Biomarker Study of Elotuzumab in High Risk Smoldering Myeloma
This study is currently recruiting participants.
Verified January 2013 by Bristol-Myers Squibb
Sponsor:
Bristol-Myers Squibb
Collaborator:
AbbVie
Information provided by (Responsible Party):
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT01441973
First received: September 27, 2011
Last updated: February 22, 2013
Last verified: January 2013
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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: | February 2012 |
| Estimated Study Completion Date: | May 2014 |
| Estimated Primary Completion Date: | February 2013 (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
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)
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01441973
Contacts
| 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. |
Locations
| United States, Connecticut | |
| Yale University School Of Medicine | Recruiting |
| New Haven, Connecticut, United States, 06520 | |
| Contact: Madhav V Dhodapkar, Site 1104 203-785-4144 | |
| United States, Illinois | |
| University Of Chicago Medical Center | Recruiting |
| Chicago, Illinois, United States, 60637 | |
| Contact: Cara Rosenbaum, Site 1111 | |
| United States, Indiana | |
| Investigative Clinical Research Of Indiana, Llc | Recruiting |
| Indianapolis, Indiana, United States, 46260 | |
| Contact: Robert F Manges, Site 1110 317-297-2208 | |
| United States, Massachusetts | |
| Dana-Farber Cancer Institute | Recruiting |
| Boston, Massachusetts, United States, 02215 | |
| Contact: Paul Richardson, Site 1102 617-632-3786 | |
| United States, North Dakota | |
| Mid Dakota Clinic, Pc | Recruiting |
| Bismarck, North Dakota, United States, 58501 | |
| Contact: Matthew Roy Thomas, Site 1106 701-530-6000 | |
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: | February 22, 2013 |
| Health Authority: | United States: Food and Drug Administration |
Additional relevant MeSH terms:
|
Multiple Myeloma Neoplasms, Plasma Cell Neoplasms by Histologic Type Neoplasms Hemostatic Disorders Vascular Diseases Cardiovascular Diseases |
Paraproteinemias Blood Protein Disorders Hematologic Diseases Hemorrhagic Disorders Lymphoproliferative Disorders Immunoproliferative Disorders Immune System Diseases |
ClinicalTrials.gov processed this record on May 19, 2013