Safety and Efficacy of Pomalidomide, Bortezomib and Low-dose Dexamethasone in Subjects With Relapsed or Refractory Multiple Myeloma

Last updated: June 5, 2023
Sponsor: Celgene
Overall Status: Completed

Phase

3

Condition

Platelet Disorders

Bone Diseases

Bone Neoplasm

Treatment

Dexamethasone

Bortezomib

Pomalidomide

Clinical Study ID

NCT01734928
CC-4047-MM-007
  • Ages > 18
  • All Genders

Study Summary

The purpose of this study is to compare the efficacy of the combination of pomalidomide, bortezomib and low dose dexamethasone to the combination of bortezomib and low dose dexamethasone in participants with relapsed/refractory multiple myeloma. This study will also assess how safe the combination of pomalidomide, bortezomib and low dose dexamethasone is compared to the combination of bortezomib and low dose dexamethasone.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Must be ≥ 18 years at the time of signing informed consent.
  • Must have documented diagnosis of multiple myeloma and have measureable disease byserum and urine protein electrophoresis.
  • Must have had at least 1 but no greater than 3 prior anti-myeloma regimens.
  • Must have documented disease progression during or after their last anti-myelomatherapy.
  • All subjects must have received prior treatment with a lenalidomide containing regimenfor at least 2 consecutive cycles.

Exclusion

Exclusion Criteria:

  • Documented progressive disease during therapy or within 60 days of the last dose of abortezomib-containing therapy under the 1.3 mg/m^2 dose twice weekly dosing schedule.
  • Peripheral neuropathy Grade 3, Grade 4 or Grade 2 with pain within 14 days prior torandomization.
  • Non-secretory multiple myeloma.
  • Subjects with severe renal impairment requiring dialysis.
  • Previous therapy with pomalidomide.

Study Design

Total Participants: 559
Treatment Group(s): 3
Primary Treatment: Dexamethasone
Phase: 3
Study Start date:
January 07, 2013
Estimated Completion Date:
May 13, 2022

Connect with a study center

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    Santa Fe, 3000
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    Australia

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    St. Pölten, 3100
    Austria

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    St. Pölten, 3100
    Austria

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  • Local Institution - 480

    Vienna, 1090
    Austria

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  • Local Institution - 481

    Vienna, 1160
    Austria

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    Vienna, 1090
    Austria

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  • Wilhelminenspital-Center for Hematology and Oncology

    Vienna, 1160
    Austria

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    Oshawa, Ontario L1G 2B9
    Canada

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    Oshawa, Ontario L1G 2B9
    Canada

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  • CSSS Champlain Charles LeMoyne

    Greenfield Park, Quebec J4V 2H1
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    Greenfield Park, Quebec J4V 2H1
    Canada

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  • Centre De Sante Et De Services Sociaux De Rimouski-Neigette

    Rimouski, Quebec G5L5T1
    Canada

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  • Centre Hospitalier Universitaire de Sherbrooke-Hospital Fleurimont

    Sherbrooke, Quebec J1H5N4
    Canada

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    Sherbrooke, Quebec J1H5N4
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    Halifax, B3H 2Y9
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    Aarhus, 8000
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    Vejle, 7100
    Denmark

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    Denmark

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    Helsinki, 290
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    Helsinki, 290
    Finland

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    Hyvinkaa, 05850
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    Hyvinkaa, 05850
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    Bayonne, 64109
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    Grenoble Cedex 09, 38043
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    Lille, 59037
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    Lille, 59037
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    Pierre-Benite, 69495
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    Pierre-Bénite Cedex, 69495
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    Poitiers Cedex, 86021
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    Rennes, 35033
    France

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    Toulouse Cedex, 31052
    France

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    Tours, 37044
    France

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    Tours cedex, 37044
    France

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    Tours cedex, 37044
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    Aachen, 52074
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    Baden-Warttemberg, 73557
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    Berlin, D-13353
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    Tuebingen, 72076
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    Ulm, 89075
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    Mexourlo, Larissa, 41110
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    Mezourlo, 41110
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    Mezourlo, 41110
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    Thessloniki, 57010
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    Dublin, Dublin 7
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    Modena, 41100
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    Modena, 41100
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    Pavia, 27100
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    Pescara, 65124
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    Reggio Emilia, 42100
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    Rome, 00161
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    Salerno, 84131
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    San Giovanni Rotondo, 71013
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    Terni, 05100
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    Terni, 05100
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    Torino, 10126
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    Torino, 10126
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    Shibuya, 150-8935
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    Shibuya-ku, 150-8935
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    Shibuya-ku, 150-8935
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    Tachikawa, 190-0014
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    Tachikawa, 190-0014
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    Groningen, 9713 GZ
    Netherlands

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    Groningen, 9713 GZ
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    Leeuwarden, 8934 AD
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    Rotterdam, 3015 CN
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    Rotterdam, 3015 CN
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    Oslo, 0372
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    Oslo, 0372
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    Trondheim, 7006
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    Brzozow, 36-200
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    Brzozow, 36-200
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    Bydgoszcz, 85-168
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    Chorzow, 41-500
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    Chorzow, 41-500
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    Gdansk, 80-952
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    Gdansk, 80-952
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    Krakow, 31-501
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    Krakow, 31-501
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    Lodz, 93-510
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    Lodz, 93-510
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    Lublin, 20-081
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    Lublin, 20-081
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    Poznan, 60-569
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    Poznan, 60-569
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    Warszawa, 02-781
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    Wroclaw, 50-367
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    Braga, 4710-243
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    Braga, 4710-243
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    Lisboa, 1649-035
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    Lisboa, 1099-023
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    Lisboa, 1099-023
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    Lisboa, 1649-035
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    Lisbon, 1400-038
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    Lisbon, 1400-038
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    Porto,
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    Porto, 4200-072
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    Porto, 4200-072
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    Porto, 0
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    Ponce, 00717
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    Moscow, 123182
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    Moscow, 125284
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    Moscow, 123182
    Russian Federation

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    Moscow, 125284
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    Nizhny Novgorod, 603126
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    Nizhny Novgorod, 603126
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    Saint Petersburg, 191024
    Russian Federation

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    Badalona (Barcelona), 08916
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    Badalona (Barcelona), 08916
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    Barcelona, 08036
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    Barcelona, 08036
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    Bilbao, 48013
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    Madrid, 28041
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    Madrid, 28041
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    Murcia, 30008
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    Murcia, 30008
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    Orense, 32005
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    Orense, 32005
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    Pamplona, 31008
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    Pamplona, 31008
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    Sevilla, 41014
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    Sevilla, 41014
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    Valencia, 46026
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    Boras, 501-82
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    Falun, 79182
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    Falun, 79182
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    Gothenburg, 60 Gothenburg
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    Gothenburg, 60 Gothenburg
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    Luleå, SE-971 80
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    Lund, 221 85
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    Stockholm, 14186
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    Stockholm, 14186
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    Sundsvall, S-85643
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    Ankara, Dikimevi Cebeci
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    Ankara, 06590
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    Ankara, 6500
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    Ankara, Dikimevi Cebeci
    Turkey

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    Ankara, 6500
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    Ankara, 06590
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    Eskisehir, 26480
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    Eskisehir, 26480
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    Gaziantep,
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    Gaziantep, 0
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    Istanbul, 34098
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    Istanbul, 34390
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    Istanbul, 34098
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    Istanbul, 34390
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    Izmir, 35100
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    Izmir, 35100
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    Trabzon, 61080
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    Trabzon, 61080
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    Canterbury Kent, CT1 3NG
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    Edinburgh Scotland, EH4 2XU
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    London, SE5 9RS
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    London, SE5 9RS
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    London, NW1 2PG
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    London, NW1 2PG
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    Oxford, OX3 7DQ
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    Oxford, OX3 7DQ
    United Kingdom

    Site Not Available

  • Derriford Hospital Plymouth Oncology Centre Clinical Trials Unit

    Plymouth, PL6 8DH
    United Kingdom

    Site Not Available

  • Local Institution - 515

    Plymouth, PL6 8DH
    United Kingdom

    Site Not Available

  • Local Institution - 500

    Sheffield, S10 2JF
    United Kingdom

    Site Not Available

  • Sheffield Teaching Hospitals NHS Foundation Trust - Royal Hallamshire Hospital

    Sheffield, S10 2JF
    United Kingdom

    Site Not Available

  • Local Institution - 493

    Southampton, SO16 6YD
    United Kingdom

    Site Not Available

  • Southampton General Hospital

    Southampton, SO16 6YD
    United Kingdom

    Site Not Available

  • University Hospital of North Staffordshire Nhs Trust - City General Hospital

    Stoke-On-Trent, ST4 6QG
    United Kingdom

    Site Not Available

  • Local Institution - 405

    Swansea, SA2 8QA
    United Kingdom

    Site Not Available

  • Singleton Hospital

    Swansea, SA2 8QA
    United Kingdom

    Site Not Available

  • Local Institution - 482

    Wolverhampton, WV10 OPQ
    United Kingdom

    Site Not Available

  • New Cross Hospital

    Wolverhampton, WV10 OPQ
    United Kingdom

    Site Not Available

  • Local Institution - 436

    Worcester, WR5 1DD
    United Kingdom

    Site Not Available

  • Worcestershire Acute Hospitals NHS Trust

    Worcester, WR5 1DD
    United Kingdom

    Site Not Available

  • Southern Cancer Center

    Mobile, Alabama 36608
    United States

    Site Not Available

  • Arizona Oncology

    Tucson, Arizona 85710
    United States

    Site Not Available

  • University of Arizona Cancer Center

    Tucson, Arizona 85724
    United States

    Site Not Available

  • Alta Bates Comprehensive Cancer Center

    Berkeley, California 94704
    United States

    Site Not Available

  • University of California San Francisco Fresno Campus

    Fresno, California 93701
    United States

    Site Not Available

  • Marin Oncology Associates

    Greenbrae, California 94904-2007
    United States

    Site Not Available

  • Moore UCSD Cancer Center

    La Jolla, California 92083
    United States

    Site Not Available

  • USC Norris Comprehensive Cancer Center

    Los Angeles, California 90033
    United States

    Site Not Available

  • Sutter Pacific Medical Foundation

    Santa Rosa, California 95403
    United States

    Site Not Available

  • University of Colorado Cancer Center

    Aurora, Colorado 80045
    United States

    Site Not Available

  • Cancer Center of Central Connecticut

    Southington, Connecticut 06489
    United States

    Site Not Available

  • Local Institution - 153

    Southington, Connecticut 06489
    United States

    Site Not Available

  • George Washington Medical Center

    Washington, District of Columbia 20037
    United States

    Site Not Available

  • George Washington Medical Center

    Washington, D.C., District of Columbia 20037
    United States

    Site Not Available

  • Lynn Cancer Institute

    Boca Raton, Florida 33486
    United States

    Site Not Available

  • University Cancer Institute

    Boynton Beach, Florida 33426
    United States

    Site Not Available

  • Broward Oncology Assoc.

    Fort Lauderdale, Florida 33316
    United States

    Site Not Available

  • Broward Oncology Associates PA

    Fort Lauderdale, Florida 33308
    United States

    Site Not Available

  • Broward Oncology Associates PA

    Ft. Lauderdale, Florida 33308
    United States

    Site Not Available

  • University of Florida

    Gainesville, Florida 32610
    United States

    Site Not Available

  • Alves Domenech Oncology and Hematology Clinic

    Hollywood, Florida 33021
    United States

    Site Not Available

  • Palm Beach Cancer Institute, LLC

    West Palm Beach, Florida 33401
    United States

    Site Not Available

  • Local Institution - 135

    Marietta, Georgia 30060
    United States

    Site Not Available

  • Northwest Georgia Oncology Centers, PCWilliam S. Gibbons Center Research Institute

    Marietta, Georgia 30060
    United States

    Site Not Available

  • University of Chicago

    Chicago, Illinois 60637-1470
    United States

    Site Not Available

  • Investigative Clinical Research of Indiana, LLC

    Indianapolis, Indiana 46254
    United States

    Site Not Available

  • University of Iowa

    Iowa City, Iowa 52242
    United States

    Site Not Available

  • Western Kentucky Hematology and Oncology Group, PSC

    Paducah, Kentucky 42003
    United States

    Site Not Available

  • Western Kentucky Hematology and Oncology Group, PSC

    Paducak, Kentucky 42003
    United States

    Site Not Available

  • Tulane University Medical Center

    New Orleans, Louisiana 70112
    United States

    Site Not Available

  • Cancer Care of Maine

    Bangor, Maine 04401
    United States

    Site Not Available

  • Local Institution - 132

    Bangor, Maine 04401
    United States

    Site Not Available

  • Celgene Study Site

    Brewer, Maine 04412
    United States

    Site Not Available

  • St. Agnes - Medical Center

    Baltimore, Maryland 21229-5299
    United States

    Site Not Available

  • Center for Cancer and Blood Disorders

    Bethesda, Maryland 20817
    United States

    Site Not Available

  • Local Institution - 125

    Bethesda, Maryland 20817
    United States

    Site Not Available

  • Medstar Health Research Institute

    Hyattsville, Maryland 20782
    United States

    Site Not Available

  • Beth Israel Deaconess Medical Center

    Boston, Massachusetts 02215
    United States

    Site Not Available

  • Dana Farber Cancer Institute

    Boston, Massachusetts 02115
    United States

    Site Not Available

  • Local Institution - 100

    Boston, Massachusetts 02115
    United States

    Site Not Available

  • Local Institution - 298

    Boston, Massachusetts 02215
    United States

    Site Not Available

  • Local Institution - 299

    Boston, Massachusetts 02114
    United States

    Site Not Available

  • Massachusetts General Hospital

    Boston, Massachusetts 02114
    United States

    Site Not Available

  • Henry Ford Medical Center - New Center One

    Detroit, Michigan 48202-268
    United States

    Site Not Available

  • Local Institution - 178

    Detroit, Michigan 48202-268
    United States

    Site Not Available

  • Cancer and Hematology Centers of Western Michigan

    Grand Rapids, Michigan 49546
    United States

    Site Not Available

  • Detroit Clinical Research Center

    Lansing, Michigan 48912
    United States

    Site Not Available

  • Beaumont Cancer Center

    Royal Oak, Michigan 48073
    United States

    Site Not Available

  • Essentia Health Duluth CCOP

    Duluth, Minnesota 55805
    United States

    Site Not Available

  • Metro MN CCOP

    Saint Louis Park, Minnesota 55416
    United States

    Site Not Available

  • Metro MN CCOP

    St. Louis Park, Minnesota 55416
    United States

    Site Not Available

  • Columbia Comprehensive

    Jefferson City, Missouri 65203
    United States

    Site Not Available

  • Kansas City VA Medical Center University of Kansas Medical Center

    Kansas City, Missouri 64128
    United States

    Site Not Available

  • St John's Mercy Medical Center

    Saint Louis, Missouri 63141
    United States

    Site Not Available

  • St. John's Clinic Cancerand Hematology - Springfield

    Springfield, Missouri 65804
    United States

    Site Not Available

  • St John's Mercy Medical Center

    St Louis, Missouri 63141
    United States

    Site Not Available

  • Celgene Study Site

    St. Louis, Missouri 63141
    United States

    Site Not Available

  • Billings Clinic

    Billings, Montana 59102
    United States

    Site Not Available

  • Southeast Nebraska Cancer Center

    Lincoln, Nebraska 68510
    United States

    Site Not Available

  • CarePoint Health Research Institute

    Jersey City, New Jersey 07306
    United States

    Site Not Available

  • Hematology-Oncology Associates of NNJ, P

    Morristown, New Jersey 07960
    United States

    Site Not Available

  • Somerset Hematology-Oncology Associates

    Somerville, New Jersey 08876
    United States

    Site Not Available

  • Local Institution - 186

    Bronx, New York 10467
    United States

    Site Not Available

  • Montefiore Medical Center

    Bronx, New York 10467
    United States

    Site Not Available

  • Mount Sinai Hospital

    New York, New York 10029
    United States

    Site Not Available

  • Stony Brook University

    Stony Brook, New York 11794-7300
    United States

    Site Not Available

  • Montefiore Medical Center

    The Bronx, New York 10467
    United States

    Site Not Available

  • New York Medical College

    Valhalla, New York 10595
    United States

    Site Not Available

  • Eastern Institute of Medical Sciences

    Greenville, North Carolina 27834
    United States

    Site Not Available

  • Boice-Willis Clinic P.A.

    Rocky Mount, North Carolina 27804
    United States

    Site Not Available

  • Gabrail Cancer Center Research

    Canton, Ohio 44718
    United States

    Site Not Available

  • Local Institution - 111

    Canton, Ohio 44718
    United States

    Site Not Available

  • MetroHealth Medical Systems

    Cleveland, Ohio 44109
    United States

    Site Not Available

  • Mid Ohio Oncology Hematology Inc

    Columbus, Ohio 43219
    United States

    Site Not Available

  • University of Toledo Medical Center

    Toledo, Ohio 43614
    United States

    Site Not Available

  • Providence Portland Medical Center

    Portland, Oregon 97213
    United States

    Site Not Available

  • Med Univ of South Carolina

    Charleston, South Carolina 29425
    United States

    Site Not Available

  • Spartanburg Regional Healthcare System - Gibbs Cancer Center & Research Institute

    Spartanburg, South Carolina 29303
    United States

    Site Not Available

  • Avera Research Institute

    Sioux Falls, South Dakota 57105
    United States

    Site Not Available

  • Local Institution - 167

    Watertown, South Dakota 57201
    United States

    Site Not Available

  • Prairie Lakes Health Care System

    Watertown, South Dakota 57201
    United States

    Site Not Available

  • University of Tennessee Medical Center - Cancer Institute

    Knoxville, Tennessee 37885
    United States

    Site Not Available

  • Vanderbilt University Medical Center

    Nashville, Tennessee 37232-5505
    United States

    Site Not Available

  • Local Institution - 114

    Dallas, Texas 75390
    United States

    Site Not Available

  • UT Southwestern Medical Center

    Dallas, Texas 75390
    United States

    Site Not Available

  • Brooke Army Medical Center Francis Street Medical Center

    Fort Sam Houston, Texas 78235-8200
    United States

    Site Not Available

  • Local Institution - 103

    Fort Sam Houston, Texas 78235-8200
    United States

    Site Not Available

  • Brooke Army Medical Center Francis Street Medical Center

    Ft. Sam Houston, Texas 78235-8200
    United States

    Site Not Available

  • Local Institution - 130

    Houston, Texas 77090
    United States

    Site Not Available

  • Northwest Cancer Center

    Houston, Texas 77090
    United States

    Site Not Available

  • Joe Arrington Cancer Research and Treatment Center

    Lubbock, Texas 79410
    United States

    Site Not Available

  • Huntsman Cancer Institute at the University of Utah

    Salt Lake City, Utah 84112
    United States

    Site Not Available

  • Utah Cancer Specialist

    Salt Lake City, Utah 84106
    United States

    Site Not Available

  • Swedish Cancer Inst

    Seattle, Washington 98104
    United States

    Site Not Available

  • Medical Oncology Associates

    Spokane, Washington 99208
    United States

    Site Not Available

  • Wenatchee Valley Hospital and Clinics

    Wenatchee, Washington 98801
    United States

    Site Not Available

  • Local Institution - 139

    Morgantown, West Virginia 25606
    United States

    Site Not Available

  • West Virginia University CTRU

    Morgantown, West Virginia 25606
    United States

    Site Not Available

  • University of Wisconsin

    Madison, Wisconsin 53792
    United States

    Site Not Available

  • Local Institution - 136

    Milwaukee, Wisconsin 53226
    United States

    Site Not Available

  • Medical College of Wisconsin

    Milwaukee, Wisconsin 53226
    United States

    Site Not Available

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