A Study to Evaluate Mezigdomide, Bortezomib and Dexamethasone (MEZIVd) Versus Pomalidomide, Bortezomib and Dexamethasone (PVd) in Participants With Relapsed or Refractory Multiple Myeloma (RRMM)

NCT05519085 | Recruiting Phase 3 DMC FDA Drug

• 2 other identifiers: CA057-0012023-509859-13
• Study Type: interventional
• Target: 810
• Locations: 28 countries
• Sites: 261

Brief Summary

The purpose of this study is to compare the efficacy and safety of mezigdomide (CC-92480), bortezomib and dexamethasone (MeziVd) versus pomalidomide, bortezomib and dexamethasone (PVd) in participants with relapsed or refractory multiple myeloma (RRMM) who received between 1 to 3 prior lines of therapy and who have had prior lenalidomide exposure.

Conditions

Relapsed or Refractory Multiple Myeloma

Keywords

Multiple myeloma; RRMM; MeziVd; PVd; CC92480; pomalidomide; bortezomib; dexamethasone; mezigdomide

Outcome Measures

Primary Outcomes (1)

• Progression-free Survival (PFS)

  From date of randomization to date of disease progression or death due to any cause (Up to approximately 5 years)

Secondary Outcomes (15)

• Recommended mezigdomide dose

  Up to 12 Months

• Plasma concentrations of mezigdomide

  Up to 134 Days

• Overall Survival (OS)

  From date of randomization to date of death due to any cause (Up to approximately 5 years)

• Overall Response (OR)

  Up to approximately 5 years

• Complete Response (CR) or better

  Up to approximately 5 Years

Study Arms (2)

MeziVd (mezigdomide, bortezomib and dexamethasone)

EXPERIMENTAL

Drug: mezigdomide; Drug: Bortezomib; Drug: Dexamethasone

PVd (pomalidomide, bortezomib and dexamethasone)

EXPERIMENTAL

Drug: Pomalidomide; Drug: Bortezomib; Drug: Dexamethasone

Interventions

mezigdomide DRUG

Specified dose on specified days

Also known as: BMS-986348, CC-92480

MeziVd (mezigdomide, bortezomib and dexamethasone)

Pomalidomide DRUG

Specified dose on specified days

Also known as: Pomalyst, Imnovid, Pom

PVd (pomalidomide, bortezomib and dexamethasone)

Bortezomib DRUG

Specified dose on specified days

Also known as: Velcade, BTZ

MeziVd (mezigdomide, bortezomib and dexamethasone); PVd (pomalidomide, bortezomib and dexamethasone)

Dexamethasone DRUG

Specified dose on specified days

Also known as: Decadron, Dex

MeziVd (mezigdomide, bortezomib and dexamethasone); PVd (pomalidomide, bortezomib and dexamethasone)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \- Participant has documented diagnosis of MM and measurable disease, defined as any of the following:.
• i) M-protein ≥ 0.5 grams per deciliter (g/dL) by serum protein electrophoresis (sPEP) or.
• ii) M-protein ≥ 200 milligrams (mg) per 24-hour urine collection by urine protein electrophoresis (uPEP).
• iii) For participants without measurable disease in sPEP or uPEP: serum free light chain (sFLC) levels \> 100 mg/L (10 mg/dL) involved light chain and an abnormal kappa/lambda FLC ratio.
• Participants received 1 to 3 prior lines of antimyeloma therapy.
• Participants achieved minimal response \[MR\] or better to at least 1 prior antimyeloma therapy.

You may not qualify if:

• \- Participant has had progression during treatment or within 60 days of the last dose of a proteasome inhibitor, except as noted below:.
• i) Subjects who progressed while being treated with, or within 60 days of last dose of bortezomib maintenance given once every 2 weeks (or less frequently) are not excluded.
• ii) Participants who progressed while being treated with ixazomib monotherapy maintenance ≥ 6 months prior to the time of starting study treatment are not excluded.
• For participants with prior treatment of a bortezomib containing regimen, the best response achieved was not a minimal response (MR) or better, or participant discontinued bortezomib due to toxicity.
• Participant has had prior treatment with mezigdomide or pomalidomide.

Sponsors & Collaborators

• Celgene: lead

Study Sites (266)

Local Institution - 0366

Los Alamitos, California, 90720, United States

ACTIVE NOT RECRUITING

Local Institution - 0272

San Diego, California, 92123, United States

COMPLETED

Local Institution - 0273

West Hollywood, California, 90069, United States

COMPLETED

Local Institution - 0381

Aurora, Colorado, 80045, United States

NOT YET RECRUITING

Local Institution - 0380

Farmington, Connecticut, 06030, United States

ACTIVE NOT RECRUITING

Local Institution - 0208

New Haven, Connecticut, 06510, United States

WITHDRAWN

Local Institution - 0303

Coral Springs, Florida, 33321, United States

ACTIVE NOT RECRUITING

Local Institution - 0403

Fort Myers, Florida, 33901, United States

ACTIVE NOT RECRUITING

Local Institution - 0401

St. Petersburg, Florida, 33701, United States

ACTIVE NOT RECRUITING

Local Institution - 0402

West Palm Beach, Florida, 33401, United States

ACTIVE NOT RECRUITING

Local Institution - 0211

Athens, Georgia, 30607, United States

ACTIVE NOT RECRUITING

Local Institution - 0048

Marietta, Georgia, 30060, United States

WITHDRAWN

Local Institution - 0330

Garden City, Kansas, 67846, United States

COMPLETED

Local Institution - 0080

Westwood, Kansas, 66205, United States

ACTIVE NOT RECRUITING

Local Institution - 0358

Baton Rouge, Louisiana, 70808, United States

ACTIVE NOT RECRUITING

Local Institution - 0255

New Orleans, Louisiana, 70112, United States

ACTIVE NOT RECRUITING

Local Institution - 0385

Shreveport, Louisiana, 71103, United States

NOT YET RECRUITING

Local Institution - 0357

Baltimore, Maryland, 21215, United States

ACTIVE NOT RECRUITING

Local Institution - 0246

Boston, Massachusetts, 02215, United States

ACTIVE NOT RECRUITING

Local Institution - 0271

Ann Arbor, Michigan, 48109, United States

ACTIVE NOT RECRUITING

Local Institution - 0364

Detroit, Michigan, 48202, United States

ACTIVE NOT RECRUITING

Local Institution - 0410

Minneapolis, Minnesota, 55404, United States

ACTIVE NOT RECRUITING

Local Institution - 0088

Hattiesburg, Mississippi, 39401, United States

ACTIVE NOT RECRUITING

Local Institution - 0242

Jackson, Mississippi, 39213, United States

WITHDRAWN

Local Institution - 0288

East Brunswick, New Jersey, 08816, United States

ACTIVE NOT RECRUITING

Local Institution - 0363

Ridgewood, New Jersey, 07450, United States

NOT YET RECRUITING

Local Institution - 0302

Albuquerque, New Mexico, 87131, United States

ACTIVE NOT RECRUITING

Local Institution - 0245

Buffalo, New York, 14215, United States

WITHDRAWN

Local Institution - 0257

Lake Success, New York, 11042, United States

ACTIVE NOT RECRUITING

Local Institution - 0373

New Hyde Park, New York, 11042, United States

COMPLETED

Local Institution - 0371

New York, New York, 10028, United States

COMPLETED

Local Institution - 0108

Rochester, New York, 14621, United States

ACTIVE NOT RECRUITING

Local Institution - 0374

Shirley, New York, 11967, United States

ACTIVE NOT RECRUITING

Local Institution - 0372

The Bronx, New York, 10469, United States

COMPLETED

Local Institution - 0274

Williamsville, New York, 14221, United States

WITHDRAWN

Local Institution - 0260

Durham, North Carolina, 27710, United States

ACTIVE NOT RECRUITING

Local Institution - 0400

Cincinnati, Ohio, 45242, United States

ACTIVE NOT RECRUITING

Local Institution - 0377

Cleveland, Ohio, 44111, United States

ACTIVE NOT RECRUITING

Local Institution - 0076

Cleveland, Ohio, 44195, United States

ACTIVE NOT RECRUITING

Local Institution - 0376

Mayfield Heights, Ohio, 44124, United States

ACTIVE NOT RECRUITING

Local Institution - 0359

Allentown, Pennsylvania, 18103, United States

COMPLETED

Local Institution - 0264

York, Pennsylvania, 17403, United States

COMPLETED

Local Institution - 0223

Germantown, Tennessee, 38138, United States

ACTIVE NOT RECRUITING

Local Institution - 0378

Abilene, Texas, 79606, United States

ACTIVE NOT RECRUITING

Local Institution - 0275

Houston, Texas, 77030, United States

ACTIVE NOT RECRUITING

Local Institution - 0267

San Antonio, Texas, 78229, United States

ACTIVE NOT RECRUITING

Local Institution - 0409

San Antonio, Texas, 78240, United States

ACTIVE NOT RECRUITING

Local Institution - 0207

Salt Lake City, Utah, 84106, United States

ACTIVE NOT RECRUITING

Local Institution - 0297

Fredericksburg, Virginia, 22408, United States

ACTIVE NOT RECRUITING

Local Institution - 0408

Norfolk, Virginia, 23502, United States

ACTIVE NOT RECRUITING

Local Institution - 0399

Roanoke, Virginia, 24014, United States

ACTIVE NOT RECRUITING

Local Institution - 0268

Seattle, Washington, 98108, United States

ACTIVE NOT RECRUITING

Local Institution - 0293

Seattle, Washington, 98109, United States

WITHDRAWN

Local Institution - 0097

Spokane, Washington, 99208, United States

WITHDRAWN

Local Institution - 0411

Vancouver, Washington, 98684, United States

ACTIVE NOT RECRUITING

Local Institution - 0220

Madison, Wisconsin, 53792, United States

WITHDRAWN

Local Institution - 0318

Chivilcoy, Buenos Aires, 6620, Argentina

ACTIVE NOT RECRUITING

Local Institution - 0213

Buenos Aires, Buenos Aires F.D., 1425, Argentina

ACTIVE NOT RECRUITING

Local Institution - 0249

Córdoba, Córdoba Province, 5016, Argentina

ACTIVE NOT RECRUITING

Local Institution - 0239

Viedma, R, R8500ACE, Argentina

ACTIVE NOT RECRUITING

Local Institution - 0200

Rosario, Santa Fe Province, 2000, Argentina

ACTIVE NOT RECRUITING

Local Institution - 0248

S3000epv, Santa Fe Province, 3000, Argentina

COMPLETED

Local Institution - 0214

Buenos Aires, CP1280AEB, Argentina

ACTIVE NOT RECRUITING

Local Institution - 0055

Liverpool, New South Wales, 2170, Australia

ACTIVE NOT RECRUITING

Local Institution - 0004

Waratah, New South Wales, 2298, Australia

ACTIVE NOT RECRUITING

Local Institution - 0017

Wollongong, New South Wales, 2500, Australia

ACTIVE NOT RECRUITING

Local Institution - 0327

Birtinya, Queensland, 4575, Australia

ACTIVE NOT RECRUITING

Local Institution - 0221

Box Hill, Victoria, 3128, Australia

ACTIVE NOT RECRUITING

Local Institution - 0003

Melbourne, Victoria, 3004, Australia

ACTIVE NOT RECRUITING

Local Institution - 0002

Melbourne, Victoria, 3065, Australia

ACTIVE NOT RECRUITING

Local Institution - 0040

Nedlands, Western Australia, 6009, Australia

ACTIVE NOT RECRUITING

Klinik Ottakring

Vienna, State of Vienna, 1160, Austria

RECRUITING

Universitätsklinikum Krems

Krems, 3500, Austria

RECRUITING

LKH Hochsteiermark - Standort Leoben

Leoben, 8700, Austria

RECRUITING

Universitätsklinikum St. Pölten

Sankt Pölten, 3100, Austria

RECRUITING

Hanusch-Krankenhaus

Vienna, 1140, Austria

RECRUITING

Ziekenhuis Oost-Limburg, Campus St.-Jan

Genk, Limburg, 3600, Belgium

RECRUITING

UZ Gent

Ghent, Oost-Vlaanderen, 9000, Belgium

RECRUITING

AZ Nikolaas

Sint-Niklaas, Oost-Vlaanderen, B-9100, Belgium

RECRUITING

ZNA Cadix

Antwerp, 2030, Belgium

RECRUITING

Instituto D'Or de Pesquisa e Ensino (IDOR) - Filial Salvador

Salvador, Estado de Bahia, 40301-155, Brazil

RECRUITING

Centro Gaucho Integrado De Oncologia, Hematologia, Ensino E Pesquisa

Porto Alegre, Rio Grande do Sul, 90110-270, Brazil

RECRUITING

Instituto Joinvilense de Hematologia e Oncologia

Joinville, Santa Catarina, 89202-050, Brazil

RECRUITING

Hospital Amaral Carvalho

Jaú, São Paulo, 17210-080, Brazil

RECRUITING

Americas Centro de Oncologia Integrado

Rio de Janeiro, 22793080, Brazil

RECRUITING

Clínica Médica São Germano S/S Ltda

São Paulo, 04537-080, Brazil

RECRUITING

Sociedade Beneficente Israelita Brasileira Hospital Albert Einstein

São Paulo, 05652-900, Brazil

RECRUITING

Local Institution - 0225

Greenfield Park, Quebec, J4V 2H1, Canada

ACTIVE NOT RECRUITING

Local Institution - 0174

Montreal, Quebec, H4J 1C5, Canada

ACTIVE NOT RECRUITING

Local Institution - 0222

Québec, Quebec, G1J 1Z4, Canada

ACTIVE NOT RECRUITING

Local Institution - 0329

Santiago, Santiago Metropolitan, 7580206, Chile

ACTIVE NOT RECRUITING

Local Institution - 0387

Santiago, Santiago Metropolitan, 8420383, Chile

ACTIVE NOT RECRUITING

Local Institution - 0332

Viña del Mar, Valparaiso, 0, Chile

ACTIVE NOT RECRUITING

Local Institution - 0062

Beijing, Beijing Municipality, 100043, China

ACTIVE NOT RECRUITING

Local Institution - 0165

Beijing, Beijing Municipality, 100043, China

COMPLETED

Local Institution - 0141

Beijing, Beijing Municipality, 100091, China

COMPLETED

Local Institution - 0144

Chongqing, Chongqing Municipality, 400016, China

ACTIVE NOT RECRUITING

Local Institution - 0237

Xiamen, Fujian, 361003, China

ACTIVE NOT RECRUITING

Local Institution - 0117

Guangzhou, Guangdong, 450008, China

ACTIVE NOT RECRUITING

Local Institution - 0177

Guangzhou, Guangdong, 510060, China

ACTIVE NOT RECRUITING

Local Institution - 0168

Guangzhou, Guangdong, 510080, China

WITHDRAWN

Local Institution - 0238

Shenzhen, Guangdong, 518039, China

ACTIVE NOT RECRUITING

Local Institution - 0412

Liuzhou, Guangxi, 0, China

COMPLETED

Local Institution - 0240

Nanning, Guangxi, 530007, China

ACTIVE NOT RECRUITING

Local Institution - 0254

Shijiazhuang, Hebei, 50000, China

ACTIVE NOT RECRUITING

Local Institution - 0395

Luoyang, Henan, 471003, China

COMPLETED

Local Institution - 0113

Zhengzhou, Henan, 450003, China

ACTIVE NOT RECRUITING

Local Institution - 0142

Wuhan, Hubei, 430022, China

ACTIVE NOT RECRUITING

Local Institution - 0155

Changsha, Hunan, 410008, China

ACTIVE NOT RECRUITING

Local Institution - 0147

Changsha, Hunan, 410013, China

ACTIVE NOT RECRUITING

Local Institution - 0111

Nanjing, Jiangsu, 210000, China

ACTIVE NOT RECRUITING

Local Institution - 0139

Wuxi, Jiangsu, 214023, China

ACTIVE NOT RECRUITING

Local Institution - 0287

Shenyang, Liaoning, 110004, China

ACTIVE NOT RECRUITING

Local Institution - 0148

Xi'an, Shaanxi, 710004, China

ACTIVE NOT RECRUITING

Local Institution - 0110

Xi'an, Shaanxi, 710126, China

COMPLETED

Local Institution - 0169

Qingdao, Shandong, 266000, China

COMPLETED

Local Institution - 0114

Shanghai, Shanghai Municipality, 200030, China

ACTIVE NOT RECRUITING

Local Institution - 0350

Shanghai, Shanghai Municipality, 200434, China

ACTIVE NOT RECRUITING

Local Institution - 0164

Taiyuan, Shanxi, 030001, China

ACTIVE NOT RECRUITING

Local Institution - 0356

Deyang, Sichuan, 618000, China

NOT YET RECRUITING

Local Institution - 0119

Tianjin, Tianjin Municipality, 300060, China

ACTIVE NOT RECRUITING

Local Institution - 0353

Ürümqi, Xinjiang, 830001, China

NOT YET RECRUITING

Local Institution - 0202

Kunming, Yunnan, 650032, China

ACTIVE NOT RECRUITING

Local Institution - 0151

Hangzhou, Zhejiang, 310003, China

WITHDRAWN

Local Institution - 0348

Linhai, Zhejiang, 317000, China

ACTIVE NOT RECRUITING

Local Institution - 0112

Ningbo, Zhejiang, 315010, China

ACTIVE NOT RECRUITING

Local Institution - 0149

Wenzhou, Zhejiang, 32500, China

ACTIVE NOT RECRUITING

Local Institution - 0150

Beijing, 100034, China

COMPLETED

Local Institution - 0176

Taiyuan, 030032, China

ACTIVE NOT RECRUITING

Local Institution - 0037

Brno, Brno-město, 625 00, Czechia

ACTIVE NOT RECRUITING

Local Institution - 0383

Prague, Praha 10, 100 34, Czechia

COMPLETED

Local Institution - 0039

Prague, 12808, Czechia

ACTIVE NOT RECRUITING

Local Institution - 0256

Kuopio, Northern Savonia, 70210, Finland

ACTIVE NOT RECRUITING

Local Institution - 0072

Helsinki, 00029, Finland

ACTIVE NOT RECRUITING

Institut de cancérologie Strasbourg Europe (ICANS)

Strasbourg, Alsace, 67033, France

RECRUITING

CHU Bordeaux Haut-Leveque

Pessac, Aquitaine, 33600, France

RECRUITING

Centre Leon Berard

Lyon Cedex08, Auvergne-Rhône-Alpes, 69373, France

RECRUITING

Hopital Claude Huriez - CHU de Lille

Lille, Nord, 59000, France

RECRUITING

Centre Hospitalier Universitaire Estaing

Clermont-Ferrand, 63100, France

RECRUITING

Centre Hospitalier Universitaire de Limoges - Hôpital Dupuytren

Limoges, 87042, France

RECRUITING

Centre Hospitalier Universitaire de Nantes - L' Hopital l'hôtel-Dieu

Nantes, 44093, France

RECRUITING

Centre Hospitalier Universitaire de Nîmes - Institut de Cancérologie du Gard - Hôpital Universitaire Carémeau

Nîmes, 30029, France

RECRUITING

Centre Hospitalier Régional Universitaire de Tours - Hôpital Bretonneau

Tours, 37032, France

RECRUITING

Hôpital Saint Antoine

Paris, Île-de-France Region, 75571, France

RECRUITING

TUM Klinikum

München, Bavaria, 81675, Germany

RECRUITING

Klinikum Traunstein

Traunstein, Bavaria, 83278, Germany

RECRUITING

Medizinisches Versorgungszentrum

Weiden, Bavaria, 92367, Germany

RECRUITING

Universitätsklinikum Marburg

Marburg, Hesse, 35033, Germany

RECRUITING

Praxis Onkologie am Raschplatz

Hanover, Lower Saxony, 30161, Germany

RECRUITING

Universitätsklinikum Bonn

Bonn, North Rhine-Westphalia, 53127, Germany

RECRUITING

Marien Hospital Düsseldorf

Düsseldorf, North Rhine-Westphalia, 40479, Germany

RECRUITING

Universitaetsklinikum Schleswig-Holstein Campus Kiel

Kiel, Schleswig-Holstein, 24105, Germany

RECRUITING

Local Institution - 0396

Erfurt, Thuringia, 99085, Germany

NOT YET RECRUITING

Universitätsklinikum Aachen

Aachen, 52074, Germany

RECRUITING

Sozialstiftung Bamberg

Bamberg, 96049, Germany

RECRUITING

Gemeinschaftspraxis Hämatologie - Onkologie Freiberg-Richter, Jacobasch, Illmer, Wolf

Dresden, 01307, Germany

RECRUITING

Universitaetsklinikum Hamburg-Eppendorf

Hamburg, 20251, Germany

RECRUITING

Asklepios Altona

Hamburg, 22763, Germany

RECRUITING

Universitaetsklinikum Tuebingen

Tübingen, 72076, Germany

RECRUITING

Gemeinschaftspraxis Dres. med. Björn Schöttker & Dominik Pretscher

Würzburg, 97080, Germany

RECRUITING

Evangelismos General Hospital of Athens

Athens, Attikí, 106 76, Greece

RECRUITING

Alexandra General Hospital of Athens

Athens, Attikí, 115 28, Greece

RECRUITING

G. Papanikolaou General Hospital

Thessaloniki, Thessaloníki, 570 10, Greece

RECRUITING

HCG Aastha Cancer Centre

Ahmedabad, Gujarat, 380060, India

RECRUITING

Marengo Asia Hospitals Gurugram

Gurugram, Haryana, 122011, India

RECRUITING

KLES Dr. Prabhakar Kore Hospital & M.R.C

Belagavi, Karnataka, 590010, India

RECRUITING

Mumbai Oncocare Centre - Nanachowk

Mumbai, Maharashtra, 400036, India

RECRUITING

Meenakshi Mission Hospital and Research Centre

Madurai, Tamil Nadu, 625107, India

RECRUITING

Tata Memorial Centre - Homi Bhabha Cancer Hospital

Varanasi, Uttar Pradesh, 221002, India

RECRUITING

Christian Medical College & Hospital

Ludhiana, 141008, India

RECRUITING

Jawaharlal Institute Of Postgraduate Medical Education And Research

Puducherry, 605006, India

RECRUITING

Local Institution - 0121

Galway, Connacht, H91 YR71, Ireland

ACTIVE NOT RECRUITING

Local Institution - 0122

Cork, T12 E8YV, Ireland

ACTIVE NOT RECRUITING

Local Institution - 0120

Dublin, D08 E9P6, Ireland

ACTIVE NOT RECRUITING

Local Institution - 0251

Limerick, V94 F858, Ireland

WITHDRAWN

Meir Medical Center

Kfar Saba, Central District, 4428164, Israel

RECRUITING

Sheba Medical Center

Ramat Gan, Central District, 5262100, Israel

RECRUITING

Hadassah Medical Center - Do Not Use - Duplicate Facility

Jerusalem, Jerusalem, 91220, Israel

RECRUITING

Rambam Health Care Campus

Haifa, Northern District, 3109601, Israel

RECRUITING

Sourasky Medical Center

Tel Aviv, Tall Abīb, 6423906, Israel

RECRUITING

Rabin Medical Center

Peatch Tikva, 49100, Israel

RECRUITING

IRCCS - Istituto Romagnolo per lo Studio dei Tumori (IRST) "Dino Amadori"

Meldola, Emilia-Romagna, 47014, Italy

RECRUITING

Azienda Ospedaliera Sant'Andrea

Rome, Roma, 00189, Italy

RECRUITING

Policlinico "G. Rodolico"

Catania, Sicily, 95123, Italy

RECRUITING

IRCCS Azienda Ospedaliero-Universitaria di Bologna, Policlinico di Sant'Orsola

Bologna, 40138, Italy

RECRUITING

Fondazione IRCCS Policlinico San Matteo

Pavia, 27100, Italy

RECRUITING

National Cancer Center Hospital East

Kashiwa, Chiba, 277-8577, Japan

RECRUITING

Japan Community Healthcare Organization Kyushu Hospital

Kitakyushu-shi, Fukuoka, 806-8501, Japan

RECRUITING

National Hospital Organization Hokkaido Cancer Center

Sapporo, Hokkaido, 003-0804, Japan

RECRUITING

Mito Medical Center

Higashiibaraki, Ibaraki, 3113117, Japan

RECRUITING

Iwate Medical University Hospital

Shiwa-gun Yahaba-cho, Iwate, 028-3695, Japan

RECRUITING

Shonan Kamakura General Hospital

Kamakura, Kanagawa, 247-8533, Japan

RECRUITING

Saitama Medical University Hospital

Iruma, Saitama, 350-0495, Japan

RECRUITING

Dokkyo Medical University Saitama Medical Center

Koshigaya, Saitama, 343-0845, Japan

RECRUITING

Shizuoka Cancer Center

Nagaizumi-cho,Sunto-gun, Shizuoka, 411-8777, Japan

RECRUITING

Nihon University Itabashi Hospital

Itabashiku, Tokyo, 173-8610, Japan

RECRUITING

Chiba University Hospital

Chiba, 260-8677, Japan

RECRUITING

National Hospital Organization Kyushu Medical Center

Fukuoka, 810-8563, Japan

RECRUITING

Japanese Red Cross Fukuoka Hospital

Fukuoka, 815-8555, Japan

RECRUITING

Hiroshima Red Cross Hospital & Atomic-bomb Survivors Hospital

Hiroshima, 730-0052, Japan

RECRUITING

Kumamoto University

Kumamoto, 860-8556, Japan

RECRUITING

The Japanese Red Cross Nagasaki Genbaku Hospital

Nagasaki, 852-8104, Japan

RECRUITING

The Jikei University Hospital

Tokyo, 105-8461, Japan

RECRUITING

Japanese Red Cross Medical Center

Tokyo, 150-8935, Japan

RECRUITING

Local Institution - 0335

Tauranga, Bay of Plenty, 3112, New Zealand

ACTIVE NOT RECRUITING

Local Institution - 0340

Dunedin, Otago, 9016, New Zealand

ACTIVE NOT RECRUITING

Local Institution - 0369

Auckland, 1023, New Zealand

ACTIVE NOT RECRUITING

Local Institution - 0334

Auckland, 2025, New Zealand

WITHDRAWN

Local Institution - 0346

Skórzewo, Greater Poland Voivodeship, 60-185, Poland

WITHDRAWN

Local Institution - 0224

Torun, Kuyavian-Pomeranian Voivodeship, 87-100, Poland

COMPLETED

Local Institution - 0325

Krakow, Lesser Poland Voivodeship, 30-727, Poland

NOT YET RECRUITING

Local Institution - 0250

Warsaw, Masovian Voivodeship, 02-776, Poland

COMPLETED

Local Institution - 0292

Słupsk, Pomeranian Voivodeship, 76-200, Poland

COMPLETED

Local Institution - 0185

Katowice, 40-519, Poland

ACTIVE NOT RECRUITING

Hospital de Braga

Braga, 4710-243, Portugal

RECRUITING

Champalimaud Foundation

Lisbon, 1400-038, Portugal

RECRUITING

Instituto Português de Oncologia do Porto Francisco Gentil, EPE

Porto, 4200-072, Portugal

RECRUITING

Local Institution - 0355

San Juan, 00909, Puerto Rico

WITHDRAWN

Fundeni Clinical Institute

Bucharest, 022328, Romania

RECRUITING

Institutul Oncologic Cluj

Cluj-Napoca, 400124, Romania

RECRUITING

Institutul Regional de Oncologie Iasi

Iași, 700483, Romania

RECRUITING

Netcare Pretoria East Hospital

Centurion, GP, 0044, South Africa

RECRUITING

Groote Schuur Hospital

Cape Town, Western Cape, 7925, South Africa

RECRUITING

Haemalife

Kuilsriver, Western Cape, 7580, South Africa

RECRUITING

Constantiaberg Haematology

Plumstead, Western Cape, 7800, South Africa

RECRUITING

Local Institution - 0106

Busan, Busan, 49241, South Korea

WITHDRAWN

Pusan National University Hospital

Busan, Busan, 49241, South Korea

RECRUITING

Local Institution - 0102

Seongnam, Gyeonggido, 13620, South Korea

WITHDRAWN

Seoul National University Bundang Hospital

Seongnam, Gyeonggido, 13620, South Korea

RECRUITING

Chonnam National University Hwasun Hospital

Hwasun, Jeonranamdo, 58128, South Korea

RECRUITING

Local Institution - 0103

Hwasun, Jeonranamdo, 58128, South Korea

WITHDRAWN

Local Institution - 0101

Seoul, Seoul Teugbyeolsi, 03080, South Korea

WITHDRAWN

Seoul National University Hospital

Seoul, Seoul Teugbyeolsi, 03080, South Korea

RECRUITING

Samsung Medical Center

Seoul, Seoul Teugbyeolsi, 06351, South Korea

RECRUITING

Local Institution - 0104

Seoul, Seoul Teugbyeolsi, 06591, South Korea

WITHDRAWN

The Catholic Univ. of Korea Seoul St. Mary's Hospital

Seoul, Seoul Teugbyeolsi, 06591, South Korea

RECRUITING

Asan Medical Center

Seoul, Seoul-teukbyeolsi [Seoul], 05505, South Korea

RECRUITING

Local Institution - 0105

Seoul, Seoul-teukbyeolsi, 05505, South Korea

WITHDRAWN

Local Institution - 0100

Seoul, 03722, South Korea

WITHDRAWN

Severance Hospital, Yonsei University Health System

Seoul, 03722, South Korea

RECRUITING

Local Institution

Seoul, 138-736, South Korea

NOT YET RECRUITING

Local Institution - 0183

Palma, Balearic Islands, 07120, Spain

WITHDRAWN

Hospital Universitari Son Espases

Palma, Balears [Baleares], 07120, Spain

RECRUITING

Hospital Clínic de Barcelona

Barcelona, Catalunya [Cataluña], 08036, Spain

RECRUITING

Local Institution - 0073

Barcelona, Catalunya [Cataluña], 08036, Spain

WITHDRAWN

Hospital General Universitario Morales Meseguer

Murcia, Murcia, Región de, 30008, Spain

RECRUITING

Hospital Costa del Sol

Marbella, Málaga, 29603, Spain

RECRUITING

Local Institution - 0182

Marbella, Málaga, 29603, Spain

WITHDRAWN

Hospital San Pedro de Alcantara

Cáceres, 10003, Spain

RECRUITING

Complejo Asistencial Universitario de León - Hospital de León

León, 24071, Spain

RECRUITING

Hospital Universitario 12 de Octubre

Madrid, 28041, Spain

RECRUITING

Local Institution - 0232

Ankara, 06620, Turkey (Türkiye)

ACTIVE NOT RECRUITING

Local Institution - 0339

Ankara, 06680, Turkey (Türkiye)

ACTIVE NOT RECRUITING

Local Institution - 0228

Istanbul, 34093, Turkey (Türkiye)

ACTIVE NOT RECRUITING

Local Institution - 0229

Izmir, 35100, Turkey (Türkiye)

ACTIVE NOT RECRUITING

Local Institution - 0226

Kayseri, 0, Turkey (Türkiye)

ACTIVE NOT RECRUITING

Local Institution - 0227

Samsun, 55139, Turkey (Türkiye)

ACTIVE NOT RECRUITING

Addenbrooke's Hospital

Cambridge, Cambridgeshire, CB2 0QQ, United Kingdom

RECRUITING

The Royal Cornwall Hospital

Truro, England, TR1 3LJ, United Kingdom

RECRUITING

Lanarkshire NHS Trust - Monklands Hospital

Airdrie, Great Britain, ML6 OJS, United Kingdom

RECRUITING

King's College Hospital

London, Greater London, SE5 9RS, United Kingdom

RECRUITING

Leicester Royal Infirmary

Leicester, Leicestershire, LE1 5WW, United Kingdom

RECRUITING

Hammersmith Hospital

London, London, City of, W12 0HS, United Kingdom

RECRUITING

Barnet Hospital

Barnet, EN5 3DJ, United Kingdom

RECRUITING

Freeman Hospital

Newcastle upon Tyne, NE7 7DN, United Kingdom

RECRUITING

Royal Stoke University Hospital

Stoke-on-Trent, ST4 6QG, United Kingdom

RECRUITING

Related Links

• BMS Clinical Trial Information
• BMS Clinical Trial Patient Recruiting

MeSH Terms

Conditions

Recurrence; Multiple Myeloma

Interventions

pomalidomide; Bortezomib; Dexamethasone; Calcium Dobesilate

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Neoplasms, Plasma Cell; Neoplasms by Histologic Type; Neoplasms; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Paraproteinemias; Blood Protein Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemorrhagic Disorders; Lymphoproliferative Disorders; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

Boronic Acids; Acids, Noncarboxylic; Acids; Inorganic Chemicals; Boron Compounds; Organic Chemicals; Pyrazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated; Benzenesulfonates; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Arylsulfonates; Arylsulfonic Acids; Sulfonic Acids; Sulfur Acids; Sulfur Compounds

Study Officials

• Bristol-Myers Squibb

  Bristol-Myers Squibb

  STUDY DIRECTOR

Central Study Contacts

BMS Clinical Trials Contact Center www.BMSClinicalTrials.com

CONTACT

855-907-3286; Clinical.Trials@bms.com

First line of the email MUST contain NCT # and Site #.

CONTACT

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 25, 2022
• First Posted: August 29, 2022
• Study Start: September 20, 2022
• Primary Completion (Estimated): January 10, 2027
• Study Completion (Estimated): November 30, 2033
• Last Updated: April 30, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• Time Frame: See Plan Description
• Access Criteria: See Plan Description

Locations

US (56); FI (2); DE (16); IN (8); KR (16); AU (8); ES (10); CA (3); NZ (4); BR (7); PL (6); JP (18); CZ (3); FR (10); IT (5); CL (3); PT (3); GR (3); CN (36); PR (1); GB (9); RO (3); IE (4); BE (4); ZA (4); IL (6); AR (7); TU (6)