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

Sponsor
Bristol-Myers Squibb (Industry)
Overall Status
Completed
CT.gov ID
NCT02726581
Collaborator
AbbVie (Industry)
170
Enrollment
117
Locations
3
Arms
66.9
Actual Duration (Months)
1.5
Patients Per Site
0
Patients Per Site Per Month

Study Details

Study Description

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
Phase 3

Study Design

Study Type:
Interventional
Actual Enrollment :
170 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 :
Aug 10, 2016
Actual Primary Completion Date :
Mar 9, 2022
Actual Study Completion Date :
Mar 9, 2022

Arms and Interventions

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 Names:
  • 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 Names:
  • BMS-936558

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

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

    Drug: Dexamethasone
    Specified dose on specified days, PO

    Outcome Measures

    Primary Outcome Measures

    1. Progression free survival (PFS) by investigator [Approximately 47 months from the time of 1st patient randomization]

    Secondary Outcome Measures

    1. Overall Survival (OS) [Approximately 47 months from the time of 1st patient randomization]

    2. Time to objective response (TTR) by investigator [Approximately 47 months from the time of 1st patient randomization]

    3. Duration of objective response (DOR) by investigator [Approximately 47 months from the time of 1st patient randomization]

    4. Objective response rate (ORR) by investigator [Approximately 47 months from the time of 1st patient randomization]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Local Institution - 0020 Birmingham Alabama United States 35294-3300
    2 Southern Cancer Center Pc Mobile Alabama United States 36608
    3 Highland Oncology Group Fayetteville Arkansas United States 72703
    4 CBCC Global Research, Inc. Bakersfield California United States 93309
    5 Compassionate Cancer Res Grp Corona California United States 92879
    6 Compassionate Cancer Res Grp Fountain Valley California United States 92708
    7 Scripps Health Dba Scripps Clinical Research Services La Jolla California United States 92037
    8 UC San Diego Moores Cancer Ctr La Jolla California United States 92093-0698
    9 Los Angeles Hematology/Oncology Medical Group Los Angeles California United States 90017
    10 Ronald Reagan Ucla Medical Center Los Angeles California United States 90095
    11 Torrance Health Association Redondo Beach California United States 90277
    12 Compassionate Cancer Res Grp Riverside California United States 92501
    13 Coastal Integrative Cancer Care San Luis Obispo California United States 93401
    14 Central Coast Med Oncology Santa Maria California United States 93454
    15 Colorado Blood Cancer Institute Denver Colorado United States 80218
    16 Poudre Valley Health Care Fort Collins Colorado United States 80528
    17 St. Mary's Hospital Med Ctr Grand Junction Colorado United States 81501
    18 Yale University School Of Medicine New Haven Connecticut United States 06520
    19 University Cancer Institute Boynton Beach Florida United States 33426
    20 Florida Cancer Specialists S. Fort Myers Florida United States 33916
    21 Memorial Cancer Institute Hollywood Florida United States 33021
    22 Cancer Specialists of North FL Jacksonville Florida United States 32256
    23 Florida Cancer Specialists Saint Petersburg Florida United States 33705
    24 Florida Cancer Specialists Tallahassee Florida United States 32308
    25 Florida Cancer Specialists West Palm Beach Florida United States 33401
    26 University Cancer Blood Ctr Athens Georgia United States 30607
    27 Piedmont Cancer Institute, PC Atlanta Georgia United States 30318
    28 Winship Cancer Institute. Atlanta Georgia United States 30322
    29 Augusta University Augusta Georgia United States 30912
    30 Rush University Medical Center Chicago Illinois United States 60612
    31 Ft. Wayne Med Onco-Hema Inc Fort Wayne Indiana United States 46845
    32 Indiana University Cancer Ctr Indianapolis Indiana United States 46202
    33 Regional Cancer Care Associates, LLC Bethesda Maryland United States 20817
    34 St. Agnes Healthcare, Inc. Baltimore Massachusetts United States 21229
    35 Local Institution - 0123 Worcester Massachusetts United States 01655
    36 Hattiesburg Clinic Hattiesburg Mississippi United States 39401
    37 St. Louis Cancer Care, Llp Bridgeton Missouri United States 63044
    38 HCA Midwest Division Kansas City Missouri United States 64132
    39 Washington University Saint Louis Missouri United States 63110
    40 Local Institution Springfield Missouri United States 65806
    41 Southeast Nebraska Cancer Center Lincoln Nebraska United States 68510
    42 Hunterdon Hematology Oncology Flemington New Jersey United States 08822
    43 John Theurer Cancer Center Hackensack New Jersey United States 07601
    44 The Cancer Institute Of New Jersey New Brunswick New Jersey United States 08903
    45 The Valley Hospital Paramus New Jersey United States 07652
    46 Roswell Park Cancer Institute Buffalo New York United States 14263
    47 Broome Oncology LLC Johnson City New York United States 13790
    48 Mount Sinai Medical Center New York New York United States 10029
    49 Weill Cornell Medical College New York New York United States 10065
    50 Duke University Medical Center Durham North Carolina United States 27710
    51 Wake Forest Baptist Health Winston-Salem North Carolina United States 27157
    52 Mid Ohio Oncology Hematology Columbus Ohio United States 43219
    53 University Of Oklahoma Oklahoma City Oklahoma United States 73104
    54 Providence Portland Med Ctr Portland Oregon United States 97213
    55 Lancaster General Hospital Lancaster Pennsylvania United States 17604
    56 University Of Pennsylvania Philadelphia Pennsylvania United States 19104
    57 Local Institution - 0036 Sayre Pennsylvania United States 18840
    58 Greenville Health System Greenville South Carolina United States 29605
    59 The West Clinic Germantown Tennessee United States 38138
    60 Tennessee Oncology, PLLC - SCRI - PPDS Nashville Tennessee United States 37203
    61 Baylor Research Institute Dallas Texas United States 75246
    62 Millennium Oncology Houston Texas United States 77090
    63 CTRC at UTHSC San Antonio San Antonio Texas United States 78229
    64 Scott And White Memorial Hosp Temple Texas United States 76508-0001
    65 Northern Utah Associates Ogden Utah United States 84403
    66 Utah Cancer Specialists Salt Lake City Utah United States 84106
    67 Emily Couric Clinical Cancer Center Charlottesville Virginia United States 22908
    68 Virginia Cancer Institute Richmond Virginia United States 23230
    69 Va Puget Sound Health Care System Seattle Washington United States 98108
    70 Elisabethinen Hospital Dept of Medicine Linz Austria 4020
    71 Universitaetsklinik Salzburg Salzburg Austria 5020
    72 Akh Vienna Austria 1090
    73 Klinikum Wels-Grieskirchen Gmbh Wels Austria 4600
    74 Wilhelminenspital Wien Austria 1160
    75 Local Institution Edmonton Alberta Canada T6G 1Z2
    76 Local Institution Vancouver British Columbia Canada V5Z 1M9
    77 Local Institution Toronto Ontario Canada M5G 2M9
    78 Centre Hospitalier De L'Universite De Montreal Montreal Quebec Canada H2X 3E4
    79 MUHC - Glen Site Montreal Quebec Canada H4A 3J1
    80 CIUSSS du Nord-de-l'ile-de-Montreal - Hopital du Sacre-Coeur de Montreal Montreal Quebec Canada H4J 1C5
    81 CISSS du Bas-Saint-Laurent Hopital Regional de Rimouski Rimouski Quebec Canada G5L 5T1
    82 Local Institution Quebec Canada G1R 2J6
    83 Interni hematologicka a onkologicka klinika Brno Czechia 625 00
    84 Klinika hematoonkologie Ostrava-Poruba Czechia 708 52
    85 I. interni klinika - klinika hematologie 1. LF UK a VFN v Praze Praha 2 Czechia 128 08
    86 Local Institution Aarhus Denmark 8200
    87 Local Institution Odense Denmark 5000
    88 Charite Universitatsmedizin Berlin Berlin Germany 12200
    89 Universitaetsklinikum Carl Gustav Carus Dresden Germany 01307
    90 Uniklinikum Duesseldorf Duesseldorf Germany 40225
    91 Universitaetsklink Schleswig-Holstein Kiel Germany 24105
    92 Klinikum Der Johannes Gutenberg Universitaet Mainz Mainz Germany 55101
    93 University Hopistal ULM Dept of Internal Medizin Ulm Germany 89081
    94 Alexandra General Hospital Of Athens Athens Greece 11528
    95 Local Institution Beer Sheva Israel 84101
    96 Local Institution Jerusalem Israel 9112001
    97 Local Institution Petah Tikva Israel 4941492
    98 Local Institution Ramat-gan Israel 52621
    99 Local Institution Tel Aviv Israel 64239
    100 Azienda Ospedaliero Universitaria Ospedali Riuniti Di Ancona Ancona Italy 60126
    101 ASST Papa Giovanni XXIII Bergamo Italy 24127
    102 A. O. U. Di Bologna, Policlinico S. Orsola Malpighi Bologna Italy 40138
    103 Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (IRST) Meldola (FC) Italy 47014
    104 Azienda Ospedaliera Santa Maria Terni Terni Italy 05100
    105 Azienda Ospedaliera Citta' Della Salute E Della Scienza Di Torino Torino Italy 10126
    106 Local Institution Oslo Norway 0372
    107 Local Institution Stavanger Norway 4011
    108 Local Institution Lisboa Portugal 1400-038
    109 Local Institution Porto Portugal 4200-072
    110 Auxilio Mutuo Cancer Center San Juan Puerto Rico 00918
    111 Local Institution Pozuelo De Alarcon Madrid Spain 28223
    112 Local Institution Badalona-Barcelona Spain 08916
    113 Local Institution Barcelona Spain 08035
    114 Local Institution Pamplona Spain 31008
    115 Local Institution Salamanca Spain 37007
    116 Local Institution Stockholm Sweden 141 86
    117 Hopitaux Universitaires de Geneve Geneve Switzerland 1211

    Sponsors and Collaborators

    • Bristol-Myers Squibb
    • AbbVie

    Investigators

    • Study Director: Bristol-Myers Squibb, Bristol-Myers Squibb

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    Bristol-Myers Squibb
    ClinicalTrials.gov Identifier:
    NCT02726581
    Other Study ID Numbers:
    • CA209-602
    • 2015-005699-21
    First Posted:
    Apr 1, 2016
    Last Update Posted:
    May 4, 2022
    Last Verified:
    Apr 1, 2022
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Multiple Myeloma
    Neoplasms, Plasma Cell
    Dexamethasone
    Nivolumab
    Pomalidomide
    Elotuzumab

    Study Results

    No Results Posted as of May 4, 2022