A Study to Evaluate Mezigdomide in Combination With Carfilzomib and Dexamethasone (MeziKD) Versus Carfilzomib and Dexamethasone (Kd) in Participants With Relapsed or Refractory Multiple Myeloma (SUCCESSOR-2)

NCT05552976 | Active Not Recruiting Phase 3 DMC FDA Drug

• 1 other identifier: CA057-008
• Study Type: interventional
• Target: 606
• Locations: 26 countries
• Sites: 204

Brief Summary

The purpose of the study is to compare Mezigdomide (CC-92480/BMS-986348) with carfilzomib and dexamethasone (MeziKD) against carfilzomib and dexamethasone (Kd) in the treatment of RRMM: SUCCESSOR-2.

Conditions

Relapsed or Refractory Multiple Myeloma

Keywords

BMS-986348; CC-92480; Carfilzomib; Dexamethasone; Multiple Myeloma; Mezigdomide

Outcome Measures

Primary Outcomes (1)

• Progression-free Survival (PFS)

  Up to approximately 5 years

Secondary Outcomes (15)

• Recommended Mezigdomide Dose

  Up to 12 months

• Plasma concentrations of Mezigdomide in Combination with Carfilzomib and Dexamethasone

  Up to 176 days

• Overall Survival (OS)

  Up to approximately 5 years

• Overall Response (OR)

  Up to approximately 5 years

• Rate Of Very Good Partial Response (VGPR) Or Better (VGPRR)

  Up to approximately 5 years

Study Arms (2)

MeziKd (Mezigdomide + Carfilzomib + Dexamethasone)

EXPERIMENTAL

Drug: Mezigdomide; Drug: Carfilzomib; Drug: Dexamethasone

Kd (Carfilzomib + Dexamethasone)

ACTIVE COMPARATOR

Drug: Carfilzomib; Drug: Dexamethasone

Interventions

Mezigdomide DRUG

Specified dose on specified days

Also known as: BMS-986348, CC-92480

MeziKd (Mezigdomide + Carfilzomib + Dexamethasone)

Carfilzomib DRUG

Specified dose on specified days

Also known as: Kyprolis

Kd (Carfilzomib + Dexamethasone); MeziKd (Mezigdomide + Carfilzomib + Dexamethasone)

Dexamethasone DRUG

Specified dose on specified days

Also known as: Decadron, Dex

Kd (Carfilzomib + Dexamethasone); MeziKd (Mezigdomide + Carfilzomib + 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 multiple myeloma and measurable disease, defined as any of the following:.
• i) Myeloma-protein (M-protein) ≥ 0.5 grams/deciliter (g/dL) by serum protein electrophoresis (sPEP), or.
• ii) M-protein ≥ 200 milligrams (mg)/24-hour urine collection by urine protein electrophoresis (uPEP) or,.
• iii) For participants without measurable disease in sPEP or uPEP: serum free light chain levels \> 100 mg/liter (L) (10 mg/dL) involved light chain and an abnormal κ/λ free light chain ratio.
• Participant has received at least one prior line of anti-myeloma therapy. Note: One line can contain several phases (e.g., induction, \[with or without\] hematopoietic stem cell transplant, (with or without) consolidation, and/or \[with or without\] maintenance therapy).
• Participant must have received prior treatment with lenalidomide and at least 2 cycles of an anti-CD38 monoclonal antibody (mAb) (participants who were intolerant of an anti-CD38 mAb and received \< 2 cycles are still eligible).
• Participant achieved minimal response or better to at least 1 prior anti-myeloma therapy.
• Participant must have documented disease progression during or after their last antimyeloma regimen.

You may not qualify if:

• Participant who has had prior treatment with mezigdomide or carfilzomib.
• Participant has previously received allogeneic stem cell transplant at any time or received autologous stem cell transplant within 12 weeks of initiating study treatment.

Sponsors & Collaborators

• Bristol-Myers Squibb: lead

Study Sites (207)

Local Institution - 0046

Mobile, Alabama, 36604, United States

Location

Local Institution - 0005

Cerritos, California, 90703, United States

Location

Local Institution - 0190

Irvine, California, 92618, United States

Location

Local Institution - 0187

Los Angeles, California, 90017, United States

Location

Local Institution - 0344

Santa Rosa, California, 95403, United States

Location

Local Institution - 0339

Stockton, California, 95204, United States

Location

Local Institution - 0279

Newark, Delaware, 19713, United States

Location

Local Institution - 0341

Fort Myers, Florida, 33901, United States

Location

Local Institution - 0342

St. Petersburg, Florida, 33705, United States

Location

Local Institution - 0340

West Palm Beach, Florida, 33401, United States

Location

Local Institution - 0348

Atlanta, Georgia, 30303, United States

Location

Local Institution - 0291

Atlanta, Georgia, 30322, United States

Location

Saint Alphonsus Regional Medical Center

Boise, Idaho, 83706, United States

Location

Local Institution - 0289

Annapolis, Maryland, 21401, United States

Location

Local Institution - 0204

Boston, Massachusetts, 02215, United States

Location

Local Institution - 0346

Minneapolis, Minnesota, 55404, United States

Location

Local Institution - 0222

Little Silver, New Jersey, 07739, United States

Location

Local Institution - 0199

The Bronx, New York, 10467, United States

Location

Local Institution - 0322

Cleveland, Ohio, 44106, United States

Location

Local Institution - 0172

Columbus, Ohio, 43214, United States

Location

Local Institution - 0321

Providence, Rhode Island, 02903, United States

Location

Local Institution - 0338

Greer, South Carolina, 29650, United States

Location

Local Institution - 0349

Chattanooga, Tennessee, 37404, United States

Location

Local Institution - 0323

Nashville, Tennessee, 37203, United States

Location

Local Institution - 0337

Fort Worth, Texas, 76104, United States

Location

Local Institution - 0328

Houston, Texas, 77025, United States

Location

Local Institution - 0044

Houston, Texas, 77030, United States

Location

Local Institution - 0195

Temple, Texas, 76508, United States

Location

Local Institution - 0345

Norfolk, Virginia, 23502, United States

Location

Local Institution - 0343

Roanoke, Virginia, 24014, United States

Location

Local Institution - 0006

Tacoma, Washington, 98405, United States

Location

Local Institution - 0347

Vancouver, Washington, 98684, United States

Location

Local Institution - 0243

Morgantown, West Virginia, 26506, United States

Location

Local Institution - 0336

Marshfield, Wisconsin, 54449, United States

Location

Local Institution - 0008

Ciudad Autónoma de Buenos Aires, Buenos Aires, C1426ANZ, Argentina

Location

Local Institution - 0079

ABB, Buenos Aires F.D., C1199ABB, Argentina

Location

Local Institution - 0182

Rosario, Santa Fe Province, 2000, Argentina

Location

Local Institution - 0319

San Miguel de Tucumán, Tucumán Province, 4000, Argentina

Location

Local Institution - 0150

Buenos Aires, 1431, Argentina

Location

Local Institution - 0151

Córdoba, 5000, Argentina

Location

Local Institution - 0077

Camperdown, New South Wales, 2050, Australia

Location

Local Institution - 0160

Gosford, New South Wales, 2250, Australia

Location

Local Institution - 0263

Port Macquarie, New South Wales, 2444, Australia

Location

Local Institution - 0078

St Leonards, New South Wales, 2065, Australia

Location

Local Institution - 0026

Sydney, New South Wales, 2010, Australia

Location

Local Institution - 0024

Adelaide, South Australia, 5000, Australia

Location

Local Institution - 0131

Bendigo, Victoria, 3550, Australia

Location

Local Institution - 0224

East Melbourne, Victoria, 3002, Australia

Location

Local Institution - 0127

Heidelberg, Victoria, 3084, Australia

Location

Local Institution - 0025

Melbourne, Victoria, 3065, Australia

Location

Local Institution - 0266

Vienna, Vienna, 1060, Austria

Location

Local Institution - 0020

Linz, 4020, Austria

Location

Local Institution - 0017

Vienna, 1090, Austria

Location

Local Institution - 0121

Salvador, Estado de Bahia, 41253-190, Brazil

Location

Local Institution - 0076

Porto Alegre, Rio Grande do Sul, 90470-340, Brazil

Location

Local Institution - 0085

São Paulo, São Paulo, 01509-010, Brazil

Location

Local Institution - 0075

Rio de Janeiro, 20775-001, Brazil

Location

Local Institution - 0073

São Paulo, 04537-080, Brazil

Location

Local Institution - 0305

Plovdiv, 4002, Bulgaria

Location

Local Institution - 0309

Sofia, 1407, Bulgaria

Location

Local Institution - 0304

Sofia, 1431, Bulgaria

Location

Local Institution - 0183

Halifax, Nova Scotia, B3H 2Y9, Canada

Location

Local Institution - 0275

London, Ontario, N6A 5W9, Canada

Location

Local Institution - 0184

Toronto, Ontario, M5G 2M9, Canada

Location

Local Institution - 0318

Hefei, Anhui, 230031, China

Location

Local Institution - 0061

Beijing, Beijing Municipality, 100020, China

Location

Local Institution - 0057

Beijing, Beijing Municipality, 100043, China

Location

Local Institution - 0056

Beijing, Beijing Municipality, 100730, China

Location

Local Institution - 0123

Fuzhou, Fujian, 350000, China

Location

Local Institution - 0138

Guangzhou, Guangdong, 510000, China

Location

Local Institution - 0315

Guangzhou, Guangdong, 510515, China

Location

Local Institution - 0051

Zhengzhou, Henan, 450008, China

Location

Local Institution - 0066

Wuhan, Hubei, 430002, China

Location

Local Institution - 0054

Wuhan, Hubei, 430030, China

Location

Local Institution - 0071

Changsha, Hunan, 410013, China

Location

Local Institution - 0103

Changsha, Hunan, 410013, China

Location

Local Institution - 0180

Nanjing, Jiangsu, 210009, China

Location

Local Institution - 0111

Nantong, Jiangsu, 226001, China

Location

Local Institution - 0104

Suzhou, Jiangsu, 215006, China

Location

Local Institution - 0069

Wuxi, Jiangsu, 214023, China

Location

Local Institution - 0095

Nanchang, Jiangxi, 330006, China

Location

Local Institution - 0052

Changchun, Jilin, 130021, China

Location

Local Institution - 0096

Shenyang, Liaoning, 110001, China

Location

Local Institution - 0176

Shenyang, Liaoning, 110004, China

Location

Local Institution - 0060

Xi'an, Shaanxi, 710126, China

Location

Local Institution - 0072

Jinan, Shandong, 250012, China

Location

Local Institution - 0118

Shanghai, Shanghai Municipality, 200025, China

Location

Local Institution - 0317

Shanghai, Shanghai Municipality, 200080, China

Location

Local Institution - 0091

Tianjin, Tianjin Municipality, 300060, China

Location

Local Institution - 0058

Kunming, Yunnan, 650101, China

Location

Local Institution - 0050

Hangzhou, Zhejiang, 310003, China

Location

Local Institution - 0115

Wenzhou, Zhejiang, 32500, China

Location

Local Institution - 0059

Taiyuan, 030032, China

Location

Local Institution - 0153

Medellín, Antioquia, 05034, Colombia

Location

Local Institution - 0156

Valledupar, Cesar Department, 200001, Colombia

Location

Local Institution - 0154

Bogota, Cundinamarca, 111151, Colombia

Location

Local Institution - 0324

Piedecuesta, Santander Department, 681017, Colombia

Location

Local Institution - 0155

Cali, 760035, Colombia

Location

Local Institution - 0032

Aarhus, Central Jutland, 8200, Denmark

Location

Local Institution - 0065

Roskilde, Region Sjælland, 4000, Denmark

Location

Local Institution - 0129

Odense, Region Syddanmark, 5000, Denmark

Location

Local Institution - 0125

Vejle, 7100, Denmark

Location

Local Institution - 0124

Ulm, Baden-Wurttemberg, 89081, Germany

Location

Local Institution - 0330

Munich, Bavaria, 81241, Germany

Location

Local Institution - 0333

Hanover, Lower Saxony, 30161, Germany

Location

Local Institution - 0335

Dortmund, North Rhine-Westphalia, 44263, Germany

Location

Local Institution - 0029

Kiel, Schleswig-Holstein, 24105, Germany

Location

Local Institution - 0331

Jena, Thuringia, 07747, Germany

Location

Local Institution - 0007

Berlin, 12203, Germany

Location

Local Institution - 0102

Cologne, 50937, Germany

Location

Local Institution - 0329

Dresden, 01307, Germany

Location

Local Institution - 0334

Düsseldorf, 40479, Germany

Location

Local Institution - 0015

Heidelberg, D-69120, Germany

Location

Local Institution - 0030

Leipzig, 04103, Germany

Location

Local Institution - 0133

Nuremberg, 90419, Germany

Location

Local Institution - 0014

Würzburg, 97080, Germany

Location

Local Institution - 0136

Pátrai, Achaḯa, 26504, Greece

Location

Local Institution - 0135

Athens, Attikí, 11528, Greece

Location

Local Institution - 0134

Thessaloniki, Thessaloníki, 570 10, Greece

Location

Local Institution - 0178

Hksar, 0, Hong Kong

Location

Local Institution - 0036

Pécs, Baranya, 7624, Hungary

Location

Local Institution - 0043

Debrecen, Hajdú-Bihar, 4032, Hungary

Location

Local Institution - 0094

Nyíregyháza, Szabolcs-Szatmár-Bereg, 4400, Hungary

Location

Local Institution - 0042

Budapest, 1088, Hungary

Location

Local Institution - 0019

Budapest, 1097, Hungary

Location

Local Institution - 0167

Gurgaon, Haryana, 122001, India

Location

Local Institution - 0161

Bengaluru, Karnataka, 560027, India

Location

Local Institution - 0168

Mumbai, Maharashtra, 400012, India

Location

Local Institution - 0171

Thane, Maharashtra, 400602, India

Location

Local Institution - 0170

New Delhi, National Capital Territory of Delhi, 110085, India

Location

Local Institution - 0261

Mohali, Punjab, 160055, India

Location

Local Institution - 0174

Chennai, Tamil Nadu, 600036, India

Location

Local Institution - 0165

Hyderabad, Telangana, 500033, India

Location

Local Institution - 0310

Hyderabad, Telangana, 500068, India

Location

Local Institution - 0164

Hyderabad, Telangana, 500084, India

Location

Local Institution - 0230

Chandigarh, 160012, India

Location

Local Institution - 0264

Holon, Central District, 5810001, Israel

Location

Local Institution - 0267

Ẕerifin, Central District, 70300, Israel

Location

Local Institution - 0277

Jerusalem, 9112001, Israel

Location

Local Institution - 0145

Meldola, Emilia-Romagna, 47014, Italy

Location

Local Institution - 0143

Milan, Lombardy, 20122, Italy

Location

Local Institution - 0142

Rozzano, Milano, 20089, Italy

Location

Local Institution - 0189

Bologna, 40138, Italy

Location

Local Institution - 0148

Catanzaro, 88100, Italy

Location

Local Institution - 0147

Lecce, 73100, Italy

Location

Local Institution - 0144

Pisa, 56100, Italy

Location

Local Institution - 0146

Udine, 33100, Italy

Location

Local Institution - 0269

Nagoya, Aichi-ken, 467-8602, Japan

Location

Local Institution - 0214

Kashiwa, Chiba, 277-8577, Japan

Location

Local Institution - 0210

Kitakyushu-shi, Fukuoka, 806-8501, Japan

Location

Local Institution - 0211

Sapporo, Hokkaido, 003-0804, Japan

Location

Local Institution - 0217

Higashiibaraki, Ibaraki, 3113117, Japan

Location

Local Institution - 0300

Kanazawa, Ishikawa-ken, 920-8641, Japan

Location

Local Institution - 0209

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

Location

Local Institution - 0234

Kamakura, Kanagawa, 247-8533, Japan

Location

Local Institution - 0225

Koshigaya, Saitama, 343-0845, Japan

Location

Local Institution - 0236

Itabashiku, Tokyo, 173-8610, Japan

Location

Local Institution - 0219

Koto-ku, Tokyo, 135-8550, Japan

Location

Local Institution - 0303

Chūō, Yamanashi, 409-3898, Japan

Location

Local Institution - 0215

Chiba, 260-8677, Japan

Location

Local Institution - 0226

Fukuoka, 810-8563, Japan

Location

Local Institution - 0235

Fukuoka, 815-8555, Japan

Location

Local Institution - 0220

Kumamoto, 860-8556, Japan

Location

Local Institution - 0216

Kyoto, 602-8566, Japan

Location

Local Institution - 0213

Nagasaki, 852-8104, Japan

Location

Local Institution - 0212

Okayama, 701-1192, Japan

Location

Local Institution - 0301

Osaka, 545-8586, Japan

Location

Local Institution - 0241

Tokyo, 105-8461, Japan

Location

Local Institution - 0218

Tokyo, 150-8935, Japan

Location

Local Institution - 0113

Breda, North Brabant, 4818 CK, Netherlands

Location

Local Institution - 0194

Enschede, 7512 KZ, Netherlands

Location

Local Institution - 0049

Bergen, Hordaland, 5021, Norway

Location

Local Institution - 0112

Stavanger, Rogaland, 4021, Norway

Location

Local Institution - 0081

Oslo, 0450, Norway

Location

Local Institution - 0316

San Juan, 00909, Puerto Rico

Location

Local Institution - 0282

Bucharest, București, 022328, Romania

Location

Local Institution - 0284

Brasov, 500052, Romania

Location

Local Institution - 0302

Bucharest, 022328, Romania

Location

Local Institution - 0287

Bucharest, 030171, Romania

Location

Local Institution - 0306

Sibiu, 557260, Romania

Location

Local Institution - 0158

Singapore, Central Singapore, 119074, Singapore

Location

Local Institution - 0159

Singapore, Central Singapore, 169608, Singapore

Location

Local Institution - 0238

Seoul, Seoul-teukbyeolsi [Seoul], 03080, South Korea

Location

Local Institution - 0239

Seoul, Seoul-teukbyeolsi [Seoul], 06351, South Korea

Location

Local Institution - 0240

Seoul, Seoul-teukbyeolsi [Seoul], 06591, South Korea

Location

Local Institution - 0126

Badalona, Barcelona [Barcelona], 08916, Spain

Location

Local Institution - 0092

Barcelona, Barcelona [Barcelona], 08035, Spain

Location

Local Institution - 0038

L'Hospitalet Del Llobregat, Barcelona [Barcelona], 08908, Spain

Location

Local Institution - 0200

Madrid, Madrid, Comunidad de, 28009, Spain

Location

Local Institution - 0108

Majadahonda, Madrid, Comunidad de, 28222, Spain

Location

Local Institution - 0201

San Cristóbal de La Laguna, Santa Cruz De Tenerife, 38320, Spain

Location

Local Institution - 0037

Valencia, Valenciana, Comunitat, 46010, Spain

Location

Local Institution - 0107

Granada, 18012, Spain

Location

Local Institution - 0047

Madrid, 28015, Spain

Location

Local Institution - 0105

Málaga, 29010, Spain

Location

Local Institution - 0274

Chiayi City, Chiayi, 613, Taiwan

Location

Local Institution - 0177

Kaohsiung Niao Sung Dist, Kaohsiung, 83301, Taiwan

Location

Local Institution - 0012

Kaohsiung City, 82445, Taiwan

Location

Local Institution - 0001

Taichung, 407, Taiwan

Location

Local Institution - 0002

Tainan, 704, Taiwan

Location

Local Institution - 0162

Taipei, 11217, Taiwan

Location

Local Institution - 0139

Plymouth, Devon, Pl6 8DH, United Kingdom

Location

Local Institution - 0067

Cringleford, England, NR4 7UY, United Kingdom

Location

Local Institution - 0196

Glasgow, Glasgow City, G12 0YN, United Kingdom

Location

Local Institution - 0273

Birmingham, B9 5SS, United Kingdom

Location

Local Institution - 0080

Leeds, LS9 7TF, United Kingdom

Location

Local Institution - 0040

Taunton, TA1 5DA, United Kingdom

Location

Related Links

• BMS Clinical Trial Information
• BMS Clinical Trial Patient Recruiting

MeSH Terms

Conditions

Recurrence; Multiple Myeloma

Interventions

carfilzomib; 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)

Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated; Benzenesulfonates; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Arylsulfonates; Arylsulfonic Acids; Sulfonic Acids; Sulfur Acids; Sulfur Compounds

Study Officials

• Bristol-Myers Squibb

  Bristol-Myers Squibb

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: This is an open-label study; however, any review of aggregate study data by the Sponsor will be performed in a blinded manner.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: This is a two-stage inferentially seamless design.

Study Record Dates

• First Submitted: September 21, 2022
• First Posted: September 23, 2022
• Study Start: January 10, 2023
• Primary Completion (Estimated): July 18, 2026
• Study Completion (Estimated): July 25, 2029
• Last Updated: April 1, 2026

Record last verified: 2026-03

Data Sharing

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

Locations

ES (10); GB (6); GR (3); DK (4); AU (10); BU (3); HU (5); JP (22); SG (2); BR (5); KR (3); TW (6); HK (1); IN (11); CN (29); RO (5); IT (8); CO (5); IL (3); AR (6); DE (14); CA (3); NL (2); NO (3); US (34); PR (1)