Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
AMG 224 · 1 trial · 1 indication
Adverse events, including DLTs, were graded using the Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. A DLT was considered as any of the below, if judged by the investigator to be possibly related to AMG 224: Hematological: * Grade 4 neutropenia lasting \> 7 days * Grade 3 or 4 neutropenia with fever \> 38.5°C * Grade 3 thrombocytopenia with ≥ Grade 2 hemorrhage * Grade 4 thrombocytopenia lasting \> 7 days * Grade 3 anemia with symptoms or required intervention * Grade 4 anemia * Lymphopenia is not considered a DLT Non-hematological: * ≥ Grade 3 nausea, vomiting or diarrhea persisting \> 3 days despite optimal medical support * Grade 3 fatigue persisting \> 7 days * ≥ Grade 3 acute kidney injury lasting \> 3 days * Elevation of aspartate aminotransferase or alanine aminotransferase \>3x to \>8x upper limit of normal (ULT) dependent on criteria * Total bilirubin \> 3x ULN Participants meeting the criteria for Hy's Law case were considered to have a DLT.
An adverse event (AE) is defined as any untoward medical occurrence in a clinical trial participant. TEAEs were any AE that occurred after receiving at least 1 dose of treatment. Treatment-related TEAEs were those considered related to study treatment by the investigator. Any clinically significant changes in ECGs, vital signs, physical examination with a neurologic assessment and clinical laboratory tests were recorded as TEAEs.
| Arm | Type | Description |
|---|---|---|
| Dose Exploration: AMG 224 Dose A | EXPERIMENTAL | Participants were administered AMG 224 Dose A as an intravenous (IV) infusion once every 3 weeks (Q3W) on Day 1 of each cycle, where each cycle is 3 weeks. |
| Dose Exploration: AMG 224 Dose B | EXPERIMENTAL | Participants were administered AMG 224 Dose B as an IV infusion Q3W on Day 1 of each cycle, where each cycle is 3 weeks. |
| Dose Exploration: AMG 224 Dose C | EXPERIMENTAL | Participants were administered AMG 224 Dose C as an IV infusion Q3W on Day 1 of each cycle, where each cycle is 3 weeks. |
| Dose Exploration: AMG 224 Dose D | EXPERIMENTAL | Participants were administered AMG 224 Dose D as an IV infusion Q3W on Day 1 of each cycle, where each cycle is 3 weeks. |
| Dose Exploration: AMG 224 Dose E | EXPERIMENTAL | Participants were administered AMG 224 Dose E as an IV infusion Q3W on Day 1 of each cycle, where each cycle is 3 weeks. |
| Dose Exploration: AMG 224 Dose F | EXPERIMENTAL | Participants were administered AMG 224 Dose F as an IV infusion Q3W on Day 1 of each cycle, where each cycle is 3 weeks. |
| Dose Exploration: AMG 224 Dose G | EXPERIMENTAL | Participants were administered AMG 224 Dose G as an IV infusion Q3W on Day 1 of each cycle, where each cycle is 3 weeks. |
| Dose Expansion: AMG 224 Dose H + prior CD38 targeting antibody treatment | EXPERIMENTAL | Participants who had prior treatment with CD38-targeting antibody were administered AMG 224 Dose H (the maximum tolerated dose \[MTD\] based on the dose exploration phase) as an IV infusion Q3W on Day 1 of each cycle, where each cycle is 3 weeks. |
| Dose Expansion: AMG 224 Dose H + no prior CD38 targeting antibody treatment | EXPERIMENTAL | Participants who had no prior treatment with CD38-targeting antibody were administered AMG 224 Dose H (the MTD based on the dose exploration phase) as an IV infusion Q3W on Day 1 of each cycle, where each cycle is 3 weeks. |
| Name | Type | Description |
|---|---|---|
| AMG 224 | DRUG | Administered as an IV infusion. |
Inclusion Criteria: \- Pathologically documented,multiple myeloma relapsed or refractory progressive disease after at least 3 lines of therapy for multiple myeloma. Prior therapeutic treatment or regimens must include proteasome inhibitors (e.g. bortezomib) and immunomodulatory drugs (e.g. lenalid...
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AMG 224 is an investigational small molecule being developed for the treatment of multiple myeloma. It is being studied in patients with relapsed or refractory multiple myeloma, meaning the disease has returned or has not responded to prior treatment. The drug is currently in Phase 1 clinical development.
AMG 224 is being developed by Amgen Inc., a biopharmaceutical company traded on the NASDAQ under the ticker symbol AMGN. The company is conducting clinical trials to evaluate the safety and efficacy of this investigational drug in patients with multiple myeloma.
AMG 224 is in Phase 1 clinical development. It is an investigational drug, meaning it has not been approved by regulatory authorities and is still being studied in clinical trials. The Phase 1 trial for AMG 224 has been completed, and the drug remains in early-stage development.
AMG 224 has one completed Phase 1 clinical trial, identified by the National Clinical Trial number NCT02561962. This study enrolled 42 participants with relapsed or refractory multiple myeloma and was conducted in the United States and Australia. The trial included adult patients aged 18 years and older.
AMG 224 is not FDA approved. It is an investigational drug currently in Phase 1 clinical development for the treatment of multiple myeloma. The drug has completed a Phase 1 trial, but it has not yet received approval from the U.S. Food and Drug Administration or any other regulatory agency.