Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Elotuzumab · 1 trial · 1 indication
The primary endpoint is a binary variable determined for each subject indicating whether the subject achieved a very good partial response (VGPR), complete response (CR), or stringent complete response (sCR) to induction treatment with KRd-Elo, as defined by the IMWG 2016 response criteria. Per IMWG 2016 criteria, VGPR is defined as serum/urine M-protein detectable by immunofixation but not electrophoresis OR \>= 90% reduction in serum M protein plus urine M-protein \<100 mg/24 h. CR is defined as negative immunofixation on serum and urine, disappearance of any soft tissue plasmacytomas, and \<5% plasma cells in bone marrow aspirates. sCR is defined as CR plus normal FLC ratio and absence of clonal cells in bone marrow by immunohistochemistry.
| Arm | Type | Description |
|---|---|---|
| KRd-Elotuzumab | EXPERIMENTAL | Induction (4 28-day cycles): Carfilzomib (IV) @ 20 mg/m\^2, Day 1 of Cycle 1; @ 56 mg/m\^2, Day 8,15 of Cycle 1; @ 56 mg/m\^2, Day 1,8,15 of Cycles 2-4 Lenalidomide (Oral) @ 25 mg, once daily at bedtime on Days 1-21 of each cycle (Cycles 1-4) Dexamethasone @ 28 mg orally OR 8 mg IV, once weekly on Day 1,8,15,22 of Cycles 1-2; @28 mg orally OR 8 mg IV on Day 1 of Cycles 3-4 Elotuzumab (IV) @ 10 mg/kg, once weekly on Day 1,8,15,22 of Cycles 1-2; @ 20 mg/kg on Day 1 of Cycles 3-4 Maintenance (28-day cycles): Elotuzumab (IV) @ 20 mg/kg, Day 1 of each cycle (Cycles 1-n) Lenalidomide (Oral) @ 15 mg (or last tolerated dose if \<15 mg), once daily at bedtime on Days 1-21 of each cycle (Cycles 1-n) |
| Name | Type | Description |
|---|---|---|
| Elotuzumab | DRUG | Experimental |
Inclusion Criteria Subject must meet all of the following applicable inclusion criteria to participate in this study: 1. Written informed consent and HIPAA authorization for release of personal health information signed by the subject or his/her legally authorized representative. 2. Age \>= 18 yea...
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Elotuzumab is an investigational small molecule being studied for the treatment of Multiple Myeloma. It is currently in Phase 2 clinical development. The drug is being evaluated in patients with relapsed or refractory Multiple Myeloma, as part of a combination regimen with Carfilzomib, Revlimid, and Dexamethasone.
Elotuzumab is being developed by Atrium Therapeutics, Inc., a biopharmaceutical company. The company's stock ticker is RNA. Atrium Therapeutics is conducting clinical trials to evaluate the safety and efficacy of Elotuzumab in patients with Multiple Myeloma.
Elotuzumab is currently in Phase 2 clinical development. It is an investigational drug and has not been approved by regulatory authorities. The drug is being studied for the treatment of Multiple Myeloma, specifically in patients with relapsed or refractory disease.
Elotuzumab is being studied in a Phase 2 clinical trial with the identifier NCT03361306. The trial is titled 'LCI-HEM-MYE-CRD-002: Carfilzomib-Revlimid-Dexamethasone-Elotuzumab in Relapsed/Refractory Multiple Myeloma.' This study has been completed and enrolled 15 participants in the United States.
Elotuzumab is not FDA approved. It is an investigational drug currently in Phase 2 clinical development for the treatment of Multiple Myeloma. The drug is being studied in clinical trials to assess its safety and efficacy, but it has not yet received regulatory approval.
Elotuzumab is a small molecule being developed for the treatment of Multiple Myeloma. The specific molecular target of Elotuzumab has not been disclosed in the available information. The drug is being evaluated in combination with other agents in a Phase 2 clinical trial.