AzTrials
AzTrials

Multiple MyelomaPhase 3OPTIMISMMNCT01734928

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

A Phase 3 study testing Pomalidomide, Bortezomib and Dexamethasone in people with Multiple Myeloma, run by Celgene at 321 sites in 22 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Multiple Myeloma
What is being tested?
Pomalidomide, Bortezomib and Dexamethasone
Could I receive a placebo?
No, everyone receives an active treatment
How many people
559 participants
Where
321 sitesin 22 countries
Study dates
7 Jan 2013to 13 May 2022
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Must be ≥ 18 years at the time of signing informed consent.
  • Must have documented diagnosis of multiple myeloma and have measureable disease by serum 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-myeloma therapy.
  • All subjects must have received prior treatment with a lenalidomide containing regimen for at least 2 consecutive cycles.

Who cannot join

  • Documented progressive disease during therapy or within 60 days of the last dose of a bortezomib-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 to randomization.
  • Non-secretory multiple myeloma.
  • Subjects with severe renal impairment requiring dialysis.
  • Previous therapy with pomalidomide.

Trial locations and contacts

321 sites in 22 countries.

321 sites in 22 countries

United States92 sites

  • University of Colorado Cancer Center

    Aurora, Colorado, 80045

  • St. Agnes - Medical Center

    Baltimore, Maryland, 21229-5299

  • Cancer Care of Maine

    Bangor, Maine, 04401

  • Local Institution - 132

    Bangor, Maine, 04401

  • Alta Bates Comprehensive Cancer Center

    Berkeley, California, 94704

  • Center for Cancer and Blood Disorders

    Bethesda, Maryland, 20817

  • Local Institution - 125

    Bethesda, Maryland, 20817

  • Billings Clinic

    Billings, Montana, 59102

  • Lynn Cancer Institute

    Boca Raton, Florida, 33486

  • Local Institution - 299

    Boston, Massachusetts, 02114

  • Massachusetts General Hospital

    Boston, Massachusetts, 02114

  • Dana Farber Cancer Institute

    Boston, Massachusetts, 02115

  • Local Institution - 100

    Boston, Massachusetts, 02115

  • Beth Israel Deaconess Medical Center

    Boston, Massachusetts, 02215

  • Local Institution - 298

    Boston, Massachusetts, 02215

  • University Cancer Institute

    Boynton Beach, Florida, 33426

  • Gabrail Cancer Center Research

    Canton, Ohio, 44718

  • Local Institution - 111

    Canton, Ohio, 44718

  • Med Univ of South Carolina

    Charleston, South Carolina, 29425

  • University of Chicago

    Chicago, Illinois, 60637-1470

  • MetroHealth Medical Systems

    Cleveland, Ohio, 44109

  • Mid Ohio Oncology Hematology Inc

    Columbus, Ohio, 43219

  • Local Institution - 114

    Dallas, Texas, 75390

  • UT Southwestern Medical Center

    Dallas, Texas, 75390

  • Henry Ford Medical Center - New Center One

    Detroit, Michigan, 48202-268

  • Local Institution - 178

    Detroit, Michigan, 48202-268

  • Essentia Health Duluth CCOP

    Duluth, Minnesota, 55805

  • Broward Oncology Associates PA

    Fort Lauderdale, Florida, 33308

  • Broward Oncology Assoc.

    Fort Lauderdale, Florida, 33316

  • Brooke Army Medical Center Francis Street Medical Center

    Fort Sam Houston, Texas, 78235-8200

  • Local Institution - 103

    Fort Sam Houston, Texas, 78235-8200

  • University of California San Francisco Fresno Campus

    Fresno, California, 93701

  • University of Florida

    Gainesville, Florida, 32610

  • Cancer and Hematology Centers of Western Michigan

    Grand Rapids, Michigan, 49546

  • Marin Oncology Associates

    Greenbrae, California, 94904-2007

  • Eastern Institute of Medical Sciences

    Greenville, North Carolina, 27834

  • Alves Domenech Oncology and Hematology Clinic

    Hollywood, Florida, 33021

  • Local Institution - 130

    Houston, Texas, 77090

  • Northwest Cancer Center

    Houston, Texas, 77090

  • Medstar Health Research Institute

    Hyattsville, Maryland, 20782

  • Investigative Clinical Research of Indiana, LLC

    Indianapolis, Indiana, 46254

  • University of Iowa

    Iowa City, Iowa, 52242

  • Columbia Comprehensive

    Jefferson City, Missouri, 65203

  • CarePoint Health Research Institute

    Jersey City, New Jersey, 07306

  • Kansas City VA Medical Center University of Kansas Medical Center

    Kansas City, Missouri, 64128

  • University of Tennessee Medical Center - Cancer Institute

    Knoxville, Tennessee, 37885

  • Moore UCSD Cancer Center

    La Jolla, California, 92083

  • Detroit Clinical Research Center

    Lansing, Michigan, 48912

  • Southeast Nebraska Cancer Center

    Lincoln, Nebraska, 68510

  • USC Norris Comprehensive Cancer Center

    Los Angeles, California, 90033

  • Joe Arrington Cancer Research and Treatment Center

    Lubbock, Texas, 79410

  • University of Wisconsin

    Madison, Wisconsin, 53792

  • Local Institution - 135

    Marietta, Georgia, 30060

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

    Marietta, Georgia, 30060

  • Local Institution - 136

    Milwaukee, Wisconsin, 53226

  • Medical College of Wisconsin

    Milwaukee, Wisconsin, 53226

  • Southern Cancer Center

    Mobile, Alabama, 36608

  • Local Institution - 139

    Morgantown, West Virginia, 25606

  • West Virginia University CTRU

    Morgantown, West Virginia, 25606

  • Hematology-Oncology Associates of NNJ, P

    Morristown, New Jersey, 07960

  • Vanderbilt University Medical Center

    Nashville, Tennessee, 37232-5505

  • Tulane University Medical Center

    New Orleans, Louisiana, 70112

  • Mount Sinai Hospital

    New York, New York, 10029

  • Western Kentucky Hematology and Oncology Group, PSC

    Paducah, Kentucky, 42003

  • Providence Portland Medical Center

    Portland, Oregon, 97213

  • Boice-Willis Clinic P.A.

    Rocky Mount, North Carolina, 27804

  • Beaumont Cancer Center

    Royal Oak, Michigan, 48073

  • Metro MN CCOP

    Saint Louis Park, Minnesota, 55416

  • Utah Cancer Specialist

    Salt Lake City, Utah, 84106

  • Huntsman Cancer Institute at the University of Utah

    Salt Lake City, Utah, 84112

  • Sutter Pacific Medical Foundation

    Santa Rosa, California, 95403

  • Swedish Cancer Inst

    Seattle, Washington, 98104

  • Avera Research Institute

    Sioux Falls, South Dakota, 57105

  • Somerset Hematology-Oncology Associates

    Somerville, New Jersey, 08876

  • Cancer Center of Central Connecticut

    Southington, Connecticut, 06489

  • Local Institution - 153

    Southington, Connecticut, 06489

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

    Spartanburg, South Carolina, 29303

  • Medical Oncology Associates

    Spokane, Washington, 99208

  • St. John's Clinic Cancerand Hematology - Springfield

    Springfield, Missouri, 65804

  • St John's Mercy Medical Center

    St Louis, Missouri, 63141

  • Stony Brook University

    Stony Brook, New York, 11794-7300

  • Local Institution - 186

    The Bronx, New York, 10467

  • Montefiore Medical Center

    The Bronx, New York, 10467

  • University of Toledo Medical Center

    Toledo, Ohio, 43614

  • Arizona Oncology

    Tucson, Arizona, 85710

  • University of Arizona Cancer Center

    Tucson, Arizona, 85724

  • New York Medical College

    Valhalla, New York, 10595

  • George Washington Medical Center

    Washington D.C., District of Columbia, 20037

  • Local Institution - 167

    Watertown, South Dakota, 57201

  • Prairie Lakes Health Care System

    Watertown, South Dakota, 57201

  • Wenatchee Valley Hospital and Clinics

    Wenatchee, Washington, 98801

  • Palm Beach Cancer Institute, LLC

    West Palm Beach, Florida, 33401

Other trials in United States

Italy24 sites

  • Local Institution - 449

    Bergamo, 24127

  • USC Ematologia, Azienda Ospedaliera Papa Giovanni XXIII

    Bergamo, 24127

  • Local Institution - 456

    Bologna, 40138

  • Policlinico S. Orsola - Malpighi

    Bologna, 40138

  • Local Institution - 415

    Catania, 95124

  • Ospedale Ferrarotto

    Catania, 95124

  • Local Institution - 403

    Modena, 41100

  • University of Modena

    Modena, 41100

  • IRCCS Policlinico San Matteo

    Pavia, 27100

  • Local Institution - 451

    Pavia, 27100

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

    Pescara, 65124

  • Local Institution - 441

    Pescara, 65124

  • Azienda Ospedaliera di Reggio Emilia - Arcispedale Santa Maria Nuova

    Reggio Emilia, 42100

  • Local Institution - 414

    Reggio Emilia, 42100

  • La Sapienza, University of Rome

    Rome, 00161

  • Local Institution - 460

    Rome, 00161

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

    Salerno, 84131

  • Local Institution - 459

    Salerno, 84131

  • IRCCS Casa Sollievo della Sofferenza

    San Giovanni Rotondo, 71013

  • Local Institution - 453

    San Giovanni Rotondo, 71013

  • Azienda Ospedaliera S Maria di Terni

    Terni, 05100

  • Local Institution - 402

    Terni, 05100

  • Azienda Ospedaliera San Giovanni Battista

    Torino, 10126

  • Local Institution - 401

    Torino, 10126

Other trials in Italy

United Kingdom24 sites

  • The Royal Bournemouth Hospital

    Bournemouth, BH7 7DW

  • Kent and Canterbury Hospital

    Canterbury Kent, CT1 3NG

  • Local Institution - 479

    Canterbury Kent, CT1 3NG

  • Local Institution - 406

    Edinburgh Scotland, EH4 2XU

  • Western General Hospital

    Edinburgh Scotland, EH4 2XU

  • Local Institution - 490

    London, NW1 2PG

  • University College London Hospitals

    London, NW1 2PG

  • Kings College Hospital

    London, SE5 9RS

  • Local Institution - 461

    London, SE5 9RS

  • Local Institution - 512

    Oxford, OX3 7DQ

  • University of Oxford

    Oxford, OX3 7DQ

  • Derriford Hospital Plymouth Oncology Centre Clinical Trials Unit

    Plymouth, PL6 8DH

  • Local Institution - 515

    Plymouth, PL6 8DH

  • Local Institution - 500

    Sheffield, S10 2JF

  • Sheffield Teaching Hospitals NHS Foundation Trust - Royal Hallamshire Hospital

    Sheffield, S10 2JF

  • Local Institution - 493

    Southampton, SO16 6YD

  • Southampton General Hospital

    Southampton, SO16 6YD

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

    Stoke-on-Trent, ST4 6QG

  • Local Institution - 405

    Swansea, SA2 8QA

  • Singleton Hospital

    Swansea, SA2 8QA

  • Local Institution - 482

    Wolverhampton, WV10 OPQ

  • New Cross Hospital

    Wolverhampton, WV10 OPQ

  • Local Institution - 436

    Worcester, WR5 1DD

  • Worcestershire Acute Hospitals NHS Trust

    Worcester, WR5 1DD

Other trials in United Kingdom

France21 sites

  • Centre Hospitalier de la cote basque

    Bayonne, 64109

  • Local Institution - 469

    Bayonne, 64109

  • Centre Hospitalier William Morey

    Chalon-sur-Saône, 71100

  • Local Institution - 498

    Chalon-sur-Saône, 71100

  • CHU Hotel

    Grenoble, 38043

  • Local Institution - 483

    Grenoble, 38043

  • GH Institut Catholique St Vincent

    Lille, 59000

  • CHRU de Lille-Hopital Claude Huriez

    Lille, 59037

  • Local Institution - 476

    Lille, 59037

  • CHRU Hotel Dieu

    Nantes, 44035

  • Local Institution - 486

    Nantes, 44035

  • Groupement Hospitalier Universitaire Est - Hopital Saint-Antoine

    Paris, 75012

  • Centre Hospitalier Lyon Sud

    Pierre-Bénite, 69495

  • Local Institution - 497

    Pierre-Bénite, 69495

  • CHU La Miletrie

    Poitiers, 86021

  • Local Institution - 516

    Poitiers, 86021

  • CHRU Rennes

    Rennes, 35033

  • Local Institution - 504

    Rennes, 35033

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

    Toulouse, 31052

  • CHRU Hopital Bretonneau

    Tours, 37044

  • Local Institution - 468

    Tours, 37044

Other trials in France

Turkey (Türkiye)20 sites

  • Ankara University Medical Faculty Cebeci Hospital

    Ankara, 06590

  • Local Institution - 428

    Ankara, 06590

  • Gazi Universitesi Tip Fakultesi Hastanesi

    Ankara, 6500

  • Local Institution - 409

    Ankara, 6500

  • Ankara Universitesi Tip Fakultesi

    Ankara, Dikimevi Cebeci

  • Local Institution - 408

    Ankara, Dikimevi Cebeci

  • Local Institution - 488

    Antalya, 07050

  • Medstar Antalya Hospital

    Antalya, 07050

  • Eskisehir Osmangazi University

    Eskişehir, 26480

  • Local Institution - 420

    Eskişehir, 26480

  • Local Institution - 421

    Gaziantep, 0

  • Gaziantep University

    Gaziantep

  • Istanbul Universitesi Cerrahpasa Tip Fakultesi

    Istanbul, 34098

  • Local Institution - 445

    Istanbul, 34098

  • Istanbul University Faculty of Medicine

    Istanbul, 34390

  • Local Institution - 474

    Istanbul, 34390

  • Ege University Medical School

    Izmir, 35100

  • Local Institution - 419

    Izmir, 35100

  • Karadeniz Teknik Universitesi Tip Fakultesi Farabi Hastanesi

    Trabzon, 61080

  • Local Institution - 404

    Trabzon, 61080

Other trials in Turkey (Türkiye)

Poland17 sites

  • Local Institution - 411

    Brzozów, 36-200

  • Szpital Specjalistyczny w Brzozowie

    Brzozów, 36-200

  • Szpital Uniwersytecki nr 2 im dr. Jana Biziela

    Bydgoszcz, 85-168

  • Local Institution - 407

    Chorzów, 41-500

  • Zespol Szpitali Miejskich

    Chorzów, 41-500

  • Klinika Hematologii Akademii Medycznej w Gdansku

    Gdansk, 80-952

  • Local Institution - 463

    Gdansk, 80-952

  • Local Institution - 440

    Krakow, 31-501

  • Oddzial Kliniczny Kliniki Hematologii

    Krakow, 31-501

  • Kopernik Memorial Hospital

    Lodz, 93-510

  • Local Institution - 418

    Lodz, 93-510

  • Klinika Hematoonkologii i Transplantacji Szpiku

    Lublin, 20-081

  • Local Institution - 439

    Lublin, 20-081

  • Local Institution - 437

    Poznan, 60-569

  • Oddzial Hematologii i Chorob Rozrostowych Ukladu Krwiotworczego

    Poznan, 60-569

  • Centrum Onkologii-Instytut im.Marii Sklodowskiej-Curie

    Warsaw, 02-781

  • Local Institution - 448

    Warsaw, 02-781

Other trials in Poland

Spain16 sites

  • Hospital Universitari Germans Trias i Pujol Can Ruti

    Badalona (Barcelona), 08916

  • Local Institution - 423

    Badalona (Barcelona), 08916

  • Hospital Clinic de Barcelona

    Barcelona, 08036

  • Local Institution - 424

    Barcelona, 08036

  • Hospital de Basurto-Osakidetza

    Bilbao, 48013

  • Hospital 12 de Octubre

    Madrid, 28041

  • Local Institution - 452

    Madrid, 28041

  • Hospital Morales Meseguer

    Murcia, 30008

  • Local Institution - 502

    Murcia, 30008

  • Complejo Hospitalario De Orense

    Ourense, 32005

  • Local Institution - 526

    Ourense, 32005

  • Clinica Universidad de Navarra

    Pamplona, 31008

  • Local Institution - 434

    Pamplona, 31008

  • Complejo Hospitalario Nuestra Senora de Valme

    Seville, 41014

  • Local Institution - 492

    Seville, 41014

  • Hospital Universitario y Politecnico La Fe

    Valencia, 46026

Other trials in Spain

Germany12 sites

  • ChariteUniversitatsmedizinCampus Benjamin Franklin

    Berlin, D-13353

  • Local Institution - 442

    Berlin, D-13353

  • Local Institution - 417

    Dresden, 01307

  • Universitaetsklinikum Carl Gustav Carus

    Dresden, 01307

  • Local Institution - 475

    Essen, 45147

  • Universitaetsklinikum EssenInnere Klinik und Poliklinik

    Essen, 45147

  • Local Institution - 496

    Freiburg im Breisgau, 79106

  • Universitatsklinikum Freiburg

    Freiburg im Breisgau, 79106

  • Local Institution - 430

    Heidelberg, 69120

  • University of Heidelberg

    Heidelberg, 69120

  • Local Institution - 410

    Tübingen, 72076

  • UKT Universitaetsklinikum Tuebingen

    Tübingen, 72076

Other trials in Germany

Portugal12 sites

  • Hospital de Braga

    Braga, 4710-243

  • Local Institution - 450

    Braga, 4710-243

  • Instituto Portugues de Oncologia de Lisboa, Francisco Gentil

    Lisbon, 1099-023

  • Local Institution - 454

    Lisbon, 1099-023

  • Fundacao Champalimaud

    Lisbon, 1400-038

  • Local Institution - 473

    Lisbon, 1400-038

  • Hospital de Santa Maria

    Lisbon, 1649-035

  • Local Institution - 466

    Lisbon, 1649-035

  • Local Institution - 464

    Porto, 0

  • Instituto Portugues de Oncologia do Porto, Francisco Gentil

    Porto, 4200-072

  • Local Institution - 425

    Porto, 4200-072

  • Hospital de Santo Antonio- Porto

    Porto

Other trials in Portugal

Japan10 sites

  • Hitachi General Hospital

    Hitachi, Ibaraki, 317-0077

  • Local Institution - 620

    Hitachi, Ibaraki, 317-0077

  • Kameda Medical Center

    Kamogawa, 296-8602

  • Local Institution - 625

    Kamogawa, 296-8602

  • Local Institution - 626

    Okayama, 701-1192

  • Okayama Medical Center

    Okayama, 701-1192

  • Japan Red Cross Medical Center

    Shibuya-ku, 150-8935

  • Local Institution - 623

    Shibuya-ku, 150-8935

  • Local Institution - 622

    Tachikawa, 190-0014

  • National Hospital Organization Disaster Medical Center

    Tachikawa, 190-0014

Other trials in Japan

Canada9 sites

  • CSSS Champlain Charles LeMoyne

    Greenfield Park, Quebec, J4V 2H1

  • Local Institution - 301

    Greenfield Park, Quebec, J4V 2H1

  • Local Institution - 304

    Halifax, B3H 2Y9

  • Queen Elizabeth II Health Sciences Centre

    Halifax, B3H 2Y9

  • Local Institution - 308

    Oshawa, Ontario, L1G 2B9

  • RSM Durham Regional Cancer Center - Lakeridge Health Oshawa

    Oshawa, Ontario, L1G 2B9

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

    Rimouski, Quebec, G5L5T1

  • Centre Hospitalier Universitaire de Sherbrooke-Hospital Fleurimont

    Sherbrooke, Quebec, J1H5N4

  • Local Institution - 307

    Sherbrooke, Quebec, J1H5N4

Other trials in Canada

Sweden9 sites

  • Falu lasarett

    Falun, 79182

  • Local Institution - 426

    Falun, 79182

  • Local Institution - 478

    Gothenburg, 60 Gothenburg

  • Sahlgrenska University Hospital

    Gothenburg, 60 Gothenburg

  • Local Institution - 429

    Luleå, SE-971 80

  • Sunderby Sjukhus

    Luleå, SE-971 80

  • Karolinska University

    Stockholm, 14186

  • Local Institution - 471

    Stockholm, 14186

  • Sundsvalls sjukhus- Medicinkliniken

    Sundsvall, S-85643

Other trials in Sweden

Denmark8 sites

  • Aarhus University Hospital

    Aarhus, 8000

  • Local Institution - 447

    Aarhus, 8000

  • Copenhagen University Hospital Rigshosptalet

    Copenhagen, 2100

  • Local Institution - 506

    Copenhagen, 2100

  • Local Institution - 400

    Odense, DK-5000

  • Odense University Hospital

    Odense, DK-5000

  • Local Institution - 499

    Vejle, 7100

  • Vejle Hospital

    Vejle, 7100

Other trials in Denmark

Greece8 sites

  • General Hospital of Athens Evangelismos

    Athens, 10676

  • Local Institution - 484

    Athens, 10676

  • Local Institution - 422

    Athens, 11528

  • University of Athens Medical school - Regional General Hospital

    Athens, 11528

  • Local Institution - 487

    Mezourlo, 41110

  • University General Hospital of Larissa

    Mezourlo, 41110

  • George Papanikolaou General Hospital of Thessaloniki

    Thessloniki, 57010

  • Local Institution - 465

    Thessloniki, 57010

Other trials in Greece

Israel7 sites

  • Rambam Health Care Campus

    Haifa, 31096

  • Hadassah Medical Center

    Jerusalem, 91120

  • Local Institution - 457

    Jerusalem, 91120

  • Local Institution - 433

    Kfar Saba, 44281

  • Meir Medical Center

    Kfar Saba, 44281

  • Chaim Sheba Medical Center

    Ramat Gan, 52621

  • Tel Aviv Sourasky Medical Center Department of Hematology

    Tel Aviv, 64239

Other trials in Israel

Russia7 sites

  • City Clinical Hospital 52

    Moscow, 123182

  • Local Institution - 521

    Moscow, 123182

  • Local Institution - 517

    Moscow, 125284

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

    Moscow, 125284

  • Local Institution - 520

    Nizhny Novgorod, 603126

  • State Budgetary Healthcare Institution of Nizhniy Novgorod Region

    Nizhny Novgorod, 603126

  • Russian Research Institute of Hematology and Transfusiology of the Federal Biomedical Agency

    Saint Petersburg, 191024

Other trials in Russia

Austria6 sites

  • Hospital St. Polten

    Sankt Pölten, 3100

  • Local Institution - 523

    Sankt Pölten, 3100

  • Local Institution - 480

    Vienna, 1090

  • Medical University of Vienna

    Vienna, 1090

  • Local Institution - 481

    Vienna, 1160

  • Wilhelminenspital-Center for Hematology and Oncology

    Vienna, 1160

Other trials in Austria

Ireland6 sites

  • Local Institution - 462

    Dublin, Dublin 7

  • Mater Misericordiae University Hospital

    Dublin, Dublin 7

  • Local Institution - 431

    Dublin, Dublin 8

  • St James Hospital

    Dublin, Dublin 8

  • Local Institution - 413

    Galway, ST46QG

  • University College Hospital Galway

    Galway, ST46QG

Other trials in Ireland

Netherlands5 sites

  • Local Institution - 514

    Groningen, 9713 GZ

  • Universitair Medisch Centrum Groningen

    Groningen, 9713 GZ

  • Medisch Centrum Leeuwarden

    Leeuwarden, 8934 AD

  • Erasmus Medical Center

    Rotterdam, 3015 CN

  • Local Institution - 494

    Rotterdam, 3015 CN

Other trials in Netherlands

Finland4 sites

  • Helsinki University Central Hospital

    Helsinki, 290

  • Local Institution - 455

    Helsinki, 290

  • Hyvinkaa Hospital

    Hyvinkää, 05850

  • Local Institution - 510

    Hyvinkää, 05850

Other trials in Finland

Norway3 sites

  • Local Institution - 412

    Oslo, 0372

  • Oslo universitetssykehus, Rikshospitalet

    Oslo, 0372

  • St Olavs Hospital

    Trondheim, 7006

Other trials in Norway

Puerto Rico1 site

  • Ad-Vance Medical Research, LLC

    Ponce, 00717

Other trials in Puerto Rico

About this study

Official title: A Phase 3, Multicenter, Randomized, Open-Label Study to Compare the Efficacy and Safety of Pomalidomide, Bortezomib and Low-Dose Dexamethasone Versus Bortezomib and Low-Dose Dexamethasone in Subjects With Relapsed or Refractory Multiple Myeloma

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.

Keywords
Multiple Myeloma, Pomalidomide
Medical subject headings
Multiple Myeloma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PomalidomideDrug

    Also called Oral Pomalidomide, CC-4047

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

  • BortezomibDrug

    Also called Velcade

    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.

  • DexamethasoneDrug

    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.

Study groups in NCT01734928
Study groupRoleWhat they receive
Pomalidomide, Bortezomib and Low Dose DexamethasoneExperimental4 mg of Pomalidomide will be taken orally on Days 1-14 of a 21-day cycle along with 1.3 mg/m2 of Bortezomib 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, and Dexamethasone 20 mg/day [≤ 75 years old] or 10 mg/day [> 75 years old] 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.
Receives: Drug: Pomalidomide; Drug: Bortezomib; Drug: Dexamethasone
Bortezomib and Low Dose DexamethasoneActive comparator1.3 mg/m2 of Bortezomib 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 along with Dexamethasone 20 mg/day [≤ 75 years old]or 10 mg/day [> 75 years old] 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.
Receives: Drug: Bortezomib; Drug: Dexamethasone

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Progression Free Survival by Independent Response Adjudication Committee (IRAC)

    Progression free survival (PFS) will be calculated as the time between the randomization and progressive disease (PD) or death.

    Progressive Disease is defined as an Increase of ≥ 25% from nadir in:

    • Serum M-component and/or (the absolute increase must be ≥ 0.5 g/dL)g
    • Urine M-component and/or (the absolute increase must be ≥ 200 mg/24 hours)
    • In patients without measurable serum and urine M-protein levels the difference between involved and uninvolved FLC levels, the absolute increase must be > 100 mg/dL.
    • Bone marrow plasma cell percentage, the absolute % must be ≥ 10%h
    • Definite development of new bone lesions or soft tissue plasmacytomas increase in the size of existing bone lesions or soft tissue plasmacytomas. -Development of hypercalcemia (corrected serum calcium > 11.5 mg/dL or 2.65 mmol/L) that can be attributed solely to the plasma cell proliferative disorder.

    Measured: From randomization to progressive disease or death during the IRAC assessment period, up to approximately 42 months

Secondary outcomes (5)

  1. Overall Survival (OS)

    Overall survival (OS) is calculated as the time from randomization to death from any cause.

    Measured: From randomization to date of death, up to approximately 65 months

  2. Overall Response Rate by Independent Response Adjudication Committee (IRAC)

    The ORR together with the relative proportions in each response category (ie, stringent CR [sCR], CR, very good PR [VGPR], PR, SD, and PD) by treatment using the IMWG criteria will be examined.

    Complete Response: Negative immunofixation on the serum and urine and disappearance of any soft tissue plasmacytomas and ≤ 5% plasma cells in bone marrow

    SCR: CR+ Normal FLC ratio and Absence of clonal cells in bone marrow by immunohistochemistry or immunofluorescence

    VGPR: Serum and urine M-protein detectable by immunofixation but not on electrophoresis or 90% or greater reduction in serum M-protein plus urine Mprotein level < 100 mg per 24 hours

    PR: ≥ 50% reduction of serum M-Protein and reduction in 24-hour urinary M-protein by ≥ 90% or to < 200 mg per 24 hours

    Progressive Disease: Please refer to Primary outcome measure for definition

    SD: Not meeting criteria for CR, VGPR, PR, or progressive disease

    Measured: From randomization to progressive disease or death during the IRAC assessment period, up to approximately 42 months

  3. Duration of Response by Independent Response Adjudication Committee (IRAC)

    Duration of myeloma response is defined as the duration from the time when the IMWG response criteria are first met for sCR or CR or VGPR or PR until the first date the response criteria are met for PD or until the subject died from any cause, whichever occurs first.

    Complete Response: Negative immunofixation on the serum and urine and disappearance of any soft tissue plasmacytomas and ≤ 5% plasma cells in bone marrow

    SCR: CR+ Normal FLC ratio and Absence of clonal cells in bone marrow by immunohistochemistry or immunofluorescence

    VGPR: Serum and urine M-protein detectable by immunofixation but not on electrophoresis or 90% or greater reduction in serum M-protein plus urine Mprotein level < 100 mg per 24 hours

    PR: ≥ 50% reduction of serum M-Protein and reduction in 24-hour urinary M-protein by ≥ 90% or to < 200 mg per 24 hours

    Progressive Disease: Please refer to Primary outcome measure for definition

    SD: Not meeting criteria for CR, VGPR, PR, or progressive disease

    Measured: From randomization to progressive disease or death during the IRAC assessment period, up to approximately 42 months

  4. Number of Participants With Grade 3-4 Treatment Emergent Adverse Events (TEAE)

    Treatment-emergent adverse events (TEAEs) are defined as any AE occurring or worsening on or after the first dose date of the study treatment and within 28 days after the last dose date.

    Measured: From first dose to 28 days after the last dose (up to approximately 44 months

  5. Number of Participants With Grade 5 Treatment Emergent Adverse Events (TEAE)

    Treatment-emergent adverse events (TEAEs) are defined as any AE occurring or worsening on or after the first dose date of the study treatment and within 28 days after the last dose date.

    Measured: From first dose to 28 days after the last dose (up to approximately 44 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Nov 2012 (estimated)
  2. Study start7 Jan 2013
  3. Primary completion9 May 2022
  4. Study completion13 May 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
559 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01734928
Sponsor's protocol ID
CC-4047-MM-007
Acronym
OPTIMISMM
Status last verified
May 2023
First submitted
23 Nov 2012
Last updated
6 Jun 2023
Data monitoring committee
Yes

Publications

  • Richardson PG, Oriol A, Beksac M, Liberati AM, Galli M, Schjesvold F, Lindsay J, Weisel K, White D, Facon T, San Miguel J, Sunami K, O'Gorman P, Sonneveld P, Robak P, Semochkin S, Schey S, Yu X, Doerr T, Bensmaine A, Biyukov T, Peluso T, Zaki M, Anderson K, Dimopoulos M; OPTIMISMM trial investigators. Pomalidomide, bortezomib, and dexamethasone for patients with relapsed or refractory multiple myeloma previously treated with lenalidomide (OPTIMISMM): a randomised, open-label, phase 3 trial. Lancet Oncol. 2019 Jun;20(6):781-794. doi: 10.1016/S1470-2045(19)30152-4. Epub 2019 May 13.

    PubMed 31097405

  • Richardson PG, Hofmeister CC, Raje NS, Siegel DS, Lonial S, Laubach J, Efebera YA, Vesole DH, Nooka AK, Rosenblatt J, Doss D, Zaki MH, Bensmaine A, Herring J, Li Y, Watkins L, Chen MS, Anderson KC. Pomalidomide, bortezomib and low-dose dexamethasone in lenalidomide-refractory and proteasome inhibitor-exposed myeloma. Leukemia. 2017 Dec;31(12):2695-2701. doi: 10.1038/leu.2017.173. Epub 2017 Jun 2.

    PubMed 28642620

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Pomalidomide, Bortezomib and Dexamethasone in people with Multiple Myeloma, run by Celgene at 321 sites in 22 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 6 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 321 sites in United States, Italy, United Kingdom, France, Turkey (Türkiye) and 17 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 6 Jun 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Progression Free Survival by Independent Response Adjudication Committee (IRAC) (time frame: From randomization to progressive disease or death during the IRAC assessment period, up to approximately 42 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01734928, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jun 2023.

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