Trial Review

Please note the ANZCTR will be unattended from Friday 20 December 2024 for the holidays. The Registry will re-open on Tuesday 7 January 2025. Submissions and updates will not be processed during that time.

Registering a new trial?

To achieve prospective registration, we recommend submitting your trial for registration at the same time as ethics submission.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT01335399




Registration number
NCT01335399
Ethics application status
Date submitted
13/04/2011
Date registered
14/04/2011
Date last updated
30/09/2022

Titles & IDs
Public title
Phase III Study of Lenalidomide and Dexamethasone With or Without Elotuzumab to Treat Newly Diagnosed, Previously Untreated Multiple Myeloma
Scientific title
A Phase 3, Randomized, Open Label Trial of Lenalidomide/Dexamethasone With or Without Elotuzumab in Subjects With Previously Untreated Multiple Myeloma
Secondary ID [1] 0 0
2010-022445-20
Secondary ID [2] 0 0
CA204-006
Universal Trial Number (UTN)
Trial acronym
ELOQUENT - 1
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Multiple Myeloma 0 0
Condition category
Condition code
Cancer 0 0 0 0
Other cancer types

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Lenalidomide
Treatment: Drugs - Dexamethasone
Treatment: Drugs - Dexamethasone
Treatment: Drugs - Dexamethasone
Treatment: Drugs - Dexamethasone
Treatment: Other - Elotuzumab (BMS-901608; HuLuc63)
Treatment: Other - Elotuzumab (BMS-901608; HuLuc63)

Active comparator: Lenalidomide + Dexamethasone -

Experimental: Lenalidomide + Dexamethasone + Elotuzumab -


Treatment: Drugs: Lenalidomide
Capsules, Oral, 25 mg, once daily, on Days 1-21, Repeat every 28 days until subject meets criteria for discontinuation of study drug

Treatment: Drugs: 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

Treatment: Drugs: Dexamethasone
Tablets, Oral, 28 mg, once daily, on Days 1, 8, 15, 22 (cycles 1\&2) ; Days 1 \&15 (cycles 3-18); Day 1 (cycle 19 and beyond), Repeat every 28 days until subject meets criteria for discontinuation of study drug

Treatment: Drugs: Dexamethasone
Tablets, Oral, 40 mg, once daily, on Days 8 \& 22 (cycles 3-18); Days 8, 15, 22 (cycle 19 and beyond), Repeat every 28 days until subject meets criteria for discontinuation of study drug

Treatment: Drugs: Dexamethasone
Solution, Intravenous (IV), 8 mg, Once daily, on Days 1, 8, 15, 22 (cycles 1\&2) ; Days 1 \&15 (cycles 3-18); Day 1 (cycle 19 and beyond), Repeat every 28 days until subject meets criteria for discontinuation of study drug

Treatment: Other: Elotuzumab (BMS-901608; HuLuc63)
Solution, Intravenous (IV), 10 mg/kg, weekly, on Days 1, 8, 15, 22 (cycles 1\&2); Days 1 and 15 (cycles 3-18), Repeat every 28 days until subject meets criteria for discontinuation of study drug

Treatment: Other: Elotuzumab (BMS-901608; HuLuc63)
Solution, Intravenous (IV), 20 mg/kg, Day 1 (cycle 19 and beyond), Repeat every 28 days until subject meets criteria for discontinuation of study drug
Intervention code [1] 0 0
Treatment: Drugs
Intervention code [2] 0 0
Treatment: Other
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Progression-Free Survival (PFS)
Timepoint [1] 0 0
From randomization to date of first documented tumor progression or death due to any cause (up to 8 years)
Secondary outcome [1] 0 0
Objective Response Rate (ORR)
Timepoint [1] 0 0
From randomization to primary completion date (approximately 8 years)
Secondary outcome [2] 0 0
Overall Survival (OS)
Timepoint [2] 0 0
From randomization to the date of death (up to 8 years)
Secondary outcome [3] 0 0
Mean Change From Baseline of Pain Severity Score and Pain Interference Score
Timepoint [3] 0 0
From Baseline to End of Treatment (approximately 8 years)
Secondary outcome [4] 0 0
Progression Free Survival (PFS) Rate at Specific Time-points
Timepoint [4] 0 0
From randomization to the specified time-point (up to 5 years)

Eligibility
Key inclusion criteria
For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com.



