Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Elotuzumab · 1 trial · 1 indication
MTD was determined by testing increasing doses up to 20 mg/kg once daily dose escalation cohorts 1 to 3 with 3 patients each. MTD reflects highest dose of drug that did not cause an unacceptable side effect (dose limiting toxicity \[DLT\]) in more than 30% of patients; e.g., hematologic toxicities like Common Toxicity Criteria for Adverse Events (CTCAE) Grade 4 neutropenia in specific conditions, platelets \< 10,000 cells/mm\^3 that do not recover to 25,000 cells/mm\^3; and specific non-hematologic/biochemical toxicities CTCAE Grade 3 or 4 (except fatigue and Grade 3 infections); CTCAE version 3.0 were used.
ORR: Percentage of participants with confirmed complete response (CR; negative immunofixation on the serum and urine, disappearance of any soft tissue plasmacytomas, and ≤5% plasma cells in bone marrow), partial response (PR; ≥50% reduction of serum M-protein and reduction in 24-hour urinary M-protein by ≥90% or to ≤200 mg per 24 hour; if serum and urine M-protein are unmeasurable, a ≥50% decrease in the difference between involved and uninvolved free light chain (FLC\] levels is required in place of the M-protein criteria; if serum and urine M-protein are unmeasurable, and serum FLC is also unmeasurable, a ≥50% reduction in plasma cells is required in place of M-protein, provided baseline bone marrow plasma cell percentage was ≥30%; and, if present at baseline, a ≥50% reduction in the size of soft tissue plasmacytomas), very good PR (VGPR; normal FLC ratio and absence of clonal cells in bone marrow by immunohistochemistry or immunofluorescence), or stringent CR (sCR; CR plus VGPR).
| Arm | Type | Description |
|---|---|---|
| Elotuzumab 5 mg/kg + Lenalidomide and Dexamethasone (Phase 1) | EXPERIMENTAL | Elotuzumab 5 mg/kg administered as an IV infusion in combination with lenalidomide 25 mg and dexamethasone 40 mg administered orally. |
| Elotuzumab 10 mg/kg + Lenalidomide and Dexamethasone (Phase 1) | EXPERIMENTAL | Elotuzumab 10 mg/kg administered as an IV infusion in combination with lenalidomide 25 mg and dexamethasone 40 mg administered orally. |
| Elotuzumab 20 mg/kg + Lenalidomide and Dexamethasone (Phase 1) | EXPERIMENTAL | Elotuzumab 20 mg/kg administered as an IV infusion in combination with lenalidomide 25 mg and dexamethasone 40 mg administered orally. |
| Elotuzumab 10 mg/kg + Lenalidomide and Dexamethasone (Phase 2) | EXPERIMENTAL | Elotuzumab 10 mg/kg administered as an IV infusion in combination with lenalidomide 25 mg and dexamethasone 40 mg administered orally. |
| Elotuzumab 20 mg/kg + Lenalidomide and Dexamethasone (Phase 2) | EXPERIMENTAL | Elotuzumab 20 mg/kg administered as an IV infusion in combination with lenalidomide 25 mg and dexamethasone 40 mg administered orally. |
| Name | Type | Description |
|---|---|---|
| elotuzumab | BIOLOGICAL | Humanized Anti-CS1 Monoclonal IgG1 Antibody (HuLuc63) administered as an intravenous infusion once a week during Cycles 1 and 2, and every other week beginning with Cycle 3. |
| lenalidomide | DRUG | Lenalidomide 25 mg administered orally once daily on Days 1 to 21 of each 28-day cycle |
| dexamethasone oral | DRUG | Dexamethasone 40 mg administered orally once weekly; during weeks when elotuzumab is also administered, dexamethasone was administered as a split dose (28 mg orally and 8 mg intravenously) |
| dexamethasone injection | DRUG | Dexamethasone 40 mg administered orally once weekly; during weeks when elotuzumab is also administered, dexamethasone was administered as a split dose (28 mg orally and 8 mg intravenously) |
Inclusion Criteria: 1. Age 18 years or older with a confirmed diagnosis of multiple myeloma (MM) and documentation of one to three prior therapies. 2. Confirmed evidence of disease progression from immediately prior MM therapy or refractory to the immediately prior treatment. 3. Measurable monoclon...
Elotuzumab is an investigational monoclonal antibody being studied for the treatment of hematologic cancer, specifically relapsed multiple myeloma. It is a humanized anti-CS1 monoclonal IgG1 antibody that targets SLAMF7, a protein expressed on myeloma cells. The drug is currently in Phase 2 clinical development.
Elotuzumab targets SLAMF7, also known as CS1, a cell surface glycoprotein expressed on multiple myeloma cells and natural killer cells. As a SLAMF7 inhibitor, it is designed to interfere with the signaling pathways that support tumor cell growth and survival in hematologic cancers.
Elotuzumab is being developed by AbbVie Inc., a biopharmaceutical company traded on the New York Stock Exchange under the ticker symbol ABBV. The drug is currently in Phase 2 clinical development for the treatment of hematologic cancer, specifically relapsed multiple myeloma.
Elotuzumab is in Phase 2 clinical development. It has completed one Phase 2 trial, NCT00742560, which was a dose-escalation study in patients with relapsed multiple myeloma. The drug is investigational and has not been approved by regulatory authorities.
Elotuzumab has been studied in one completed clinical trial, NCT00742560, titled 'A Phase 1b/2, Dose-Escalation Study of Elotuzumab (Humanized Anti-CS1 Monoclonal IgG1 Antibody) in Relapsed Multiple Myeloma.' This trial enrolled 101 participants aged 18 years and older with hematologic cancer.
Yes, elotuzumab is a humanized anti-CS1 monoclonal IgG1 antibody. CS1 is another name for SLAMF7, the molecular target of elotuzumab. The drug is designed to bind to CS1/SLAMF7 on myeloma cells, and it is being investigated for its potential role in treating relapsed multiple myeloma.