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

Multiple Myeloma Clinical Trial

— ELOQUENT - 2  

Official title:

Phase 3, Randomized, Open Label Trial of Lenalidomide/Dexamethasone With or Without Elotuzumab in Relapsed or Refractory Multiple Myeloma (MM)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01239797
• Other study ID #: CA204-004
• Secondary ID: 2010-020347-12
• Status: Completed
• Phase: Phase 3
• Start date: June 20, 2011
• Est. completion date: April 21, 2021

Study information

• Verified date: May 2022
• Source: Bristol-Myers Squibb
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 646
• Est. completion date: April 21, 2021
• Est. primary completion date: September 2, 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Lymphoma
• Multiple Myeloma
• Neoplasms, Plasma Cell

Intervention

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
• 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
• 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
• 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

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

Locations

Country	Name	City	State
Australia	Local Institution	Adelaide	South Australia
Australia	Local Institution	Albury	New South Wales
Australia	Local Institution	Canberra	New South Wales
Australia	Local Institution	Malvern	Victoria
Australia	Local Institution	Melbourne	Victoria
Australia	Local Institution	Murdoch
Australia	Local Institution	Nedlands	Western Australia
Australia	Local Institution	South Brisbane	Queensland
Austria	Local Institution	Rankweil
Austria	Local Institution	Steyr
Austria	Local Institution	Wels
Austria	Local Institution	Wien
Belgium	Local Institution	Antwerpen
Belgium	Local Institution	Brussels
Belgium	Local Institution	Brussels
Belgium	Local Institution	Brussels
Belgium	Local Institution	Brussles
Belgium	Local Institution	Edegem-antwerp
Belgium	Local Institution	Liege
Belgium	Local Institution	Yvoir
Canada	Local Institution	Barrie
Canada	Local Institution	Calgary	Alberta
Canada	Local Institution	Edmonton	Alberta
Canada	Local Institution	Halifax	Nova Scotia
Canada	Local Institution	London	Ontario
Canada	Local Institution	Montreal
Canada	Local Institution	Montreal	Quebec
Canada	Local Institution	Saskatoon	Saskatchewan
Canada	Local Institution	Toronto	Ontario
Czechia	Local Institution	Brno
Czechia	Local Institution	Hradec Kralove
Czechia	Local Institution	Praha 10
Czechia	Local Institution	Praha 2
Denmark	Local Institution	Copenhagen
Denmark	Local Institution	Odense C
Denmark	Local Institution	Vejle
France	Local Institution	Blois
France	Local Institution	Bordeaux
France	Local Institution	Caen
France	Local Institution	Clamart Cedex
France	Local Institution	La Roche Sur Yon
France	Local Institution	La Tronche
France	Local Institution	Lille
France	Local Institution	Limoges
France	Local Institution	Nantes
France	Local Institution	Paris 12
France	Local Institution	Pierre Benita
France	Local Institution	Toulouse
France	Local Institution	Tours Cedex
France	Local Institution	Vandoeuvre
Germany	Local Institution	Aschaffenburg
Germany	Local Institution	Berlin
Germany	Local Institution	Berlin
Germany	Local Institution	Chemnitz
Germany	Local Institution	Dresden
Germany	Local Institution	Hamburg
Germany	Local Institution	Hamburg
Germany	Local Institution	Hamburg
Germany	Local Institution	Hamm
Germany	Local Institution	Heidelberg
Germany	Local Institution	Jena
Germany	Local Institution	Kiel
Germany	Local Institution	Koln
Germany	Local Institution	Marburg
Germany	Local Institution	Munchen
Germany	Local Institution	Munchen
Germany	Local Institution	Munster
Germany	Local Institution	Ravensburg
Germany	Local Institution	Tuebingen
Germany	Local Institution	Ulm
Germany	Local Institution	Wurzburg
Greece	Local Institution	Athens
Greece	Local Institution	Ioannina
Greece	Local Institution	Larissa
Hungary	Local Institution	Budapest
Hungary	Local Institution	Debrecen
Hungary	Local Institution	Gyor
Hungary	Local Institution	Szeged
Ireland	Local Institution	Dublin
Ireland	Local Institution	Tullamore
Israel	Local Institution	Afula
Israel	Local Institution	Jerusalem
Israel	Local Institution	Petah Tikva
Israel	Local Institution	Rehovot
Israel	Local Institution	Zerifin
Italy	Local Institution	Ancona
Italy	Local Institution	Bergamo
Italy	Local Institution	Bologna
Italy	Local Institution	Firenze
Italy	Local Institution	Genova
Italy	Local Institution	Meldola
Italy	Local Institution	Milano
Italy	Local Institution	Palermo
Italy	Local Institution	Ravenna
Italy	Local Institution	Rimini
Italy	Local Institution	Roma
Italy	Local Institution	Roma
Italy	Local Institution	Torino
Japan	Local Institution	Bunkyo-Ku	Tokyo
Japan	Local Institution	Chiba-shi
Japan	Local Institution	Fukuoka
Japan	Local Institution	Kamogawa	Toyko
Japan	Local Institution	Koto-ku	Tokyo
Japan	Local Institution	Kyoto
Japan	Local Institution	Maebashi-shi	Gunma
Japan	Local Institution	Nagoya-shi	Aichi
Japan	Local Institution	Nagoya-shi	Aichi
Japan	Local Institution	Niigata
Japan	Local Institution	Okayama
Japan	Local Institution	Osaka-shi	Osaka
Japan	Local Institution	Sapporo-city	Hokkaido
Japan	Local Institution	Sendai-shi	Miyagi
Japan	Local Institution	Shibukawa-shi	Gunma
Japan	Local Institution	Shibuya-ku	Tokyo
Japan	Local Institution	Shinjuuku-ku	Tokyo
Japan	Local Institution	Toyohashi-shi
Poland	Local Institution	Bialystok
Poland	Local Institution	Chorzow
Poland	Local Institution	Lublin
Poland	Local Institution	Poznan
Poland	Local Institution	Warszawa
Poland	Local Institution	Warszawa
Poland	Local Institution	Warszawa
Poland	Local Institution	Wroclaw
Puerto Rico	Local Institution	Ponce
Puerto Rico	Local Institution	San Juan
Romania	Local Institution	Brasov
Romania	Local Institution	Brasov
Romania	Local Institution	Bucaresti
Romania	Local Institution	Bucuresti
Spain	Local Institution	Badalona-Barcelona
Spain	Local Institution	Madrid
Spain	Local Institution	Madrid
Spain	Local Institution	Murcia
Spain	Local Institution	Salamanca
Spain	Local Institution	Santiago De Comp-coruna
Spain	Local Institution	Toledo
Switzerland	Local Institution	Bern
Switzerland	Local Institution	Geneve 14
Turkey	Local Institution	Ankara
Turkey	Local Institution	Istanbul	Capa
Turkey	Local Institution	Izmir
Turkey	Local Institution	Izmir	Bornova
United Arab Emirates	Local Institution	Leicester
United Kingdom	Local Institution	Airdrie	Lancashire
United Kingdom	Local Institution	Edinburgh	Midlothian
United Kingdom	Local Institution	Leeds
United Kingdom	Local Institution	London
United Kingdom	Local Institution	London	Greater London
United Kingdom	Local Institution	Manchester	Greater Manchester
United Kingdom	Local Institution	Newcastle Upon Tyne
United Kingdom	Local Institution	Nottingham	Nottinghamshire
United Kingdom	Local Institution	Sutton	Surrey
United States	Winship Cancer Institute.	Atlanta	Georgia
United States	Georgia Health Science University	Augusta	Georgia
United States	Local Institution	Berkeley	California
United States	Local Institution	Bethlehem	Pennsylvania
United States	Local Institution	Bismarck	North Dakota
United States	Local Institution	Boca Raton	Florida
United States	Dana Farber Cancer Inst	Boston	Massachusetts
United States	Dana-Farber Cancer Institute	Boston	Massachusetts
United States	Cancer Care Centers Of Florida	Brooksville	Florida
United States	Local Institution	Burbank	California
United States	Local Institution	Charleston	South Carolina
United States	Levine Cancer Institute	Charlotte	North Carolina
United States	Compassionate Cancer Res Grp	Corona	California
United States	Local Institution	Corona	California
United States	Cancer Specialists Of South Texas, Pa	Corpus Christi	Texas
United States	Ut Southwestern Medical Center	Dallas	Texas
United States	Henry Ford Health System	Detroit	Michigan
United States	San Diego Pacific Oncology& Hematology Associates, Inc	Encinitas	California
United States	Hematology-Oncology Associates Of Fredricksburg, Inc	Fredericksburg	Virginia
United States	Gaston Hematology & Oncology	Gastonia	North Carolina
United States	Local Institution	Greenbrae	California
United States	Local Institution	Greenville	South Carolina
United States	Northwest Cancer Center	Houston	Texas
United States	University Of Texas Md Anderson Cancer Ctr	Houston	Texas
United States	Local Institution	Indianapolis	Indiana
United States	Local Institution	Iowa City	Iowa
United States	Capitol Comprehensive Cancer Care Center	Jefferson City	Missouri
United States	Local Institution	Knoxville	Tennessee
United States	Gundersen Clinic, Ltd	La Crosse	Wisconsin
United States	Cancer Center Of Acadiana At Lafayette General	Lafayette	Louisiana
United States	Local Institution	Las Vegas	Nevada
United States	Local Institution	Lexington	Kentucky
United States	Ucla-Division Of Hematology/Oncology	Los Angeles	California
United States	Local Institution	Louisville	Kentucky
United States	University Of Wisconsin Hospital And Clinics	Madison	Wisconsin
United States	The West Clinic	Memphis	Tennessee
United States	Mount Sinai Comprehensive Cancer Center	Miami Beach	Florida
United States	Medical College of Wisconsin	Milwaukee	Wisconsin
United States	Local Institution	Mishawaka	Indiana
United States	Northwest Alabama Cancer Center, Pc	Muscle Shoals	Alabama
United States	Local Institution	New Port Richey	Florida
United States	Local Institution	New York	New York
United States	NYU Clinical Cancer Center	New York	New York
United States	Weill Cornell Medical College	New York	New York
United States	University Of Oklahoma Health Sciences Center	Oklahoma City	Oklahoma
United States	Medical Oncology Care Associates	Orange	California
United States	Cancer Institute Of Florida	Orlando	Florida
United States	Pikeville Medical Center	Pikeville	Kentucky
United States	Western Pennsylvania Hospital	Pittsburgh	Pennsylvania
United States	Washington University School Of Medicine	Saint Louis	Missouri
United States	Sharp Clinical Oncology Research	San Diego	California
United States	Va Puget Sound Health Care System	Seattle	Washington
United States	Local Institution	Shreveport	Louisiana
United States	Local Institution	Shreveport	Louisiana
United States	Willis Knighton Cancer Center	Shreveport	Louisiana
United States	Orchard Healthcare Research Inc.	Skokie	Illinois
United States	Local Institution	Springfield	Missouri
United States	Local Institution	Stony Brook	New York
United States	Local Institution	Titusville	Florida
United States	Acrc/Arizona Clinical Research Center, Inc.	Tucson	Arizona
United States	Local Institution	Tulsa	Oklahoma
United States	Local Institution	Vallejo	California
United States	Florida Cancer Specialists	West Palm Beach	Florida

Sponsors (2)

Lead Sponsor	Collaborator
Bristol-Myers Squibb	AbbVie

Countries where clinical trial is conducted

United States,  Australia,  Austria,  Belgium,  Canada,  Czechia,  Denmark,  France,  Germany,  Greece,  Hungary,  Ireland,  Israel,  Italy,  Japan,  Poland,  Puerto Rico,  Romania,  Spain,  Switzerland,  Turkey,  United Arab Emirates,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Median Progression Free Survival (PFS)	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.	From randomization up to 326 events (up to approximately 38 months)
Primary	Objective Response Rate (ORR)	Objective response rate (ORR) defined as the percentage 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.	From randomization up to approximately 38 months
Secondary	Median Overall Survival (OS)	Overall survival is defined as the time from randomization to the date of death from any cause. If a subject has not died, their survival time will be censored at the date of last contact ("last known alive date"). A subject will be censored at the date of randomization if they were randomized but had no follow-up. (Based on Kaplan Meier estimates)	Randomization to the date of death from any cause (up to approximately 9 years)
Secondary	Change From Baseline of Mean Score Pain Severity (BPI-SF)	The change from baseline of the mean score of pain severity at the end of treatment 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.	From baseline up to approximately 38 months
Secondary	Change From Baseline of Mean Score Pain Interference (BPI-SF)	The change from baseline of the mean score of pain interference at the end of treatment 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.	From baseline up to approximately 38 months

External Links

•   BMS Clinical Trial Information
•   BMS Clinical Trial Patient Recruiting
•   FDA Safety Alerts and Recalls