Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Elotuzumab · 2 trials · 2 indications
The proportion of patients having achieved at least partial response.
Response will be determined according to the International Myeloma Working Group (IMWG) response criteria for multiple myeloma. sCR is defined as CR plus : * normal FLC ratio and * absence of clonal cells in bone marrow by immunohistochemistry or 2 - 4 color flow cytometry CR is defined as below : * Negative immunofixation on the serum and urine and * disappearance of any soft tissue plasmacytomas and * \< 5% plasma cells in bone marrow. * In subjects with only FLC disease, a normal FLC ratio of 0.26-1.65 is required.
Subjects will be tested for Minimal Residual Disease (MRD) by Next Generation Sequencing (NGS) and flow cytometry after cycle 8. The flow cytometry analysis procedure used to determine MRD is performed on a NAVIOS FLOW CYTOMETER SYSTEM manufactured by BECKMAN COULTER, INC., using a laboratory developed assay. The Premarket Notification 510(k) (Number K130373) for the device can be found using the following link. https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K130373.
Response will be determined according to the International Myeloma Working Group (IMWG) response criteria for multiple myeloma. sCR is defined as CR plus : * normal FLC ratio and * absence of clonal cells in bone marrow by immunohistochemistry or 2 - 4 color flow cytometry CR is defined as below : * Negative immunofixation on the serum and urine and * disappearance of any soft tissue plasmacytomas and * \< 5% plasma cells in bone marrow. * In subjects with only FLC disease, a normal FLC ratio of 0.26-1.65 is required. Subjects will be tested for Minimal Residual Disease (MRD) by Next Generation Sequencing (NGS) and flow cytometry after cycles 4,8,12,18 and 24. The flow cytometry analysis procedure used to determine MRD is performed on a NAVIOS FLOW CYTOMETER SYSTEM manufactured by BECKMAN COULTER, INC., using a laboratory developed assay.
| Arm | Type | Description |
|---|---|---|
| Carfilzomib, elotuzumab, dexamethasone | EXPERIMENTAL | Carfilzomib 70 milligram(mg)/m2 iv (56 mg/m2 for first five patients for cycles 1-2) once weekly, on days 1, 8 and 15 (cycles 1-8), from cycle 9 on days 1 and 15 until progression or toxicity; elotuzumab 10 mg/kg iv on days 1,8,15 for cycles 1-2, on days 1and 15 from cycle 3 until progression or toxicity; dexamethasone 40 mg weekly (shared to po and iv) |
| Elo-KRd regimen | EXPERIMENTAL | Subjects will be tested for Minimal Residual Disease (MRD) by Next Generation Sequencing (NGS) and flow cytometry after cycles 8 and 12. A treatment decision was made after cycle 12 based on these results. There are three outcomes based on the IFM trial (Avet-Loiseau et al., 2015): 1) if the subject is MRD-negative by NGS after cycle 8 and 12, the subject went on E-Rd maintenance until disease progression. 2) If the subject is MRD-positive after cycle 8 but MRD-negative after cycle 12, 6 more cycles of E-KRd was given and at the end of 18 cycles, the subject went on E-Rd maintenance until disease progression. 3) Finally, if the subject is MRD-positive at both instances, 12 additional cycles of E-KRd was given and at the end of 24 cycles total, the subject went on E-Rd maintenance until disease progression. |
| Name | Type | Description |
|---|---|---|
| Carfilzomib for Inj 60 milligram (MG) | DRUG | All patients will have similar effective study drug combination; karfilzomib plus elotuzumab plus dexamethasone |
| Elotuzumab 400 MG | DRUG | All patients will have similar effective study drug combination; karfilzomib plus elotuzumab plus dexamethasone |
| Dexamethasone | DRUG | All patients will have similar effective study drug combination; karfilzomib plus elotuzumab plus dexamethasone |
| Elotuzumab | DRUG | Elotuzumab will be given on Cycles 1-2 on days 1, 8, 15, 22, Cycles 3 and Beyond on days 1 and 15 |
| Carfilzomib | DRUG | Carfilzomib will be given on Day 1 and 8 of Cycle 1, Days 1, 8, and 15 of Cycles 2-8, and Days 1 and 15 of Cycles 9 and beyond |
| Lenalidomide | DRUG | Lenalidomide will be given on days 1-21 for all cycles. |
Inclusion Criteria: 1. Male or female patients at the age of 18 to below 75 years with the life expectancy of at least three months. 2. Prior confirmed diagnosis of multiple myeloma and measurable disease in blood or urine with at least one of the following: Serum M-protein ≥ 5g/l, Urine M-protein ...
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Elotuzumab is an investigational oncology drug being studied for the treatment of multiple myeloma, including multiple myeloma in relapse. It is being evaluated in combination with other therapies such as carfilzomib, lenalidomide, and dexamethasone for patients with this blood cancer.
Elotuzumab 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 drug's safety and efficacy 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. Clinical trials are ongoing to assess its potential as a treatment for multiple myeloma, including relapsed disease.
Elotuzumab has been studied in two completed Phase 2 clinical trials. NCT02969837 evaluated initial treatment with elotuzumab, carfilzomib, lenalidomide, and dexamethasone in multiple myeloma, enrolling 46 participants in the United States. NCT03155100 assessed carfilzomib plus elotuzumab and dexamethasone for relapsed multiple myeloma after 1-3 prior treatment lines, enrolling 15 participants in Finland and Sweden.
Elotuzumab is not FDA approved. It is an investigational drug currently in Phase 2 clinical trials for the treatment of multiple myeloma. The drug has not completed the clinical development process required for regulatory approval, and its safety and efficacy have not been established.