Phase 2 N=31 Treatment

Biomarker Study of Elotuzumab in High Risk Smoldering Myeloma

Smoldering Multiple Myeloma

Bottom Line

View on ClinicalTrials.gov: NCT01441973 ↗

Enrolled (actual)

Serious AEs

48.4%

Results posted

Jan 2016

Primary outcome: Primary: Linear Regression of Maximal Percent Reduction in Serum Monoclonal (M) Protein on Baseline Percent CD56^Dim Cells in Bone Marrow — -2.562; 2.464; 0.274 % chg from BL in M pro/% chg CD56^dim cs

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: Elotuzumab (BMS-901608; HuLuc63) (Biological)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Bristol-Myers Squibb
Primary completion: May 2014

Outcome Measures

Outcome	Result	p-value
PRIMARY Linear Regression of Maximal Percent Reduction in Serum Monoclonal (M) Protein on Baseline Percent CD56^Dim Cells in Bone Marrow	-2.562; 2.464; 0.274	—
SECONDARY Number of Participants Who Died and With Serious Adverse Events (SAEs), Adverse Events (AEs) Leading to Discontinuation, and Infusion Reactions	0; 0; 0; 8; 7; 15	—
SECONDARY Number of Participants With Laboratory Test Results Meeting the Criteria for Grade 3-4 Abnormality	2; 1; 3; 1; 1; 2	—
SECONDARY Number of Participants With a Dose- or Concentration-related Effect on QTcF Interval, PR Interval, QRS Interval, and Heart Rate	0; 0; 0	—
SECONDARY Progression Free Survival (PFS) Rate	0.71; 0.54; 0.62	—
SECONDARY Objective Response Rate (ORR)	13.3; 6.3; 9.7	—

Summary

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)

Eligibility Criteria

For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com.

Key Inclusion Criteria

Participants with a confirmed diagnosis, according to criteria of the International Myeloma Working Group, of smoldering multiple myeloma, considered high risk according to the following:

Serum monoclonal (M) protein ≥3 gm/dL and bone marrow plasma cells (BMPC) ≥10% or
Serum M protein 1-3 g/dL and BMPC ≥10% and abnormal free light chain ratio of 8.0
Urine M protein >200 mg/24 hours, ≥10% BMPC, and serum free light chain ratio ≤0.125 or ≥8.0

Key Exclusion Criteria

Active multiple myeloma
Monoclonal gammopathy of undetermined significance
Active plasma cell leukemia
Positive for hepatitis B or C virus or HIV infection

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01441973). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.