* Subjects who are newly diagnosed with symptomatic Multiple Myeloma (MM) and who:

* have not received any prior systemic anti-myeloma therapy AND
* 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 CA204006 for a subject < 65 years old. There must be a comorbidity that prevents SCT for a subject < 65 years old
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
4/08/2011
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
3/09/2021
Sample size
Target
Accrual to date
Final
748
Recruitment in Australia
Recruitment state(s)
ACT,NSW,QLD,SA,VIC
Recruitment hospital [1] 0 0
Local Institution - 3600 - Garran
Recruitment hospital [2] 0 0
Local Institution - 3607 - Waratah
Recruitment hospital [3] 0 0
Local Institution - 3610 - Westmead
Recruitment hospital [4] 0 0
Local Institution - 3609 - Herston
Recruitment hospital [5] 0 0
Local Institution - 3608 - Milton
Recruitment hospital [6] 0 0
Local Institution - 3612 - Adelaide
Recruitment hospital [7] 0 0
Local Institution - 3606 - Woodville South
Recruitment hospital [8] 0 0
Local Institution - 3601 - Fitzroy
Recruitment hospital [9] 0 0
Local Institution - 3602 - Frankston
Recruitment hospital [10] 0 0
Local Institution - 3603 - Heidelberg Melbourne
Recruitment hospital [11] 0 0
Local Institution - 3604 - Wodonga
Recruitment hospital [12] 0 0
Local Institution - 3605 - Murdoch
Recruitment hospital [13] 0 0
Local Institution - 3611 - Nedlands
Recruitment postcode(s) [1] 0 0
2605 - Garran
Recruitment postcode(s) [2] 0 0
2298 - Waratah
Recruitment postcode(s) [3] 0 0
2145 - Westmead
Recruitment postcode(s) [4] 0 0
4029 - Herston
Recruitment postcode(s) [5] 0 0
4064 - Milton
Recruitment postcode(s) [6] 0 0
5000 - Adelaide
Recruitment postcode(s) [7] 0 0
5001 - Woodville South
Recruitment postcode(s) [8] 0 0
3065 - Fitzroy
Recruitment postcode(s) [9] 0 0
3199 - Frankston
Recruitment postcode(s) [10] 0 0
3084 - Heidelberg Melbourne
Recruitment postcode(s) [11] 0 0
3690 - Wodonga
Recruitment postcode(s) [12] 0 0
6150 - Murdoch
Recruitment postcode(s) [13] 0 0
6009 - Nedlands
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Alabama
Country [2] 0 0
United States of America
State/province [2] 0 0
Arizona
Country [3] 0 0
United States of America
State/province [3] 0 0
California
Country [4] 0 0
United States of America
State/province [4] 0 0
Connecticut
Country [5] 0 0
United States of America
State/province [5] 0 0
District of Columbia
Country [6] 0 0
United States of America
State/province [6] 0 0
Florida
Country [7] 0 0
United States of America
State/province [7] 0 0
Georgia
Country [8] 0 0
United States of America
State/province [8] 0 0
Hawaii
Country [9] 0 0
United States of America
State/province [9] 0 0
Illinois
Country [10] 0 0
United States of America
State/province [10] 0 0
Indiana
Country [11] 0 0
United States of America
State/province [11] 0 0
Iowa
Country [12] 0 0
United States of America
State/province [12] 0 0
Kentucky
Country [13] 0 0
United States of America
State/province [13] 0 0
Louisiana
Country [14] 0 0
United States of America
State/province [14] 0 0
Maryland
Country [15] 0 0
United States of America
State/province [15] 0 0
Massachusetts
Country [16] 0 0
United States of America
State/province [16] 0 0
Michigan
Country [17] 0 0
United States of America
State/province [17] 0 0
Missouri
Country [18] 0 0
United States of America
State/province [18] 0 0
Nebraska
Country [19] 0 0
United States of America
State/province [19] 0 0
New York
Country [20] 0 0
United States of America
State/province [20] 0 0
North Carolina
Country [21] 0 0
United States of America
State/province [21] 0 0
Ohio
Country [22] 0 0
United States of America
State/province [22] 0 0
Oklahoma
Country [23] 0 0
United States of America
State/province [23] 0 0
Pennsylvania
Country [24] 0 0
United States of America
State/province [24] 0 0
South Carolina
Country [25] 0 0
United States of America
State/province [25] 0 0
South Dakota
Country [26] 0 0
United States of America
State/province [26] 0 0
Tennessee
Country [27] 0 0
United States of America
State/province [27] 0 0
Texas
Country [28] 0 0
United States of America
State/province [28] 0 0
Utah
Country [29] 0 0
United States of America
State/province [29] 0 0
Virginia
Country [30] 0 0
United States of America
State/province [30] 0 0
Washington
Country [31] 0 0
United States of America
State/province [31] 0 0
West Virginia
Country [32] 0 0
United States of America
State/province [32] 0 0
Wisconsin
Country [33] 0 0
Austria
State/province [33] 0 0
Fadingerstraße 1
Country [34] 0 0
Austria
State/province [34] 0 0
Innsbruck
Country [35] 0 0
Austria
State/province [35] 0 0
Rankweil
Country [36] 0 0
Austria
State/province [36] 0 0
Wels
Country [37] 0 0
Belgium
State/province [37] 0 0
Brussels
Country [38] 0 0
Belgium
State/province [38] 0 0
Brussles
Country [39] 0 0
Belgium
State/province [39] 0 0
Charleroi
Country [40] 0 0
Belgium
State/province [40] 0 0
Haine St Paul
Country [41] 0 0
Belgium
State/province [41] 0 0
Leuven
Country [42] 0 0
Belgium
State/province [42] 0 0
Liege
Country [43] 0 0
Belgium
State/province [43] 0 0
Roeselare
Country [44] 0 0
Belgium
State/province [44] 0 0
Yvoir
Country [45] 0 0
Canada
State/province [45] 0 0
Alberta
Country [46] 0 0
Canada
State/province [46] 0 0
Manitoba
Country [47] 0 0
Canada
State/province [47] 0 0
New Brunswick
Country [48] 0 0
Canada
State/province [48] 0 0
Nova Scotia
Country [49] 0 0
Canada
State/province [49] 0 0
Ontario
Country [50] 0 0
Canada
State/province [50] 0 0
Quebec
Country [51] 0 0
Czechia
State/province [51] 0 0
Hradec Kralove
Country [52] 0 0
Czechia
State/province [52] 0 0
Praha 10
Country [53] 0 0
Czechia
State/province [53] 0 0
Praha 2
Country [54] 0 0
Germany
State/province [54] 0 0
Aschaffenburg
Country [55] 0 0
Germany
State/province [55] 0 0
Berlin
Country [56] 0 0
Germany
State/province [56] 0 0
Chemnitz
Country [57] 0 0
Germany
State/province [57] 0 0
Dresden
Country [58] 0 0
Germany
State/province [58] 0 0
Hamm
Country [59] 0 0
Germany
State/province [59] 0 0
Heidelberg
Country [60] 0 0
Germany
State/province [60] 0 0
Jena
Country [61] 0 0
Germany
State/province [61] 0 0
Koln
Country [62] 0 0
Germany
State/province [62] 0 0
Mainz
Country [63] 0 0
Germany
State/province [63] 0 0
Munchen
Country [64] 0 0
Germany
State/province [64] 0 0
Munster
Country [65] 0 0
Germany
State/province [65] 0 0
Offenbach
Country [66] 0 0
Germany
State/province [66] 0 0
Stuttgart
Country [67] 0 0
Germany
State/province [67] 0 0
Tuebingen
Country [68] 0 0
Germany
State/province [68] 0 0
Ulm
Country [69] 0 0
Greece
State/province [69] 0 0
Athens
Country [70] 0 0
Greece
State/province [70] 0 0
Ioannina
Country [71] 0 0
Greece
State/province [71] 0 0
Larissa
Country [72] 0 0
Greece
State/province [72] 0 0
Patras
Country [73] 0 0
Hungary
State/province [73] 0 0
Budapest
Country [74] 0 0
Hungary
State/province [74] 0 0
Debrecen
Country [75] 0 0
Hungary
State/province [75] 0 0
Gyor
Country [76] 0 0
Hungary
State/province [76] 0 0
Szeged
Country [77] 0 0
Ireland
State/province [77] 0 0
Dublin
Country [78] 0 0
Ireland
State/province [78] 0 0
Galway
Country [79] 0 0
Israel
State/province [79] 0 0
Afula
Country [80] 0 0
Israel
State/province [80] 0 0
Ashkelon
Country [81] 0 0
Israel
State/province [81] 0 0
Haifa
Country [82] 0 0
Israel
State/province [82] 0 0
Jerusalem
Country [83] 0 0
Israel
State/province [83] 0 0
Kfar Saba
Country [84] 0 0
Israel
State/province [84] 0 0
Nahariya
Country [85] 0 0
Israel
State/province [85] 0 0
Petah Tikva
Country [86] 0 0
Israel
State/province [86] 0 0
Tel Aviv
Country [87] 0 0
Israel
State/province [87] 0 0
Zerifin
Country [88] 0 0
Italy
State/province [88] 0 0
Ancona
Country [89] 0 0
Italy
State/province [89] 0 0
Bari
Country [90] 0 0
Italy
State/province [90] 0 0
Bergamo
Country [91] 0 0
Italy
State/province [91] 0 0
Bologna
Country [92] 0 0
Italy
State/province [92] 0 0
Firenze
Country [93] 0 0
Italy
State/province [93] 0 0
Genova
Country [94] 0 0
Italy
State/province [94] 0 0
Meldola
Country [95] 0 0
Italy
State/province [95] 0 0
Milano
Country [96] 0 0
Italy
State/province [96] 0 0
Milan
Country [97] 0 0
Italy
State/province [97] 0 0
Monza
Country [98] 0 0
Italy
State/province [98] 0 0
Napoli
Country [99] 0 0
Italy
State/province [99] 0 0
Palermo
Country [100] 0 0
Italy
State/province [100] 0 0
Ravenna
Country [101] 0 0
Italy
State/province [101] 0 0
Reggio Nell Emilia (RE)
Country [102] 0 0
Italy
State/province [102] 0 0
Rimini
Country [103] 0 0
Italy
State/province [103] 0 0
Roma
Country [104] 0 0
Italy
State/province [104] 0 0
Rome
Country [105] 0 0
Italy
State/province [105] 0 0
Terni
Country [106] 0 0
Italy
State/province [106] 0 0
Torino
Country [107] 0 0
Poland
State/province [107] 0 0
Bialystok
Country [108] 0 0
Poland
State/province [108] 0 0
Chorzow
Country [109] 0 0
Poland
State/province [109] 0 0
Gdansk
Country [110] 0 0
Poland
State/province [110] 0 0
Krakow
Country [111] 0 0
Poland
State/province [111] 0 0
Lodz
Country [112] 0 0
Poland
State/province [112] 0 0
Lublin
Country [113] 0 0
Poland
State/province [113] 0 0
Poznan
Country [114] 0 0
Poland
State/province [114] 0 0
Szczecin
Country [115] 0 0
Poland
State/province [115] 0 0
Warszawa
Country [116] 0 0
Poland
State/province [116] 0 0
Wroclaw
Country [117] 0 0
Puerto Rico
State/province [117] 0 0
Ponce
Country [118] 0 0
Puerto Rico
State/province [118] 0 0
San Juan
Country [119] 0 0
Romania
State/province [119] 0 0
Brasov
Country [120] 0 0
Romania
State/province [120] 0 0
Bucaresti
Country [121] 0 0
Romania
State/province [121] 0 0
Bucuresti
Country [122] 0 0
Romania
State/province [122] 0 0
Lasi
Country [123] 0 0
Russian Federation
State/province [123] 0 0
Samara
Country [124] 0 0
Russian Federation
State/province [124] 0 0
St. Petersburg
Country [125] 0 0
Spain
State/province [125] 0 0
Badalona-barcelona
Country [126] 0 0
Spain
State/province [126] 0 0
Barcelona
Country [127] 0 0
Spain
State/province [127] 0 0
La Laguna- Tenerife
Country [128] 0 0
Spain
State/province [128] 0 0
Madrid
Country [129] 0 0
Spain
State/province [129] 0 0
Pamplona
Country [130] 0 0
Spain
State/province [130] 0 0
Salamanca
Country [131] 0 0
Spain
State/province [131] 0 0
San Sebastian
Country [132] 0 0
Spain
State/province [132] 0 0
Toledo
Country [133] 0 0
Switzerland
State/province [133] 0 0
Bern
Country [134] 0 0
Switzerland
State/province [134] 0 0
St Gallen
Country [135] 0 0
Switzerland
State/province [135] 0 0
Zurich
Country [136] 0 0
Turkey
State/province [136] 0 0
Bornova
Country [137] 0 0
Turkey
State/province [137] 0 0
Dikimevi
Country [138] 0 0
Turkey
State/province [138] 0 0
Inciralti
Country [139] 0 0
Turkey
State/province [139] 0 0
Gaziantep
Country [140] 0 0
United Kingdom
State/province [140] 0 0
Antrim
Country [141] 0 0
United Kingdom
State/province [141] 0 0
Greater London
Country [142] 0 0
United Kingdom
State/province [142] 0 0
London

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Bristol-Myers Squibb
Address
Country
Other collaborator category [1] 0 0
Commercial sector/industry
Name [1] 0 0
AbbVie
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Bristol-Myers Squibb
Address 0 0
Bristol-Myers Squibb
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

No information has been provided regarding IPD availability


What supporting documents are/will be available?




Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results are available at https://clinicaltrials.gov/study/NCT01335399