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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT01239797




Registration number
NCT01239797
Ethics application status
Date submitted
8/11/2010
Date registered
11/11/2010
Date last updated
1/06/2022

Titles & IDs
Public title
Phase III Study of Lenalidomide and Dexamethasone With or Without Elotuzumab to Treat Relapsed or Refractory Multiple Myeloma
Scientific title
Phase 3, Randomized, Open Label Trial of Lenalidomide/Dexamethasone With or Without Elotuzumab in Relapsed or Refractory Multiple Myeloma (MM)
Secondary ID [1] 0 0
2010-020347-12
Secondary ID [2] 0 0
CA204-004
Universal Trial Number (UTN)
Trial acronym
ELOQUENT - 2
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Lymphoma 0 0
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 (Oral)
Treatment: Drugs - Dexamethasone (IV)
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 (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

Treatment: Drugs: 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

Treatment: Other: 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
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
Median Progression Free Survival (PFS)
Timepoint [1] 0 0
From randomization up to 326 events (up to approximately 38 months)
Primary outcome [2] 0 0
Objective Response Rate (ORR)
Timepoint [2] 0 0
From randomization up to approximately 38 months
Secondary outcome [1] 0 0
Median Overall Survival (OS)
Timepoint [1] 0 0
Randomization to the date of death from any cause (up to approximately 9 years)
Secondary outcome [2] 0 0
Change From Baseline of Mean Score Pain Severity (BPI-SF)
Timepoint [2] 0 0
From baseline up to approximately 38 months
Secondary outcome [3] 0 0
Change From Baseline of Mean Score Pain Interference (BPI-SF)
Timepoint [3] 0 0
From baseline up to approximately 38 months

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



* 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
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 serum free light-chain only myeloma
* 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
20/06/2011
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
21/04/2021
Sample size
Target
Accrual to date
Final
646
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC,WA
Recruitment hospital [1] 0 0
Local Institution - Albury
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Local Institution - Canberra
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Local Institution - South Brisbane
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Local Institution - Adelaide
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Local Institution - Malvern
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Local Institution - Melbourne
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Local Institution - Nedlands
Recruitment hospital [8] 0 0
Local Institution - Murdoch
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2640 - Albury
Recruitment postcode(s) [2] 0 0
2605 - Canberra
Recruitment postcode(s) [3] 0 0
4101 - South Brisbane
Recruitment postcode(s) [4] 0 0
5000 - Adelaide
Recruitment postcode(s) [5] 0 0
3144 - Malvern
Recruitment postcode(s) [6] 0 0
3004 - Melbourne
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6009 - Nedlands
Recruitment postcode(s) [8] 0 0
6150 - Murdoch
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Izmir
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United Arab Emirates
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Leicester
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Leeds
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London
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Newcastle Upon Tyne

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
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).
Trial website
https://clinicaltrials.gov/study/NCT01239797
Trial related presentations / publications
Dimopoulos MA, Lonial S, Betts KA, Chen C, Zichlin ML, Brun A, Signorovitch JE, Makenbaeva D, Mekan S, Sy O, Weisel K, Richardson PG. Elotuzumab plus lenalidomide and dexamethasone in relapsed/refractory multiple myeloma: Extended 4-year follow-up and analysis of relative progression-free survival from the randomized ELOQUENT-2 trial. Cancer. 2018 Oct 15;124(20):4032-4043. doi: 10.1002/cncr.31680. Epub 2018 Sep 11.
Passey C, Mora J, Dodge R, Gibiansky L, Sheng J, Roy A, Bello A, Gupta M. An Integrated Assessment of the Effects of Immunogenicity on the Pharmacokinetics, Safety, and Efficacy of Elotuzumab. AAPS J. 2017 Mar;19(2):557-567. doi: 10.1208/s12248-016-0033-9. Epub 2017 Jan 9.
Lonial S, Dimopoulos M, Palumbo A, White D, Grosicki S, Spicka I, Walter-Croneck A, Moreau P, Mateos MV, Magen H, Belch A, Reece D, Beksac M, Spencer A, Oakervee H, Orlowski RZ, Taniwaki M, Rollig C, Einsele H, Wu KL, Singhal A, San-Miguel J, Matsumoto M, Katz J, Bleickardt E, Poulart V, Anderson KC, Richardson P; ELOQUENT-2 Investigators. Elotuzumab Therapy for Relapsed or Refractory Multiple Myeloma. N Engl J Med. 2015 Aug 13;373(7):621-31. doi: 10.1056/NEJMoa1505654. Epub 2015 Jun 2.
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



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT01239797