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Biomarker Study of Elotuzumab in High Risk Smoldering Myeloma

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
AbbVie
Information provided by (Responsible Party):
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT01441973
First received: September 27, 2011
Last updated: August 7, 2014
Last verified: August 2014
  Purpose

The purpose of this study is to determine if patients with high risk smoldering myeloma who have more CD56dim cells (a marker for the health of the body's immune system) will have better responses to Elotuzumab


Condition Intervention Phase
Smoldering Multiple Myeloma
Biological: Elotuzumab (BMS-901608; HuLuc63)
Phase 2

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

Resource links provided by NLM:


Further study details as provided by Bristol-Myers Squibb:

Primary Outcome Measures:
  • The association between Elotuzumab-induced change in monoclonal protein and baseline percentage of CD56dim/CD16+/CD3-/CD45+ Natural Killer (NK) cells in bone marrow [ Time Frame: Baseline (for NK cells in bone marrow) and once every 4 weeks +/- 7 days (for monoclonal protein) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Objective Response Rate: the proportion of subjects who have a partial or better response according to modified International Myeloma Working Group (IMWG) criteria [ Time Frame: Once every 4 weeks +/- 7 days ] [ Designated as safety issue: No ]
  • Electrocardiogram (ECG) Endpoint: The change from baseline in corrected QC Interval (QTc) [ Time Frame: Baseline and Day 1 on Cycle 1 ] [ Designated as safety issue: Yes ]
  • Electrocardiogram (ECG) Endpoint: The change from baseline in corrected QC Interval (QTc) [ Time Frame: Baseline and Day 1 on Cycle 3 ] [ Designated as safety issue: Yes ]
  • 2 year progression free survival: The time from first dose of Elotuzumab until documented disease progression or death [ Time Frame: Once every 4 weeks +/- 7 days until documented disease progression ] [ Designated as safety issue: No ]

Estimated Enrollment: 40
Study Start Date: December 2011
Estimated Study Completion Date: June 2015
Primary Completion Date: April 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Cohort 1: Elotuzumab (first 15 patients)
Elotuzumab 20 mg/kg Solution, Intravenous (IV), Cycle 1: Day 1 & Day 8; Cycle 2 and beyond: once monthly, Repeat every 28 days until subject meets criteria for discontinuation of study drug
Biological: Elotuzumab (BMS-901608; HuLuc63)
Experimental: Cohort 2: Elotuzumab (second 15 patients)
Elotuzumab 10 mg/kg Solution, Intravenous (IV), Cycle 1 and 2: Weekly (On Days 1, 8, 15, and 22); Cycle 3 and beyond: Every 2 weeks (Days 1 and 15), Repeat every 28 days until subject meets criteria for discontinuation of study drug
Biological: Elotuzumab (BMS-901608; HuLuc63)

Detailed Description:

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)

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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

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
  • Urine M protein >200 mg/24 hours, ≥10% bone marrow plasma cells and serum free light chain (FLC) ratio ≤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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01441973

Locations
United States, California
Sharp Clinical Oncology Research
San Diego, California, United States, 92123
United States, Connecticut
Yale University School Of Medicine
New Haven, Connecticut, United States, 06520
Va Connecticut Healthcare System
West Haven, Connecticut, United States, 06516
United States, Georgia
Winship Cancer Institute, Emory University
Atlanta, Georgia, United States, 30322
United States, Illinois
University Of Chicago Medical Center
Chicago, Illinois, United States, 60637
United States, Indiana
Investigative Clinical Research Of Indiana, Llc
Indianapolis, Indiana, United States, 46260
United States, Massachusetts
Dana Farber Cancer Institute
Boston, Massachusetts, United States, 02215
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02215
United States, Missouri
Washington University School Of Medicine
Saint Louis, Missouri, United States, 63110
United States, New York
Mount Sinai Medical Center
New York, New York, United States, 10029
Weill Cornell Medical College
New York, New York, United States, 10021
United States, North Dakota
Mid Dakota Clinic, Pc
Bismarck, North Dakota, United States, 58501
Sponsors and Collaborators
Bristol-Myers Squibb
AbbVie
Investigators
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
  More Information

Additional Information:
No publications provided

Responsible Party: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT01441973     History of Changes
Other Study ID Numbers: CA204-011
Study First Received: September 27, 2011
Last Updated: August 7, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Multiple Myeloma
Neoplasms, Plasma Cell
Blood Protein Disorders
Cardiovascular Diseases
Hematologic Diseases
Hemorrhagic Disorders
Hemostatic Disorders
Immune System Diseases
Immunoproliferative Disorders
Lymphoproliferative Disorders
Neoplasms
Neoplasms by Histologic Type
Paraproteinemias
Vascular Diseases

ClinicalTrials.gov processed this record on November 27, 2014