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An Investigational Immuno-therapy Study of Nivolumab, Pomalidomide and Dexamethasone Combinations in Patients With Multiple Myeloma (CheckMate 602)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02726581
Recruitment Status : Active, not recruiting
First Posted : April 1, 2016
Last Update Posted : August 29, 2019
Sponsor:
Collaborator:
AbbVie
Information provided by (Responsible Party):
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.


Condition or disease Intervention/treatment Phase
Multiple Myeloma Biological: Nivolumab Biological: Elotuzumab Drug: Pomalidomide Drug: Dexamethasone Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 348 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open-Label, Randomized Phase 3 Trial of Combinations of Nivolumab, Pomalidomide and Dexamethasone in Relapsed and Refractory Multiple Myeloma
Actual Study Start Date : April 21, 2016
Estimated Primary Completion Date : March 15, 2020
Estimated Study Completion Date : December 8, 2022


Arm Intervention/treatment
Experimental: Investigational Arm

Nivolumab, Pomalidomide and Dexamethasone

Enrollment is closed for this arm

Biological: Nivolumab
Specified dose on specified days, IV (intravenous)
Other Name: BMS-936558

Drug: Pomalidomide
Specified dose on specified days, PO (by mouth)

Drug: Dexamethasone
Specified dose on specified days, PO

Active Comparator: Control Arm

Pomalidomide and Dexamethasone

Enrollment is closed for this arm

Drug: Pomalidomide
Specified dose on specified days, PO (by mouth)

Drug: Dexamethasone
Specified dose on specified days, PO

Experimental: Exploratory Arm

Nivolumab, Elotuzumab, Pomalidomide and Dexamethasone

Enrollment is closed for this arm

Biological: Nivolumab
Specified dose on specified days, IV (intravenous)
Other Name: BMS-936558

Biological: Elotuzumab
Specified dose on specified days, IV
Other Name: BMS-901608

Drug: Pomalidomide
Specified dose on specified days, PO (by mouth)

Drug: Dexamethasone
Specified dose on specified days, PO




Primary Outcome Measures :
  1. Progression free survival (PFS) by investigator [ Time Frame: Approximately 47 months from the time of 1st patient randomization ]

Secondary Outcome Measures :
  1. Overall Survival (OS) [ Time Frame: Approximately 47 months from the time of 1st patient randomization ]
  2. Time to objective response (TTR) by investigator [ Time Frame: Approximately 47 months from the time of 1st patient randomization ]
  3. Duration of objective response (DOR) by investigator [ Time Frame: Approximately 47 months from the time of 1st patient randomization ]
  4. Objective response rate (ORR) by investigator [ Time Frame: Approximately 47 months from the time of 1st patient randomization ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com

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 could apply


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02726581


  Hide Study Locations
Locations
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United States, Alabama
Uab Comprehensive Cancer Center
Birmingham, Alabama, United States, 35294
Southern Cancer Center Pc
Mobile, Alabama, United States, 36608
United States, Arkansas
Highland Oncology Group
Fayetteville, Arkansas, United States, 72703
United States, California
CBCC Global Research, Inc.
Bakersfield, California, United States, 93309
Compassionate Cancer Res Grp
Corona, California, United States, 92879
Compassionate Cancer Res Grp
Fountain Valley, California, United States, 92708
Scripps Health Dba Scripps Clinical Research Services
La Jolla, California, United States, 92037
UC San Diego Moores Cancer Ctr
La Jolla, California, United States, 92093-0698
Los Angeles Hematology/Oncology Medical Group
Los Angeles, California, United States, 90017
Ronald Reagan Ucla Medical Center
Los Angeles, California, United States, 90095
Torrance Health Association
Redondo Beach, California, United States, 90277
Compassionate Cancer Res Grp
Riverside, California, United States, 92501
San Luis Obispo Oncology & Hematology Health Center
San Luis Obispo, California, United States, 93401
Central Coast Med Oncology
Santa Maria, California, United States, 93454
United States, Colorado
Colorado Blood Cancer Institute
Denver, Colorado, United States, 80218
Poudre Valley Health Care
Fort Collins, Colorado, United States, 80528
St. Mary's Hospital Regional Cancer Center
Grand Junction, Colorado, United States, 81501
United States, Connecticut
Yale University School Of Medicine
New Haven, Connecticut, United States, 06520
United States, Florida
University Cancer Institute
Boynton Beach, Florida, United States, 33426
Florida Cancer Specialists S.
Fort Myers, Florida, United States, 33916
Memorial Healthcare System
Hollywood, Florida, United States, 33021
Cancer Specialists of North FL
Jacksonville, Florida, United States, 32256
Florida Cancer Specialists
Saint Petersburg, Florida, United States, 33705
Florida Cancer Specialists
Tallahassee, Florida, United States, 32308
Florida Cancer Specialists
West Palm Beach, Florida, United States, 33401
United States, Georgia
University Cancer Blood Ctr
Athens, Georgia, United States, 30607
Piedmont Cancer Institute, PC
Atlanta, Georgia, United States, 30318
Winship Cancer Institute.
Atlanta, Georgia, United States, 30322
Augusta University
Augusta, Georgia, United States, 30912
United States, Illinois
Rush University Medical Center
Chicago, Illinois, United States, 60612
United States, Indiana
Ft. Wayne Med Onco-Hema Inc
Fort Wayne, Indiana, United States, 46845
Indiana University Cancer Ctr
Indianapolis, Indiana, United States, 46202
United States, Maryland
St. Agnes Healthcare, Inc.
Baltimore, Maryland, United States, 21229
Regional Cancer Care Associates, LLC
Bethesda, Maryland, United States, 20817
United States, Massachusetts
Department Of Medicine Division Of Hematology/Oncology
Worcester, Massachusetts, United States, 01655
United States, Mississippi
Hattiesburg Clinic
Hattiesburg, Mississippi, United States, 39401
United States, Missouri
St. Louis Cancer Care, Llp
Bridgeton, Missouri, United States, 63044
HCA Midwest Division
Kansas City, Missouri, United States, 64132
Washington University
Saint Louis, Missouri, United States, 63110
Mercy Medical Research Institute
Springfield, Missouri, United States, 65806
United States, Nebraska
Southeast Nebraska Cancer Center
Lincoln, Nebraska, United States, 68510
United States, New Jersey
Hunterdon Hematology Oncology
Flemington, New Jersey, United States, 08822
John Theurer Cancer Center
Hackensack, New Jersey, United States, 07061
The Cancer Institute Of New Jersey
New Brunswick, New Jersey, United States, 08903
The Valley Hospital
Paramus, New Jersey, United States, 07652
United States, New York
Roswell Park Cancer Institute
Buffalo, New York, United States, 14263
Broome Oncology
Johnson City, New York, United States, 13790
Mount Sinai Medical Center
New York, New York, United States, 10029
Weill Cornell Medical College
New York, New York, United States, 10065
United States, North Carolina
Duke University Medical Center
Durham, North Carolina, United States, 27710
Wake Forest Baptist Health
Winston-Salem, North Carolina, United States, 27157
United States, Ohio
Mid Ohio Oncology Hematology
Columbus, Ohio, United States, 43219
United States, Oklahoma
University Of Oklahoma
Oklahoma City, Oklahoma, United States, 73104
United States, Oregon
Providence Portland Med Ctr
Portland, Oregon, United States, 97213
United States, Pennsylvania
Lancaster General Hospital
Lancaster, Pennsylvania, United States, 17604
University Of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
Donald Guthrie Foundation
Sayre, Pennsylvania, United States, 18840
United States, South Carolina
Greenville Health System
Greenville, South Carolina, United States, 29605
United States, Tennessee
The West Clinic
Germantown, Tennessee, United States, 38138
Tennessee Oncology, PLLC
Nashville, Tennessee, United States, 37203
United States, Texas
Baylor Research Institute
Dallas, Texas, United States, 75246
Millennium Oncology
Houston, Texas, United States, 77090
CTRC at UTHSC San Antonio
San Antonio, Texas, United States, 78229
Scott And White Memorial Hosp
Temple, Texas, United States, 76508-0001
United States, Utah
Northern Utah Associates
Ogden, Utah, United States, 84403
Utah Cancer Specialists
Salt Lake City, Utah, United States, 84106
United States, Virginia
Emily Couric Clinical Cancer Center
Charlottesville, Virginia, United States, 22908
Virginia Cancer Institute
Richmond, Virginia, United States, 23230
United States, Washington
Va Puget Sound Health Care System
Seattle, Washington, United States, 98108
Austria
Elisabethinen Hospital Dept of Medicine
Linz, Austria, 4020
Universitaetsklinik Salzburg
Salzburg, Austria, 5020
Akh
Vienna, Austria, 1090
Klinikum Wels-Grieskirchen Gmbh
Wels, Austria, 4600
Wilhelminenspital
Wien, Austria, 1160
Canada, Alberta
Local Institution
Edmonton, Alberta, Canada, T6G 1Z2
Canada, British Columbia
Local Institution
Vancouver, British Columbia, Canada, V5Z 1M9
Canada, Ontario
Local Institution
Toronto, Ontario, Canada, M5G 2M9
Canada, Quebec
MUHC - Glen Site
Montreal, Quebec, Canada, H4A 3J1
CIUSSS du Nord-de-l'ile-de-Montreal - Hopital du Sacre-Coeur de Montreal
Montreal, Quebec, Canada, H4J 1C5
CISSS du Bas-Saint-Laurent Hopital Regional de Rimouski
Rimouski, Quebec, Canada, G5L 5T1
Canada
Centre Hospitalier De L'Universite De Montreal
Montreal, Canada, H2X 3E4
Local Institution
Quebec, Canada, G1R 2J6
Czechia
Interni hematologicka a onkologicka klinika
Brno, Czechia, 625 00
Klinika hematoonkologie
Ostrava-Poruba, Czechia, 708 52
I. interni klinika - klinika hematologie 1. LF UK a VFN v Praze
Praha 2, Czechia, 128 08
Denmark
Local Institution
Aarhus, Denmark, 8200
Local Institution
Odense, Denmark, 5000
Germany
Charite Universitatsmedizin Berlin
Berlin, Germany, 12200
Universitaetsklinikum Carl Gustav Carus
Dresden, Germany, 01307
Uniklinikum Duesseldorf
Duesseldorf, Germany, 40225
Universitaetsklink Schleswig-Holstein
Kiel, Germany, 24105
Klinikum Der Johannes Gutenberg Universitaet Mainz
Mainz, Germany, 55101
University Hopistal ULM Dept of Internal Medizin
Ulm, Germany, 89081
Greece
Alexandra General Hospital Of Athens
Athens, Greece, 11528
Israel
Local Institution
Beer Sheva, Israel, 84101
Local Institution
Jerusalem, Israel, 9112001
Local Institution
Petah Tikva, Israel, 4941492
Local Institution
Ramat-gan, Israel, 52621
Local Institution
Tel Aviv, Israel, 64239
Italy
Azienda Ospedaliero Universitaria Ospedali Riuniti Di Ancona
Ancona, Italy, 60126
ASST Papa Giovanni XXIII
Bergamo, Italy, 24127
A. O. U. Di Bologna, Policlinico S. Orsola Malpighi
Bologna, Italy, 40138
Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (IRST)
Meldola (FC), Italy, 47014
Azienda Ospedaliera S. Maria
Terni, Italy, 05100
Azienda Ospedaliera Citta' Della Salute E Della Scienza Di Torino
Torino, Italy, 10126
Norway
Local Institution
Oslo, Norway, 0372
Local Institution
Stavanger, Norway, 4011
Portugal
Local Institution
Lisboa, Portugal, 1400-038
Local Institution
Porto, Portugal, 4200-072
Puerto Rico
Auxilio Mutuo Cancer Center
San Juan, Puerto Rico, 00918
Spain
Local Institution
Pozuelo De Alarcon, Madrid, Spain, 28223
Local Institution
Badalona-Barcelona, Spain, 08916
Local Institution
Barcelona, Spain, 08035
Local Institution
Pamplona, Spain, 31008
Local Institution
Salamanca, Spain, 37007
Sweden
Local Institution
Stockholm, Sweden, 141 86
Switzerland
Hopitaux Universitaires de Geneve
Geneve, Switzerland, 1211
Sponsors and Collaborators
Bristol-Myers Squibb
AbbVie
Investigators
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Study Director: Bristol-Myers Squibb Bristol-Myers Squibb

Additional Information:
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Responsible Party: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT02726581     History of Changes
Other Study ID Numbers: CA209-602
2015-005699-21 ( EudraCT Number )
First Posted: April 1, 2016    Key Record Dates
Last Update Posted: August 29, 2019
Last Verified: August 2019

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Multiple Myeloma
Neoplasms, Plasma Cell
Neoplasms by Histologic Type
Neoplasms
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Paraproteinemias
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Lymphoproliferative Disorders
Immunoproliferative Disorders
Immune System Diseases
Thalidomide
Dexamethasone
Dexamethasone acetate
Nivolumab
Pomalidomide
Elotuzumab
BB 1101
Anti-Inflammatory Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists