Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Avadomide · 1 trial · 1 indication
Frequency of dose-limiting toxicities (DLTs) associated with the addition of avadomide (CC-122) to R-CHOP-21 therapy
CR is defined as target nodes/nodal masses regress to ≤ 1.5 cm in LDi; no extralymphatic sites of disease; no measurable lesions, no organ enlargement and normal morphology on bone marrow (BM) exam; immunohistochemically (IHC) negative
| Arm | Type | Description |
|---|---|---|
| Avadomide (CC-122) plus R-CHOP-21 | EXPERIMENTAL | Avadomide (CC-122) by mouth (PO) at varying dose levels (Ph 1) on Days 1 through 5 and Days 8 through 12 plus Rituxan 375 mg/m2 by intravenous (IV) infusion, cyclophosphamide 750mg/m2 by IV infusion, doxorubicin 50 mg/m2 IV, vincristine 1.4 mg/m2 (max is 2.0 mg) IV and 100 mg PO prednisone/prednisolone on Days 1 through 5 of each 21-day treatment cycles for up to 6 total treatment cycles (approximately 18 weeks or 4 months) |
| Name | Type | Description |
|---|---|---|
| Avadomide (CC-122) | DRUG | Avadomide (CC-122) by mouth at the assigned dose in Ph 1 starting on Day 1 for 5 consecutive days per week, followed by 2 days without avadomide (CC-122) administration (5/7) for the first two weeks of a 21-day treatment cycle. If the highest proposed dose level to be explored in Phase 1 is applied, the dosing regimen will be 5/7 days for all 3 weeks of each 21-day treatment cycle. |
| Rituximab | DRUG | Rituxan 375 mg/m2 on Day 1 by intravenous (IV) infusion of a 21-day treatment cycle for up to a total of 6 cycles |
| Cyclophosphamide 750mg/m2 by IV infusion | DRUG | Cyclophosphamide 750mg/m2 on Day 1 by IV infusion of a 21-day treatment cycle for up to a total of 6 cycles |
| Vincristine | DRUG | Vincristine 1.4 mg/m2 (maximum of 2.0 mg total) on Day 1 by IV bolus on Day 1 of a 21-day treatment cycle for up to a total of 6 cycles |
| Prednisone | DRUG | Prednisone 100 mg PO on Days 1 through 5 of each 21-day treatment or 100mg IV on Day 1 is also acceptable for up to a total of 6 cycles |
Inclusion Criteria: 1\. Subject is ≥ 18 years of age at the time of signing the informed consent form (ICF). 2\. Subject has documented, histologically locally confirmed, previously untreated CD20+ DLBCL (NOS) and the following histologies; refer to the World Health Organization (WHO) 2016 classif...
Avadomide is an investigational small molecule being studied for the treatment of diffuse B-cell lymphoma, a type of cancer. It is currently in Phase 1 clinical development and has not been approved by regulatory authorities. The drug is being evaluated in patients with newly diagnosed diffuse large B-cell lymphoma who have poor risk factors.
Avadomide is being developed by Bristol-Myers Squibb Company, a biopharmaceutical company listed on the New York Stock Exchange under the ticker symbol BMY. The company is conducting clinical trials to evaluate the safety and efficacy of this investigational drug for the treatment of diffuse B-cell lymphoma.
Avadomide is in Phase 1 clinical development. It is an investigational drug, meaning it has not been approved by the FDA or other regulatory agencies. The drug is being studied in a completed Phase 1 trial for diffuse B-cell lymphoma, and it remains in early-stage clinical development.
Avadomide has been studied in one clinical trial with the identifier NCT03283202. This was a Phase 1 study titled 'Study of Safety and Efficacy of Avadomide (CC-122) Combined With RCHOP for Newly-diagnosed DLBCL With Poor Risk Factors.' The trial enrolled 35 participants and was conducted in the United States, Belgium, Canada, and Spain.
Yes, Avadomide is also known as CC-122. In clinical trial NCT03283202, the drug is referred to as Avadomide (CC-122), indicating that these names refer to the same investigational compound. This alternative name may be used in scientific literature and clinical trial registries.