Clinical trial NCT02726581: An Investigational Immuno-therapy Study of Nivolumab, Pomalidomide and Dexamethasone Combinations in Patients With Multiple Myeloma
Official title: An Open-Label, Randomized Phase 3 Trial of Combinations of Nivolumab, Pomalidomide and Dexamethasone in Relapsed and Refractory Multiple Myeloma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Multiple Myeloma
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
Collaborators: name: AbbVie
First posted: 2016-04-01
Enrollment: 170
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the safety and effectiveness of several combination therapies for Multiple Myeloma. Upon entry into the study, patients will be randomized (assigned by chance) to receive either:

Group 1: nivolumab, pomalidomide and dexamethasone OR Group 2: pomalidomide and dexamethasone OR Group 3: nivolumab, elotuzumab, pomalidomide and dexamethasone.

Enrollment is closed for all groups.


Eligibility criteria: Inclusion Criteria:

* Refractory or relapsed and refractory multiple myeloma
* Measurable disease
* Have received ≥ 2 lines of prior therapy which must have included an immune modulatory drug (IMiD) and a proteasome inhibitor alone or in combination

Exclusion Criteria:

* Solitary bone or extramedullary plasmacytoma disease only
* Active plasma cell leukemia

Other protocol defined inclusion/exclusion criteria apply

Primary outcomes:
measure: Progression Free Survival (PFS)
timeFrame: From randomization to the date of the first documented tumor progression or death due to any cause, whichever occurred first (Up to approximately 64 month)
Secondary outcomes:
measure: Overall Survival (OS)
timeFrame: From randomization to the date of death due to any cause (up to approximately 64 months)
measure: Objective Response Rate (ORR)
timeFrame: From randomization up to approximately 64 months
measure: Time to Objective Response (TTR)
timeFrame: From the date of randomization to the date of the first sCR, CR, VGPR, or PR (up to approximately 64 months)
measure: Duration of Objective Response (DOR)
timeFrame: From randomization to the date of the first objectively documented tumor progression or death due to any cause prior to subsequent anti-cancer therapy (up to approximately 64 months)
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Local Institution - 0020
state: Alabama
city: Mobile
country: United States
facility: Local Institution - 0160
state: Alabama
city: Fayetteville
country: United States
facility: Local Institution - 0163
state: Arkansas
city: Bakersfield
country: United States
facility: Local Institution - 0118
state: California
city: Corona
country: United States
facility: Local Institution - 0093
state: California
city: Fountain Valley
country: United States
facility: Local Institution - 0016
state: California
city: La Jolla
country: United States
facility: Local Institution - 0164
state: California
city: La Jolla
country: United States
facility: UC San Diego Moores Cancer Ctr
state: California
city: Los Angeles
country: United States
facility: Local Institution - 0138
state: California
city: Los Angeles
country: United States
facility: Local Institution - 0155
state: California
city: Redondo Beach
country: United States
facility: Local Institution - 0117
state: California
city: Riverside
country: United States
facility: Local Institution - 0092
state: California
city: San Luis Obispo
country: United States
facility: Coastal Integrative Cancer Care
state: California
city: Santa Maria
country: United States
facility: Local Institution - 0113
state: California
city: Denver
country: United States
facility: Colorado Blood Cancer Institute
state: Colorado
city: Fort Collins
country: United States
facility: Poudre Valley Health Care
state: Colorado
city: Grand Junction
country: United States
facility: Local Institution - 0116
state: Colorado
city: New Haven
country: United States
facility: Yale University School Of Medicine
state: Connecticut
city: Washington
country: United States
facility: Local Institution - 0147
state: District of Columbia
city: Boynton Beach
country: United States
facility: Local Institution - 0011
state: Florida
