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Biomarker Study of Elotuzumab in High Risk Smoldering Myeloma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01441973
Recruitment Status : Completed
First Posted : September 28, 2011
Results First Posted : January 29, 2016
Last Update Posted : January 23, 2018
Information provided by (Responsible Party):
Bristol-Myers Squibb

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)

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

Detailed Description:
Intervention model: Dosing is sequential

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 41 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (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
Actual Study Start Date : December 28, 2011
Actual Primary Completion Date : May 30, 2014
Actual Study Completion Date : January 17, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Multiple Myeloma
Drug Information available for: Elotuzumab

Arm Intervention/treatment
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.
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.
Biological: Elotuzumab (BMS-901608; HuLuc63)

Primary Outcome Measures :
  1. 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 ]
    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)

Secondary Outcome Measures :
  1. 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 ]
    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.

  2. Number of Participants With Laboratory Test Results Meeting the Criteria for Grade 3-4 Abnormality [ Time Frame: From date of first dose to date of last dose plus 60 days (assessed up to August 2017, approximately 59 months ]
    Clinical laboratory evaluations included hematology, chemistry, and liver and renal functioning.

  3. Number of Participants With a Dose- or Concentration-related Effect on QTcF Interval, PR Interval, QRS Interval, and Heart Rate [ Time Frame: cycle 1 to first day of cycle 3 assessed up to 08/17, approximately 59 months ]
    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.

  4. Progression Free Survival (PFS) Rate [ Time Frame: Up to 2 years from the initiation of study therapy by dose cohort (approximately 24 months) ]
    The probability was estimated from the K-M curve of subjects being alive and without disease progression (modified IMWG criteria) at 2 years from the initiation of study therapy by dose cohort

  5. Objective Response Rate (ORR) [ Time Frame: From first dose to date of progression or objective response (assessed up to August 2017, approximately 59 months) ]
    ORR is defined as the number of participants with stringent compete response [SCR], complete response [CR], very good partial response [VGPR], and partial response [PR])/number of participants in arm, expressed as a percentage. 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

Information from the National Library of Medicine

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, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

For more information regarding BMS clinical trial participation, please visit

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01441973

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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.
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
Weill Cornell Medical College
New York, New York, United States, 10021
Mount Sinai Medical Center
New York, New York, United States, 10029
United States, North Dakota
Mid Dakota Clinic, Pc
Bismarck, North Dakota, United States, 58501
Sponsors and Collaborators
Bristol-Myers Squibb
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Study Director: Bristol-Myers Squibb Bristol-Myers Squibb

Additional Information:
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Responsible Party: Bristol-Myers Squibb Identifier: NCT01441973     History of Changes
Other Study ID Numbers: CA204-011
First Posted: September 28, 2011    Key Record Dates
Results First Posted: January 29, 2016
Last Update Posted: January 23, 2018
Last Verified: December 2017

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

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