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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

September 27, 2011
August 7, 2014
December 2011
April 2014   (final data collection date for primary 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 [ Time Frame: Baseline (for NK cells in bone marrow) and once every 4 weeks +/- 7 days (for monoclonal protein) ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01441973 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
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

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

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)

Interventional
Phase 2
Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Smoldering Multiple Myeloma
Biological: Elotuzumab (BMS-901608; HuLuc63)
  • 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
    Intervention: 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
    Intervention: Biological: Elotuzumab (BMS-901608; HuLuc63)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
40
June 2015
April 2014   (final data collection date for primary outcome measure)

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)
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01441973
CA204-011
No
Bristol-Myers Squibb
Bristol-Myers Squibb
AbbVie
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
Bristol-Myers Squibb
August 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP