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) (SUCCESSOR-2)

A Phase 3, Two-stage, Randomized, Multicenter, Open-label Study Comparing Mezigdomide (CC-92480/BMS-986348), Carfilzomib, and Dexamethasone (MeziKD) Versus Carfilzomib and Dexamethasone (Kd) in Participants With Relapsed or Refractory Multiple Myeloma (RRMM): SUCCESSOR-2

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Relapsed or Refractory Multiple Myeloma
• Intervention / Treatment: Drug: Dexamethasone; Drug: Carfilzomib; Drug: Mezigdomide

• Study Type: Interventional
• Enrollment (Actual): 606
• Phase: Phase 3

Contacts and Locations

Study Locations

• Argentina
  • Buenos Aires, Argentina, 1431
    • Local Institution - 0150
  • Córdoba, Argentina, 5000
    • Local Institution - 0151
  • Buenos Aires
    • Ciudad Autónoma de Buenos Aires, Buenos Aires, Argentina, C1426ANZ
      • Local Institution - 0008
  • Buenos Aires F.D.
    • ABB, Buenos Aires F.D., Argentina, C1199ABB
      • Local Institution - 0079
  • Santa Fe Province
    • Rosario, Santa Fe Province, Argentina, 2000
      • Local Institution - 0182
  • Tucumán Province
    • San Miguel de Tucumán, Tucumán Province, Argentina, 4000
      • Local Institution - 0319
• Australia
  • New South Wales
    • Camperdown, New South Wales, Australia, 2050
      • Local Institution - 0077
    • Gosford, New South Wales, Australia, 2250
      • Local Institution - 0160
    • Port Macquarie, New South Wales, Australia, 2444
      • Local Institution - 0263
    • St Leonards, New South Wales, Australia, 2065
      • Local Institution - 0078
    • Sydney, New South Wales, Australia, 2010
      • Local Institution - 0026
  • South Australia
    • Adelaide, South Australia, Australia, 5000
      • Local Institution - 0024
  • Victoria
    • Bendigo, Victoria, Australia, 3550
      • Local Institution - 0131
    • East Melbourne, Victoria, Australia, 3002
      • Local Institution - 0224
    • Heidelberg, Victoria, Australia, 3084
      • Local Institution - 0127
    • Melbourne, Victoria, Australia, 3065
      • Local Institution - 0025
• Austria
  • Linz, Austria, 4020
    • Local Institution - 0020
  • Vienna, Austria, 1090
    • Local Institution - 0017
  • Vienna
    • Vienna, Vienna, Austria, 1060
      • Local Institution - 0266
• Brazil
  • Rio de Janeiro, Brazil, 20775-001
    • Local Institution - 0075
  • São Paulo, Brazil, 04537-080
    • Local Institution - 0073
  • Estado de Bahia
    • Salvador, Estado de Bahia, Brazil, 41253-190
      • Local Institution - 0121
  • Rio Grande do Sul
    • Porto Alegre, Rio Grande do Sul, Brazil, 90470-340
      • Local Institution - 0076
  • São Paulo
    • São Paulo, São Paulo, Brazil, 01509-010
      • Local Institution - 0085
• Bulgaria
  • Plovdiv, Bulgaria, 4002
    • Local Institution - 0305
  • Sofia, Bulgaria, 1407
    • Local Institution - 0309
  • Sofia, Bulgaria, 1431
    • Local Institution - 0304
• Canada
  • Nova Scotia
    • Halifax, Nova Scotia, Canada, B3H 2Y9
      • Local Institution - 0183
  • Ontario
    • London, Ontario, Canada, N6A 5W9
      • Local Institution - 0275
    • Toronto, Ontario, Canada, M5G 2M9
      • Local Institution - 0184
• China
  • Taiyuan, China, 030032
    • Local Institution - 0059
  • Anhui
    • Hefei, Anhui, China, 230031
      • Local Institution - 0318
  • Beijing Municipality
    • Beijing, Beijing Municipality, China, 100020
      • Local Institution - 0061
    • Beijing, Beijing Municipality, China, 100043
      • Local Institution - 0057
    • Beijing, Beijing Municipality, China, 100730
      • Local Institution - 0056
  • Fujian
    • Fuzhou, Fujian, China, 350000
      • Local Institution - 0123
  • Guangdong
    • Guangzhou, Guangdong, China, 510000
      • Local Institution - 0138
    • Guangzhou, Guangdong, China, 510515
      • Local Institution - 0315
  • Henan
    • Zhengzhou, Henan, China, 450008
      • Local Institution - 0051
  • Hubei
    • Wuhan, Hubei, China, 430002
      • Local Institution - 0066
    • Wuhan, Hubei, China, 430030
      • Local Institution - 0054
  • Hunan
    • Changsha, Hunan, China, 410013
      • Local Institution - 0071
    • Changsha, Hunan, China, 410013
      • Local Institution - 0103
  • Jiangsu
    • Nanjing, Jiangsu, China, 210009
      • Local Institution - 0180
    • Nantong, Jiangsu, China, 226001
      • Local Institution - 0111
    • Suzhou, Jiangsu, China, 215006
      • Local Institution - 0104
    • Wuxi, Jiangsu, China, 214023
      • Local Institution - 0069
  • Jiangxi
    • Nanchang, Jiangxi, China, 330006
      • Local Institution - 0095
  • Jilin
    • Changchun, Jilin, China, 130021
      • Local Institution - 0052
  • Liaoning
    • Shenyang, Liaoning, China, 110001
      • Local Institution - 0096
    • Shenyang, Liaoning, China, 110004
      • Local Institution - 0176
  • Shaanxi
    • Xi'an, Shaanxi, China, 710126
      • Local Institution - 0060
  • Shandong
    • Jinan, Shandong, China, 250012
      • Local Institution - 0072
  • Shanghai Municipality
    • Shanghai, Shanghai Municipality, China, 200025
      • Local Institution - 0118
    • Shanghai, Shanghai Municipality, China, 200080
      • Local Institution - 0317
  • Tianjin Municipality
    • Tianjin, Tianjin Municipality, China, 300060
      • Local Institution - 0091
  • Yunnan
    • Kunming, Yunnan, China, 650101
      • Local Institution - 0058
  • Zhejiang
    • Hangzhou, Zhejiang, China, 310003
      • Local Institution - 0050
    • Wenzhou, Zhejiang, China, 32500
      • Local Institution - 0115
• Colombia
  • Cali, Colombia, 760035
    • Local Institution - 0155
  • Antioquia
    • Medellín, Antioquia, Colombia, 05034
      • Local Institution - 0153
  • Cesar Department
    • Valledupar, Cesar Department, Colombia, 200001
      • Local Institution - 0156
  • Cundinamarca
    • Bogota, Cundinamarca, Colombia, 111151
      • Local Institution - 0154
  • Santander Department
    • Piedecuesta, Santander Department, Colombia, 681017
      • Local Institution - 0324
• Denmark
  • Vejle, Denmark, 7100
    • Local Institution - 0125
  • Central Jutland
    • Aarhus, Central Jutland, Denmark, 8200
      • Local Institution - 0032
  • Region Sjælland
    • Roskilde, Region Sjælland, Denmark, 4000
      • Local Institution - 0065
  • Region Syddanmark
    • Odense, Region Syddanmark, Denmark, 5000
      • Local Institution - 0129
• Germany
  • Berlin, Germany, 12203
    • Local Institution - 0007
  • Cologne, Germany, 50937
    • Local Institution - 0102
  • Dresden, Germany, 01307
    • Local Institution - 0329
  • Düsseldorf, Germany, 40479
    • Local Institution - 0334
  • Heidelberg, Germany, D-69120
    • Local Institution - 0015
  • Leipzig, Germany, 04103
    • Local Institution - 0030
  • Nuremberg, Germany, 90419
    • Local Institution - 0133
  • Würzburg, Germany, 97080
    • Local Institution - 0014
  • Baden-Wurttemberg
    • Ulm, Baden-Wurttemberg, Germany, 89081
      • Local Institution - 0124
  • Bavaria
    • Munich, Bavaria, Germany, 81241
      • Local Institution - 0330
  • Lower Saxony
    • Hanover, Lower Saxony, Germany, 30161
      • Local Institution - 0333
  • North Rhine-Westphalia
    • Dortmund, North Rhine-Westphalia, Germany, 44263
      • Local Institution - 0335
  • Schleswig-Holstein
    • Kiel, Schleswig-Holstein, Germany, 24105
      • Local Institution - 0029
  • Thuringia
    • Jena, Thuringia, Germany, 07747
      • Local Institution - 0331
• Greece
  • Achaḯa
    • Pátrai, Achaḯa, Greece, 26504
      • Local Institution - 0136
  • Attikí
    • Athens, Attikí, Greece, 11528
      • Local Institution - 0135
  • Thessaloníki
    • Thessaloniki, Thessaloníki, Greece, 570 10
      • Local Institution - 0134
• Hong Kong
  • Hksar, Hong Kong
    • Local Institution - 0178
• Hungary
  • Budapest, Hungary, 1088
    • Local Institution - 0042
  • Budapest, Hungary, 1097
    • Local Institution - 0019
  • Baranya
    • Pécs, Baranya, Hungary, 7624
      • Local Institution - 0036
  • Hajdú-Bihar
    • Debrecen, Hajdú-Bihar, Hungary, 4032
      • Local Institution - 0043
  • Szabolcs-Szatmár-Bereg
    • Nyíregyháza, Szabolcs-Szatmár-Bereg, Hungary, 4400
      • Local Institution - 0094
• India
  • Chandigarh, India, 160012
    • Local Institution - 0230
  • Haryana
    • Gurgaon, Haryana, India, 122001
      • Local Institution - 0167
  • Karnataka
    • Bengaluru, Karnataka, India, 560027
      • Local Institution - 0161
  • Maharashtra
    • Mumbai, Maharashtra, India, 400012
      • Local Institution - 0168
    • Thane, Maharashtra, India, 400602
      • Local Institution - 0171
  • National Capital Territory of Delhi
    • New Delhi, National Capital Territory of Delhi, India, 110085
      • Local Institution - 0170
  • Punjab
    • Mohali, Punjab, India, 160055
      • Local Institution - 0261
  • Tamil Nadu
    • Chennai, Tamil Nadu, India, 600036
      • Local Institution - 0174
  • Telangana
    • Hyderabad, Telangana, India, 500033
      • Local Institution - 0165
    • Hyderabad, Telangana, India, 500068
      • Local Institution - 0310
    • Hyderabad, Telangana, India, 500084
      • Local Institution - 0164
• Israel
  • Jerusalem, Israel, 9112001
    • Local Institution - 0277
  • Central District
    • Holon, Central District, Israel, 5810001
      • Local Institution - 0264
    • Ẕerifin, Central District, Israel, 70300
      • Local Institution - 0267
• Italy
  • Bologna, Italy, 40138
    • Local Institution - 0189
  • Catanzaro, Italy, 88100
    • Local Institution - 0148
  • Lecce, Italy, 73100
    • Local Institution - 0147
  • Pisa, Italy, 56100
    • Local Institution - 0144
  • Udine, Italy, 33100
    • Local Institution - 0146
  • Emilia-Romagna
    • Meldola, Emilia-Romagna, Italy, 47014
      • Local Institution - 0145
  • Lombardy
    • Milan, Lombardy, Italy, 20122
      • Local Institution - 0143
  • Milano
    • Rozzano, Milano, Italy, 20089
      • Local Institution - 0142
• Japan
  • Chiba, Japan, 260-8677
    • Local Institution - 0215
  • Fukuoka, Japan, 810-8563
    • Local Institution - 0226
  • Fukuoka, Japan, 815-8555
    • Local Institution - 0235
  • Kumamoto, Japan, 860-8556
    • Local Institution - 0220
  • Kyoto, Japan, 602-8566
    • Local Institution - 0216
  • Nagasaki, Japan, 852-8104
    • Local Institution - 0213
  • Okayama, Japan, 701-1192
    • Local Institution - 0212
  • Osaka, Japan, 545-8586
    • Local Institution - 0301
  • Tokyo, Japan, 105-8461
    • Local Institution - 0241
  • Tokyo, Japan, 150-8935
    • Local Institution - 0218
  • Aichi-ken
    • Nagoya, Aichi-ken, Japan, 467-8602
      • Local Institution - 0269
  • Chiba
    • Kashiwa, Chiba, Japan, 277-8577
      • Local Institution - 0214
  • Fukuoka
    • Kitakyushu-shi, Fukuoka, Japan, 806-8501
      • Local Institution - 0210
  • Hokkaido
    • Sapporo, Hokkaido, Japan, 003-0804
      • Local Institution - 0211
  • Ibaraki
    • Higashiibaraki, Ibaraki, Japan, 3113117
      • Local Institution - 0217
  • Ishikawa-ken
    • Kanazawa, Ishikawa-ken, Japan, 920-8641
      • Local Institution - 0300
  • Iwate
    • Shiwa-gun Yahaba-cho, Iwate, Japan, 028-3695
      • Local Institution - 0209
  • Kanagawa
    • Kamakura, Kanagawa, Japan, 247-8533
      • Local Institution - 0234
  • Saitama
    • Koshigaya, Saitama, Japan, 343-0845
      • Local Institution - 0225
  • Tokyo
    • Itabashiku, Tokyo, Japan, 173-8610
      • Local Institution - 0236
    • Koto-ku, Tokyo, Japan, 135-8550
      • Local Institution - 0219
  • Yamanashi
    • Chūō, Yamanashi, Japan, 409-3898
      • Local Institution - 0303
• Netherlands
  • Enschede, Netherlands, 7512 KZ
    • Local Institution - 0194
  • North Brabant
    • Breda, North Brabant, Netherlands, 4818 CK
      • Local Institution - 0113
• Norway
  • Oslo, Norway, 0450
    • Local Institution - 0081
  • Hordaland
    • Bergen, Hordaland, Norway, 5021
      • Local Institution - 0049
  • Rogaland
    • Stavanger, Rogaland, Norway, 4021
      • Local Institution - 0112
• Puerto Rico
  • San Juan, Puerto Rico, 00909
    • Local Institution - 0316
• Romania
  • Brasov, Romania, 500052
    • Local Institution - 0284
  • Bucharest, Romania, 022328
    • Local Institution - 0302
  • Bucharest, Romania, 030171
    • Local Institution - 0287
  • Sibiu, Romania, 557260
    • Local Institution - 0306
  • București
    • Bucharest, București, Romania, 022328
      • Local Institution - 0282
• Singapore
  • Central Singapore
    • Singapore, Central Singapore, Singapore, 119074
      • Local Institution - 0158
    • Singapore, Central Singapore, Singapore, 169608
      • Local Institution - 0159
• South Korea
  • Seoul-teukbyeolsi [Seoul]
    • Seoul, Seoul-teukbyeolsi [Seoul], South Korea, 03080
      • Local Institution - 0238
    • Seoul, Seoul-teukbyeolsi [Seoul], South Korea, 06351
      • Local Institution - 0239
    • Seoul, Seoul-teukbyeolsi [Seoul], South Korea, 06591
      • Local Institution - 0240
• Spain
  • Granada, Spain, 18012
    • Local Institution - 0107
  • Madrid, Spain, 28015
    • Local Institution - 0047
  • Málaga, Spain, 29010
    • Local Institution - 0105
  • Barcelona [Barcelona]
    • Badalona, Barcelona [Barcelona], Spain, 08916
      • Local Institution - 0126
    • Barcelona, Barcelona [Barcelona], Spain, 08035
      • Local Institution - 0092
    • L'Hospitalet Del Llobregat, Barcelona [Barcelona], Spain, 08908
      • Local Institution - 0038
  • Madrid, Comunidad de
    • Madrid, Madrid, Comunidad de, Spain, 28009
      • Local Institution - 0200
    • Majadahonda, Madrid, Comunidad de, Spain, 28222
      • Local Institution - 0108
  • Santa Cruz De Tenerife
    • San Cristóbal de La Laguna, Santa Cruz De Tenerife, Spain, 38320
      • Local Institution - 0201
  • Valenciana, Comunitat
    • Valencia, Valenciana, Comunitat, Spain, 46010
      • Local Institution - 0037
• Taiwan
  • Kaohsiung City, Taiwan, 82445
    • Local Institution - 0012
  • Taichung, Taiwan, 407
    • Local Institution - 0001
  • Tainan, Taiwan, 704
    • Local Institution - 0002
  • Taipei, Taiwan, 11217
    • Local Institution - 0162
  • Chiayi
    • Chiayi City, Chiayi, Taiwan, 613
      • Local Institution - 0274
  • Kaohsiung
    • Kaohsiung Niao Sung Dist, Kaohsiung, Taiwan, 83301
      • Local Institution - 0177
• United Kingdom
  • Birmingham, United Kingdom, B9 5SS
    • Local Institution - 0273
  • Leeds, United Kingdom, LS9 7TF
    • Local Institution - 0080
  • Taunton, United Kingdom, TA1 5DA
    • Local Institution - 0040
  • Devon
    • Plymouth, Devon, United Kingdom, Pl6 8DH
      • Local Institution - 0139
  • England
    • Cringleford, England, United Kingdom, NR4 7UY
      • Local Institution - 0067
  • Glasgow City
    • Glasgow, Glasgow City, United Kingdom, G12 0YN
      • Local Institution - 0196
• United States
  • Alabama
    • Mobile, Alabama, United States, 36604
      • Local Institution - 0046
  • California
    • Cerritos, California, United States, 90703
      • Local Institution - 0005
    • Irvine, California, United States, 92618
      • Local Institution - 0190
    • Los Angeles, California, United States, 90017
      • Local Institution - 0187
    • Santa Rosa, California, United States, 95403
      • Local Institution - 0344
    • Stockton, California, United States, 95204
      • Local Institution - 0339
  • Delaware
    • Newark, Delaware, United States, 19713
      • Local Institution - 0279
  • Florida
    • Fort Myers, Florida, United States, 33901
      • Local Institution - 0341
    • St. Petersburg, Florida, United States, 33705
      • Local Institution - 0342
    • West Palm Beach, Florida, United States, 33401
      • Local Institution - 0340
  • Georgia
    • Atlanta, Georgia, United States, 30303
      • Local Institution - 0348
    • Atlanta, Georgia, United States, 30322
      • Local Institution - 0291
  • Idaho
    • Boise, Idaho, United States, 83706
      • Saint Alphonsus Regional Medical Center
  • Maryland
    • Annapolis, Maryland, United States, 21401
      • Local Institution - 0289
  • Massachusetts
    • Boston, Massachusetts, United States, 02215
      • Local Institution - 0204
  • Minnesota
    • Minneapolis, Minnesota, United States, 55404
      • Local Institution - 0346
  • New Jersey
    • Little Silver, New Jersey, United States, 07739
      • Local Institution - 0222
  • New York
    • The Bronx, New York, United States, 10467
      • Local Institution - 0199
  • Ohio
    • Cleveland, Ohio, United States, 44106
      • Local Institution - 0322
    • Columbus, Ohio, United States, 43214
      • Local Institution - 0172
  • Rhode Island
    • Providence, Rhode Island, United States, 02903
      • Local Institution - 0321
  • South Carolina
    • Greer, South Carolina, United States, 29650
      • Local Institution - 0338
  • Tennessee
    • Chattanooga, Tennessee, United States, 37404
      • Local Institution - 0349
    • Nashville, Tennessee, United States, 37203
      • Local Institution - 0323
  • Texas
    • Fort Worth, Texas, United States, 76104
      • Local Institution - 0337
    • Houston, Texas, United States, 77025
      • Local Institution - 0328
    • Houston, Texas, United States, 77030
      • Local Institution - 0044
    • Temple, Texas, United States, 76508
      • Local Institution - 0195
  • Virginia
    • Norfolk, Virginia, United States, 23502
      • Local Institution - 0345
    • Roanoke, Virginia, United States, 24014
      • Local Institution - 0343
  • Washington
    • Tacoma, Washington, United States, 98405
      • Local Institution - 0006
    • Vancouver, Washington, United States, 98684
      • Local Institution - 0347
  • West Virginia
    • Morgantown, West Virginia, United States, 26506
      • Local Institution - 0243
  • Wisconsin
    • Marshfield, Wisconsin, United States, 54449
      • Local Institution - 0336

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria

- 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.

Exclusion Criteria

• 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.
• Other protocol-defined Inclusion/Exclusion criteria apply.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Kd (Carfilzomib + Dexamethasone)	Drug: Dexamethasone; Specified dose on specified days; Other Names: Decadron; Dex; Drug: Carfilzomib; Specified dose on specified days; Other Names: Kyprolis
Experimental: MeziKd (Mezigdomide + Carfilzomib + Dexamethasone)	Drug: Dexamethasone; Specified dose on specified days; Other Names: Decadron; Dex; Drug: Carfilzomib; Specified dose on specified days; Other Names: Kyprolis; Drug: Mezigdomide; Specified dose on specified days; Other Names: BMS-986348; CC-92480

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Progression-free Survival (PFS)	Up to approximately 5 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Progression-free Survival 2 (PFS-2)		Up to approximately 5 years
Overall Survival (OS)		Up to approximately 5 years
Rate Of Very Good Partial Response (VGPR) Or Better (VGPRR)	VGPRR will be calculated as the percentage of participants who achieve best response of VGPR or better according to the International Myeloma Working Group (IMWG) Uniform Response Criteria for Multiple Myeloma.	Up to approximately 5 years
Time To Response (TTR)		Up to approximately 5 years
Duration Of Response (DOR)		Up to approximately 5 years
Time To Progression (TTP)		Up to approximately 5 years
Time To Next Treatment (TTNT)		Up to approximately 5 years
Minimal Residual Disease (MRD) Negativity Rate		Up to approximately 5 years
Number Of Participants With Adverse Events (AEs)		Up to approximately 5 years
Overall Response (OR)		Up to approximately 5 years
Recommended Mezigdomide Dose	Stage 1 only	Up to 12 months
Plasma concentrations of Mezigdomide in Combination with Carfilzomib and Dexamethasone	Stage 1 only	Up to 176 days
Complete Response (CR) Or Better (CRR)	CRR will be calculated as the percentage of participants who achieve best response of CR or better according to the IMWG Uniform Response Criteria for Multiple Myeloma.	Up to approximately 5 years
Change From Baseline in the European Organization for Research and Treatment of Cancer - Quality of Life C30 Questionnaire (EORTC QLQ-C30)	The EORTC QLQ-C30 is the most commonly used quality of life instrument in oncology trials. The QLQ-C30 consists of 30 questions incorporated into 5 functional domains physical, role, cognitive, emotional, and social), 9 symptom/other scales (fatigue, pain, nausea and vomiting, dyspnea, insomnia, appetite loss, constipation, diarrhea, and financial difficulties), and a single global Quality of Life (QoL)/global health status score. Items in the functional and symptom scale use raw participant response of 1 to 4, where 1 = "not at all" and 4 = "very much." The 2 global items contain responses ranging from 1 "very poor" to 7 "excellent." The recall period is 1 week. All domain scores are transformed in a range from 0 to 100, where a higher functional score indicates more favorable outcomes and a higher score on the symptom domains indicates a less favorable participant outcome. Stage 2 only.	Up to approximately 5 years
Change From Baseline in the European Quality of Life Multiple Myeloma Module (EORTC QLQ-MY20)	The EORTC QLQ-MY20 is a 20-item myeloma module intended for use among participants varying in disease stage and treatment modality. Participants rate symptoms or problems on a scale from 1 to 4 where 1 = "not at all" and 4 = "very much." Stage 2 only.	Up to approximately 5 years

Collaborators and Investigators

• Sponsor: Bristol-Myers Squibb
• Investigators: Study Director: Bristol-Myers Squibb, Bristol-Myers Squibb

Publications and helpful links

Helpful Links

• BMS Clinical Trial Information
• BMS Clinical Trial Patient Recruiting

Study record dates

Study Major Dates

• Study Start (Actual): January 10, 2023
• Primary Completion (Estimated): July 18, 2026
• Study Completion (Estimated): July 25, 2029

Study Registration Dates

• First Submitted: September 21, 2022
• First Submitted That Met QC Criteria: September 21, 2022
• First Posted (Actual): September 23, 2022

Study Record Updates

• Last Update Posted (Actual): April 1, 2026
• Last Update Submitted That Met QC Criteria: March 30, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: Multiple Myeloma; Dexamethasone; Carfilzomib; CC-92480; BMS-986348; Mezigdomide
• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Pathologic Processes; Neoplasms; Disease Attributes; Immune System Diseases; Neoplasms by Histologic Type; Hematologic Diseases; Lymphoproliferative Disorders; Immunoproliferative Disorders; Neoplasms, Plasma Cell; Hemostatic Disorders; Paraproteinemias; Blood Protein Disorders; Hemorrhagic Disorders; Pathological Conditions, Signs and Symptoms; Hemic and Lymphatic Diseases; Recurrence; Multiple Myeloma; Sulfur Compounds; Organic Chemicals; Hydrocarbons; Hydrocarbons, Cyclic; Hydrocarbons, Aromatic; Polycyclic Compounds; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Steroids, Fluorinated; Benzene Derivatives; Sulfonic Acids; Sulfur Acids; Pregnadienetriols; Benzenesulfonates; Arylsulfonates; Arylsulfonic Acids; Dexamethasone; Calcium Dobesilate; carfilzomib
• Other Study ID Numbers: CA057-008

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: BMS will provide access to individual anonymized participant data upon request from qualified researchers, and subject to certain criteria. Additional information regarding Bristol Myer Squibb's data sharing policy and process can be found at https://www.bms.com/researchers-and-partners/clinical-trials-and-research.html
• IPD Sharing Time Frame: See Plan Description
• IPD Sharing Access Criteria: See Plan Description
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No