ELOQUENT - 2: Phase III Study of Lenalidomide and Dexamethasone With or Without Elotuzumab to Treat Relapsed or Refractory Multiple Myeloma

Sponsor
Bristol-Myers Squibb (Industry)
Overall Status
Completed
CT.gov ID
NCT01239797
Collaborator
AbbVie (Industry)
761
Enrollment
216
Locations
2
Arms
118
Actual Duration (Months)
3.5
Patients Per Site
0
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of the study is to determine whether the addition of Elotuzumab to Lenalidomide/low-dose Dexamethasone will increase the progression free survival (PFS).

Condition or DiseaseIntervention/TreatmentPhase
Phase 3

Study Design

Study Type:
Interventional
Actual Enrollment :
761 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Phase 3, Randomized, Open Label Trial of Lenalidomide/Dexamethasone With or Without Elotuzumab in Relapsed or Refractory Multiple Myeloma (MM)
Actual Study Start Date :
Jun 20, 2011
Actual Primary Completion Date :
Sep 2, 2014
Actual Study Completion Date :
Apr 21, 2021

Arms and Interventions

ArmIntervention/Treatment
Active Comparator: Lenalidomide + Dexamethasone

Drug: Lenalidomide
Capsules, Oral, 25 mg, once daily, on Days 1-21, Repeat every 28 days until subject meets criteria for discontinuation of study drug
Other Names:
  • Revlimid®
  • Drug: Dexamethasone
    Tablets, Oral, 40 mg, weekly, on Days 1, 8, 15, 22, Repeat every 28 days until subject meets criteria for discontinuation of study drug
    Other Names:
  • Decadron®
  • Dexamethasone Intensol®
  • Dexpak®
  • Taperpak®
  • Experimental: Lenalidomide + Dexamethasone +Elotuzumab

    Drug: Lenalidomide
    Capsules, Oral, 25 mg, once daily, on Days 1-21, Repeat every 28 days until subject meets criteria for discontinuation of study drug
    Other Names:
  • Revlimid®
  • Drug: Dexamethasone (Oral)
    On weeks without Elotuzumab dosing: Tablets, Oral, 40mg, Repeat every 28 days until subject meets criteria for discontinuation of study drug. On weeks with Elotuzumab dosing: Tablets, Oral, 28 mg, Repeat every 28 days until subject meets criteria for discontinuation of study drug
    Other Names:
  • Decadron®
  • Dexamethasone Intensol®
  • Dexpak®
  • Taperpak®
  • Drug: Dexamethasone (IV)
    On weeks without Elotuzumab dosing: Not Applicable (N/A) On weeks with Elotuzumab dosing: Solution, Intravenous (IV), 8 mg, weekly, Repeat every 28 days until subject meets criteria for discontinuation of study drug
    Other Names:
  • Decadron®
  • Dexamethasone Intensol®
  • Dexpak®
  • Taperpak®
  • Biological: Elotuzumab (BMS-901608; HuLuc63)
    Solution, IV, 10 mg/kg, weekly, on Days 1, 8, 15, 22 (cycles 1&2); Days 1 and 15 (cycles 3 and beyond), Repeat every 28 days until subject meets criteria for discontinuation of study drug

    Outcome Measures

    Primary Outcome Measures

    1. Median Progression Free Survival (PFS) [Randomization until 326 events (approximately 2 years)]

      Primary definition of Progression-free survival (PFS) defined as the time from randomization to the date of first documented tumor progression or death due to any cause. Participants were censored at the last adequate assessment prior to the start of any subsequent systemic-therapy or at the last adequate assessment prior to 2 missing assessments (> 10 weeks). Participants who died more than 10 weeks after the randomization date and had no on-treatment assessment were censored at the randomization date. Clinical deterioration was not considered progression. The primary analysis of PFS was based on the primary definition using the Independent Review Committee (IRC) tumor assessment using the European Group for Blood and Bone Marrow Transplant (EBMT) criteria. Tumor assessments were made every 4 weeks (±1 week) relative to the first dose of study medication.

    2. Objective Response Rate (ORR) [Randomization to end of treatment (approximately 2 years)]

      Objective response rate (ORR) defined as the proportion of participants with a best response on-study of partial response (PR) or better (stringent CR [sCR], complete response [CR], very good partial response [VGPR], and partial response [PR]) based on the Independent Review Committee (IRC) assessment of best response using the European Group for Blood and Bone Marrow Transplant (EBMT) assessment criteria. Participants were censored at the last adequate assessment prior to the start of any subsequent systemic-therapy or at the last adequate assessment prior to 2 missing assessments (> 10 weeks). Participants who died more than 10 weeks after the randomization date and had no on-treatment assessment were censored at the randomization date. Clinical deterioration was not considered progression. Assessments were made every 4 weeks.

    Secondary Outcome Measures

    1. Median Overall Survival (OS) [Randomization to 427 deaths (approximately 7 years)]

      Overall Survival (OS), measured in months, was based on Kaplan Meier estimates.

    2. Change in Baseline of Brief Pain Inventory-Short Form (BPI-SF) Scores [Baseline to Study Completion (up to 7 years)]

      Outcome measure reports the change from baseline of the mean score of pain severity and the change from baseline of the mean score of pain interference between the two treatments using the Brief Pain Inventory-Short Form (BPI-SF). The BPI-SF is a self administered questionnaire developed to assess the severity of pain (the sensory dimension) as well as the degree to which pain interferes with function (the reactive dimension). The BPI-SF uses 0 ("No pain", "No interference") to 10 ("Pain as bad as you can imagine", "Highest imaginable interference") numeric rating scale.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No

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

    Inclusion Criteria:
    • Documented progression from most recent line of therapy

    • 1-3 prior lines of therapy

    • Measurable disease

    • Life expectancy ≥3 months

    • Prior treatment with Lenalidomide permitted if:

    1. Best response achieved was ≥Partial Response (PR)

    2. Patient was not refractory

    3. Patient did not discontinue due to a Grade ≥3 related adverse event

    4. Subject did not receive more than 9 cycles of Lenalidomide and had at least 9 months between the last dose of Lenalidomide and progression

    Exclusion Criteria:
    • Subjects with non-secretory or oligo-secretory or serum free light-chain only myeloma

    • Active plasma cell leukemia

    • Known Human immunodeficiency virus (HIV) infection or active hepatitis A, B, or C

    Contacts and Locations

    Locations

    SiteCityStateCountryPostal Code
    1Northwest Alabama Cancer Center, PcMuscle ShoalsAlabamaUnited States35661
    2Acrc/Arizona Clinical Research Center, Inc.TucsonArizonaUnited States85715
    3Local InstitutionBerkeleyCaliforniaUnited States94704
    4Local InstitutionBurbankCaliforniaUnited States91505
    5Compassionate Cancer Res GrpCoronaCaliforniaUnited States92879
    6Local InstitutionCoronaCaliforniaUnited States92879
    7San Diego Pacific Oncology& Hematology Associates, IncEncinitasCaliforniaUnited States92024
    8Local InstitutionGreenbraeCaliforniaUnited States94904
    9Ucla-Division Of Hematology/OncologyLos AngelesCaliforniaUnited States90095
    10Medical Oncology Care AssociatesOrangeCaliforniaUnited States92868
    11Sharp Clinical Oncology ResearchSan DiegoCaliforniaUnited States92123
    12Local InstitutionVallejoCaliforniaUnited States94589
    13Local InstitutionBoca RatonFloridaUnited States33486
    14Cancer Care Centers Of FloridaBrooksvilleFloridaUnited States34613
    15Mount Sinai Comprehensive Cancer CenterMiami BeachFloridaUnited States33140
    16Local InstitutionNew Port RicheyFloridaUnited States34652
    17Cancer Institute Of FloridaOrlandoFloridaUnited States32804
    18Local InstitutionTitusvilleFloridaUnited States32796
    19Florida Cancer SpecialistsWest Palm BeachFloridaUnited States33401
    20Winship Cancer Institute.AtlantaGeorgiaUnited States30322
    21Georgia Health Science UniversityAugustaGeorgiaUnited States30912
    22Orchard Healthcare Research Inc.SkokieIllinoisUnited States60077
    23Local InstitutionIndianapolisIndianaUnited States46260
    24Local InstitutionMishawakaIndianaUnited States46545
    25Local InstitutionIowa CityIowaUnited States52242
    26Local InstitutionLexingtonKentuckyUnited States40503
    27Local InstitutionLouisvilleKentuckyUnited States40207
    28Pikeville Medical CenterPikevilleKentuckyUnited States41501
    29Cancer Center Of Acadiana At Lafayette GeneralLafayetteLouisianaUnited States70503
    30Local InstitutionShreveportLouisianaUnited States71101
    31Local InstitutionShreveportLouisianaUnited States71103
    32Willis Knighton Cancer CenterShreveportLouisianaUnited States71103
    33Dana Farber Cancer InstBostonMassachusettsUnited States02215
    34Dana-Farber Cancer InstituteBostonMassachusettsUnited States02215
    35Henry Ford Health SystemDetroitMichiganUnited States48202
    36Capitol Comprehensive Cancer Care CenterJefferson CityMissouriUnited States65101
    37Washington University School Of MedicineSaint LouisMissouriUnited States63110
    38Local InstitutionSpringfieldMissouriUnited States65807
    39Local InstitutionLas VegasNevadaUnited States89106
    40NYU Clinical Cancer CenterNew YorkNew YorkUnited States10016
    41Local InstitutionNew YorkNew YorkUnited States10019
    42Weill Cornell Medical CollegeNew YorkNew YorkUnited States10065
    43Local InstitutionStony BrookNew YorkUnited States11794-8151
    44Levine Cancer InstituteCharlotteNorth CarolinaUnited States28204
    45Gaston Hematology & OncologyGastoniaNorth CarolinaUnited States28054
    46Local InstitutionBismarckNorth DakotaUnited States58501
    47University Of Oklahoma Health Sciences CenterOklahoma CityOklahomaUnited States73104
    48Local InstitutionTulsaOklahomaUnited States74136
    49Local InstitutionBethlehemPennsylvaniaUnited States18015
    50Western Pennsylvania HospitalPittsburghPennsylvaniaUnited States15224
    51Local InstitutionCharlestonSouth CarolinaUnited States29414
    52Local InstitutionGreenvilleSouth CarolinaUnited States29615
    53Local InstitutionKnoxvilleTennesseeUnited States37909
    54The West ClinicMemphisTennesseeUnited States38120
    55Cancer Specialists Of South Texas, PaCorpus ChristiTexasUnited States78412
    56Ut Southwestern Medical CenterDallasTexasUnited States75390-8565
    57University Of Texas Md Anderson Cancer CtrHoustonTexasUnited States77030
    58Northwest Cancer CenterHoustonTexasUnited States77090
    59Hematology-Oncology Associates Of Fredricksburg, IncFredericksburgVirginiaUnited States22408
    60Va Puget Sound Health Care SystemSeattleWashingtonUnited States98108
    61Gundersen Clinic, LtdLa CrosseWisconsinUnited States54601
    62University Of Wisconsin Hospital And ClinicsMadisonWisconsinUnited States53792
    63Medical College Of WisconsinMilwaukeeWisconsinUnited States53226
    64Local InstitutionAlburyNew South WalesAustralia2640
    65Local InstitutionCanberraNew South WalesAustralia2605
    66Local InstitutionSouth BrisbaneQueenslandAustralia4101
    67Local InstitutionAdelaideSouth AustraliaAustralia5000
    68Local InstitutionMalvernVictoriaAustralia3144
    69Local InstitutionMelbourneVictoriaAustralia3004
    70Local InstitutionNedlandsWestern AustraliaAustralia6009
    71Local InstitutionMurdochAustralia6150
    72Local InstitutionRankweilAustria6830
    73Local InstitutionSteyrAustria4400
    74Local InstitutionWelsAustria4600
    75Local InstitutionWienAustria1220
    76Local InstitutionAntwerpenBelgium2060
    77Local InstitutionBrusselsBelgium1000
    78Local InstitutionBrusselsBelgium1020
    79Local InstitutionBrusselsBelgium1090
    80Local InstitutionBrusslesBelgium1200
    81Local InstitutionEdegem-antwerpBelgium2650
    82Local InstitutionLiegeBelgium4000
    83Local InstitutionYvoirBelgium5530
    84Local InstitutionCalgaryAlbertaCanadaT2N 4N2
    85Local InstitutionEdmontonAlbertaCanadaT6G 1Z2
    86Local InstitutionHalifaxNova ScotiaCanadaB3H 2Y9
    87Local InstitutionLondonOntarioCanadaN6A 4G5
    88Local InstitutionTorontoOntarioCanadaM5G 2M9
    89Local InstitutionMontrealQuebecCanadaH4J 1C5
    90Local InstitutionSaskatoonSaskatchewanCanadaS7N 4H4
    91Local InstitutionBarrieCanadaL4M 6M2
    92Local InstitutionMontrealCanadaH4A 3J1
    93Local InstitutionBrnoCzechia625 00
    94Local InstitutionHradec KraloveCzechia500 05
    95Local InstitutionPraha 10Czechia100 34
    96Local InstitutionPraha 2Czechia128 08
    97Local InstitutionCopenhagenDenmark2100
    98Local InstitutionOdense CDenmark5000
    99Local InstitutionVejleDenmark7100
    100Local InstitutionBloisFrance41016
    101Local InstitutionBordeauxFrance33076
    102Local InstitutionCaenFrance14000
    103Local InstitutionClamart CedexFrance92140
    104Local InstitutionLa Roche Sur YonFrance85925
    105Local InstitutionLa TroncheFrance38700
    106Local InstitutionLilleFrance59037
    107Local InstitutionLimogesFrance87042
    108Local InstitutionNantesFrance44093
    109Local InstitutionParis 12France75012
    110Local InstitutionPierre BenitaFrance69495
    111Local InstitutionToulouseFrance31059
    112Local InstitutionTours CedexFrance37044
    113Local InstitutionVandoeuvreFrance54511
    114Local InstitutionAschaffenburgGermany63739
    115Local InstitutionBerlinGermany12200
    116Local InstitutionBerlinGermany13125
    117Local InstitutionChemnitzGermany09113
    118Local InstitutionDresdenGermany01307
    119Local InstitutionHamburgGermany20246
    120Local InstitutionHamburgGermany22763
    121Local InstitutionHamburgGermany66421
    122Local InstitutionHammGermany59071
    123Local InstitutionHeidelbergGermany69120
    124Local InstitutionJenaGermany07747
    125Local InstitutionKielGermany24105
    126Local InstitutionKolnGermany50937
    127Local InstitutionMarburgGermany35037
    128Local InstitutionMunchenGermany81377
    129Local InstitutionMunchenGermany81675
    130Local InstitutionMunsterGermany48149
    131Local InstitutionRavensburgGermany88212
    132Local InstitutionTuebingenGermany72076
    133Local InstitutionUlmGermany89081
    134Local InstitutionWurzburgGermany97080
    135Local InstitutionAthensGreece11528
    136Local InstitutionIoanninaGreece45500
    137Local InstitutionLarissaGreece41110
    138Local InstitutionBudapestHungary1125
    139Local InstitutionDebrecenHungaryH-4032
    140Local InstitutionGyorHungary9024
    141Local InstitutionSzegedHungaryH-6725
    142Local InstitutionDublinIreland7
    143Local InstitutionTullamoreIreland
    144Local InstitutionAfulaIsrael18101
    145Local InstitutionJerusalemIsrael91120
    146Local InstitutionPetah TikvaIsrael49100
    147Local InstitutionRehovotIsrael76100
    148Local InstitutionZerifinIsrael70300
    149Local InstitutionAnconaItaly60126
    150Local InstitutionBergamoItaly24127
    151Local InstitutionBolognaItaly40138
    152Local InstitutionFirenzeItaly50134
    153Local InstitutionGenovaItaly16132
    154Local InstitutionMeldolaItaly47014
    155Local InstitutionMilanoItaly20133
    156Local InstitutionPalermoItaly90146
    157Local InstitutionRavennaItaly48100
    158Local InstitutionRiminiItaly47923
    159Local InstitutionRomaItaly00161
    160Local InstitutionRomaItaly00168
    161Local InstitutionTorinoItaly10126
    162Local InstitutionNagoya-shiAichiJapan4600001
    163Local InstitutionNagoya-shiAichiJapan4678602
    164Local InstitutionMaebashi-shiGunmaJapan371-8511
    165Local InstitutionShibukawa-shiGunmaJapan3770280
    166Local InstitutionSapporo-cityHokkaidoJapan0608543
    167Local InstitutionSendai-shiMiyagiJapan980-8754
    168Local InstitutionOsaka-shiOsakaJapan5438555
    169Local InstitutionBunkyo-KuTokyoJapan1138677
    170Local InstitutionKoto-kuTokyoJapan1358550
    171Local InstitutionShibuya-kuTokyoJapan1508935
    172Local InstitutionShinjuuku-kuTokyoJapan1608582
    173Local InstitutionKamogawaToykoJapan296-8602
    174Local InstitutionChiba-shiJapan260-8677
    175Local InstitutionFukuokaJapan812-8582
    176Local InstitutionKyotoJapan602-8566
    177Local InstitutionNiigataJapan9518566
    178Local InstitutionOkayamaJapan7011192
    179Local InstitutionToyohashi-shiJapan4418570
    180Local InstitutionBialystokPoland15-276
    181Local InstitutionChorzowPoland41-500
    182Local InstitutionLublinPoland20-081
    183Local InstitutionPoznanPoland60-569
    184Local InstitutionWarszawaPoland02-106
    185Local InstitutionWarszawaPoland02-507
    186Local InstitutionWarszawaPoland02-776
    187Local InstitutionWroclawPoland50-367
    188Local InstitutionPoncePuerto Rico00716
    189Local InstitutionSan JuanPuerto Rico00918
    190Local InstitutionBrasovRomania500152
    191Local InstitutionBucarestiRomania030171
    192Local InstitutionBucurestiRomania22328
    193Local InstitutionLasiRomania700483
    194Local InstitutionBadalona-BarcelonaSpain08916
    195Local InstitutionMadridSpain28006
    196Local InstitutionMadridSpain28007
    197Local InstitutionMurciaSpain30008
    198Local InstitutionSalamancaSpain37007
    199Local InstitutionSantiago De Comp-corunaSpain15706
    200Local InstitutionToledoSpain45004
    201Local InstitutionBernSwitzerland3010
    202Local InstitutionGeneve 14Switzerland1211
    203Local InstitutionIzmirBornovaTurkey35100
    204Local InstitutionIstanbulCapaTurkey34390
    205Local InstitutionAnkaraTurkey06620
    206Local InstitutionIzmirTurkey35330
    207Local InstitutionLeicesterUnited Arab EmiratesLE1 5WW
    208Local InstitutionLondonGreater LondonUnited KingdomEC1A 7BE
    209Local InstitutionManchesterGreater ManchesterUnited KingdomM20 4BX
    210Local InstitutionAirdrieLancashireUnited KingdomML6 OJS
    211Local InstitutionEdinburghMidlothianUnited KingdomEH4 2XU
    212Local InstitutionNottinghamNottinghamshireUnited KingdomNG5 1PB
    213Local InstitutionSuttonSurreyUnited KingdomSM2 5PT
    214Local InstitutionLeedsUnited KingdomLS9 7FT
    215Local InstitutionLondonUnited KingdomNW1 2PG
    216Local InstitutionNewcastle Upon TyneUnited KingdomNE7 7DN

    Sponsors and Collaborators

    • Bristol-Myers Squibb
    • AbbVie

    Investigators

    • Study Director: Bristol-Myers Squibb, Bristol-Myers Squibb

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    Bristol-Myers Squibb
    ClinicalTrials.gov Identifier:
    NCT01239797
    Other Study ID Numbers:
    • CA204-004
    • 2010-020347-12
    First Posted:
    Nov 11, 2010
    Last Update Posted:
    Oct 20, 2021
    Last Verified:
    Sep 1, 2021
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:

    Study Results

    Participant Flow

    Recruitment DetailsStudy initiated: June 2011; Study Completion: Study on-going
    Pre-assignment Detail761 participants were enrolled and 646 participants were randomized (321 Lenalidomide with Elotuzumab, E-Ld and 325 Lenalidomide, Ld). 635 were treated (318 Lenalidomide with Elotuzumab, E-Ld and 317 Lenalidomide, Ld). Reason for non-treatment include 11 non-specified reasons.
    Arm/Group TitleLenalidomide + Dexamethasone + ElotuzumabLenalidomide + Dexamethasone
    Arm/Group DescriptionLenalidomide: Capsules, Oral, 25 mg, once daily, on Days 1-21 Repeat every 28 days until participants met criteria for discontinuation of study drug Dexamethasone (Oral): On weeks without Elotuzumab dosing: Tablets, Oral, 40mg Repeat every 28 days until participants met criteria for discontinuation of study drug On weeks with Elotuzumab dosing: Tablets, Oral, 28 mg Repeat every 28 days until participants met criteria for discontinuation of study drug Dexamethasone (IV): On weeks without Elotuzumab dosing: Not Applicable (N/A) On weeks with Elotuzumab dosing: Solution, Intravenous (IV), 8 mg, weekly Repeat every 28 days until participants met criteria for discontinuation of study drug Elotuzumab (BMS-901608; HuLuc63): Solution, IV, 10 mg/kg, weekly, on Days 1, 8, 15, 22 (cycles 1&2); Days 1 and 15 (cycles 3 and beyond) Repeat every 28 days until participants met criteria for discontinuation of study drugLenalidomide: Capsules, Oral, 25 mg, once daily, on Days 1-21 Regimen repeated every 28 days until participants met criteria for discontinuation of study drug Dexamethasone: Tablets, Oral, 40 mg, weekly, on Days 1, 8, 15, 22 Regimen repeated every 28 days until participants met criteria for discontinuation of study drug
    Period Title: Randomized Participants
    STARTED321325
    COMPLETED319316
    NOT COMPLETED29
    Period Title: Randomized Participants
    STARTED318317
    COMPLETED8343
    NOT COMPLETED235274

    Baseline Characteristics

    Arm/Group TitleLenalidomide + Dexamethasone + ElotuzumabLenalidomide + DexamethasoneTotal
    Arm/Group DescriptionLenalidomide: Capsules, Oral, 25 mg, once daily, on Days 1-21 Repeat every 28 days until participants met criteria for discontinuation of study drug Dexamethasone (Oral): On weeks without Elotuzumab dosing: Tablets, Oral, 40mg Repeat every 28 days until participants met criteria for discontinuation of study drug On weeks with Elotuzumab dosing: Tablets, Oral, 28 mg Repeat every 28 days until participants met criteria for discontinuation of study drug Dexamethasone (IV): On weeks without Elotuzumab dosing: Not Applicable (N/A) On weeks with Elotuzumab dosing: Solution, Intravenous (IV), 8 mg, weekly Repeat every 28 days until participants met criteria for discontinuation of study drug Elotuzumab (BMS-901608; HuLuc63): Solution, IV, 10 mg/kg, weekly, on Days 1, 8, 15, 22 (cycles 1&2); Days 1 and 15 (cycles 3 and beyond) Repeat every 28 days until participants met criteria for discontinuation of study drugLenalidomide: Capsules, Oral, 25 mg, once daily, on Days 1-21 Regimen repeated every 28 days until participants met criteria for discontinuation of study drug Dexamethasone: Tablets, Oral, 40 mg, weekly, on Days 1, 8, 15, 22 Regimen repeated every 28 days until participants met criteria for discontinuation of study drugTotal of all reporting groups
    Overall Participants321325646
    Age (years) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [years]
    66.2
    (9.34)
    65.3
    (10.26)
    65.7
    (9.81)
    Age, Customized (participants) [Number]
    < 65 years old
    134
    41.7%
    142
    43.7%
    276
    42.7%
    >= 65 and < 75 years old
    119
    37.1%
    122
    37.5%
    241
    37.3%
    >= 75 years old
    68
    21.2%
    61
    18.8%
    129
    20%
    Sex: Female, Male (Count of Participants)
    Female
    129
    40.2%
    132
    40.6%
    261
    40.4%
    Male
    192
    59.8%
    193
    59.4%
    385
    59.6%
    Ethnicity (NIH/OMB) (Count of Participants)
    Hispanic or Latino
    5
    1.6%
    1
    0.3%
    6
    0.9%
    Not Hispanic or Latino
    28
    8.7%
    33
    10.2%
    61
    9.4%
    Unknown or Not Reported
    288
    89.7%
    291
    89.5%
    579
    89.6%
    Race/Ethnicity, Customized (participants) [Number]
    White
    264
    82.2%
    280
    86.2%
    544
    84.2%
    Black or African American
    13
    4%
    10
    3.1%
    23
    3.6%
    American Indian or Alaska Native
    0
    0%
    0
    0%
    0
    0%
    Asian
    33
    10.3%
    31
    9.5%
    64
    9.9%
    Native Hawaiian or Other Pacific Islander
    1
    0.3%
    0
    0%
    1
    0.2%
    Other
    9
    2.8%
    4
    1.2%
    13
    2%
    Not Reported
    1
    0.3%
    0
    0%
    1
    0.2%

    Outcome Measures

    1. Primary Outcome
    TitleMedian Progression Free Survival (PFS)
    DescriptionPrimary definition of Progression-free survival (PFS) defined as the time from randomization to the date of first documented tumor progression or death due to any cause. Participants were censored at the last adequate assessment prior to the start of any subsequent systemic-therapy or at the last adequate assessment prior to 2 missing assessments (> 10 weeks). Participants who died more than 10 weeks after the randomization date and had no on-treatment assessment were censored at the randomization date. Clinical deterioration was not considered progression. The primary analysis of PFS was based on the primary definition using the Independent Review Committee (IRC) tumor assessment using the European Group for Blood and Bone Marrow Transplant (EBMT) criteria. Tumor assessments were made every 4 weeks (±1 week) relative to the first dose of study medication.
    Time FrameRandomization until 326 events (approximately 2 years)

    Outcome Measure Data

    Analysis Population Description
    All participants randomized to any treatment group
    Arm/Group TitleLenalidomide + Dexamethasone + ElotuzumabLenalidomide + Dexamethasone
    Arm/Group DescriptionLenalidomide: Capsules, Oral, 25 mg, once daily, on Days 1-21 Repeat every 28 days until participants met criteria for discontinuation of study drug Dexamethasone (Oral): On weeks without Elotuzumab dosing: Tablets, Oral, 40mg Repeat every 28 days until participants met criteria for discontinuation of study drug On weeks with Elotuzumab dosing: Tablets, Oral, 28 mg Repeat every 28 days until participants met criteria for discontinuation of study drug Dexamethasone (IV): On weeks without Elotuzumab dosing: Not Applicable (N/A) On weeks with Elotuzumab dosing: Solution, Intravenous (IV), 8 mg, weekly Repeat every 28 days until participants met criteria for discontinuation of study drug Elotuzumab (BMS-901608; HuLuc63): Solution, IV, 10 mg/kg, weekly, on Days 1, 8, 15, 22 (cycles 1&2); Days 1 and 15 (cycles 3 and beyond) Repeat every 28 days until participants met criteria for discontinuation of study drugLenalidomide: Capsules, Oral, 25 mg, once daily, on Days 1-21 Regimen repeated every 28 days until participants met criteria for discontinuation of study drug Dexamethasone: Tablets, Oral, 40 mg, weekly, on Days 1, 8, 15, 22 Regimen repeated every 28 days until participants met criteria for discontinuation of study drug
    Measure Participants321325
    Median (95% Confidence Interval) [months]
    19.35
    14.85
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Lenalidomide + Dexamethasone + Elotuzumab, Lenalidomide + Dexamethasone
    Comments Hazard Ratio of Lenalidomide + Dexamethasone + Elotuzumab to Lenalidomide + Dexamethasone
    Type of Statistical Test Superiority or Other (legacy)
    Comments
    Statistical Test of Hypothesisp-Value0.0014
    Comments
    MethodLog Rank
    Comments2-sided p-value for stratified log rank test
    Method of EstimationEstimation ParameterHazard Ratio (HR)
    Estimated Value0.73
    Confidence Interval (2-Sided) 95%
    0.60 to 0.89
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    2. Primary Outcome
    TitleObjective Response Rate (ORR)
    DescriptionObjective response rate (ORR) defined as the proportion of participants with a best response on-study of partial response (PR) or better (stringent CR [sCR], complete response [CR], very good partial response [VGPR], and partial response [PR]) based on the Independent Review Committee (IRC) assessment of best response using the European Group for Blood and Bone Marrow Transplant (EBMT) assessment criteria. Participants were censored at the last adequate assessment prior to the start of any subsequent systemic-therapy or at the last adequate assessment prior to 2 missing assessments (> 10 weeks). Participants who died more than 10 weeks after the randomization date and had no on-treatment assessment were censored at the randomization date. Clinical deterioration was not considered progression. Assessments were made every 4 weeks.
    Time FrameRandomization to end of treatment (approximately 2 years)

    Outcome Measure Data

    Analysis Population Description
    All participants randomized to any treatment group
    Arm/Group TitleLenalidomide + Dexamethasone + ElotuzumabLenalidomide + Dexamethasone
    Arm/Group DescriptionLenalidomide: Capsules, Oral, 25 mg, once daily, on Days 1-21 Repeat every 28 days until participants met criteria for discontinuation of study drug Dexamethasone (Oral): On weeks without Elotuzumab dosing: Tablets, Oral, 40mg Repeat every 28 days until participants met criteria for discontinuation of study drug On weeks with Elotuzumab dosing: Tablets, Oral, 28 mg Repeat every 28 days until participants met criteria for discontinuation of study drug Dexamethasone (IV): On weeks without Elotuzumab dosing: Not Applicable (N/A) On weeks with Elotuzumab dosing: Solution, Intravenous (IV), 8 mg, weekly Repeat every 28 days until participants met criteria for discontinuation of study drug Elotuzumab (BMS-901608; HuLuc63): Solution, IV, 10 mg/kg, weekly, on Days 1, 8, 15, 22 (cycles 1&2); Days 1 and 15 (cycles 3 and beyond) Repeat every 28 days until participants met criteria for discontinuation of study drugLenalidomide: Capsules, Oral, 25 mg, once daily, on Days 1-21 Regimen repeated every 28 days until participants met criteria for discontinuation of study drug Dexamethasone: Tablets, Oral, 40 mg, weekly, on Days 1, 8, 15, 22 Regimen repeated every 28 days until participants met criteria for discontinuation of study drug
    Measure Participants321325
    Number (95% Confidence Interval) [percentage of participants]
    78.5
    24.5%
    65.5
    20.2%
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Lenalidomide + Dexamethasone + Elotuzumab, Lenalidomide + Dexamethasone
    Comments Ratio of Lenalidomide + Dexamethasone + Elotuzumab to Lenalidomide + Dexamethasone
    Type of Statistical Test Superiority or Other (legacy)
    Comments
    Statistical Test of Hypothesisp-Value0.0002
    Comments
    MethodCochran-Mantel-Haenszel
    CommentsStratified by B2 microglobulin (<3.5 mg/L vs >=3.5 mg/L), number of prior lines of therapy (1 vs >=2), and immunomodulatory drug use at randomization
    Method of EstimationEstimation ParameterOdds Ratio (OR)
    Estimated Value1.95
    Confidence Interval (2-Sided) 95%
    1.36 to 2.78
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection Lenalidomide + Dexamethasone + Elotuzumab, Lenalidomide + Dexamethasone
    Comments Difference of Lenalidomide + Dexamethasone + Elotuzumab minus Lenalidomide + Dexamethasone computed using the method of DerSimonian and Laird (weighted average over the strata)
    Type of Statistical Test Superiority or Other (legacy)
    Comments
    Statistical Test of Hypothesisp-Value
    Comments
    Method
    Comments
    Method of EstimationEstimation ParameterDifference in Percentage
    Estimated Value12.7
    Confidence Interval (2-Sided) 95%
    6.2 to 19.3
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    3. Secondary Outcome
    TitleMedian Overall Survival (OS)
    DescriptionOverall Survival (OS), measured in months, was based on Kaplan Meier estimates.
    Time FrameRandomization to 427 deaths (approximately 7 years)

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title
    Arm/Group Description
    4. Secondary Outcome
    TitleChange in Baseline of Brief Pain Inventory-Short Form (BPI-SF) Scores
    DescriptionOutcome measure reports the change from baseline of the mean score of pain severity and the change from baseline of the mean score of pain interference between the two treatments using the Brief Pain Inventory-Short Form (BPI-SF). The BPI-SF is a self administered questionnaire developed to assess the severity of pain (the sensory dimension) as well as the degree to which pain interferes with function (the reactive dimension). The BPI-SF uses 0 ("No pain", "No interference") to 10 ("Pain as bad as you can imagine", "Highest imaginable interference") numeric rating scale.
    Time FrameBaseline to Study Completion (up to 7 years)

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title
    Arm/Group Description

