by cohort dose level from Day 1-21 of each 28-day cycle |
| Oral Dexamethasone | DRUG | 40 mg (\<=75 years old); 20 mg (\>75 years old) |
Inclusion Criteria: 1. Documented newly diagnosed multiple myeloma a. At least 25% of patients accrued should be high risk as defined by IMWG or mSMART criteria. 2. Patient should be deemed transplant eligible. 3. Patients may not have had more than 1 cycle of prior induction therapy. If a pati...
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Iberdomide is an investigational small molecule being studied for the treatment of Multiple Myeloma. It is currently in Phase 1 clinical development, specifically being evaluated in combination with carfilzomib and dexamethasone in transplant-eligible patients with Multiple Myeloma.
Iberdomide targets cereblon, a protein that is part of the -domide class of drugs. By binding to cereblon, Iberdomide modulates the ubiquitin-proteasome pathway, which can lead to the degradation of certain proteins involved in cancer cell growth and survival.
Iberdomide is being developed by Meridian Bioscience Inc, which trades under the ticker symbol VIVO. The company is conducting a Phase 1 clinical trial of Iberdomide in Multiple Myeloma.
Iberdomide is in Phase 1 clinical development. It is an investigational drug and has not been approved by the FDA. The ongoing Phase 1 trial is recruiting patients with Multiple Myeloma who are eligible for transplant.
Iberdomide is being studied in a Phase 1 clinical trial with the identifier NCT05199311. The trial, titled 'Carfilzomib, Iberdomide (CC-220) and Dexamethasone (KID) in Transplant Eligible Multiple Myeloma', is recruiting 66 participants in the United States.
Yes, Iberdomide is also known as CC-220. The clinical trial NCT05199311 refers to Iberdomide as CC-220 in its title, confirming that these names refer to the same investigational drug.