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

Phase 3

Terminated

• Conditions: Newly Diagnosed, Previously Untreated Multiple Myeloma
• Interventions: Drug: Lenalidomide; Drug: Dexamethasone; Biological: Elotuzumab

• Registration Number: NCT01891643
• Lead Sponsor: Bristol-Myers Squibb

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

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2013-06-28
• Study First Submitted QC: 2013-06-28
• Study First Posted: 2013-07-03
• Study Start: 2013-09-30
• Primary Completion: 2020-06-25
• Study Completion: 2020-06-25
• Status Verified: 2021-06
• Results First Submitted: 2021-06-02
• Results First Submitted QC: 2021-06-29
• Last Update Submitted: 2021-06-29
• Results First Posted: 2021-07-01
• Last Update Posted: 2021-07-01

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 23

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Arm 2: Lenalidomide + Dexamethasone + Elotuzumab	Elotuzumab	Lenalidomide 25 mg capsules by mouth once daily (Days 1-21) Dexamethasone 28 mg tablets by mouth once daily \[Days 1, 8, 15, 22 (cycles 1 \& 2); Days 1 \& 15(cycles 3-18); Day 1 (cycle 19 \& beyond)\] Dexamethasone 40 mg tablets by mouth once daily \[Days 8 \& 22 (cycles 3-18); Days 8, 15, 22 (cycle 19 \& beyond)\] Dexamethasone 8 mg IV (intravenous) solution once daily \[Days 1, 8, 15, 22 (cycles 1 \& 2); Days 1 \& 15 (cycles 3-18); Day 1 (cycle 19 \& beyond)\] Elotuzumab 10 mg/kg IV solution weekly \[Days 1, 8, 15, 22 (cycles 1 \& 2); Days 1 \& 15 (cycles 3-18)\] Elotuzumab 20 mg/kg IV solution on Day 1 (cycle 19 \& beyond) Repeat above-mentioned dose cycles every 28 days until subject meets criteria for discontinuation of study drug
Arm 1: Lenalidomide + Dexamethasone	Lenalidomide	Lenalidomide 25 mg capsules by mouth once daily (on Days 1-21), repeat every 28 days until subject meets criteria for discontinuation of study drug Dexamethasone 40 mg tablets by mouth weekly (on Days 1, 8, 15, 22), repeat every 28 days until subject meets criteria for discontinuation of study drug
Arm 2: Lenalidomide + Dexamethasone + Elotuzumab	Lenalidomide	Lenalidomide 25 mg capsules by mouth once daily (Days 1-21) Dexamethasone 28 mg tablets by mouth once daily \[Days 1, 8, 15, 22 (cycles 1 \& 2); Days 1 \& 15(cycles 3-18); Day 1 (cycle 19 \& beyond)\] Dexamethasone 40 mg tablets by mouth once daily \[Days 8 \& 22 (cycles 3-18); Days 8, 15, 22 (cycle 19 \& beyond)\] Dexamethasone 8 mg IV (intravenous) solution once daily \[Days 1, 8, 15, 22 (cycles 1 \& 2); Days 1 \& 15 (cycles 3-18); Day 1 (cycle 19 \& beyond)\] Elotuzumab 10 mg/kg IV solution weekly \[Days 1, 8, 15, 22 (cycles 1 \& 2); Days 1 \& 15 (cycles 3-18)\] Elotuzumab 20 mg/kg IV solution on Day 1 (cycle 19 \& beyond) Repeat above-mentioned dose cycles every 28 days until subject meets criteria for discontinuation of study drug
Arm 2: Lenalidomide + Dexamethasone + Elotuzumab	Dexamethasone	Lenalidomide 25 mg capsules by mouth once daily (Days 1-21) Dexamethasone 28 mg tablets by mouth once daily \[Days 1, 8, 15, 22 (cycles 1 \& 2); Days 1 \& 15(cycles 3-18); Day 1 (cycle 19 \& beyond)\] Dexamethasone 40 mg tablets by mouth once daily \[Days 8 \& 22 (cycles 3-18); Days 8, 15, 22 (cycle 19 \& beyond)\] Dexamethasone 8 mg IV (intravenous) solution once daily \[Days 1, 8, 15, 22 (cycles 1 \& 2); Days 1 \& 15 (cycles 3-18); Day 1 (cycle 19 \& beyond)\] Elotuzumab 10 mg/kg IV solution weekly \[Days 1, 8, 15, 22 (cycles 1 \& 2); Days 1 \& 15 (cycles 3-18)\] Elotuzumab 20 mg/kg IV solution on Day 1 (cycle 19 \& beyond) Repeat above-mentioned dose cycles every 28 days until subject meets criteria for discontinuation of study drug
Arm 1: Lenalidomide + Dexamethasone	Dexamethasone	Lenalidomide 25 mg capsules by mouth once daily (on Days 1-21), repeat every 28 days until subject meets criteria for discontinuation of study drug Dexamethasone 40 mg tablets by mouth weekly (on Days 1, 8, 15, 22), repeat every 28 days until subject meets criteria for discontinuation of study drug

Primary Outcome Measures

Name	Time	Method
Change From Baseline to Progression of the Cell Surface Expression of CS1 From Bone Marrow-Derived Multiple Myeloma (MM) Cells	From baseline (screening) to time of progression (up to approximately 54 months)	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)

Secondary Outcome Measures

Name	Time	Method
Percent of Bone Marrow-Derived Multiple Myeloma (MM) Cells Expressing Cell Surface CS1 at Time of Progression	Time of progression (up to approximately 54 months from pre-treatment screening)	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)
Levels of CS1 Soluble Form (sCS1) in Serum	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)	Expression levels of the free form of soluble CS1 were analyzed at different timepoints from serum samples derived from peripheral blood collection
Change From Baseline in the Levels of CS1 Soluble Form (sCS1) in Serum During Therapy and At Progression	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)	Expression levels of the free form of soluble CS1 were analyzed at different timepoints from serum samples derived from peripheral blood collection
Change From Baseline in the Number of Circulating Multiple Myeloma (MM) Cells	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)	Circulating MM cells isolated from peripheral blood
Change From Baseline in Cell Surface CS1 Expression Levels in Circulating Multiple Myeloma (MM) Cells	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)	Circulating MM cells isolated from peripheral blood
CS1 Expression Levels in Matched Samples of Bone Marrow-Derived Multiple Myeloma (MM) Cells and Circulating MM Cells	At baseline (screening), during main study therapy (cycle 3 day 1) and at time of progression (up to approximately 54 months)	CS1 expression levels analyzed from matching bone marrow aspirates (for bone marrow-derived MM cells) and from peripheral blood (for circulating tumor cells) collected from the same participants

Trial Locations

Locations (10)

Crescent City Research Consortium, LLC; 🇺🇸 Marrero, Louisiana, United States

Illinois Cancercare, Pc; 🇺🇸 Peoria, Illinois, United States

Memorial Cancer Institute; 🇺🇸 Hollywood, Florida, United States

Local Institution; 🇵🇱 Lublin, Poland

Baptist Cancer Center; 🇺🇸 Memphis, Tennessee, United States

Medical University Of South Carolina Hollings Cancer Center; 🇺🇸 Charleston, South Carolina, United States

Pacific Hematology Oncology Associates; 🇺🇸 San Francisco, California, United States

Franciscan St. Francis Health; 🇺🇸 Indianapolis, Indiana, United States

Ohio State University Medical Center; 🇺🇸 Columbus, Ohio, United States

Northern Utah Associates; 🇺🇸 Ogden, Utah, United States