    Adverse Events

    Time FrameDay 1 (date of first dose) up to 60 days post last dose of study therapy
    Adverse Event Reporting Description Study initiated: Jun 2011; Study Completion: study on-going
    Arm/Group TitleLenalidomide + Dexamethasone + ElotuzumabLenalidomide + Dexamethasone
    Arm/Group DescriptionLenalidomide: Capsules, Oral, 25 mg, once daily, on Days 1-21 Repeat every 28 days until participants met criteria for discontinuation of study drug Dexamethasone (Oral): On weeks without Elotuzumab dosing: Tablets, Oral, 40mg Repeat every 28 days until participants met criteria for discontinuation of study drug On weeks with Elotuzumab dosing: Tablets, Oral, 28 mg Repeat every 28 days until participants met criteria for discontinuation of study drug Dexamethasone (IV): On weeks without Elotuzumab dosing: Not Applicable (N/A) On weeks with Elotuzumab dosing: Solution, Intravenous (IV), 8 mg, weekly Repeat every 28 days until participants met criteria for discontinuation of study drug Elotuzumab (BMS-901608; HuLuc63): Solution, IV, 10 mg/kg, weekly, on Days 1, 8, 15, 22 (cycles 1&2); Days 1 and 15 (cycles 3 and beyond) Repeat every 28 days until participants met criteria for discontinuation of study drugLenalidomide: Capsules, Oral, 25 mg, once daily, on Days 1-21 Regimen repeated every 28 days until participants met criteria for discontinuation of study drug Dexamethasone: Tablets, Oral, 40 mg, weekly, on Days 1, 8, 15, 22 Regimen repeated every 28 days until participants met criteria for discontinuation of study drug
    All Cause Mortality
    Lenalidomide + Dexamethasone + ElotuzumabLenalidomide + Dexamethasone
    Affected / at Risk (%)# EventsAffected / at Risk (%)# Events
    Total/ (NaN) / (NaN)
    Serious Adverse Events
    Lenalidomide + Dexamethasone + ElotuzumabLenalidomide + Dexamethasone
    Affected / at Risk (%)# EventsAffected / at Risk (%)# Events
    Total208/318 (65.4%) 179/317 (56.5%)
    Blood and lymphatic system disorders
    Febrile neutropenia5/318 (1.6%) 4/317 (1.3%)
    Neutropenia1/318 (0.3%) 3/317 (0.9%)
    Pancytopenia1/318 (0.3%) 0/317 (0%)
    Splenic infarction0/318 (0%) 1/317 (0.3%)
    Eosinophilia1/318 (0.3%) 0/317 (0%)
    Anaemia9/318 (2.8%) 6/317 (1.9%)
    Bone marrow failure1/318 (0.3%) 0/317 (0%)
    Thrombocytopenia5/318 (1.6%) 2/317 (0.6%)
    Microangiopathic haemolytic anaemia1/318 (0.3%) 0/317 (0%)
    Cardiac disorders
    Acute coronary syndrome1/318 (0.3%) 2/317 (0.6%)
    Arrhythmia0/318 (0%) 1/317 (0.3%)
    Cardio-respiratory arrest1/318 (0.3%) 0/317 (0%)
    Myocardial infarction0/318 (0%) 3/317 (0.9%)
    Sick sinus syndrome0/318 (0%) 1/317 (0.3%)
    Left ventricular failure0/318 (0%) 1/317 (0.3%)
    Ventricular failure1/318 (0.3%) 0/317 (0%)
    Cardiac failure congestive2/318 (0.6%) 1/317 (0.3%)
    Acute myocardial infarction0/318 (0%) 2/317 (0.6%)
    Angina pectoris1/318 (0.3%) 0/317 (0%)
    Atrial fibrillation6/318 (1.9%) 8/317 (2.5%)
    Cardiac failure1/318 (0.3%) 2/317 (0.6%)
    Atrioventricular block complete1/318 (0.3%) 0/317 (0%)
    Cardiac arrest1/318 (0.3%) 1/317 (0.3%)
    Myocardial ischaemia0/318 (0%) 2/317 (0.6%)
    Supraventricular tachycardia1/318 (0.3%) 0/317 (0%)
    Eye disorders
    Visual impairment1/318 (0.3%) 0/317 (0%)
    Cataract nuclear1/318 (0.3%) 0/317 (0%)
    Cataract5/318 (1.6%) 4/317 (1.3%)
    Gastrointestinal disorders
    Ileus0/318 (0%) 1/317 (0.3%)
    Ileus paralytic0/318 (0%) 1/317 (0.3%)
    Large intestinal ulcer0/318 (0%) 1/317 (0.3%)
    Abdominal pain2/318 (0.6%) 0/317 (0%)
    Constipation1/318 (0.3%) 1/317 (0.3%)
    Gastrointestinal haemorrhage2/318 (0.6%) 1/317 (0.3%)
    Intestinal obstruction1/318 (0.3%) 0/317 (0%)
    Large intestine perforation1/318 (0.3%) 0/317 (0%)
    Pancreatitis acute2/318 (0.6%) 0/317 (0%)
    Colitis1/318 (0.3%) 2/317 (0.6%)
    Enteritis1/318 (0.3%) 0/317 (0%)
    Gastric ulcer0/318 (0%) 1/317 (0.3%)
    Haemorrhoids0/318 (0%) 1/317 (0.3%)
    Intestinal haemorrhage0/318 (0%) 1/317 (0.3%)
    Mouth haemorrhage1/318 (0.3%) 0/317 (0%)
    Pancreatitis0/318 (0%) 1/317 (0.3%)
    Upper gastrointestinal haemorrhage0/318 (0%) 1/317 (0.3%)
    Vomiting1/318 (0.3%) 3/317 (0.9%)
    Nausea1/318 (0.3%) 1/317 (0.3%)
    Inguinal hernia, obstructive0/318 (0%) 1/317 (0.3%)
    Lower gastrointestinal haemorrhage0/318 (0%) 1/317 (0.3%)
    Subileus0/318 (0%) 1/317 (0.3%)
    Abdominal pain upper1/318 (0.3%) 0/317 (0%)
    Diarrhoea5/318 (1.6%) 8/317 (2.5%)
    General disorders
    Chest pain1/318 (0.3%) 0/317 (0%)
    Pain1/318 (0.3%) 0/317 (0%)
    Device dislocation0/318 (0%) 1/317 (0.3%)
    Mucosal haemorrhage1/318 (0.3%) 0/317 (0%)
    Multi-organ failure1/318 (0.3%) 0/317 (0%)
    Pyrexia22/318 (6.9%) 15/317 (4.7%)
    Asthenia2/318 (0.6%) 0/317 (0%)
    Chills0/318 (0%) 1/317 (0.3%)
    Fatigue1/318 (0.3%) 0/317 (0%)
    Death1/318 (0.3%) 1/317 (0.3%)
    Disease progression13/318 (4.1%) 10/317 (3.2%)
    Malaise1/318 (0.3%) 0/317 (0%)
    General physical health deterioration6/318 (1.9%) 4/317 (1.3%)
    Hepatobiliary disorders
    Cholelithiasis1/318 (0.3%) 0/317 (0%)
    Hepatitis1/318 (0.3%) 0/317 (0%)
    Cholangitis1/318 (0.3%) 0/317 (0%)
    Hepatic failure1/318 (0.3%) 0/317 (0%)
    Hepatic function abnormal0/318 (0%) 1/317 (0.3%)
    Hyperbilirubinaemia2/318 (0.6%) 0/317 (0%)
    Cholecystitis1/318 (0.3%) 0/317 (0%)
    Cholecystitis acute1/318 (0.3%) 0/317 (0%)
    Cholecystitis chronic1/318 (0.3%) 0/317 (0%)
    Infections and infestations
    Diverticulitis1/318 (0.3%) 0/317 (0%)
    Pyelonephritis1/318 (0.3%) 0/317 (0%)
    Respiratory syncytial virus infection1/318 (0.3%) 1/317 (0.3%)
    Skin infection0/318 (0%) 1/317 (0.3%)
    Streptococcal bacteraemia0/318 (0%) 1/317 (0.3%)
    Bronchitis7/318 (2.2%) 7/317 (2.2%)
    Clostridium difficile infection0/318 (0%) 1/317 (0.3%)
    Cytomegalovirus infection1/318 (0.3%) 0/317 (0%)
    Endocarditis1/318 (0.3%) 2/317 (0.6%)
    Enteritis infectious1/318 (0.3%) 0/317 (0%)
    Lung infection2/318 (0.6%) 1/317 (0.3%)
    Meningitis staphylococcal1/318 (0.3%) 0/317 (0%)
    Neutropenic sepsis1/318 (0.3%) 1/317 (0.3%)
    Pyelonephritis acute0/318 (0%) 1/317 (0.3%)
    Staphylococcal sepsis0/318 (0%) 1/317 (0.3%)
    Urinary tract infection3/318 (0.9%) 5/317 (1.6%)
    Urosepsis1/318 (0.3%) 0/317 (0%)
    Abscess oral0/318 (0%) 1/317 (0.3%)
    Cerebral aspergillosis1/318 (0.3%) 0/317 (0%)
    Osteomyelitis1/318 (0.3%) 1/317 (0.3%)
    Pneumonia pneumococcal3/318 (0.9%) 1/317 (0.3%)
    Staphylococcal bacteraemia0/318 (0%) 1/317 (0.3%)
    Tooth abscess0/318 (0%) 1/317 (0.3%)
    Bacterial sepsis1/318 (0.3%) 0/317 (0%)
    Cellulitis5/318 (1.6%) 0/317 (0%)
    Enterocolitis viral1/318 (0.3%) 0/317 (0%)
    Gastroenteritis1/318 (0.3%) 2/317 (0.6%)
    Pneumonia fungal1/318 (0.3%) 0/317 (0%)
    Viral diarrhoea1/318 (0.3%) 0/317 (0%)
    Viral infection1/318 (0.3%) 0/317 (0%)
    Wound infection1/318 (0.3%) 0/317 (0%)
    Atypical pneumonia2/318 (0.6%) 0/317 (0%)
    Bacteraemia0/318 (0%) 1/317 (0.3%)
    Bronchopneumonia6/318 (1.9%) 3/317 (0.9%)
    Device related sepsis0/318 (0%) 1/317 (0.3%)
    Endophthalmitis0/318 (0%) 1/317 (0.3%)
    Febrile infection1/318 (0.3%) 0/317 (0%)
    Herpes zoster3/318 (0.9%) 2/317 (0.6%)
    Infection2/318 (0.6%) 2/317 (0.6%)
    Listeriosis0/318 (0%) 1/317 (0.3%)
    Lower respiratory tract infection4/318 (1.3%) 3/317 (0.9%)
    Periodontitis0/318 (0%) 1/317 (0.3%)
    Peritonitis0/318 (0%) 1/317 (0.3%)
    Pharyngitis1/318 (0.3%) 1/317 (0.3%)
    Pneumonia35/318 (11%) 27/317 (8.5%)
    Septic shock2/318 (0.6%) 5/317 (1.6%)
    Sinusitis2/318 (0.6%) 1/317 (0.3%)
    Implant site abscess0/318 (0%) 1/317 (0.3%)
    Influenza2/318 (0.6%) 5/317 (1.6%)
    Pneumocystis jirovecii pneumonia2/318 (0.6%) 1/317 (0.3%)
    Pneumonia bacterial1/318 (0.3%) 0/317 (0%)
    Pneumonia influenzal1/318 (0.3%) 2/317 (0.6%)
    Respiratory tract infection10/318 (3.1%) 4/317 (1.3%)
    Sepsis5/318 (1.6%) 6/317 (1.9%)
    Upper respiratory tract infection2/318 (0.6%) 1/317 (0.3%)
    Bronchopulmonary aspergillosis1/318 (0.3%) 0/317 (0%)
    Device related infection1/318 (0.3%) 0/317 (0%)
    Infectious colitis1/318 (0.3%) 0/317 (0%)
    Lung abscess0/318 (0%) 1/317 (0.3%)
    Pneumococcal sepsis1/318 (0.3%) 0/317 (0%)
    Acute sinusitis0/318 (0%) 1/317 (0.3%)
    Arthritis bacterial0/318 (0%) 2/317 (0.6%)
    Campylobacter gastroenteritis0/318 (0%) 1/317 (0.3%)
    Erythema infectiosum0/318 (0%) 1/317 (0.3%)
    Gastroenteritis viral1/318 (0.3%) 4/317 (1.3%)
    H1N1 influenza1/318 (0.3%) 1/317 (0.3%)
    Lobar pneumonia3/318 (0.9%) 3/317 (0.9%)
    Ophthalmic herpes zoster0/318 (0%) 1/317 (0.3%)
    Urinary tract infection enterococcal0/318 (0%) 1/317 (0.3%)
    Injury, poisoning and procedural complications
    Femoral neck fracture1/318 (0.3%) 1/317 (0.3%)
    Hip fracture1/318 (0.3%) 2/317 (0.6%)
    Humerus fracture2/318 (0.6%) 0/317 (0%)
    Rib fracture2/318 (0.6%) 0/317 (0%)
    Subdural haematoma0/318 (0%) 1/317 (0.3%)
    Upper limb fracture1/318 (0.3%) 0/317 (0%)
    Chemical injury1/318 (0.3%) 0/317 (0%)
    Compression fracture0/318 (0%) 1/317 (0.3%)
    Fall1/318 (0.3%) 0/317 (0%)
    Ilium fracture1/318 (0.3%) 0/317 (0%)
    Lumbar vertebral fracture2/318 (0.6%) 1/317 (0.3%)
    Stenosis of vesicourethral anastomosis0/318 (0%) 1/317 (0.3%)
    Ankle fracture0/318 (0%) 1/317 (0.3%)
    Pelvic fracture1/318 (0.3%) 1/317 (0.3%)
    Seroma0/318 (0%) 1/317 (0.3%)
    Spinal compression fracture2/318 (0.6%) 1/317 (0.3%)
    Femur fracture1/318 (0.3%) 1/317 (0.3%)
    Craniocerebral injury0/318 (0%) 2/317 (0.6%)
    Laceration0/318 (0%) 1/317 (0.3%)
    Soft tissue injury0/318 (0%) 1/317 (0.3%)
    Thoracic vertebral fracture0/318 (0%) 1/317 (0.3%)
    Lip injury1/318 (0.3%) 0/317 (0%)
    Post procedural haemorrhage0/318 (0%) 1/317 (0.3%)
    Tendon rupture0/318 (0%) 1/317 (0.3%)
    Traumatic fracture0/318 (0%) 2/317 (0.6%)
    Road traffic accident0/318 (0%) 1/317 (0.3%)
    Investigations
    International normalised ratio increased1/318 (0.3%) 0/317 (0%)
    Laboratory test abnormal0/318 (0%) 1/317 (0.3%)
    Blood creatinine increased0/318 (0%) 1/317 (0.3%)
    Viral test positive1/318 (0.3%) 0/317 (0%)
    Liver function test abnormal1/318 (0.3%) 0/317 (0%)
    Escherichia test positive1/318 (0.3%) 0/317 (0%)
    Haemoglobin decreased0/318 (0%) 1/317 (0.3%)
    Clostridium test positive1/318 (0.3%) 0/317 (0%)
    Hepatic enzyme increased0/318 (0%) 1/317 (0.3%)
    Metabolism and nutrition disorders
    Dehydration2/318 (0.6%) 1/317 (0.3%)
    Hyponatraemia0/318 (0%) 1/317 (0.3%)
    Failure to thrive1/318 (0.3%) 0/317 (0%)
    Hypoglycaemia0/318 (0%) 1/317 (0.3%)
    Hypocalcaemia0/318 (0%) 1/317 (0.3%)
    Hypokalaemia1/318 (0.3%) 2/317 (0.6%)
    Hypercalcaemia3/318 (0.9%) 2/317 (0.6%)
    Tumour lysis syndrome0/318 (0%) 1/317 (0.3%)
    Decreased appetite2/318 (0.6%) 1/317 (0.3%)
    Diabetes mellitus1/318 (0.3%) 0/317 (0%)
    Hyperglycaemia2/318 (0.6%) 1/317 (0.3%)
    Fluid retention1/318 (0.3%) 0/317 (0%)
    Musculoskeletal and connective tissue disorders
    Arthralgia1/318 (0.3%) 1/317 (0.3%)
    Bone pain1/318 (0.3%) 0/317 (0%)
    Musculoskeletal pain2/318 (0.6%) 0/317 (0%)
    Pathological fracture0/318 (0%) 1/317 (0.3%)
    Spinal column stenosis1/318 (0.3%) 0/317 (0%)
    Cervical spinal stenosis0/318 (0%) 1/317 (0.3%)
    Fistula discharge0/318 (0%) 1/317 (0.3%)
    Muscle mass1/318 (0.3%) 0/317 (0%)
    Muscular weakness2/318 (0.6%) 0/317 (0%)
    Musculoskeletal chest pain1/318 (0.3%) 0/317 (0%)
    Pain in extremity1/318 (0.3%) 0/317 (0%)
    Rhabdomyolysis0/318 (0%) 2/317 (0.6%)
    Back pain5/318 (1.6%) 5/317 (1.6%)
    Bone lesion1/318 (0.3%) 0/317 (0%)
    Osteonecrosis of jaw0/318 (0%) 3/317 (0.9%)
    Exostosis0/318 (0%) 1/317 (0.3%)
    Osteonecrosis1/318 (0.3%) 1/317 (0.3%)
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Adenocarcinoma of colon1/318 (0.3%) 1/317 (0.3%)
    Bladder transitional cell carcinoma1/318 (0.3%) 0/317 (0%)
    Breast cancer1/318 (0.3%) 0/317 (0%)
    Haemangioma of bone0/318 (0%) 1/317 (0.3%)
    Malignant melanoma in situ0/318 (0%) 1/317 (0.3%)
    Malignant neoplasm of unknown primary site0/318 (0%) 1/317 (0.3%)
    Squamous cell carcinoma1/318 (0.3%) 0/317 (0%)
    Lung neoplasm malignant2/318 (0.6%) 0/317 (0%)
    Malignant neoplasm progression5/318 (1.6%) 4/317 (1.3%)
    Myelodysplastic syndrome2/318 (0.6%) 3/317 (0.9%)
    Plasmacytoma2/318 (0.6%) 2/317 (0.6%)
    Prostatic adenoma1/318 (0.3%) 1/317 (0.3%)
    Tumour associated fever0/318 (0%) 1/317 (0.3%)
    Basal cell carcinoma4/318 (1.3%) 3/317 (0.9%)
    Endometrial cancer0/318 (0%) 1/317 (0.3%)
    Gastrointestinal neoplasm1/318 (0.3%) 0/317 (0%)
    Meningioma1/318 (0.3%) 0/317 (0%)
    Prostate cancer0/318 (0%) 1/317 (0.3%)
    Plasma cell myeloma5/318 (1.6%) 5/317 (1.6%)
    Erythroleukaemia1/318 (0.3%) 0/317 (0%)
    Haemangioma0/318 (0%) 1/317 (0.3%)
    Squamous cell carcinoma of skin6/318 (1.9%) 2/317 (0.6%)
    Tonsil cancer0/318 (0%) 1/317 (0.3%)
    Chronic lymphocytic leukaemia1/318 (0.3%) 0/317 (0%)
    Lung cancer metastatic0/318 (0%) 1/317 (0.3%)
    Malignant pleural effusion1/318 (0.3%) 0/317 (0%)
    Mesothelioma1/318 (0.3%) 0/317 (0%)
    Nervous system disorders
    Cerebrovascular accident1/318 (0.3%) 2/317 (0.6%)
    Hemiparesis0/318 (0%) 1/317 (0.3%)
    Hypoaesthesia1/318 (0.3%) 0/317 (0%)
    Syncope3/318 (0.9%) 1/317 (0.3%)
    Paraesthesia0/318 (0%) 1/317 (0.3%)
    Somnolence1/318 (0.3%) 0/317 (0%)
    Transient ischaemic attack1/318 (0.3%) 1/317 (0.3%)
    Cerebral ischaemia0/318 (0%) 1/317 (0.3%)
    Dementia1/318 (0.3%) 0/317 (0%)
    Dizziness2/318 (0.6%) 0/317 (0%)
    Presyncope1/318 (0.3%) 0/317 (0%)
    Status epilepticus0/318 (0%) 1/317 (0.3%)
    Optic neuritis1/318 (0.3%) 0/317 (0%)
    Encephalopathy0/318 (0%) 2/317 (0.6%)
    Paraparesis1/318 (0.3%) 1/317 (0.3%)
    Cerebral infarction1/318 (0.3%) 0/317 (0%)
    Convulsion1/318 (0.3%) 0/317 (0%)
    Neuropathy peripheral0/318 (0%) 1/317 (0.3%)
    Spinal cord disorder0/318 (0%) 1/317 (0.3%)
    Cerebral haemorrhage0/318 (0%) 1/317 (0.3%)
    Neurological symptom1/318 (0.3%) 0/317 (0%)
    Spinal cord compression1/318 (0.3%) 2/317 (0.6%)
    Psychiatric disorders
    Completed suicide1/318 (0.3%) 0/317 (0%)
    Depression1/318 (0.3%) 0/317 (0%)
    Mental status changes1/318 (0.3%) 0/317 (0%)
    Confusional state4/318 (1.3%) 1/317 (0.3%)
    Renal and urinary disorders
    Haemorrhage urinary tract1/318 (0.3%) 0/317 (0%)
    Nephrolithiasis0/318 (0%) 1/317 (0.3%)
    Urinary retention1/318 (0.3%) 3/317 (0.9%)
    Renal failure acute8/318 (2.5%) 6/317 (1.9%)
    Neurogenic bladder1/318 (0.3%) 0/317 (0%)
    Obstructive uropathy1/318 (0.3%) 0/317 (0%)
    Renal tubular acidosis1/318 (0.3%) 0/317 (0%)
    Prerenal failure1/318 (0.3%) 0/317 (0%)
    Renal failure4/318 (1.3%) 5/317 (1.6%)
    Renal impairment2/318 (0.6%) 0/317 (0%)
    Urinary tract obstruction0/318 (0%) 1/317 (0.3%)
    Reproductive system and breast disorders
    Benign prostatic hyperplasia0/318 (0%) 1/317 (0.3%)
    Respiratory, thoracic and mediastinal disorders
    Epistaxis1/318 (0.3%) 0/317 (0%)
    Pulmonary alveolar haemorrhage1/318 (0.3%) 0/317 (0%)
    Obliterative bronchiolitis1/318 (0.3%) 0/317 (0%)
    Cough1/318 (0.3%) 0/317 (0%)
    Dyspnoea4/318 (1.3%) 4/317 (1.3%)
    Haemoptysis0/318 (0%) 1/317 (0.3%)
    Organising pneumonia1/318 (0.3%) 0/317 (0%)
    Pleural effusion2/318 (0.6%) 1/317 (0.3%)
    Respiratory failure1/318 (0.3%) 1/317 (0.3%)
    Acute respiratory failure1/318 (0.3%) 0/317 (0%)
    Bronchial disorder0/318 (0%) 1/317 (0.3%)
    Chronic obstructive pulmonary disease3/318 (0.9%) 1/317 (0.3%)
    Lung disorder4/318 (1.3%) 1/317 (0.3%)
    Bronchial hyperreactivity1/318 (0.3%) 0/317 (0%)
    Pneumonitis1/318 (0.3%) 2/317 (0.6%)
    Pulmonary embolism10/318 (3.1%) 8/317 (2.5%)
    Hypoxia0/318 (0%) 1/317 (0.3%)
    Interstitial lung disease0/318 (0%) 2/317 (0.6%)
    Acute pulmonary oedema0/318 (0%) 1/317 (0.3%)
    Asthma1/318 (0.3%) 0/317 (0%)
    Skin and subcutaneous tissue disorders
    Pustular psoriasis1/318 (0.3%) 0/317 (0%)
    Skin haemorrhage1/318 (0.3%) 0/317 (0%)
    Rash maculo-papular1/318 (0.3%) 0/317 (0%)
    Skin ulcer0/318 (0%) 1/317 (0.3%)
    Surgical and medical procedures
    Skin neoplasm excision1/318 (0.3%) 0/317 (0%)
    Vascular disorders
    Aortic aneurysm rupture1/318 (0.3%) 0/317 (0%)
    Orthostatic hypotension0/318 (0%) 1/317 (0.3%)
    Thrombosis0/318 (0%) 1/317 (0.3%)
    Deep vein thrombosis5/318 (1.6%) 4/317 (1.3%)
    Subclavian vein thrombosis1/318 (0.3%) 0/317 (0%)
    Thrombophlebitis0/318 (0%) 2/317 (0.6%)
    Peripheral ischaemia1/318 (0.3%) 0/317 (0%)
    Thrombophlebitis superficial0/318 (0%) 1/317 (0.3%)
    Embolism0/318 (0%) 1/317 (0.3%)
    Hypotension1/318 (0.3%) 1/317 (0.3%)
    Peripheral artery thrombosis1/318 (0.3%) 0/317 (0%)
    Venous thrombosis0/318 (0%) 1/317 (0.3%)
    Pelvic venous thrombosis1/318 (0.3%) 0/317 (0%)
    Venous thrombosis limb1/318 (0.3%) 0/317 (0%)
    Other (Not Including Serious) Adverse Events
