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NCT01335399 Clinical Trial

Phase III Study of Lenalidomide and Dexamethasone With or Without Elotuzumab to Treat Newly Diagnosed, Previously Untreated Multiple Myeloma

Multiple Myeloma Clinical Trial

— ELOQUENT - 1  

Official title:
A Phase 3, Randomized, Open Label Trial of Lenalidomide/Dexamethasone With or Without Elotuzumab in Subjects With Previously Untreated Multiple Myeloma

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01335399
Other study ID # CA204-006
Secondary ID 2010-022445-20
Status Completed
Phase Phase 3
First received
Last updated
Start date August 4, 2011
Est. completion date September 3, 2021

Study information
Verified date September 2022
Source Bristol-Myers Squibb
Contact n/a
Is FDA regulated No
Health authority
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 748
Est. completion date September 3, 2021
Est. primary completion date October 1, 2019
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: - 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 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

Related Conditions & MeSH terms

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
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
• 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
• 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
Biological:
• 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
• 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

Locations
Country Name City State
Australia Local Institution - 3612 Adelaide South Australia
Australia Local Institution - 3601 Fitzroy Victoria
Australia Local Institution - 3602 Frankston Victoria
Australia Local Institution - 3600 Garran Australian Capital Territory
Australia Local Institution - 3603 Heidelberg Melbourne Victoria
Australia Local Institution - 3609 Herston Queensland
Australia Local Institution - 3608 Milton Queensland
Australia Local Institution - 3605 Murdoch
Australia Local Institution - 3611 Nedlands
Australia Local Institution - 3607 Waratah New South Wales
Australia Local Institution - 3610 Westmead New South Wales
Australia Local Institution - 3604 Wodonga Victoria
Australia Local Institution - 3606 Woodville South South Australia
Austria Local Institution - 4052 Fadingerstraße 1
Austria Local Institution - 4051 Innsbruck
Austria Local Institution - 4054 Rankweil
Austria Local Institution - 4053 Wels
Belgium Local Institution - 4156 Brussels
Belgium Local Institution - 4160 Brussels
Belgium Local Institution - 4157 Brussles
Belgium Local Institution - 4154 Charleroi
Belgium Local Institution - 4159 Haine St Paul
Belgium Local Institution - 4158 Leuven
Belgium Local Institution - 4150 Liege
Belgium Local Institution - 4153 Roeselare
Belgium Local Institution - 4151 Yvoir
Canada Local Institution - 2601 Calgary Alberta
Canada Local Institution - 2600 Edmonton Alberta
Canada Local Institution - 2603 Greenfield Park Quebec
Canada Local Institution - 2610 Halifax Nova Scotia
Canada Local Institution - 2606 London Ontario
Canada Local Institution - 2605 Montreal Quebec
Canada Local Institution - 2607 Montreal Quebec
Canada Local Institution - 2611 Saint John New Brunswick
Canada Local Institution - 2612 Toronto Ontario
Canada Local Institution - 2602 Winnipeg Manitoba
Czechia Local Institution - 4252 Hradec Kralove
Czechia Local Institution - 4250 Praha 10
Czechia Local Institution - 4251 Praha 2
Germany Local Institution - 4565 Aschaffenburg
Germany Local Institution - 4550 Berlin
Germany Local Institution - 4555 Chemnitz
Germany Local Institution - 4562 Dresden
Germany Local Institution - 4552 Hamm
Germany Local Institution - 4553 Heidelberg
Germany Local Institution - 4560 Jena
Germany Local Institution - 4563 Koln
Germany Local Institution - 4554 Mainz
Germany Local Institution - 4561 Munchen
Germany Local Institution - 4558 Munster
Germany Local Institution - 4551 Offenbach
Germany Local Institution - 4556 Stuttgart
Germany Local Institution - 4564 Tuebingen
Germany Local Institution - 4559 Ulm
Greece Local Institution - 4651 Athens
Greece Local Institution - 4653 Athens
Greece Local Institution - 4650 Ioannina
Greece Local Institution - 4652 Larissa
Greece Local Institution - 4654 Patras
Hungary Local Institution - 4751 Budapest
Hungary Local Institution - 4754 Budapest
Hungary Local Institution - 4750 Debrecen
Hungary Local Institution - 4753 Gyor
Hungary Local Institution - 4752 Szeged
Ireland Local Institution - 4850 Dublin
Ireland Local Institution - 4852 Dublin
Ireland Local Institution - 4851 Galway
Israel Local Institution - 4950 Afula
Israel Local Institution - 4956 Ashkelon
Israel Local Institution - 4960 Haifa
Israel Local Institution - 4951 Jerusalem
Israel Local Institution - 4958 Jerusalem
Israel Local Institution - 4959 Kfar Saba
Israel Local Institution - 4954 Nahariya
Israel Local Institution - 4952 Petah Tikva
Israel Local Institution - 4957 Tel Aviv
Israel Local Institution - 4955 Zerifin
Italy Local Institution - 5067 Ancona
Italy Local Institution - 5065 Bari
Italy Local Institution - 5053 Bergamo
Italy Local Institution - 5070 Bologna
Italy Local Institution - 5066 Firenze
Italy Local Institution - 5050 Genova
Italy Local Institution - 5057 Meldola
Italy Local Institution - 5069 Milan
Italy Local Institution - 5075 Milano
Italy Local Institution - 5052 Monza
Italy Local Institution - 5062 Napoli
Italy Local Institution - 5068 Napoli
Italy Local Institution - 5055 Palermo
Italy Local Institution - 5063 Ravenna
Italy Local Institution - 5073 Reggio Nell Emilia (RE)
Italy Local Institution - 5064 Rimini
Italy Local Institution - 5054 Roma
Italy Local Institution - 5058 Roma
Italy Local Institution - 5056 Rome
Italy Local Institution - 5072 Terni
Italy Local Institution - 5051 Torino
Poland Local Institution - 5250 Bialystok
Poland Local Institution - 5252 Chorzow
Poland Local Institution - 5254 Gdansk
Poland Local Institution - 7626 Krakow
Poland Local Institution - 5258 Lodz
Poland Local Institution - 5257 Lublin
Poland Local Institution - 5259 Poznan
Poland Local Institution - 5255 Szczecin
Poland Local Institution - 5253 Warszawa
Poland Local Institution - 5256 Warszawa
Poland Local Institution - 5260 Warszawa
Poland Local Institution - 5251 Wroclaw
Puerto Rico Local Institution - 7600 Ponce
Puerto Rico Local Institution - 7602 San Juan
Romania Local Institution - 5356 Brasov
Romania Local Institution - 5350 Bucaresti
Romania Local Institution - 5352 Bucuresti
Romania Local Institution - 5353 Bucuresti
Romania Local Institution - 5355 Bucuresti
Romania Local Institution - 5351 Lasi
Russian Federation Local Institution - 5453 Samara
Russian Federation Local Institution - 5450 St. Petersburg
Russian Federation Local Institution - 5452 St. Petersburg
Spain Local Institution - 5552 Badalona-barcelona
Spain Local Institution - 5555 Barcelona
Spain Local Institution - 5559 Barcelona
Spain Local Institution - 5561 La Laguna- Tenerife
Spain Local Institution - 5551 Madrid
Spain Local Institution - 5553 Madrid
Spain Local Institution - 5554 Madrid
Spain Local Institution - 5560 Madrid
Spain Local Institution - 5558 Pamplona
Spain Local Institution - 5550 Salamanca
Spain Local Institution - 5557 San Sebastian
Spain Local Institution - 5556 Toledo
Switzerland Local Institution - 5751 Bern
Switzerland Local Institution - 5750 St Gallen
Switzerland Local Institution - 5752 Zurich
Switzerland Local Institution - 5753 Zurich
Turkey Local Institution - 5851 Ankara Dikimevi
Turkey Local Institution - 5856 Gaziantep
Turkey Local Institution - 5853 Izmir Bornova
Turkey Local Institution - 5854 Izmir Inciralti
United Kingdom Local Institution - 5951 Belfast Antrim
United Kingdom Local Institution - 5950 London
United Kingdom Local Institution - 5952 London
United Kingdom Local Institution - 5953 London Greater London
United Kingdom Local Institution - 5954 London
United Kingdom Local Institution - 5955 London
United States Local Institution - 1630 Atlanta Georgia
United States Local Institution - 1618 Bakersfield California
United States Local Institution - 1650 Baltimore Maryland
United States Local Institution - 1676 Baltimore Maryland
United States Local Institution - 1602 Berkeley California
United States Local Institution - 1628 Birmingham Alabama
United States Local Institution - 7616 Bloomington Indiana
United States Local Institution - 1682 Boca Raton Florida
United States Local Institution - 1619 Boston Massachusetts
United States Local Institution - 1699 Boston Massachusetts
United States Local Institution - 1617 Brooksville Florida
United States Local Institution - 7617 Chandler Arizona
United States Local Institution - 1629 Charleston South Carolina
United States Local Institution - 7615 Charleston South Carolina
United States Local Institution - 1607 Chicago Illinois
United States Local Institution - 1635 Chicago Illinois
United States Local Institution - 1608 Cleveland Ohio
United States Local Institution - 1693 Cleveland Ohio
United States Local Institution - 1638 Columbus Ohio
United States Local Institution - 1664 Columbus Ohio
United States Local Institution - 1636 Corona California
United States Local Institution - 1668 Corona California
United States Local Institution - 1634 Corpus Christi Texas
United States Local Institution - 7612 Dallas Texas
United States Local Institution - 1604 Detroit Michigan
United States Local Institution - 1648 Fort Myers Florida
United States Local Institution - 1657 Fredericksburg Virginia
United States Local Institution - 7604 Goldsboro North Carolina
United States Local Institution - 1616 Greenbrae California
United States Local Institution - 1624 Greenville South Carolina
United States Local Institution - 7613 Hollywood Florida
United States Local Institution - 1684 Honolulu Hawaii
United States Local Institution - 1642 Houston Texas
United States Local Institution - 1643 Houston Texas
United States Local Institution - 1686 Houston Texas
United States Local Institution - 1601 Huntington West Virginia
United States Local Institution - 1669 Indianapolis Indiana
United States Local Institution - 7620 Indianapolis Indiana
United States Local Institution - 1633 Iowa City Iowa
United States Local Institution - 1623 Jacksonville Florida
United States Local Institution - 1667 Jefferson City Missouri
United States Local Institution - 1600 Knoxville Tennessee
United States Gundersen Clinic, Ltd La Crosse Wisconsin
United States Local Institution - 1646 Lafayette Louisiana
United States Local Institution - 7611 Langhorne Pennsylvania
United States Local Institution - 1674 Lexington Kentucky
United States Local Institution - 7609 Long Beach California
United States Local Institution - 1660 Los Angeles California
United States Local Institution - 1683 Louisville Kentucky
United States Local Institution - 1609 Madison Wisconsin
United States Local Institution - 1663 Madison Wisconsin
United States Local Institution - 7614 Marrero Louisiana
United States Local Institution - 1632 Maywood Illinois
United States Local Institution - 7628 Memphis Tennessee
United States Local Institution - 1690 Middletown Ohio
United States Local Institution - 7621 Mineola New York
United States Local Institution - 1656 Mishawaka Indiana
United States Local Institution - 7618 Mobile Alabama
United States Local Institution - 7619 Mobile Alabama
United States Local Institution - 1627 Nashville Tennessee
United States Local Institution - 1670 Nashville Tennessee
United States Local Institution - 1621 New Haven Connecticut
United States Local Institution - 1626 New Orleans Louisiana
United States Local Institution - 1625 New Port Richey Florida
United States Local Institution - 1615 New York New York
United States Local Institution - 7623 Ogden Utah
United States Local Institution - 1637 Omaha Nebraska
United States Local Institution - 1673 Orange California
United States Local Institution - 7606 Peoria Illinois
United States Local Institution - 1647 Pittsburgh Pennsylvania
United States Local Institution - 1679 Pittsburgh Pennsylvania
United States Local Institution - 1645 Saint Louis Missouri
United States Local Institution - 1649 Saint Petersburg Florida
United States Local Institution - 1613 San Diego California
United States Local Institution - 1677 Sayre Pennsylvania
United States Local Institution - 1631 Seattle Washington
United States Local Institution - 1640 Seattle Washington
United States Local Institution - 1652 Shreveport Louisiana
United States Local Institution - 7607 Sioux Falls South Dakota
United States Local Institution - 7610 Skokie Illinois
United States Local Institution - 1651 Springfield Missouri
United States Local Institution - 1671 Stony Brook New York
United States Local Institution - 1644 Tucson Arizona
United States Local Institution - 1655 Tulsa Oklahoma
United States Local Institution - 1603 Urbana Illinois
United States Local Institution - 1612 Washington District of Columbia
United States Local Institution - 1611 West Palm Beach Florida
United States Local Institution - 1610 Winston-Salem North Carolina

Sponsors (2)
Lead Sponsor Collaborator
Bristol-Myers Squibb AbbVie

Countries where clinical trial is conducted

United States,  Australia,  Austria,  Belgium,  Canada,  Czechia,  Germany,  Greece,  Hungary,  Ireland,  Israel,  Italy,  Poland,  Puerto Rico,  Romania,  Russian Federation,  Spain,  Switzerland,  Turkey,  United Kingdom, 

Outcome
Type Measure Description Time frame Safety issue
Primary Progression-Free Survival (PFS) PFS is defined as the time from randomization to the date of the first documented tumor progression (as determined by the Independent Review Committee (IRC)) or death due to any cause.
The IRC conducted a blinded, independent review of the tumor assessments based on the European Group for Blood and Bone Marrow Transplant (EBMT) criteria.
Censoring rules applied:
Participants receiving subsequent systemic anti-myeloma therapy prior to documented progression were censored at the date of the last adequate tumor assessment prior to new therapy.
Participants who had an event (progression or death) > 10 weeks after their last tumor assessment were censored at their last adequate tumor assessment prior to the event.
Participants without progression or death (and not receiving subsequent therapy prior to progression) were censored at their last adequate tumor assessment.
Participants without any post-baseline tumor assessments were censored on the date of randomization		 From randomization to date of first documented tumor progression or death due to any cause (up to 8 years)
Secondary Objective Response Rate (ORR) ORR is defined as the percentage of participants with objective response among all randomized subjects. Participants with an objective response are those participants experiencing a partial response (PR) or better, based on Independent Review Committee (IRC) assessment, as per EBMT criteria. From randomization to primary completion date (approximately 8 years)
Secondary Overall Survival (OS) Survival is defined as the time from randomization to the date of death. A participant who did not die had his or her survival duration censored at the date of last contact ('last known date alive"). From randomization to the date of death (up to 8 years)
Secondary Mean Change From Baseline of Pain Severity Score and Pain Interference Score Pain severity (sensory dimension) and pain interference (reactive dimension, assessing the degree to which pain interferes with function) are measured using the Brief Pain Inventory- Short Form (BPI-SF).
BPI-SF numeric rating scale goes from 0 (No pain) to 10 (Pain as bad as you can imagine).		 From Baseline to End of Treatment (approximately 8 years)
Secondary Progression Free Survival (PFS) Rate at Specific Time-points PFS rate is defined as the percentage of participants experiencing PFS at the defined time-points. From randomization to the specified time-point (up to 5 years)
See also
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Recruiting NCT05971056 - Providing Cancer Care Closer to Home for Patients With Multiple Myeloma N/A
Recruiting NCT05243797 - Phase 3 Study of Teclistamab in Combination With Lenalidomide and Teclistamab Alone Versus Lenalidomide Alone in Participants With Newly Diagnosed Multiple Myeloma as Maintenance Therapy Following Autologous Stem Cell Transplantation Phase 3
Active, not recruiting NCT04555551 - MCARH109 Chimeric Antigen Receptor (CAR) Modified T Cells for the Treatment of Multiple Myeloma Phase 1
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Terminated NCT03399448 - NY-ESO-1-redirected CRISPR (TCRendo and PD1) Edited T Cells (NYCE T Cells) Phase 1
Completed NCT03665155 - First-in- Human Imaging of Multiple Myeloma Using 89Zr-DFO-daratumumab, a CD38-targeting Monoclonal Antibody Phase 1/Phase 2
Completed NCT02812706 - Isatuximab Single Agent Study in Japanese Relapsed AND Refractory Multiple Myeloma Patients Phase 1/Phase 2
Active, not recruiting NCT05024045 - Study of Oral LOXO-338 in Patients With Advanced Blood Cancers Phase 1
Active, not recruiting NCT03792763 - Denosumab for High Risk SMM and SLiM CRAB Positive, Early Myeloma Patients Phase 2
Active, not recruiting NCT03989414 - A Study to Determine the Recommended Dose and Regimen and to Evaluate the Safety and Preliminary Efficacy of CC-92480 in Combination With Standard Treatments in Participants With Relapsed or Refractory Multiple Myeloma (RRMM) and Newly Diagnosed Multiple Myeloma (NDMM) Phase 1/Phase 2
Withdrawn NCT03608501 - A Study of Ixazomib, Thalidomide and Dexamethasone in Newly Diagnosed and Treatment-naive Multiple Myeloma (MM) Participants Non-eligible for Autologous Stem-cell Transplantation Phase 2
Recruiting NCT04537442 - Clinical Study to Evaluate the Safety and Efficacy of IM21 CAR-T Cells in the Treatment of Elderly Patients With Relapsed or Refractory Multiple Myeloma Phase 1
Completed NCT02546167 - CART-BCMA Cells for Multiple Myeloma Phase 1

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