An Investigational Immuno-therapy Study of Nivolumab, Pomalidomide and Dexamethasone Combinations in Patients With Multiple Myeloma
- Conditions
- Multiple Myeloma
- Interventions
- Registration Number
- NCT02726581
- Lead Sponsor
- Bristol-Myers Squibb
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 170
- 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
- Solitary bone or extramedullary plasmacytoma disease only
- Active plasma cell leukemia
Other protocol defined inclusion/exclusion criteria apply
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Exploratory Arm Elotuzumab Nivolumab, Elotuzumab, Pomalidomide and Dexamethasone Enrollment is closed for this arm Control Arm Dexamethasone Pomalidomide and Dexamethasone Enrollment is closed for this arm Exploratory Arm Nivolumab Nivolumab, Elotuzumab, Pomalidomide and Dexamethasone Enrollment is closed for this arm Investigational Arm Nivolumab Nivolumab, Pomalidomide and Dexamethasone Enrollment is closed for this arm Investigational Arm Pomalidomide Nivolumab, Pomalidomide and Dexamethasone Enrollment is closed for this arm Control Arm Pomalidomide Pomalidomide and Dexamethasone Enrollment is closed for this arm Investigational Arm Dexamethasone Nivolumab, Pomalidomide and Dexamethasone Enrollment is closed for this arm Exploratory Arm Dexamethasone Nivolumab, Elotuzumab, Pomalidomide and Dexamethasone Enrollment is closed for this arm Exploratory Arm Pomalidomide Nivolumab, Elotuzumab, Pomalidomide and Dexamethasone Enrollment is closed for this arm
- Primary Outcome Measures
Name Time Method Progression Free Survival (PFS) 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) Randomization to first documented tumor progression or death due to any cause, whichever occurred first. Participants who die without reported prior progression are considered to have progressed on date of their death. Participants who did not progress or die will be censored at their last efficacy assessment. Participants who did not have on study efficacy assessments and alive will be censored on randomization date. Participants who started subsequent anti-cancer therapy without prior reported progression will be censored at last efficacy assessment prior to subsequent anti-cancer therapy. Progression is 1) increase of 25% from lowest confirmed response value in specific Serum M-protein and Urine M-protein criteria and increase of FLC for patients with no measurable M protein in blood or urine at baseline and/or 2) appearance of a new lesion(s), \>/= 50% increase from nadir in SPD of \> 1 lesion, or \>/= 50% increase in the longest diameter of a previous lesion \> 1 cm in short axis.
- Secondary Outcome Measures
Name Time Method Overall Survival (OS) From randomization to the date of death due to any cause (up to approximately 64 months) The time between the date of randomization and the date of death due to any cause. OS will be censored on the last date a participant was known to be alive.
Duration of Objective Response (DOR) 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) The time between the date of first response to the date of the first objectively documented tumor progression as assessed by the investigator according to International Myeloma Working Group (IMWG) criteria or death due to any cause prior to subsequent anti-cancer therapy. Participants who neither progress nor die will be censored on the date of their last tumor assessment prior to subsequent anti-cancer therapy. Progression is 1) increase of 25% from lowest confirmed response value in specific Serum M-protein and Urine M-protein criteria and increase of FLC for patients with no measurable M protein in blood or urine at baseline and/or 2) appearance of a new lesion(s), \>/= 50% increase from nadir in SPD of \> 1 lesion, or \>/= 50% increase in the longest diameter of a previous lesion \> 1 cm in short axis.
Objective Response Rate (ORR) From randomization up to approximately 64 months The percentage of randomized participants who achieved a best overall response (BOR) of stringent complete response (sCR), complete response (CR), very good partial response (VGPR), or partial response (PR) using International Myeloma Working Group (IMWG) criteria.
sCR= Complete response as defined below plus normal FLC ratio and absence of clonal cells in bone marrow biopsy by immunohistochemistry.
CR = Negative immunofixation on the serum and urine and disappearance of any soft tissue plasmacytomas and \< 5% plasma cells in bone marrow aspirates.
VGPR = Serum and urine M-protein detectable by immunofixation but not on electrophoresis or \>/= 90% reduction in serum M-protein plus urine M-protein level \< 100 mg per 24 h.
PR = \>/= 50% reduction of serum M-protein plus reduction in 24 h urinary M-protein by \>/= 90% or to \< 200 mg per 24 h.Time to Objective Response (TTR) From the date of randomization to the date of the first sCR, CR, VGPR, or PR (up to approximately 64 months) The time from the date of randomization to the date of the first stringent complete response (sCR), complete response (CR), very good partial response (VGPR), or partial response (PR).
sCR= Complete response as defined below plus normal FLC ratio and absence of clonal cells in bone marrow biopsy by immunohistochemistry.
CR = Negative immunofixation on the serum and urine and disappearance of any soft tissue plasmacytomas and \< 5% plasma cells in bone marrow aspirates.
VGPR = Serum and urine M-protein detectable by immunofixation but not on electrophoresis or \>/= 90% reduction in serum M-protein plus urine M-protein level \< 100 mg per 24 h.
PR = \>/= 50% reduction of serum M-protein plus reduction in 24 h urinary M-protein by \>/= 90% or to \< 200 mg per 24 h.
Trial Locations
- Locations (111)
Local Institution - 0035
🇺🇸Chicago, Illinois, United States
Local Institution - 0064
🇸🇪Huddinge, Sweden
Local Institution - 0016
🇺🇸Fountain Valley, California, United States
Local Institution - 0164
🇺🇸La Jolla, California, United States
Local Institution - 0093
🇺🇸Corona, California, United States
Local Institution - 0117
🇺🇸Redondo Beach, California, United States
Local Institution - 0155
🇺🇸Los Angeles, California, United States
Local Institution - 0130
🇺🇸Tallahassee, Florida, United States
Local Institution - 0049
🇺🇸Springfield, Missouri, United States
Local Institution - 0138
🇺🇸Los Angeles, California, United States
Local Institution - 0092
🇺🇸Riverside, California, United States
Coastal Integrative Cancer Care
🇺🇸San Luis Obispo, California, United States
Uniklinikum Duesseldorf
🇩🇪Duesseldorf, Germany
Local Institution - 0046
🇺🇸Temple, Texas, United States
Mount Sinai Medical Center
🇺🇸New York, New York, United States
Local Institution - 0050
🇩🇪Berlin, Germany
Interni hematologicka a onkologicka klinika
🇨🇿Brno, Czechia
Local Institution - 0160
🇺🇸Mobile, Alabama, United States
Local Institution - 0118
🇺🇸Bakersfield, California, United States
Florida Cancer Specialists S.
🇺🇸Fort Myers, Florida, United States
UC San Diego Moores Cancer Ctr
🇺🇸La Jolla, California, United States
Cancer Specialists of North FL
🇺🇸Jacksonville, Florida, United States
Local Institution - 0119
🇺🇸Athens, Georgia, United States
Washington University
🇺🇸Saint Louis, Missouri, United States
Local Institution - 0076
🇺🇸Flemington, New Jersey, United States
Local Institution - 0074
🇨🇦Toronto, Ontario, Canada
Local Institution - 0113
🇺🇸Santa Maria, California, United States
Poudre Valley Health Care
🇺🇸Fort Collins, Colorado, United States
St. Louis Cancer Care, Llp
🇺🇸Bridgeton, Missouri, United States
Broome Oncology LLC
🇺🇸Johnson City, New York, United States
Local Institution - 0017
🇺🇸New York, New York, United States
Local Institution - 0126
🇺🇸Saint Petersburg, Florida, United States
Local Institution - 0082
🇺🇸Pensacola, Florida, United States
Local Institution - 0012
🇺🇸Columbus, Ohio, United States
Local Institution - 0021
🇺🇸Philadelphia, Pennsylvania, United States
Local Institution - 0029
🇦🇹Linz, Austria
Local Institution - 0010
🇺🇸Buffalo, New York, United States
Virginia Cancer Institute
🇺🇸Richmond, Virginia, United States
Local Institution - 0116
🇺🇸Grand Junction, Colorado, United States
Local Institution - 0098
🇪🇸Badalona-Barcelona, Spain
Local Institution - 0022
🇺🇸Ogden, Utah, United States
Local Institution - 0099
🇪🇸Salamanca, Spain
Local Institution - 0101
🇪🇸Pozuelo De Alarcon, Madrid, Spain
Emily Couric Clinical Cancer Center
🇺🇸Charlottesville, Virginia, United States
I. interni klinika - klinika hematologie 1. LF UK a VFN v Praze
🇨🇿Praha 2, Czechia
Universitaetsklinikum Carl Gustav Carus
🇩🇪Dresden, Germany
Klinikum Der Johannes Gutenberg Universitaet Mainz
🇩🇪Mainz, Germany
Local Institution - 0135
🇩🇪Kiel, Germany
MUHC - Glen Site
🇨🇦Montreal, Quebec, Canada
Local Institution - 0100
🇪🇸Barcelona, Spain
Local Institution - 0097
🇪🇸Pamplona, Spain
Hopitaux Universitaires de Geneve
🇨🇭Geneve, Switzerland
Local Institution - 0054
🇩🇪Ulm, Germany
Klinika hematoonkologie
🇨🇿Ostrava-Poruba, Czechia
Local Institution - 0044
🇺🇸Houston, Texas, United States
Local Institution - 0144
🇺🇸Seattle, Washington, United States
Local Institution - 0001
🇺🇸Durham, North Carolina, United States
Local Institution - 0037
🇺🇸San Antonio, Texas, United States
Local Institution - 0153
🇺🇸Salt Lake City, Utah, United States
Local Institution - 0011
🇺🇸Boynton Beach, Florida, United States
Indiana University Cancer Ctr
🇺🇸Indianapolis, Indiana, United States
Local Institution - 0123
🇺🇸Worcester, Massachusetts, United States
Local Institution - 0136
🇺🇸Lancaster, Pennsylvania, United States
Local Institution - 0036
🇺🇸Sayre, Pennsylvania, United States
Local Institution - 0026
🇦🇹Vienna, Austria
Local Institution - 0075
🇳🇴Stavanger, Norway
Local Institution - 0132
🇵🇹Lisbon, Lisboa, Portugal
Local Institution - 0186
🇹🇷Istanbul, Turkey
Local Institution - 0020
🇺🇸Birmingham, Alabama, United States
University Of Oklahoma
🇺🇸Oklahoma City, Oklahoma, United States
Local Institution - 0042
🇮🇹Torino, Piemonte, Italy
Azienda Ospedaliero Universitaria Ospedali Riuniti Di Ancona
🇮🇹Ancona, Italy
Local Institution - 0089
🇮🇹Bergamo, Italy
A. O. U. Di Bologna, Policlinico S. Orsola Malpighi
🇮🇹Bologna, Italy
Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (IRST)
🇮🇹Meldola (FC), Italy
Azienda Ospedaliera Santa Maria Terni
🇮🇹Terni, Italy
Local Institution - 0114
🇺🇸Hollywood, Florida, United States
Local Institution - 0125
🇺🇸West Palm Beach, Florida, United States
Local Institution - 0111
🇺🇸Fort Wayne, Indiana, United States
Local Institution - 0009
🇺🇸Atlanta, Georgia, United States
Local Institution - 0150
🇺🇸Ypsilanti, Michigan, United States
Local Institution - 0024
🇺🇸Atlanta, Georgia, United States
Augusta University
🇺🇸Augusta, Georgia, United States
Baylor Research Institute
🇺🇸Dallas, Texas, United States
Local Institution - 0006
🇺🇸Baltimore, Massachusetts, United States
Colorado Blood Cancer Institute
🇺🇸Denver, Colorado, United States
Yale University School Of Medicine
🇺🇸New Haven, Connecticut, United States
Local Institution - 0018
🇺🇸Bethesda, Maryland, United States
Local Institution - 0128
🇺🇸Kansas City, Missouri, United States
Local Institution - 0096
🇺🇸Winston-Salem, North Carolina, United States
Local Institution - 0145
🇺🇸Portland, Oregon, United States
Local Institution - 0071
🇵🇷San Juan, Puerto Rico
Alexandra General Hospital Of Athens
🇬🇷Athens, Greece
Local Institution - 0154
🇨🇦Montreal, Quebec, Canada
Local Institution - 0147
🇺🇸Washington, District of Columbia, United States
Local Institution - 0087
🇮🇱Beer Sheva, Israel
Local Institution - 0137
🇺🇸Hattiesburg, Mississippi, United States
Local Institution - 0079
🇺🇸Lincoln, Nebraska, United States
Local Institution - 0002
🇺🇸Hackensack, New Jersey, United States
Tennessee Oncology, PLLC - SCRI - PPDS
🇺🇸Nashville, Tennessee, United States
Universitaetsklinik Salzburg
🇦🇹Salzburg, Austria
Local Institution
🇵🇹Porto, Portugal
Local Institution - 0039
🇨🇦Montreal, Quebec, Canada
Local Institution - 0152
🇺🇸Greenville, South Carolina, United States
Local Institution - 0163
🇺🇸Fayetteville, Arkansas, United States
Klinikum Wels-Grieskirchen Gmbh
🇦🇹Wels, Austria
Wilhelminenspital
🇦🇹Wien, Austria
Local Institution - 0095
🇺🇸New Brunswick, New Jersey, United States
Local Institution - 0142
🇺🇸Paramus, New Jersey, United States
Local Institution - 0069
🇺🇸Germantown, Tennessee, United States
Local Institution - 0157
🇨🇦Rimouski, Quebec, Canada