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: May 16, 2016
Last verified: December 2015

September 27, 2011
May 16, 2016
December 2011
May 2014   (final data collection date for primary outcome measure)
Linear Regression of Maximal Percent Reduction in Serum Monoclonal (M) Protein on Baseline Percent CD56^Dim Cells in Bone Marrow [ Time Frame: From day of last patient, first dose to 6 months ] [ Designated as safety issue: No ]
Estimated using linear regression model, with baseline CD56^dim cells as the independent covariate, and maximal percent reduction in serum M protein as the dependent variable. For 1 patient who had nonmeasurable disease at baseline, the percent change in serum kappa-lambda difference was used instead of the percent change in serum M protein. Unit of measure=percent change from baseline in M protein cells/ percent change in CD56^dim cells (% chg from BL in M pro/% chg CD56^dim cs)
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 ]
Complete list of historical versions of study NCT01441973 on ClinicalTrials.gov Archive Site
  • Objective Response Rate (ORR) [ Time Frame: From day of last patient, first dose to 6 months ] [ Designated as safety issue: No ]
    ORR is defined by criteria of modified International Myeloma Working Group as the number of responders (those with stringent compete response [SCR], complete response [CR], very good partial response [VGPR], and partial response [PR])/number of participants in arm. Confidence intervals computed using the Clopper and Pearson method. SCR=CR plus normal free light chain ratio and absence of clonal cells in bone marrow by immunohistochemistry or immunofluorescence. CR=Negative immunofixation on serum and urine and 5% or fewer plasma cells in bone marrow. VGPR=Serum and urine monoclonal (M) protein detectable by immunofixation but not on electrophoresis or 90% reduction in serum M protein level plus urine M protein level <100 mg/24 hour. PR=50% reduction of serum M protein and reduction in 24-hour urinary M protein by 90% or to <200 mg/24 hour.
  • Number of Participants Who Died and With Serious Adverse Events (SAEs), Adverse Events (AEs) Leading to Discontinuation, and Infusion Reactions [ Time Frame: From day of last patient, first dose to 6 months ] [ Designated as safety issue: Yes ]
    AE=any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. SAE=a medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization.
  • Number of Participants With Laboratory Test Results Meeting the Criteria for Grade 3-4 Abnormality [ Time Frame: From day of last patient, first dose to 6 months ] [ Designated as safety issue: Yes ]
    Clinical laboratory evaluations included hematology, chemistry, and liver and renal functioning.
  • Number of Participants With a Dose- or Concentration-related Effect on QTcF Interval, PR Interval, QRS Interval, and Heart Rate [ Time Frame: From day of last patient, first dose to 6 months ] [ Designated as safety issue: Yes ]
    All on-treatment electrocardiograms (ECGs) were performed in triplicates ( 1 ECG test equaled 3 consecutive individual 12-lead ECGs performed within a 4-minute period). The timing of the ECG was critical to the endpoint of the study. The investigative site documented any deviations from the protocol or procedures related to ECG collection or serum sampling. No ECGs were excluded due to timing deviations; no deviations were considered clinically relevant and all ECG data were included.
  • 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 ]
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 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)
Intervention model: Dosing is sequential
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: Elotuzumab, 20 mg/kg
    Intravenous solution administered in 28-day cycles. Cycle 1: Days 1 and 8. Cycle 2 and beyond: Day 1 only.
    Intervention: Biological: Elotuzumab (BMS-901608; HuLuc63)
  • Experimental: Elotuzumab, 10 mg/kg
    Intravenous solution administered in 28-day cycles. Cycle 1 and 2: Days 1, 8, 15, and 22. Cycle 3 and beyond: Days 1 and 15.
    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
41
June 2016
May 2014   (final data collection date for primary outcome measure)

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
Both
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01441973
CA204-011
No
Not Provided
Not Provided
Bristol-Myers Squibb
Bristol-Myers Squibb
AbbVie
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
Bristol-Myers Squibb
December 2015

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