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

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ClinicalTrials.gov Identifier: NCT01891643
Recruitment Status : Terminated (Insufficient enrollment)
First Posted : July 3, 2013
Results First Posted : July 1, 2021
Last Update Posted : July 1, 2021
Sponsor:
Collaborator:
Abbott
Information provided by (Responsible Party):
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

Condition or disease Intervention/treatment Phase
Newly Diagnosed, Previously Untreated Multiple Myeloma Drug: Lenalidomide Drug: Dexamethasone Biological: Elotuzumab Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 23 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: A Phase 3, Randomized, Open Label Trial of Lenalidomide/Dexamethasone With or Without Elotuzumab in Subjects With Previously Untreated Multiple Myeloma
Actual Study Start Date : September 30, 2013
Actual Primary Completion Date : June 25, 2020
Actual Study Completion Date : June 25, 2020


Arm Intervention/treatment
Experimental: Arm 1: Lenalidomide + 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

Drug: Lenalidomide
Other Name: Revlimid®

Drug: Dexamethasone
Other Names:
  • Decadron®
  • Dexamethasone Intensol®
  • Dexpak®
  • Taperpak®

Experimental: Arm 2: Lenalidomide + Dexamethasone + 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

Drug: Lenalidomide
Other Name: Revlimid®

Drug: Dexamethasone
Other Names:
  • Decadron®
  • Dexamethasone Intensol®
  • Dexpak®
  • Taperpak®

Biological: Elotuzumab
Other Name: BMS-901608




Primary Outcome Measures :
  1. Change From Baseline to Progression of the Cell Surface Expression of CS1 From Bone Marrow-Derived Multiple Myeloma (MM) Cells [ Time Frame: 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 :
  1. Percent of Bone Marrow-Derived Multiple Myeloma (MM) Cells Expressing Cell Surface CS1 at Time of Progression [ Time Frame: 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)


  2. Levels of CS1 Soluble Form (sCS1) in Serum [ 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) ]
    Expression levels of the free form of soluble CS1 were analyzed at different timepoints from serum samples derived from peripheral blood collection

  3. Change From Baseline in the Levels of CS1 Soluble Form (sCS1) in Serum During Therapy and At Progression [ 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) ]
    Expression levels of the free form of soluble CS1 were analyzed at different timepoints from serum samples derived from peripheral blood collection

  4. Change From Baseline in the Number of Circulating Multiple Myeloma (MM) Cells [ Time Frame: 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

  5. Change From Baseline in Cell Surface CS1 Expression Levels in Circulating Multiple Myeloma (MM) Cells [ Time Frame: 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

  6. CS1 Expression Levels in Matched Samples of Bone Marrow-Derived Multiple Myeloma (MM) Cells and Circulating MM Cells [ Time Frame: 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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01891643


Locations
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United States, California
Pacific Hematology Oncology Associates
San Francisco, California, United States, 94115
United States, Florida
Memorial Cancer Institute
Hollywood, Florida, United States, 33021
United States, Illinois
Illinois Cancercare, Pc
Peoria, Illinois, United States, 61615
United States, Indiana
Franciscan St. Francis Health
Indianapolis, Indiana, United States, 46237
United States, Louisiana
Crescent City Research Consortium, LLC
Marrero, Louisiana, United States, 70072
United States, Ohio
Ohio State University Medical Center
Columbus, Ohio, United States, 43210
United States, South Carolina
Medical University Of South Carolina Hollings Cancer Center
Charleston, South Carolina, United States, 29425
United States, Tennessee
Baptist Cancer Center
Memphis, Tennessee, United States, 38120
United States, Utah
Northern Utah Associates
Ogden, Utah, United States, 84405
Greece
Local Institution
Athens, Greece, 11528
Italy
Local Institution
Genova, Italy, 16132
Local Institution
Rome, Italy, 00161
Poland
Local Institution
Chorzow, Poland, 41-500
Local Institution
Lublin, Poland, 20-081
Sponsors and Collaborators
Bristol-Myers Squibb
Abbott
Investigators
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Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
  Study Documents (Full-Text)

Documents provided by Bristol-Myers Squibb:
Study Protocol  [PDF] February 19, 2013
Statistical Analysis Plan  [PDF] February 19, 2013

Additional Information:
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Responsible Party: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT01891643    
Other Study ID Numbers: CA204-006 (Biomarker Substudy)
2010-022445-20 ( EudraCT Number )
First Posted: July 3, 2013    Key Record Dates
Results First Posted: July 1, 2021
Last Update Posted: July 1, 2021
Last Verified: June 2021
Additional relevant MeSH terms:
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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
Dexamethasone
Dexamethasone acetate
Lenalidomide
Elotuzumab
BB 1101
Anti-Inflammatory Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents