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NCT01891643 · REGISTRY CONDITION SEARCH

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

Found through the registry condition index, not selected as a treatment recommendation. This discovery collection was restricted to studies with posted results.

Phase
PHASE3
Status at capture
TERMINATED
Registry last update
2021-07-01

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

Open the original ClinicalTrials.gov record → · Download preserved record

What did the study report?

Outcomes, safety and baseline populations are separate source sections. Quality-of-life measures appear under their original outcome titles.

flow

Participant flow

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baseline

Baseline characteristics

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outcome · POSTED

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

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outcome · POSTED

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

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outcome · POSTED

Levels of CS1 Soluble Form (sCS1) in Serum

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outcome · POSTED

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

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outcome · POSTED

Change From Baseline in the Number of Circulating Multiple Myeloma (MM) Cells

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outcome · POSTED

Change From Baseline in Cell Surface CS1 Expression Levels in Circulating Multiple Myeloma (MM) Cells

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outcome · POSTED

CS1 Expression Levels in Matched Samples of Bone Marrow-Derived Multiple Myeloma (MM) Cells and Circulating MM Cells

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adverse events

Adverse events

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more info

Limitations, agreements, and source contact

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Who could take part
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
healthy Volunteers
false
minimum Age
18 Years
sex
ALL
std Ages
  1. ADULT
  2. OLDER_ADULT
Treatment arms and interventions
arm Groups
  1. description
    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
    intervention Names
    1. Drug: Lenalidomide
    2. Drug: Dexamethasone
    label
    Arm 1: Lenalidomide + Dexamethasone
    type
    EXPERIMENTAL
  2. description
    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
    intervention Names
    1. Drug: Lenalidomide
    2. Drug: Dexamethasone
    3. Biological: Elotuzumab
    label
    Arm 2: Lenalidomide + Dexamethasone + Elotuzumab
    type
    EXPERIMENTAL
interventions
  1. arm Group Labels
    1. Arm 1: Lenalidomide + Dexamethasone
    2. Arm 2: Lenalidomide + Dexamethasone + Elotuzumab
    name
    Lenalidomide
    other Names
    1. Revlimid®
    type
    DRUG
  2. arm Group Labels
    1. Arm 1: Lenalidomide + Dexamethasone
    2. Arm 2: Lenalidomide + Dexamethasone + Elotuzumab
    name
    Dexamethasone
    other Names
    1. Decadron®
    2. Dexamethasone Intensol®
    3. Dexpak®
    4. Taperpak®
    type
    DRUG
  3. arm Group Labels
    1. Arm 2: Lenalidomide + Dexamethasone + Elotuzumab
    name
    Elotuzumab
    other Names
    1. BMS-901608
    type
    BIOLOGICAL
Study design
allocation
RANDOMIZED
intervention Model
PARALLEL
masking Info
masking
NONE
primary Purpose
BASIC_SCIENCE
Enrollment
count
23
type
ACTUAL
Registered outcome plans (not posted results)
primary Outcomes
  1. description
    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)
    measure
    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)
secondary Outcomes
  1. description
    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)
    measure
    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)
  2. description
    Expression levels of the free form of soluble CS1 were analyzed at different timepoints from serum samples derived from peripheral blood collection
    measure
    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)
  3. description
    Expression levels of the free form of soluble CS1 were analyzed at different timepoints from serum samples derived from peripheral blood collection
    measure
    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)
  4. description
    Circulating MM cells isolated from peripheral blood
    measure
    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)
  5. description
    Circulating MM cells isolated from peripheral blood
    measure
    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)
  6. description
    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
    measure
    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)
Full study description
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
Source references
see Also Links
Source notices and limitations
    Discovery and provenance
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      payload
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      true
      id
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      nct id
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      occurrences
      1. context exact
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        11
        exact text
        NCT01891643
        start
        0
      offset unit
      unicode_code_points
      query cond
      Plasma Cell Neoplasms
      query disease state id
      ds-plasma-cell-neoplasms
      source file
      /Users/arunverma/Documents/ChatGPT/Cancer Statistics Website/research-data/2026-09-10/clinicaltrials-condition/round-0000/raw/cond-plasma-cell-neoplasms-000.json
      source file sha256
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      source json pointer
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      source kind
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      source string sha256
      a2d0061002f4a0964131257c83d6c7fc70602535e0fbbc956bd6704d42041527

    Preserved source evidence · Not medical advice