Clinical trial NCT01891643: PH III Study of Lenalidomide and Dexamethasone With or Without Elotuzumab to Treat Previously Untreated Multiple Myeloma (ELO 1 Substudy)
Official title: A Phase 3, Randomized, Open Label Trial of Lenalidomide/Dexamethasone With or Without Elotuzumab in Subjects With Previously Untreated Multiple Myeloma
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Newly Diagnosed, Previously Untreated Multiple Myeloma
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
Collaborators: name: Abbott
First posted: 2013-07-03
Enrollment: 23
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: The purpose of the study is to look at subjects who receive Lenalidomide, Dexamethasone, and Elotuzumab and determine if they will have lower surface CS1 expression on malignant plasma cells at the time of progression than those who receive Lenalidomide and Dexamethasone without Elotuzumab


Eligibility criteria: For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com.

Inclusion Criteria:

Subjects who are newly diagnosed with symptomatic MM and who:

* Have not received any prior systemic anti-myeloma therapy
* Have measurable disease
* And are not candidates for high-dose therapy plus stem-cell transplantation (SCT) because of age (≥65 years) or coexisting conditions. Refusal to undergo high dose therapy with SCT is NOT sufficient for entry onto CA204-006 for a subject \<65 years old. There must be a comorbidity that prevents SCT for a subject \<65 years old

Exclusion Criteria:

* Subjects with non-secretory or oligo-secretory or free light-chain only myeloma
* Smoldering MM, defined as asymptomatic MM with absence of lytic bone lesions
* Monoclonal Gammopathy of Undetermined Significance (MGUS)
* Active plasma cell leukemia
* Known Human Immunodeficiency Virus (HIV) infection or active hepatitis A, B, or C

Primary outcomes:
measure: Change From Baseline to Progression of the Cell Surface Expression of CS1 From Bone Marrow-Derived Multiple Myeloma (MM) Cells
timeFrame: From baseline (screening) to time of progression (up to approximately 54 months)
Secondary outcomes:
measure: Percent of Bone Marrow-Derived Multiple Myeloma (MM) Cells Expressing Cell Surface CS1 at Time of Progression
timeFrame: Time of progression (up to approximately 54 months from pre-treatment screening)
measure: Levels of CS1 Soluble Form (sCS1) in Serum
timeFrame: At baseline (screening), during main study therapy (cycle 3 day 1, up to 64 days) and at time of progression (up to approximately 31 months)
measure: Change From Baseline in the Levels of CS1 Soluble Form (sCS1) in Serum During Therapy and At Progression
timeFrame: From baseline (screening) to cycle 3 day 1 of the main study therapy (up to 64 days) and from baseline (screening) to time of progression (up to approximately 31 months)
measure: Change From Baseline in the Number of Circulating Multiple Myeloma (MM) Cells
timeFrame: From baseline (screening) to cycle 3 day 1 of the main study therapy (up to 64 days) and from baseline (screening) to the time of progression (up to approximately 54 months)
measure: Change From Baseline in Cell Surface CS1 Expression Levels in Circulating Multiple Myeloma (MM) Cells
timeFrame: From baseline (screening) to cycle 3 day 1 of the main study therapy (up to 64 days) and from baseline (screening) to the time of progression (up to approximately 54 months)
measure: CS1 Expression Levels in Matched Samples of Bone Marrow-Derived Multiple Myeloma (MM) Cells and Circulating MM Cells
timeFrame: At baseline (screening), during main study therapy (cycle 3 day 1) and at time of progression (up to approximately 54 months)
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: Pacific Hematology Oncology Associates
state: California
city: Hollywood
country: United States
facility: Memorial Cancer Institute
state: Florida
city: Peoria
country: United States
facility: Illinois Cancercare, Pc
state: Illinois
city: Indianapolis
country: United States
facility: Franciscan St. Francis Health
state: Indiana
city: Marrero
country: United States
facility: Crescent City Research Consortium, LLC
state: Louisiana
city: Columbus
country: United States
facility: Ohio State University Medical Center
state: Ohio
city: Charleston
country: United States
facility: Medical University Of South Carolina Hollings Cancer Center
state: South Carolina
city: Memphis
country: United States
facility: Baptist Cancer Center
state: Tennessee
city: Ogden
country: United States
facility: Northern Utah Associates
state: Utah
city: Athens
country: Greece
facility: Local Institution
city: Genova
country: Italy
facility: Local Institution
city: Rome
country: Italy
facility: Local Institution
city: Chorzow
country: Poland
facility: Local Institution
city: Lublin
country: Poland
facility: Local Institution
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References: