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

PHASE3CompletedINTERVENTIONAL
Enrollment

559

Participants

Timeline

Start Date

January 7, 2013

Primary Completion Date

May 9, 2022

Study Completion Date

May 13, 2022

Conditions
Multiple Myeloma
Interventions
DRUG

Pomalidomide

Pomalidomide 4 mg will be taken orally on Days 1-14 of a 21-day cycle.

DRUG

Bortezomib

Bortezomib 1.3 mg/m2 will be administered subcutaneously on Days 1, 4, 8 and 11 of 21 days for cycles 1 -8 and on Days 1, 8 of 21 days for cycle 9 and onward until disease progression.

DRUG

Dexamethasone

Dexamethasone 20 mg/day \[≤ 75 years old\] or 10 mg/day \[\>75 years old\] will be taken orally on Days 1, 2, 4, 5, 8, 9, 11, 12 of 21 days for cycles 1-8 and on Days 1, 2, 8, 9 of 21 days for cycles 9 and onward until disease progression.

Trial Locations (321)

0

Local Institution - 464, Porto

Local Institution - 421, Gaziantep

290

Helsinki University Central Hospital, Helsinki

Local Institution - 455, Helsinki

1090

Local Institution - 480, Vienna

Medical University of Vienna, Vienna

1160

Local Institution - 481, Vienna

Wilhelminenspital-Center for Hematology and Oncology, Vienna

2100

Copenhagen University Hospital Rigshosptalet, Copenhagen

Local Institution - 506, Copenhagen

3100

Hospital St. Polten, Sankt Pölten

Local Institution - 523, Sankt Pölten

6500

Gazi Universitesi Tip Fakultesi Hastanesi, Ankara

Local Institution - 409, Ankara

7006

St Olavs Hospital, Trondheim

7100

Local Institution - 499, Vejle

Vejle Hospital, Vejle

8000

Aarhus University Hospital, Aarhus

Local Institution - 447, Aarhus

10029

Mount Sinai Hospital, New York

10126

Azienda Ospedaliera San Giovanni Battista, Torino

Local Institution - 401, Torino

10467

Local Institution - 186, The Bronx

Montefiore Medical Center, The Bronx

10595

New York Medical College, Valhalla

10676

General Hospital of Athens Evangelismos, Athens

Local Institution - 484, Athens

11528

Local Institution - 422, Athens

University of Athens Medical school - Regional General Hospital, Athens

14186

Karolinska University, Stockholm

Local Institution - 471, Stockholm

20037

George Washington Medical Center, Washington D.C.

20782

Medstar Health Research Institute, Hyattsville

20817

Center for Cancer and Blood Disorders, Bethesda

Local Institution - 125, Bethesda

24127

Local Institution - 449, Bergamo

USC Ematologia, Azienda Ospedaliera Papa Giovanni XXIII, Bergamo

25606

Local Institution - 139, Morgantown

West Virginia University CTRU, Morgantown

26480

Eskisehir Osmangazi University, Eskişehir

Local Institution - 420, Eskişehir

27100

IRCCS Policlinico San Matteo, Pavia

Local Institution - 451, Pavia

27804

Boice-Willis Clinic P.A., Rocky Mount

27834

Eastern Institute of Medical Sciences, Greenville

28041

Hospital 12 de Octubre, Madrid

Local Institution - 452, Madrid

29303

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

29425

Med Univ of South Carolina, Charleston

30008

Hospital Morales Meseguer, Murcia

Local Institution - 502, Murcia

30060

Local Institution - 135, Marietta

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

31008

Clinica Universidad de Navarra, Pamplona

Local Institution - 434, Pamplona

31052

Institut Universitaire du Cancer de Toulouse (IUCT) - Oncopole, Toulouse

31096

Rambam Health Care Campus, Haifa

32005

Complejo Hospitalario De Orense, Ourense

Local Institution - 526, Ourense

32610

University of Florida, Gainesville

33021

Alves Domenech Oncology and Hematology Clinic, Hollywood

33308

Broward Oncology Associates PA, Fort Lauderdale

33316

Broward Oncology Assoc., Fort Lauderdale

33401

Palm Beach Cancer Institute, LLC, West Palm Beach

33426

University Cancer Institute, Boynton Beach

33486

Lynn Cancer Institute, Boca Raton

34098

Istanbul Universitesi Cerrahpasa Tip Fakultesi, Istanbul

Local Institution - 445, Istanbul

34390

Istanbul University Faculty of Medicine, Istanbul

Local Institution - 474, Istanbul

35033

CHRU Rennes, Rennes

Local Institution - 504, Rennes

35100

Ege University Medical School, Izmir

Local Institution - 419, Izmir

36608

Southern Cancer Center, Mobile

37044

CHRU Hopital Bretonneau, Tours

Local Institution - 468, Tours

37885

University of Tennessee Medical Center - Cancer Institute, Knoxville

38043

CHU Hotel, Grenoble

Local Institution - 483, Grenoble

40138

Local Institution - 456, Bologna

Policlinico S. Orsola - Malpighi, Bologna

41014

Complejo Hospitalario Nuestra Senora de Valme, Seville

Local Institution - 492, Seville

41100

Local Institution - 403, Modena

University of Modena, Modena

41110

Local Institution - 487, Mezourlo

University General Hospital of Larissa, Mezourlo

42003

Western Kentucky Hematology and Oncology Group, PSC, Paducah

42100

Azienda Ospedaliera di Reggio Emilia - Arcispedale Santa Maria Nuova, Reggio Emilia

Local Institution - 414, Reggio Emilia

43219

Mid Ohio Oncology Hematology Inc, Columbus

43614

University of Toledo Medical Center, Toledo

44035

CHRU Hotel Dieu, Nantes

Local Institution - 486, Nantes

44109

MetroHealth Medical Systems, Cleveland

44281

Local Institution - 433, Kfar Saba

Meir Medical Center, Kfar Saba

44718

Gabrail Cancer Center Research, Canton

Local Institution - 111, Canton

45147

Local Institution - 475, Essen

Universitaetsklinikum EssenInnere Klinik und Poliklinik, Essen

46026

Hospital Universitario y Politecnico La Fe, Valencia

46254

Investigative Clinical Research of Indiana, LLC, Indianapolis

48013

Hospital de Basurto-Osakidetza, Bilbao

48073

Beaumont Cancer Center, Royal Oak

48912

Detroit Clinical Research Center, Lansing

49546

Cancer and Hematology Centers of Western Michigan, Grand Rapids

52242

University of Iowa, Iowa City

52621

Chaim Sheba Medical Center, Ramat Gan

53226

Local Institution - 136, Milwaukee

Medical College of Wisconsin, Milwaukee

53792

University of Wisconsin, Madison

55416

Metro MN CCOP, Saint Louis Park

55805

Essentia Health Duluth CCOP, Duluth

57010

George Papanikolaou General Hospital of Thessaloniki, Thessloniki

Local Institution - 465, Thessloniki

57105

Avera Research Institute, Sioux Falls

57201

Local Institution - 167, Watertown

Prairie Lakes Health Care System, Watertown

59000

GH Institut Catholique St Vincent, Lille

59037

CHRU de Lille-Hopital Claude Huriez, Lille

Local Institution - 476, Lille

59102

Billings Clinic, Billings

61080

Karadeniz Teknik Universitesi Tip Fakultesi Farabi Hastanesi, Trabzon

Local Institution - 404, Trabzon

63141

St John's Mercy Medical Center, St Louis

64109

Centre Hospitalier de la cote basque, Bayonne

Local Institution - 469, Bayonne

64128

Kansas City VA Medical Center University of Kansas Medical Center, Kansas City

64239

Tel Aviv Sourasky Medical Center Department of Hematology, Tel Aviv

65124

Azienda Unita Sanitaria Locale (Ausl) Pescara - Presidio Ospedaliero Di Pescara, Pescara

Local Institution - 441, Pescara

65203

Columbia Comprehensive, Jefferson City

65804

St. John's Clinic Cancerand Hematology - Springfield, Springfield

68510

Southeast Nebraska Cancer Center, Lincoln

69120

Local Institution - 430, Heidelberg

University of Heidelberg, Heidelberg

69495

Centre Hospitalier Lyon Sud, Pierre-Bénite

Local Institution - 497, Pierre-Bénite

70112

Tulane University Medical Center, New Orleans

71013

IRCCS Casa Sollievo della Sofferenza, San Giovanni Rotondo

Local Institution - 453, San Giovanni Rotondo

71100

Centre Hospitalier William Morey, Chalon-sur-Saône

Local Institution - 498, Chalon-sur-Saône

72076

Local Institution - 410, Tübingen

UKT Universitaetsklinikum Tuebingen, Tübingen

75012

Groupement Hospitalier Universitaire Est - Hopital Saint-Antoine, Paris

75390

Local Institution - 114, Dallas

UT Southwestern Medical Center, Dallas

77090

Local Institution - 130, Houston

Northwest Cancer Center, Houston

79106

Local Institution - 496, Freiburg im Breisgau

Universitatsklinikum Freiburg, Freiburg im Breisgau

79182

Falu lasarett, Falun

Local Institution - 426, Falun

79410

Joe Arrington Cancer Research and Treatment Center, Lubbock

80045

University of Colorado Cancer Center, Aurora

84106

Utah Cancer Specialist, Salt Lake City

84112

Huntsman Cancer Institute at the University of Utah, Salt Lake City

84131

A.O.U.S. Giovanni e Ruggi d'Aragona UOC UTIC, Salerno

Local Institution - 459, Salerno

85710

Arizona Oncology, Tucson

85724

University of Arizona Cancer Center, Tucson

86021

CHU La Miletrie, Poitiers

Local Institution - 516, Poitiers

90033

USC Norris Comprehensive Cancer Center, Los Angeles

91120

Hadassah Medical Center, Jerusalem

Local Institution - 457, Jerusalem

92083

Moore UCSD Cancer Center, La Jolla

93701

University of California San Francisco Fresno Campus, Fresno

94704

Alta Bates Comprehensive Cancer Center, Berkeley

95124

Local Institution - 415, Catania

Ospedale Ferrarotto, Catania

95403

Sutter Pacific Medical Foundation, Santa Rosa

97213

Providence Portland Medical Center, Portland

98104

Swedish Cancer Inst, Seattle

98801

Wenatchee Valley Hospital and Clinics, Wenatchee

99208

Medical Oncology Associates, Spokane

123182

City Clinical Hospital 52, Moscow

Local Institution - 521, Moscow

125284

Local Institution - 517, Moscow

Moscow State Healthcare Institution City clinical hospital n.a. S.P.Botkin, Moscow

191024

Russian Research Institute of Hematology and Transfusiology of the Federal Biomedical Agency, Saint Petersburg

603126

Local Institution - 520, Nizhny Novgorod

State Budgetary Healthcare Institution of Nizhniy Novgorod Region, Nizhny Novgorod

94904-2007

Marin Oncology Associates, Greenbrae

06489

Cancer Center of Central Connecticut, Southington

Local Institution - 153, Southington

60637-1470

University of Chicago, Chicago

04401

Cancer Care of Maine, Bangor

Local Institution - 132, Bangor

21229-5299

St. Agnes - Medical Center, Baltimore

02114

Local Institution - 299, Boston

Massachusetts General Hospital, Boston

02115

Dana Farber Cancer Institute, Boston

Local Institution - 100, Boston

02215

Beth Israel Deaconess Medical Center, Boston

Local Institution - 298, Boston

48202-268

Henry Ford Medical Center - New Center One, Detroit

Local Institution - 178, Detroit

07306

CarePoint Health Research Institute, Jersey City

07960

Hematology-Oncology Associates of NNJ, P, Morristown

08876

Somerset Hematology-Oncology Associates, Somerville

11794-7300

Stony Brook University, Stony Brook

37232-5505

Vanderbilt University Medical Center, Nashville

78235-8200

Brooke Army Medical Center Francis Street Medical Center, Fort Sam Houston

Local Institution - 103, Fort Sam Houston

L1G 2B9

Local Institution - 308, Oshawa

RSM Durham Regional Cancer Center - Lakeridge Health Oshawa, Oshawa

J4V 2H1

CSSS Champlain Charles LeMoyne, Greenfield Park

Local Institution - 301, Greenfield Park

G5L5T1

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

J1H5N4

Centre Hospitalier Universitaire de Sherbrooke-Hospital Fleurimont, Sherbrooke

Local Institution - 307, Sherbrooke

B3H 2Y9

Local Institution - 304, Halifax

Queen Elizabeth II Health Sciences Centre, Halifax

DK-5000

Local Institution - 400, Odense

Odense University Hospital, Odense

05850

Hyvinkaa Hospital, Hyvinkää

Local Institution - 510, Hyvinkää

D-13353

ChariteUniversitatsmedizinCampus Benjamin Franklin, Berlin

Local Institution - 442, Berlin

01307

Local Institution - 417, Dresden

Universitaetsklinikum Carl Gustav Carus, Dresden

Dublin 7

Local Institution - 462, Dublin

Mater Misericordiae University Hospital, Dublin

Dublin 8

Local Institution - 431, Dublin

St James Hospital, Dublin

ST46QG

Local Institution - 413, Galway

University College Hospital Galway, Galway

00161

La Sapienza, University of Rome, Rome

Local Institution - 460, Rome

05100

Azienda Ospedaliera S Maria di Terni, Terni

Local Institution - 402, Terni

317-0077

Hitachi General Hospital, Hitachi, Ibaraki

Local Institution - 620, Hitachi, Ibaraki

296-8602

Kameda Medical Center, Kamogawa

Local Institution - 625, Kamogawa

701-1192

Local Institution - 626, Okayama

Okayama Medical Center, Okayama

150-8935

Japan Red Cross Medical Center, Shibuya-ku

Local Institution - 623, Shibuya-ku

190-0014

Local Institution - 622, Tachikawa

National Hospital Organization Disaster Medical Center, Tachikawa

9713 GZ

Local Institution - 514, Groningen

Universitair Medisch Centrum Groningen, Groningen

8934 AD

Medisch Centrum Leeuwarden, Leeuwarden

3015 CN

Erasmus Medical Center, Rotterdam

Local Institution - 494, Rotterdam

0372

Local Institution - 412, Oslo

Oslo universitetssykehus, Rikshospitalet, Oslo

36-200

Local Institution - 411, Brzozów

Szpital Specjalistyczny w Brzozowie, Brzozów

85-168

Szpital Uniwersytecki nr 2 im dr. Jana Biziela, Bydgoszcz

41-500

Local Institution - 407, Chorzów

Zespol Szpitali Miejskich, Chorzów

80-952

Klinika Hematologii Akademii Medycznej w Gdansku, Gdansk

Local Institution - 463, Gdansk

31-501

Local Institution - 440, Krakow

Oddzial Kliniczny Kliniki Hematologii, Krakow

93-510

Kopernik Memorial Hospital, Lodz

Local Institution - 418, Lodz

20-081

Klinika Hematoonkologii i Transplantacji Szpiku, Lublin

Local Institution - 439, Lublin

60-569

Local Institution - 437, Poznan

Oddzial Hematologii i Chorob Rozrostowych Ukladu Krwiotworczego, Poznan

02-781

Centrum Onkologii-Instytut im.Marii Sklodowskiej-Curie, Warsaw

Local Institution - 448, Warsaw

4710-243

Hospital de Braga, Braga

Local Institution - 450, Braga

1099-023

Instituto Portugues de Oncologia de Lisboa, Francisco Gentil, Lisbon

Local Institution - 454, Lisbon

1400-038

Fundacao Champalimaud, Lisbon

Local Institution - 473, Lisbon

1649-035

Hospital de Santa Maria, Lisbon

Local Institution - 466, Lisbon

4200-072

Instituto Portugues de Oncologia do Porto, Francisco Gentil, Porto

Local Institution - 425, Porto

Unknown

Hospital de Santo Antonio- Porto, Porto

Gaziantep University, Gaziantep

00717

Ad-Vance Medical Research, LLC, Ponce

08916

Hospital Universitari Germans Trias i Pujol Can Ruti, Badalona (Barcelona)

Local Institution - 423, Badalona (Barcelona)

08036

Hospital Clinic de Barcelona, Barcelona

Local Institution - 424, Barcelona

60 Gothenburg

Local Institution - 478, Gothenburg

Sahlgrenska University Hospital, Gothenburg

SE-971 80

Local Institution - 429, Luleå

Sunderby Sjukhus, Luleå

S-85643

Sundsvalls sjukhus- Medicinkliniken, Sundsvall

06590

Ankara University Medical Faculty Cebeci Hospital, Ankara

Local Institution - 428, Ankara

Dikimevi Cebeci

Ankara Universitesi Tip Fakultesi, Ankara

Local Institution - 408, Ankara

07050

Local Institution - 488, Antalya

Medstar Antalya Hospital, Antalya

BH7 7DW

The Royal Bournemouth Hospital, Bournemouth

CT1 3NG

Kent and Canterbury Hospital, Canterbury Kent

Local Institution - 479, Canterbury Kent

EH4 2XU

Local Institution - 406, Edinburgh Scotland

Western General Hospital, Edinburgh Scotland

NW1 2PG

Local Institution - 490, London

University College London Hospitals, London

SE5 9RS

Kings College Hospital, London

Local Institution - 461, London

OX3 7DQ

Local Institution - 512, Oxford

University of Oxford, Oxford

PL6 8DH

Derriford Hospital Plymouth Oncology Centre Clinical Trials Unit, Plymouth

Local Institution - 515, Plymouth

S10 2JF

Local Institution - 500, Sheffield

Sheffield Teaching Hospitals NHS Foundation Trust - Royal Hallamshire Hospital, Sheffield

SO16 6YD

Local Institution - 493, Southampton

Southampton General Hospital, Southampton

ST4 6QG

University Hospital of North Staffordshire Nhs Trust - City General Hospital, Stoke-on-Trent

SA2 8QA

Local Institution - 405, Swansea

Singleton Hospital, Swansea

WV10 OPQ

Local Institution - 482, Wolverhampton

New Cross Hospital, Wolverhampton

WR5 1DD

Local Institution - 436, Worcester

Worcestershire Acute Hospitals NHS Trust, Worcester

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Celgene

INDUSTRY

NCT01734928 - Safety and Efficacy of Pomalidomide, Bortezomib and Low-dose Dexamethasone in Subjects With Relapsed or Refractory Multiple Myeloma | Biotech Hunter | Biotech Hunter