city: Fort Myers
country: United States
facility: Florida Cancer Specialists S.
state: Florida
city: Hollywood
country: United States
facility: Local Institution - 0114
state: Florida
city: Jacksonville
country: United States
facility: Cancer Specialists of North FL
state: Florida
city: Pensacola
country: United States
facility: Local Institution - 0082
state: Florida
city: Saint Petersburg
country: United States
facility: Local Institution - 0126
state: Florida
city: Tallahassee
country: United States
facility: Local Institution - 0130
state: Florida
city: West Palm Beach
country: United States
facility: Local Institution - 0125
state: Florida
city: Athens
country: United States
facility: Local Institution - 0119
state: Georgia
city: Atlanta
country: United States
facility: Local Institution - 0009
state: Georgia
city: Atlanta
country: United States
facility: Local Institution - 0024
state: Georgia
city: Augusta
country: United States
facility: Augusta University
state: Georgia
city: Chicago
country: United States
facility: Local Institution - 0035
state: Illinois
city: Fort Wayne
country: United States
facility: Local Institution - 0111
state: Indiana
city: Indianapolis
country: United States
facility: Indiana University Cancer Ctr
state: Indiana
city: Bethesda
country: United States
facility: Local Institution - 0018
state: Maryland
city: Baltimore
country: United States
facility: Local Institution - 0006
state: Massachusetts
city: Worcester
country: United States
facility: Local Institution - 0123
state: Massachusetts
city: Ypsilanti
country: United States
facility: Local Institution - 0150
state: Michigan
city: Hattiesburg
country: United States
facility: Local Institution - 0137
state: Mississippi
city: Bridgeton
country: United States
facility: St. Louis Cancer Care, Llp
state: Missouri
city: Kansas City
country: United States
facility: Local Institution - 0128
state: Missouri
city: Saint Louis
country: United States
facility: Washington University
state: Missouri
city: Springfield
country: United States
facility: Local Institution - 0049
state: Missouri
city: Lincoln
country: United States
facility: Local Institution - 0079
state: Nebraska
city: Flemington
country: United States
facility: Local Institution - 0076
state: New Jersey
city: Hackensack
country: United States
facility: Local Institution - 0002
state: New Jersey
city: New Brunswick
country: United States
facility: Local Institution - 0095
state: New Jersey
city: Paramus
country: United States
facility: Local Institution - 0142
state: New Jersey
city: Buffalo
country: United States
facility: Local Institution - 0010
state: New York
city: Johnson City
country: United States
facility: Broome Oncology LLC
state: New York
city: New York
country: United States
facility: Mount Sinai Medical Center
state: New York
city: New York
country: United States
facility: Local Institution - 0017
state: New York
city: Durham
country: United States
facility: Local Institution - 0001
state: North Carolina
city: Winston-Salem
country: United States
facility: Local Institution - 0096
state: North Carolina
city: Columbus
country: United States
facility: Local Institution - 0012
state: Ohio
city: Oklahoma City
country: United States
facility: University Of Oklahoma
state: Oklahoma
city: Portland
country: United States
facility: Local Institution - 0145
state: Oregon
city: Lancaster
country: United States
facility: Local Institution - 0136
state: Pennsylvania
city: Philadelphia
country: United States
facility: Local Institution - 0021
state: Pennsylvania
city: Sayre
country: United States
facility: Local Institution - 0036
state: Pennsylvania
city: Greenville
country: United States
facility: Local Institution - 0152
state: South Carolina
city: Germantown
country: United States
facility: Local Institution - 0069
state: Tennessee
city: Nashville
country: United States
facility: Tennessee Oncology, PLLC - SCRI - PPDS
state: Tennessee
city: Dallas
country: United States
facility: Baylor Research Institute
state: Texas
city: Houston
country: United States
facility: Local Institution - 0044
state: Texas
city: San Antonio
country: United States
facility: Local Institution - 0037
state: Texas
city: Temple
country: United States
facility: Local Institution - 0046
state: Texas
city: Ogden
country: United States
facility: Local Institution - 0022
state: Utah
city: Salt Lake City
country: United States
facility: Local Institution - 0153
state: Utah
city: Charlottesville
country: United States
facility: Emily Couric Clinical Cancer Center
state: Virginia
city: Richmond
country: United States
facility: Virginia Cancer Institute
state: Virginia
city: Seattle
country: United States
facility: Local Institution - 0144
state: Washington
city: Linz
country: Austria
facility: Local Institution - 0029
city: Salzburg
country: Austria
facility: Universitaetsklinik Salzburg
city: Vienna
country: Austria
facility: Local Institution - 0026
city: Wels
country: Austria
facility: Klinikum Wels-Grieskirchen Gmbh
city: Wien
country: Austria
facility: Wilhelminenspital
city: Edmonton
country: Canada
facility: Local Institution
state: Alberta
city: Vancouver
country: Canada
facility: Local Institution
state: British Columbia
city: Toronto
country: Canada
facility: Local Institution - 0074
state: Ontario
city: Montreal
country: Canada
facility: Local Institution - 0039
state: Quebec
city: Montreal
country: Canada
facility: MUHC - Glen Site
state: Quebec
city: Montreal
country: Canada
facility: Local Institution - 0154
state: Quebec
city: Rimouski
country: Canada
facility: Local Institution - 0157
state: Quebec
city: Quebec
country: Canada
facility: Local Institution
city: Brno
country: Czechia
facility: Interni hematologicka a onkologicka klinika
city: Ostrava-Poruba
country: Czechia
facility: Klinika hematoonkologie
city: Praha 2
country: Czechia
facility: I. interni klinika - klinika hematologie 1. LF UK a VFN v Praze
city: Aarhus
country: Denmark
facility: Local Institution
city: Odense
country: Denmark
facility: Local Institution
city: Berlin
country: Germany
facility: Local Institution - 0050
city: Dresden
country: Germany
facility: Universitaetsklinikum Carl Gustav Carus
city: Duesseldorf
country: Germany
facility: Uniklinikum Duesseldorf
city: Kiel
country: Germany
facility: Local Institution - 0135
city: Mainz
country: Germany
facility: Klinikum Der Johannes Gutenberg Universitaet Mainz
city: Ulm
country: Germany
facility: Local Institution - 0054
city: Athens
country: Greece
facility: Alexandra General Hospital Of Athens
city: Beer Sheva
country: Israel
facility: Local Institution - 0087
city: Jerusalem
country: Israel
facility: Local Institution
city: Petah Tikva
country: Israel
facility: Local Institution
city: Ramat-gan
country: Israel
facility: Local Institution
city: Tel Aviv
country: Israel
facility: Local Institution
city: Torino
country: Italy
facility: Local Institution - 0042
state: Piemonte
city: Ancona
country: Italy
facility: Azienda Ospedaliero Universitaria Ospedali Riuniti Di Ancona
city: Bergamo
country: Italy
facility: Local Institution - 0089
city: Bologna
country: Italy
facility: A. O. U. Di Bologna, Policlinico S. Orsola Malpighi
city: Meldola (FC)
country: Italy
facility: Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (IRST)
city: Terni
country: Italy
facility: Azienda Ospedaliera Santa Maria Terni
city: Oslo
country: Norway
facility: Local Institution
city: Stavanger
country: Norway
facility: Local Institution - 0075
city: Lisbon
country: Portugal
facility: Local Institution - 0132
state: Lisboa
city: Porto
country: Portugal
facility: Local Institution
city: San Juan
country: Puerto Rico
facility: Local Institution - 0071
city: Pozuelo De Alarcon
country: Spain
facility: Local Institution - 0101
state: Madrid
city: Badalona-Barcelona
country: Spain
facility: Local Institution - 0098
city: Barcelona
country: Spain
facility: Local Institution - 0100
city: Pamplona
country: Spain
facility: Local Institution - 0097
city: Salamanca
country: Spain
facility: Local Institution - 0099
city: Huddinge
country: Sweden
facility: Local Institution - 0064
city: Geneve
country: Switzerland
facility: Hopitaux Universitaires de Geneve
city: Istanbul
country: Turkey
facility: Local Institution - 0186
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References: