Biomarker Study of Elotuzumab in High Risk Smoldering Myeloma

This study is currently recruiting participants.

Verified May 2013 by Bristol-Myers Squibb

Sponsor:

Collaborator:

AbbVie

Information provided by (Responsible Party):

Bristol-Myers Squibb

ClinicalTrials.gov Identifier:

NCT01441973

First received: September 27, 2011

Last updated: May 31, 2013

Last verified: May 2013

History of Changes

Tracking Information

First Received Date ^ICMJE

September 27, 2011

Last Updated Date

May 31, 2013

Start Date ^ICMJE

February 2012

Estimated Primary Completion Date

May 2014 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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 ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01441973 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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 ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Biomarker Study of Elotuzumab in High Risk Smoldering Myeloma

Official Title ^ICMJE

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

Brief Summary

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

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)

Study Type ^ICMJE

Interventional

Study Phase

Phase 2

Study Design ^ICMJE

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

Condition ^ICMJE

Smoldering Multiple Myeloma

Intervention ^ICMJE

Biological: Elotuzumab (BMS-901608; HuLuc63)

Study Arm (s)

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)

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

Estimated Completion Date

May 2014

Estimated Primary Completion Date

May 2014 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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)

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact: For participation information at a USA site use a phone number below. For site information outside the USA please email:		Clinical.Trials@bms.com
Contact: First line of email MUST contain NCT# & Site#. Only trial sites that are recruiting have contact information at this time.

Location Countries ^ICMJE

United States

Administrative Information

NCT Number ^ICMJE

NCT01441973

Other Study ID Numbers ^ICMJE

CA204-011

Has Data Monitoring Committee

Responsible Party

Bristol-Myers Squibb

Study Sponsor ^ICMJE

Bristol-Myers Squibb

Collaborators ^ICMJE

AbbVie

Investigators ^ICMJE

Study Director:

Bristol-Myers Squibb

Information Provided By

Bristol-Myers Squibb

Verification Date

May 2013

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

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