    Lenalidomide + Dexamethasone + ElotuzumabLenalidomide + Dexamethasone
    Affected / at Risk (%)# EventsAffected / at Risk (%)# Events
    Total313/318 (98.4%) 309/317 (97.5%)
    Blood and lymphatic system disorders
    Leukopenia24/318 (7.5%) 25/317 (7.9%)
    Neutropenia107/318 (33.6%) 135/317 (42.6%)
    Anaemia122/318 (38.4%) 116/317 (36.6%)
    Thrombocytopenia84/318 (26.4%) 72/317 (22.7%)
    Lymphopenia42/318 (13.2%) 22/317 (6.9%)
    Eye disorders
    Vision blurred27/318 (8.5%) 16/317 (5%)
    Cataract38/318 (11.9%) 20/317 (6.3%)
    Gastrointestinal disorders
    Abdominal pain38/318 (11.9%) 27/317 (8.5%)
    Constipation113/318 (35.5%) 85/317 (26.8%)
    Dyspepsia32/318 (10.1%) 19/317 (6%)
    Stomatitis27/318 (8.5%) 14/317 (4.4%)
    Vomiting46/318 (14.5%) 27/317 (8.5%)
    Nausea76/318 (23.9%) 68/317 (21.5%)
    Abdominal pain upper22/318 (6.9%) 17/317 (5.4%)
    Diarrhoea148/318 (46.5%) 111/317 (35%)
    General disorders
    Oedema peripheral82/318 (25.8%) 70/317 (22.1%)
    Chest pain25/318 (7.9%) 11/317 (3.5%)
    Influenza like illness19/318 (6%) 15/317 (4.7%)
    Pyrexia111/318 (34.9%) 70/317 (22.1%)
    Asthenia69/318 (21.7%) 53/317 (16.7%)
    Chills24/318 (7.5%) 12/317 (3.8%)
    Fatigue149/318 (46.9%) 123/317 (38.8%)
    Malaise17/318 (5.3%) 11/317 (3.5%)
    Infections and infestations
    Bronchitis50/318 (15.7%) 47/317 (14.8%)
    Nasopharyngitis78/318 (24.5%) 61/317 (19.2%)
    Urinary tract infection25/318 (7.9%) 30/317 (9.5%)
    Rhinitis23/318 (7.2%) 12/317 (3.8%)
    Herpes zoster16/318 (5%) 7/317 (2.2%)
    Lower respiratory tract infection24/318 (7.5%) 15/317 (4.7%)
    Pharyngitis16/318 (5%) 11/317 (3.5%)
    Pneumonia19/318 (6%) 14/317 (4.4%)
    Sinusitis19/318 (6%) 14/317 (4.4%)
    Influenza18/318 (5.7%) 17/317 (5.4%)
    Respiratory tract infection27/318 (8.5%) 28/317 (8.8%)
    Upper respiratory tract infection72/318 (22.6%) 55/317 (17.4%)
    Oral herpes17/318 (5.3%) 13/317 (4.1%)
    Injury, poisoning and procedural complications
    Contusion36/318 (11.3%) 26/317 (8.2%)
    Investigations
    Blood creatinine increased30/318 (9.4%) 21/317 (6.6%)
    Aspartate aminotransferase increased20/318 (6.3%) 28/317 (8.8%)
    Weight decreased44/318 (13.8%) 19/317 (6%)
    Alanine aminotransferase increased24/318 (7.5%) 32/317 (10.1%)
    Metabolism and nutrition disorders
    Hyponatraemia19/318 (6%) 11/317 (3.5%)
    Hypomagnesaemia16/318 (5%) 6/317 (1.9%)
    Hypocalcaemia43/318 (13.5%) 31/317 (9.8%)
    Hypokalaemia53/318 (16.7%) 46/317 (14.5%)
    Decreased appetite66/318 (20.8%) 39/317 (12.3%)
    Hyperglycaemia55/318 (17.3%) 43/317 (13.6%)
    Musculoskeletal and connective tissue disorders
    Arthralgia52/318 (16.4%) 39/317 (12.3%)
    Bone pain32/318 (10.1%) 40/317 (12.6%)
    Musculoskeletal pain40/318 (12.6%) 28/317 (8.8%)
    Myalgia22/318 (6.9%) 23/317 (7.3%)
    Muscle spasms95/318 (29.9%) 84/317 (26.5%)
    Neck pain16/318 (5%) 11/317 (3.5%)
    Muscular weakness35/318 (11%) 25/317 (7.9%)
    Musculoskeletal chest pain31/318 (9.7%) 26/317 (8.2%)
    Pain in extremity52/318 (16.4%) 32/317 (10.1%)
    Back pain88/318 (27.7%) 87/317 (27.4%)
    Nervous system disorders
    Hypoaesthesia21/318 (6.6%) 11/317 (3.5%)
    Headache49/318 (15.4%) 24/317 (7.6%)
    Paraesthesia32/318 (10.1%) 28/317 (8.8%)
    Peripheral sensory neuropathy29/318 (9.1%) 35/317 (11%)
    Dizziness43/318 (13.5%) 37/317 (11.7%)
    Tremor29/318 (9.1%) 29/317 (9.1%)
    Dysgeusia32/318 (10.1%) 20/317 (6.3%)
    Neuropathy peripheral45/318 (14.2%) 26/317 (8.2%)
    Psychiatric disorders
    Mood altered22/318 (6.9%) 8/317 (2.5%)
    Depression16/318 (5%) 14/317 (4.4%)
    Insomnia73/318 (23%) 82/317 (25.9%)
    Anxiety23/318 (7.2%) 21/317 (6.6%)
    Confusional state17/318 (5.3%) 10/317 (3.2%)
    Respiratory, thoracic and mediastinal disorders
    Dyspnoea exertional18/318 (5.7%) 13/317 (4.1%)
    Epistaxis18/318 (5.7%) 19/317 (6%)
    Oropharyngeal pain32/318 (10.1%) 14/317 (4.4%)
    Cough100/318 (31.4%) 57/317 (18%)
    Dyspnoea66/318 (20.8%) 58/317 (18.3%)
    Productive cough19/318 (6%) 4/317 (1.3%)
    Dysphonia24/318 (7.5%) 30/317 (9.5%)
    Skin and subcutaneous tissue disorders
    Pruritus32/318 (10.1%) 28/317 (8.8%)
    Rash58/318 (18.2%) 58/317 (18.3%)
    Hyperhidrosis37/318 (11.6%) 22/317 (6.9%)
    Erythema22/318 (6.9%) 17/317 (5.4%)
    Night sweats22/318 (6.9%) 9/317 (2.8%)
    Vascular disorders
    Hypertension29/318 (9.1%) 19/317 (6%)
    Deep vein thrombosis19/318 (6%) 9/317 (2.8%)
    Hypotension29/318 (9.1%) 11/317 (3.5%)
    Flushing16/318 (5%) 6/317 (1.9%)

    Limitations/Caveats

    [Not Specified]

    More Information

    Certain Agreements

    Principal Investigators are NOT employed by the organization sponsoring the study.

    Bristol-Myers Squibb Co. agreements with investigators vary; constant is our right to embargo communications regarding trial results prior to public release for a period ≤60 days from submittal for review. We will not prohibit investigators from publishing, but will prohibit the disclosure of previously undisclosed confidential information other than study results, and request postponement of single-center publications until after disclosure of the clinical trial's primary publication.

    Results Point of Contact

    Name/TitleBristol-Myers Squibb Study Director
    OrganizationBristol-Myers Squibb
    Phone
    EmailClinical.Trials@bms.com
    Responsible Party:
    Bristol-Myers Squibb
    ClinicalTrials.gov Identifier:
    NCT01239797
    Other Study ID Numbers:
    • CA204-004
    • 2010-020347-12
    First Posted:
    Nov 11, 2010
    Last Update Posted:
    Oct 20, 2021
    Last Verified:
    Sep 1, 2021