PH III Study of Lenalidomide and Dexamethasone With or Without Elotuzumab to Treat Previously Untreated Multiple Myeloma (ELO 1 Substudy)

Phase 3TerminatedNCT01891643

Bristol-Myers Squibb23 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

NONE

Enrollment

Conditions

Newly Diagnosed, Previously Untreated Multiple Myeloma

Interventions

LenalidomideDRUG

DexamethasoneDRUG

ElotuzumabBIOLOGICAL

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (14)

Pacific Hematology Oncology Associates

San Francisco, California, United States

Memorial Cancer Institute

Hollywood, Florida, United States

Illinois Cancercare, Pc

Peoria, Illinois, United States

Outcomes

Primary Outcomes

Change From Baseline to Progression of the Cell Surface Expression of CS1 From Bone Marrow-Derived Multiple Myeloma (MM) Cells

CS1 (CD2 subset-1, also known as CRACC, SLAMF7, CD319) expression levels in multiple myeloma cells were analyzed from bone-marrow aspirates collected at baseline and at time of progression through mean fluorescent intensity. The following conditions were considered to describe multiple myeloma cells expressing CS1 (CS1+/CD38++/CD138+/CD56+/CD19-/CD45DIM)

Time frame: From baseline (screening) to time of progression (up to approximately 54 months)

Secondary Outcomes

Percent of Bone Marrow-Derived Multiple Myeloma (MM) Cells Expressing Cell Surface CS1 at Time of Progression

CS1 (CD2 subset-1, also known as CRACC, SLAMF7, CD319) expression levels in multiple myeloma cells were analyzed from bone-marrow aspirates collected at time of progression. The following conditions were considered to describe multiple myeloma cells expressing CS1 (CS1+/CD38++/CD138+/CD56+/CD19-/CD45DIM)

Time frame: Time of progression (up to approximately 54 months from pre-treatment screening)

Levels of CS1 Soluble Form (sCS1) in Serum

Expression levels of the free form of soluble CS1 were analyzed at different timepoints from serum samples derived from peripheral blood collection

Time frame: 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)

Change From Baseline in the Levels of CS1 Soluble Form (sCS1) in Serum During Therapy and At Progression

Expression levels of the free form of soluble CS1 were analyzed at different timepoints from serum samples derived from peripheral blood collection

Time frame: 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)

Data from ClinicalTrials.gov

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