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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


Phase 2
18 Years
N/A
Open (Enrolling)
Both
Smoldering Multiple Myeloma

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Trial Information

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


Intervention model: The actual design is sequential (the first 15 patients are in once
monthly dosing, followed by the second cohort of 15 with twice monthly dosing)


For additional information, please contact the BMS oncology clinical trial information
service at 855-216-0126 or email MyCancerStudyConnect@emergingmed.com. Please visit
www.BMSStudyConnect.com for more information on clinical trial participation.

Inclusion Criteria:



- Subjects with a confirmed diagnosis of smoldering multiple myeloma according to IMWG
and that is considered high risk according to the following:

- Serum 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

Exclusion Criteria:

- Active multiple myeloma

- Monoclonal Gammopathy of Undetermined Significance (MGUS)

- Active plasma cell leukemia

- Positive for Hepatitis B, C or Human Immunodeficiency Virus (HIV)

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

The association between Elotuzumab-induced change in monoclonal protein and baseline percentage of CD56dim/CD16+/CD3-/CD45+ Natural Killer (NK) cells in bone marrow

Outcome Time Frame:

Baseline (for NK cells in bone marrow) and once every 4 weeks +/- 7 days (for monoclonal protein)

Safety Issue:

No

Principal Investigator

Bristol-Myers Squibb

Investigator Role:

Study Director

Investigator Affiliation:

Bristol-Myers Squibb

Authority:

United States: Food and Drug Administration

Study ID:

CA204-011

NCT ID:

NCT01441973

Start Date:

February 2012

Completion Date:

May 2014

Related Keywords:

  • Smoldering Multiple Myeloma
  • Multiple Myeloma
  • Neoplasms, Plasma Cell

Name

Location

Dana-Farber Cancer InstituteBoston, Massachusetts  02115
Mid Dakota Clinic, PCBismarck, North Dakota  58501
University of Chicago Medical CenterChicago, Illinois  60637
VA Connecticut Healthcare SystemWest Haven, Connecticut  06516
Yale University School Of MedicineNew Haven, Connecticut  06520
Winship Cancer Institute, Emory UniversityAtlanta, Georgia  30322
Investigative Clinical Research of Indiana, LLCIndianapolis, Indiana  46254