Neoplasms

Heart and Blood Diseases

Blood and Lymph Conditions

Immune System Diseases

All Conditions

Symptoms and General Pathology

Rare Diseases

Multiple Myeloma

Neoplasms, Plasma Cell

Smoldering Multiple Myeloma

Neoplasms by Histologic Type

Hemostatic Disorders

Blood Coagulation Disorders

Vascular Diseases

Paraproteinemias

Blood Protein Disorders

Hematologic Diseases

Hemorrhagic Disorders

Lymphoproliferative Disorders

Immunoproliferative Disorders

Precancerous Conditions

Hypergammaglobulinemia

All Drugs and Chemicals

Pharmaceutical Solutions

Antineoplastic Agents

Antibodies

Immunoglobulins

Elotuzumab

Intravenous solution administered in 28-day cycles. Cycle 1: Days 1 and 8. Cycle 2 and beyond: Day 1 only.

Intravenous solution administered in 28-day cycles. Cycle 1 and 2: Days 1, 8, 15, and 22. Cycle 3 and beyond: Days 1 and 15.

Elotuzumab (BMS-901608; HuLuc63)

Bristol-Myers Squibb

The purpose of this study is to determine whether elotuzumab will improve response in patients with high risk smoldering myeloma who have more CD56\^dim cells (a marker for the health of the body's immune system)

Biomarker Study of Elotuzumab in High Risk Smoldering Myeloma

A Phase 2 Biomarker Study of Elotuzumab (Humanized Anti-CS1 Monoclonal IgG1 Antibody) Monotherapy to Assess the Association Between NK Cell Status and Efficacy in High Risk Smoldering Myeloma

Estimated using linear regression model, with baseline CD56\^dim cells as the independent covariate, and maximal percent reduction in serum M protein as the dependent variable. For 1 patient who had nonmeasurable disease at baseline, the percent change in serum kappa-lambda difference was used instead of the percent change in serum M protein. Unit of measure=percent change from baseline in M protein cells/ percent change in CD56\^dim cells (% chg from BL in M pro/% chg CD56\^dim cs)

AE=any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. SAE=a medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization.

Clinical laboratory evaluations included hematology, chemistry, and liver and renal functioning.

All on-treatment electrocardiograms (ECGs) were performed in triplicates ( 1 ECG test equaled 3 consecutive individual 12-lead ECGs performed within a 4-minute period). The timing of the ECG was critical to the endpoint of the study. The investigative site documented any deviations from the protocol or procedures related to ECG collection or serum sampling. No ECGs were excluded due to timing deviations; no deviations were considered clinically relevant and all ECG data were included.

The probability was estimated from the K-M curve of subjects being alive and without disease progression (modified IMWG criteria) at 2 years from the initiation of study therapy by dose cohort

ORR is defined as the number of participants with stringent compete response \[SCR\], complete response \[CR\], very good partial response \[VGPR\], and partial response \[PR\])/number of participants in arm, expressed as a percentage. Confidence intervals computed using the Clopper and Pearson method. SCR=CR plus normal free light chain ratio and absence of clonal cells in bone marrow by immunohistochemistry or immunofluorescence. CR=Negative immunofixation on serum and urine and 5% or fewer plasma cells in bone marrow. VGPR=Serum and urine monoclonal (M) protein detectable by immunofixation but not on electrophoresis or 90% reduction in serum M protein level plus urine M protein level \<100 mg/24 hour. PR=50% reduction of serum M protein and reduction in 24-hour urinary M protein by 90% or to \<200 mg/24 hour

AbbVie

Elotuzumab(E) : 10 mg/kg/Dose

Elotuzumab(E) : 20 mg/kg/Dose

Participants in 2 arms were enrolled sequentially. The first group of participants received elotuzumab intravenously at a dose of 20 mg/kg on Days 1 and 8 per 28-day cycle for Cycle 1 and then on Day 1 only in subsequent cycles.

Elotuzumab, 20 mg/kg

Participants in the second group received elotuzumab intravenously at a dose of 10 mg/kg weekly per 28-day cycle in Cycles 1 and 2, then on Days 1 and 15 in subsequent cycles.

Elotuzumab, 10 mg/kg

Total

Age, Continuous

Younger than 65 years

65 years and older to younger than 75 years

75 years and older

Age, Customized

Sex: Female, Male

Ethnicity (NIH/OMB)

White

Black or African American

Race/Ethnicity, Customized

Serum monoclonal (M) protein

Urine M protein

Time from diagnosis to enrollment

All participants who received at least 1 dose of study medication

Bristol-Myers Squibb Study Director

Deaths

SAEs

AEs leading to discontinuation

Infusion reactions

All participants on Elotuzumab therapy. Comprised of both the 20mg/kg and 10mg/kg arms

Elotuzumab, All Dosages

All participants who received at least 1 dose of study drug

Number of Participants Who Died and With Serious Adverse Events (SAEs), Adverse Events (AEs) Leading to Discontinuation, and Infusion Reactions

All participants who received at least 1 dose of study drug and had the required data (4 participants did not have baseline data available).

Linear Regression of Maximal Percent Reduction in Serum Monoclonal (M) Protein on Baseline Percent CD56^Dim Cells in Bone Marrow

Lymphocytes

Hyponatremia

Hyperkalemia

Hyperglycemia

Number of Participants With Laboratory Test Results Meeting the Criteria for Grade 3-4 Abnormality

Number of Participants With a Dose- or Concentration-related Effect on QTcF Interval, PR Interval, QRS Interval, and Heart Rate

Progression Free Survival (PFS) Rate

Objective Response Rate (ORR)

Overall Study

Spots Global Cancer Trial Database for Biomarker Study of Elotuzumab in High Risk Smoldering Myeloma

Trial Identification

Conditions

Interventions

Study Description

Keywords

Eligibility

Locations

Contact Details

Useful links and downloads for this trial