Clinical trial NCT01441973: Biomarker Study of Elotuzumab in High Risk Smoldering Myeloma
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Smoldering Multiple Myeloma
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
Collaborators: name: AbbVie
First posted: 2011-09-28
Enrollment: 41
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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)

Detailed description: Intervention model: Dosing is sequential

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 \<0.125 or \>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

Primary outcomes:
measure: Linear Regression of Maximal Percent Reduction in Serum Monoclonal (M) Protein on Baseline Percent CD56^Dim Cells in Bone Marrow
timeFrame: From day of last patient, first dose to 6 months
Secondary outcomes:
measure: Number of Participants Who Died and With Serious Adverse Events (SAEs), Adverse Events (AEs) Leading to Discontinuation, and Infusion Reactions
timeFrame: From day of last patient, first dose to 6 months
measure: Number of Participants With Laboratory Test Results Meeting the Criteria for Grade 3-4 Abnormality
timeFrame: From date of first dose to date of last dose plus 60 days (assessed up to August 2017, approximately 59 months
measure: Number of Participants With a Dose- or Concentration-related Effect on QTcF Interval, PR Interval, QRS Interval, and Heart Rate
timeFrame: cycle 1 to first day of cycle 3 assessed up to 08/17, approximately 59 months
measure: Progression Free Survival (PFS) Rate
timeFrame: Up to 2 years from the initiation of study therapy by dose cohort (approximately 24 months)
measure: Objective Response Rate (ORR)
timeFrame: From first dose to date of progression or objective response (assessed up to August 2017, approximately 59 months)
Other outcomes:
Locations:
city: San Diego
country: United States
facility: Sharp Clinical Oncology Research
state: California
city: New Haven
country: United States
facility: Yale University School Of Medicine
state: Connecticut
city: West Haven
country: United States
facility: Va Connecticut Healthcare System
state: Connecticut
city: Atlanta
country: United States
facility: Winship Cancer Institute.
state: Georgia
city: Chicago
country: United States
facility: University Of Chicago Medical Center
state: Illinois
city: Indianapolis
country: United States
facility: Investigative Clinical Research Of Indiana, Llc
state: Indiana
city: Boston
country: United States
facility: Dana Farber Cancer Institute
state: Massachusetts
city: Boston
country: United States
facility: Dana-Farber Cancer Institute
state: Massachusetts
city: Saint Louis
country: United States
facility: Washington University School Of Medicine
state: Missouri
city: New York
country: United States
facility: Weill Cornell Medical College
state: New York
city: New York
country: United States
facility: Mount Sinai Medical Center
state: New York
city: Bismarck
country: United States
facility: Mid Dakota Clinic, Pc
state: North Dakota
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References: