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NCT05519085PHASE3Recruiting

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

Celgene

Start Date

9/20/2022

Completion Date

11/30/2033

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.

Eligibility Criteria

Age Range: 18 years to No maximum

Inclusion Criteria \- 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. Exclusion Criteria \- 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. * Other protocol-defined Inclusion/Exclusion criteria apply.

Interventions

DRUG

mezigdomide

DRUG

Pomalidomide

DRUG

Bortezomib

DRUG

Dexamethasone

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Conditions

Relapsed or Refractory Multiple Myeloma

Locations

Local Institution - 0366

Los Alamitos, California 90720

United States

Local Institution - 0272

San Diego, California 92123

United States

Local Institution - 0273

West Hollywood, California 90069

United States

Local Institution - 0381

Aurora, Colorado 80045

United States

Local Institution - 0380

Farmington, Connecticut 06030

United States

Local Institution - 0208

New Haven, Connecticut 06510

United States

Local Institution - 0303

Coral Springs, Florida 33321

United States

Local Institution - 0403

Fort Myers, Florida 33901

United States

Local Institution - 0401

St. Petersburg, Florida 33701

United States

Local Institution - 0402

West Palm Beach, Florida 33401

United States

Local Institution - 0211

Athens, Georgia 30607

United States

Local Institution - 0048

Marietta, Georgia 30060

United States

Local Institution - 0330

Garden City, Kansas 67846

United States

Local Institution - 0080

Westwood, Kansas 66205

United States

Local Institution - 0358

Baton Rouge, Louisiana 70808

United States

Local Institution - 0255

New Orleans, Louisiana 70112

United States

Local Institution - 0385

Shreveport, Louisiana 71103

United States

Local Institution - 0357

Baltimore, Maryland 21215

United States

Local Institution - 0246

Boston, Massachusetts 02215

United States

Local Institution - 0271

Ann Arbor, Michigan 48109

United States

Local Institution - 0364

Detroit, Michigan 48202

United States

Local Institution - 0410

Minneapolis, Minnesota 55404

United States

Local Institution - 0088

Hattiesburg, Mississippi 39401

United States

Local Institution - 0242

Jackson, Mississippi 39213

United States

Local Institution - 0288

East Brunswick, New Jersey 08816

United States

Local Institution - 0363

Ridgewood, New Jersey 07450

United States

Local Institution - 0302

Albuquerque, New Mexico 87131

United States

Local Institution - 0245

Buffalo, New York 14215

United States

Local Institution - 0257

Lake Success, New York 11042

United States

Local Institution - 0373

New Hyde Park, New York 11042

United States

Local Institution - 0371

New York, New York 10028

United States

Local Institution - 0108

Rochester, New York 14621

United States

Local Institution - 0374

Shirley, New York 11967

United States

Local Institution - 0372

The Bronx, New York 10469

United States

Local Institution - 0274

Williamsville, New York 14221

United States

Local Institution - 0260

Durham, North Carolina 27710

United States

Local Institution - 0400

Cincinnati, Ohio 45242

United States

Local Institution - 0377

Cleveland, Ohio 44111

United States

Local Institution - 0076

Cleveland, Ohio 44195

United States

Local Institution - 0376

Mayfield Heights, Ohio 44124

United States

Local Institution - 0359

Allentown, Pennsylvania 18103

United States

Local Institution - 0264

York, Pennsylvania 17403

United States

Local Institution - 0223

Germantown, Tennessee 38138

United States

Local Institution - 0378

Abilene, Texas 79606

United States

Local Institution - 0275

Houston, Texas 77030

United States

Local Institution - 0267

San Antonio, Texas 78229

United States

Local Institution - 0409

San Antonio, Texas 78240

United States

Local Institution - 0207

Salt Lake City, Utah 84106

United States

Local Institution - 0297

Fredericksburg, Virginia 22408

United States

Local Institution - 0408

Norfolk, Virginia 23502

United States

Local Institution - 0399

Roanoke, Virginia 24014

United States

Local Institution - 0268

Seattle, Washington 98108

United States

Local Institution - 0293

Seattle, Washington 98109

United States

Local Institution - 0097

Spokane, Washington 99208

United States

Local Institution - 0411

Vancouver, Washington 98684

United States

Local Institution - 0220

Madison, Wisconsin 53792

United States

Local Institution - 0318

Chivilcoy, Buenos Aires 6620

Argentina

Local Institution - 0213

Buenos Aires, Buenos Aires F.D. 1425

Argentina

Local Institution - 0249

Córdoba, Córdoba Province 5016

Argentina

Local Institution - 0239

Viedma, R R8500ACE

Argentina

Local Institution - 0200

Rosario, Santa Fe Province 2000

Argentina

Local Institution - 0248

S3000epv, Santa Fe Province 3000

Argentina

Local Institution - 0214

Buenos Aires, CP1280AEB

Argentina

Local Institution - 0055

Liverpool, New South Wales 2170

Australia

Local Institution - 0004

Waratah, New South Wales 2298

Australia

Local Institution - 0017

Wollongong, New South Wales 2500

Australia

Local Institution - 0327

Birtinya, Queensland 4575

Australia

Local Institution - 0221

Box Hill, Victoria 3128

Australia

Local Institution - 0003

Melbourne, Victoria 3004

Australia

Local Institution - 0002

Melbourne, Victoria 3065

Australia

Local Institution - 0040

Nedlands, Western Australia 6009

Australia

Local Institution - 0012

Vienna, State of Vienna 1160

Austria

Local Institution - 0008

Krems, 3500

Austria

Local Institution - 0024

Leoben, 8700

Austria

Local Institution - 0011

Sankt Pölten, 3100

Austria

Local Institution - 0025

Vienna, 1140

Austria

Ziekenhuis Oost-Limburg, Campus St.-Jan

Genk, Limburg 3600

Belgium

UZ Gent

Ghent, Oost-Vlaanderen 9000

Belgium

AZ Nikolaas

Sint-Niklaas, Oost-Vlaanderen B-9100

Belgium

ZNA Cadix

Antwerp, 2030

Belgium

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

Salvador, Estado de Bahia 40301-155

Brazil

Centro Gaucho Integrado De Oncologia, Hematologia, Ensino E Pesquisa

Porto Alegre, Rio Grande do Sul 90110-270

Brazil

Instituto Joinvilense de Hematologia e Oncologia

Joinville, Santa Catarina 89202-050

Brazil

Hospital Amaral Carvalho

Jaú, São Paulo 17210-080

Brazil

Americas Centro de Oncologia Integrado

Rio de Janeiro, 22793080

Brazil

Clínica Médica São Germano S/S Ltda

São Paulo, 04537-080

Brazil

Sociedade Beneficente Israelita Brasileira Hospital Albert Einstein

São Paulo, 05652-900

Brazil

Local Institution - 0225

Greenfield Park, Quebec J4V 2H1

Canada

Local Institution - 0174

Montreal, Quebec H4J 1C5

Canada

Local Institution - 0222

Québec, Quebec G1J 1Z4

Canada

Local Institution - 0329

Santiago, Santiago Metropolitan 7580206

Chile

Local Institution - 0387

Santiago, Santiago Metropolitan 8420383

Chile

Local Institution - 0332

Viña del Mar, Valparaiso 0

Chile

Local Institution - 0062

Beijing, Beijing Municipality 100043

China

Local Institution - 0165

Beijing, Beijing Municipality 100043

China

Local Institution - 0141

Beijing, Beijing Municipality 100091

China

Local Institution - 0144

Chongqing, Chongqing Municipality 400016

China

Local Institution - 0237

Xiamen, Fujian 361003

China

Local Institution - 0117

Guangzhou, Guangdong 450008

China

Local Institution - 0177

Guangzhou, Guangdong 510060

China

Local Institution - 0168

Guangzhou, Guangdong 510080

China

Local Institution - 0238

Shenzhen, Guangdong 518039

China

Local Institution - 0412

Liuzhou, Guangxi 0

China

Local Institution - 0240

Nanning, Guangxi 530007

China

Local Institution - 0254

Shijiazhuang, Hebei 50000

China

Local Institution - 0395

Luoyang, Henan 471003

China

Local Institution - 0113

Zhengzhou, Henan 450003

China

Local Institution - 0142

Wuhan, Hubei 430022

China

Local Institution - 0155

Changsha, Hunan 410008

China

Local Institution - 0147

Changsha, Hunan 410013

China

Local Institution - 0111

Nanjing, Jiangsu 210000

China

Local Institution - 0139

Wuxi, Jiangsu 214023

China

Local Institution - 0287

Shenyang, Liaoning 110004

China

Local Institution - 0148

Xi'an, Shaanxi 710004

China

Local Institution - 0110

Xi'an, Shaanxi 710126

China

Local Institution - 0169

Qingdao, Shandong 266000

China

Local Institution - 0114

Shanghai, Shanghai Municipality 200030

China

Local Institution - 0350

Shanghai, Shanghai Municipality 200434

China

Local Institution - 0164

Taiyuan, Shanxi 030001

China

Local Institution - 0356

Deyang, Sichuan 618000

China

Local Institution - 0119

Tianjin, Tianjin Municipality 300060

China

Local Institution - 0353

Ürümqi, Xinjiang 830001

China

Local Institution - 0202

Kunming, Yunnan 650032

China

Local Institution - 0151

Hangzhou, Zhejiang 310003

China

Local Institution - 0348

Linhai, Zhejiang 317000

China

Local Institution - 0112

Ningbo, Zhejiang 315010

China

Local Institution - 0149

Wenzhou, Zhejiang 32500

China

Local Institution - 0150

Beijing, 100034

China

Local Institution - 0176

Taiyuan, 030032

China

Local Institution - 0037

Brno, Brno-město 625 00

Czechia

Local Institution - 0383

Prague, Praha 10 100 34

Czechia

Local Institution - 0039

Prague, 12808

Czechia

Local Institution - 0256

Kuopio, Northern Savonia 70210

Finland

Local Institution - 0072

Helsinki, 00029

Finland

Institut de cancérologie Strasbourg Europe (ICANS)

Strasbourg, Alsace 67033

France

Local Institution - 0091

Pessac, Aquitaine 33600

France

Centre Leon Berard

Lyon Cedex08, Auvergne-Rhône-Alpes 69373

France

Hopital Claude Huriez - CHU de Lille

Lille, Nord 59000

France

Centre Hospitalier Universitaire Estaing

Clermont-Ferrand, 63100

France

Centre Hospitalier Universitaire de Limoges - Hôpital Dupuytren

Limoges, 87042

France

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

Nantes, 44093

France

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

Nîmes, 30029

France

Centre Hospitalier Régional Universitaire de Tours - Hôpital Bretonneau

Tours, 37032

France

Hôpital Saint Antoine

Paris, Île-de-France Region 75571

France

TUM Klinikum

München, Bavaria 81675

Germany

Klinikum Traunstein

Traunstein, Bavaria 83278

Germany

Medizinisches Versorgungszentrum

Weiden, Bavaria 92367

Germany

Universitaetsklinik Marburg

Marburg, Hesse 35033

Germany

Praxis Onkologie am Raschplatz

Hanover, Lower Saxony 30161

Germany

Universitätsklinikum Bonn

Bonn, North Rhine-Westphalia 53127

Germany

Marien Hospital Düsseldorf

Düsseldorf, North Rhine-Westphalia 40479

Germany

Universitaetsklinikum Schleswig-Holstein Campus Kiel

Kiel, Schleswig-Holstein 24105

Germany

Local Institution - 0396

Erfurt, Thuringia 99085

Germany

Universitätsklinikum Aachen

Aachen, 52074

Germany

Sozialstiftung Bamberg

Bamberg, 96049

Germany

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

Dresden, 01307

Germany

Universitaetsklinikum Hamburg-Eppendorf

Hamburg, 20251

Germany

Asklepios Altona

Hamburg, 22763

Germany

Universitaetsklinikum Tuebingen

Tübingen, 72076

Germany

Gemeinschaftspraxis Dres. med. Björn Schöttker & Dominik Pretscher

Würzburg, 97080

Germany

Local Institution - 0190

Athens, Attikí 106 76

Greece

Local Institution - 0191

Athens, Attikí 115 28

Greece

G. Papanikolaou General Hospital

Thessaloniki, Thessaloníki 570 10

Greece

HCG Aastha Cancer Centre

Ahmedabad, Gujarat 380060

India

Marengo Asia Hospitals Gurugram

Gurugram, Haryana 122011

India

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

Belagavi, Karnataka 590010

India

Mumbai Oncocare Centre - Nanachowk

Mumbai, Maharashtra 400036

India

Local Institution - 0344

Madurai, Tamil Nadu 625107

India

Local Institution - 0341

Varanasi, Uttar Pradesh 221002

India

Christian Medical College & Hospital

Ludhiana, 141008

India

Jawaharlal Institute Of Postgraduate Medical Education And Research

Puducherry, 605006

India

Local Institution - 0121

Galway, Connacht H91 YR71

Ireland

Local Institution - 0122

Cork, T12 E8YV

Ireland

Local Institution - 0120

Dublin, D08 E9P6

Ireland

Local Institution - 0251

Limerick, V94 F858

Ireland

Local Institution - 0196

Kfar Saba, Central District 4428164

Israel

Local Institution - 0195

Ramat Gan, Central District 5262100

Israel

Local Institution - 0197

Jerusalem, Jerusalem 91220

Israel

Local Institution - 0192

Haifa, Northern District 3109601

Israel

Local Institution - 0193

Tel Aviv, Tall Abīb 6423906

Israel

Local Institution - 0194

Peatch Tikva, 49100

Israel

Local Institution - 0384

Meldola, Emilia-Romagna 47014

Italy

Local Institution - 0212

Rome, Roma 00189

Italy

Local Institution - 0160

Catania, Sicily 95123

Italy

Local Institution - 0159

Bologna, 40138

Italy

Local Institution - 0158

Pavia, 27100

Italy

National Cancer Center Hospital East

Kashiwa, Chiba 277-8577

Japan

Japan Community Healthcare Organization Kyushu Hospital

Kitakyushu-shi, Fukuoka 806-8501

Japan

Local Institution - 0280

Sapporo, Hokkaido 003-0804

Japan

Mito Medical Center

Higashiibaraki, Ibaraki 3113117

Japan

Local Institution - 0276

Shiwa-gun Yahaba-cho, Iwate 028-3695

Japan

Shonan Kamakura General Hospital

Kamakura, Kanagawa 247-8533

Japan

Saitama Medical University Hospital

Iruma, Saitama 350-0495

Japan

Dokkyo Medical University Saitama Medical Center

Koshigaya, Saitama 3438555

Japan

Shizuoka Cancer Center

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

Japan

Local Institution - 0296

Itabashiku, Tokyo 173-8610

Japan

Local Institution - 0283

Shibuya-ku, Tokyo 150-8935

Japan

Chiba University Hospital

Chiba, 260-8677

Japan

National Hospital Organization Kyushu Medical Center

Fukuoka, 810-8563

Japan

Japanese Red Cross Fukuoka Hospital

Fukuoka, 815-8555

Japan

Local Institution - 0291

Hiroshima, 730-8619

Japan

Local Institution - 0284

Kumamoto, 860-8556

Japan

Local Institution - 0277

Nagasaki, 852-8511

Japan

The Jikei University Hospital

Tokyo, 105-000

Japan

Local Institution - 0335

Tauranga, Bay of Plenty 3112

New Zealand

Local Institution - 0340

Dunedin, Otago 9016

New Zealand

Local Institution - 0369

Auckland, 1023

New Zealand

Local Institution - 0334

Auckland, 2025

New Zealand

Local Institution - 0346

Skórzewo, Greater Poland Voivodeship 60-185

Poland

Local Institution - 0224

Torun, Kuyavian-Pomeranian Voivodeship 87-100

Poland

Local Institution - 0325

Krakow, Lesser Poland Voivodeship 30-727

Poland

Local Institution - 0250

Warsaw, Masovian Voivodeship 02-776

Poland

Local Institution - 0292

Słupsk, Pomeranian Voivodeship 76-200

Poland

Local Institution - 0185

Katowice, 40-519

Poland

Hospital de Braga

Braga, 4710-243

Portugal

Champalimaud Foundation

Lisbon, 1400-038

Portugal

Instituto Português de Oncologia do Porto Francisco Gentil, EPE

Porto, 4200-072

Portugal

Local Institution - 0355

San Juan, 00909

Puerto Rico

Local Institution - 0021

Bucharest, 022328

Romania

Local Institution - 0052

Cluj-Napoca, 400124

Romania

Local Institution - 0035

Iași, 700483

Romania

Netcare Pretoria East Hospital

Centurion, GP 0044

South Africa

Groote Schuur Hospital

Cape Town, Western Cape 7925

South Africa

Haemalife

Kuilsriver, Western Cape 7580

South Africa

Constantiaberg Haematology

Plumstead, Western Cape 7800

South Africa

Local Institution - 0106

Busan, Busan 49241

South Korea

Pusan National University Hospital

Busan, Busan 49241

South Korea

Local Institution - 0102

Seongnam, Gyeonggido 13620

South Korea

Seoul National University Bundang Hospital

Seongnam, Gyeonggido 13620

South Korea

Chonnam National University Hwasun Hospital

Hwasun, Jeonranamdo 58128

South Korea

Local Institution - 0103

Hwasun, Jeonranamdo 58128

South Korea

Local Institution - 0101

Seoul, Seoul Teugbyeolsi 03080

South Korea

Seoul National University Hospital

Seoul, Seoul Teugbyeolsi 03080

South Korea

Samsung Medical Center

Seoul, Seoul Teugbyeolsi 06351

South Korea

Local Institution - 0104

Seoul, Seoul Teugbyeolsi 06591

South Korea

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

Seoul, Seoul Teugbyeolsi 06591

South Korea

Asan Medical Center

Seoul, Seoul-teukbyeolsi [Seoul] 05505

South Korea

Local Institution - 0105

Seoul, Seoul-teukbyeolsi 05505

South Korea

Local Institution - 0100

Seoul, 03722

South Korea

Severance Hospital, Yonsei University Health System

Seoul, 03722

South Korea

Local Institution

Seoul, 138-736

South Korea

Local Institution - 0183

Palma, Balearic Islands 07120

Spain

Local Institution - 0252

Palma, Balears [Baleares] 07120

Spain

Local Institution - 0073

Barcelona, Catalunya [Cataluña] 08036

Spain

Local Institution - 0210

Barcelona, Catalunya [Cataluña] 08036

Spain

Local Institution - 0075

Murcia, Murcia, Región de 30008

Spain

Local Institution - 0182

Marbella, Málaga 29603

Spain

Local Institution - 0253

Marbella, Málaga 29603

Spain

Local Institution - 0328

Cáceres, 10003

Spain

Local Institution - 0074

León, 24071

Spain

Local Institution - 0181

Madrid, 28041

Spain

Local Institution - 0232

Ankara, 06620

Turkey (Türkiye)

Local Institution - 0339

Ankara, 06680

Turkey (Türkiye)

Local Institution - 0228

Istanbul, 34093

Turkey (Türkiye)

Local Institution - 0229

Izmir, 35100

Turkey (Türkiye)

Local Institution - 0226

Kayseri, 0

Turkey (Türkiye)

Local Institution - 0227

Samsun, 55139

Turkey (Türkiye)

Addenbrooke's Hospital

Cambridge, Cambridgeshire CB2 0QQ

United Kingdom

The Royal Cornwall Hospital

Truro, England TR1 3LJ

United Kingdom

Lanarkshire NHS Trust - Monklands Hospital

Airdrie, Great Britain ML6 OJS

United Kingdom

King's College Hospital

London, Greater London SE5 9RS

United Kingdom

Leicester Royal Infirmary

Leicester, Leicestershire LE1 5WW

United Kingdom

Hammersmith Hospital

London, London, City of W12 0HS

United Kingdom

Barnet Hospital

Barnet, EN5 3DJ

United Kingdom

Freeman Hospital

Newcastle upon Tyne, NE7 7DN

United Kingdom

Royal Stoke University Hospital

Stoke-on-Trent, ST4 6QG

United Kingdom