Relapsed or Refractory Multiple MyelomaPhase 3SUCCESSOR-2NCT05552976
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)
A Phase 3 study testing Mezigdomide, Carfilzomib and Dexamethasone in people with Relapsed or Refractory Multiple Myeloma, run by Bristol-Myers Squibb at 204 sites in 27 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Relapsed or Refractory Multiple Myeloma
- What is being tested?
- Mezigdomide, Carfilzomib and Dexamethasone
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 606 participants
- Where
- 204 sitesin 27 countries
- Study dates
- 10 Jan 2023to 25 Jul 2029
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Participant has documented diagnosis of multiple myeloma and measurable disease, defined as any of the following:.
- Myeloma-protein (M-protein) ≥ 0.5 grams/deciliter (g/dL) by serum protein electrophoresis (sPEP), or.
- M-protein ≥ 200 milligrams (mg)/24-hour urine collection by urine protein electrophoresis (uPEP) or,.
- 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.
Who cannot join
- 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.
Trial locations and contacts
204 sites in 27 countries.
204 sites in 27 countries
United States33 sites
Local Institution - 0289
Annapolis, Maryland, 21401
Local Institution - 0348
Atlanta, Georgia, 30303
Local Institution - 0291
Atlanta, Georgia, 30322
Saint Alphonsus Regional Medical Center
Boise, Idaho, 83706
Local Institution - 0204
Boston, Massachusetts, 02215
Local Institution - 0005
Cerritos, California, 90703
Local Institution - 0349
Chattanooga, Tennessee, 37404
Local Institution - 0322
Cleveland, Ohio, 44106
Local Institution - 0172
Columbus, Ohio, 43214
Local Institution - 0341
Fort Myers, Florida, 33901
Local Institution - 0337
Fort Worth, Texas, 76104
Local Institution - 0338
Greer, South Carolina, 29650
Local Institution - 0328
Houston, Texas, 77025
Local Institution - 0044
Houston, Texas, 77030
Local Institution - 0190
Irvine, California, 92618
Local Institution - 0222
Little Silver, New Jersey, 07739
Local Institution - 0187
Los Angeles, California, 90017
Local Institution - 0336
Marshfield, Wisconsin, 54449
Local Institution - 0346
Minneapolis, Minnesota, 55404
Local Institution - 0046
Mobile, Alabama, 36604
Local Institution - 0243
Morgantown, West Virginia, 26506
Local Institution - 0323
Nashville, Tennessee, 37203
Local Institution - 0345
Norfolk, Virginia, 23502
Local Institution - 0321
Providence, Rhode Island, 02903
Local Institution - 0343
Roanoke, Virginia, 24014
Local Institution - 0344
Santa Rosa, California, 95403
Local Institution - 0342
St. Petersburg, Florida, 33705
Local Institution - 0339
Stockton, California, 95204
Local Institution - 0006
Tacoma, Washington, 98405
Local Institution - 0195
Temple, Texas, 76508
Local Institution - 0199
The Bronx, New York, 10467
Local Institution - 0347
Vancouver, Washington, 98684
Local Institution - 0340
West Palm Beach, Florida, 33401
China27 sites
Local Institution - 0061
Beijing, Beijing Municipality, 100020
Local Institution - 0057
Beijing, Beijing Municipality, 100043
Local Institution - 0056
Beijing, Beijing Municipality, 100730
Local Institution - 0052
Changchun, Jilin, 130021
Local Institution - 0071
Changsha, Hunan, 410013
Local Institution - 0103
Changsha, Hunan, 410013
Local Institution - 0123
Fuzhou, Fujian, 350000
Local Institution - 0138
Guangzhou, Guangdong, 510000
Local Institution - 0050
Hangzhou, Zhejiang, 310003
Local Institution - 0072
Jinan, Shandong, 250012
Local Institution - 0058
Kunming, Yunnan, 650101
Local Institution - 0095
Nanchang, Jiangxi, 330006
Local Institution - 0180
Nanjing, Jiangsu, 210009
Local Institution - 0111
Nantong, Jiangsu, 226001
Local Institution - 0118
Shanghai, Shanghai Municipality, 200025
Local Institution - 0317
Shanghai, Shanghai Municipality, 200080
Local Institution - 0096
Shenyang, Liaoning, 110001
Local Institution - 0176
Shenyang, Liaoning, 110004
Local Institution - 0104
Suzhou, Jiangsu, 215006
Local Institution - 0059
Taiyuan, 030032
Local Institution - 0091
Tianjin, Tianjin Municipality, 300060
Local Institution - 0115
Wenzhou, Zhejiang, 32500
Local Institution - 0066
Wuhan, Hubei, 430002
Local Institution - 0054
Wuhan, Hubei, 430030
Local Institution - 0069
Wuxi, Jiangsu, 214023
Local Institution - 0060
Xi'an, Shaanxi, 710126
Local Institution - 0051
Zhengzhou, Henan, 450008
Japan22 sites
Local Institution - 0215
Chiba, 260-8677
Local Institution - 0303
Chūō, Yamanashi, 409-3898
Local Institution - 0226
Fukuoka, 810-8563
Local Institution - 0235
Fukuoka, 815-8555
Local Institution - 0217
Higashiibaraki, Ibaraki, 3113117
Local Institution - 0234
Kamakura, Kanagawa, 247-8533
Local Institution - 0300
Kanazawa, Ishikawa-ken, 920-8641
Local Institution - 0214
Kashiwa, Chiba, 277-8577
Local Institution - 0210
Kitakyushu-shi, Fukuoka, 806-8501
Local Institution - 0225
Koshigaya, Saitama, 343-0845
Local Institution - 0219
Koto-ku, Tokyo, 135-8550
Local Institution - 0220
Kumamoto, 860-8556
Local Institution - 0216
Kyoto, 602-8566
Local Institution - 0213
Nagasaki, 852-8104
Local Institution - 0269
Nagoya, Aichi-ken, 467-8602
Local Institution - 0212
Okayama, 701-1192
Local Institution - 0301
Osaka, 545-8586
Local Institution - 0211
Sapporo, Hokkaido, 003-0804
Local Institution - 0209
Shiwa-gun Yahaba-cho, Iwate, 028-3695
Local Institution - 0236
tabashi City, Tokyo, 173-8610
Local Institution - 0241
Tokyo, 105-8461
Local Institution - 0218
Tokyo, 150-8935
Germany14 sites
Local Institution - 0007
Berlin, 12203
Local Institution - 0102
Cologne, 50937
Local Institution - 0335
Dortmund, North Rhine-Westphalia, 44263
Local Institution - 0329
Dresden, 01307
Local Institution - 0334
Düsseldorf, 40479
Local Institution - 0333
Hanover, Lower Saxony, 30161
Local Institution - 0015
Heidelberg, D-69120
Local Institution - 0331
Jena, Thuringia, 07747
Local Institution - 0029
Kiel, Schleswig-Holstein, 24105
Local Institution - 0030
Leipzig, 04103
Local Institution - 0330
Munich, Bavaria, 81241
Local Institution - 0133
Nuremberg, 90419
Local Institution - 0124
Ulm, Baden-Wurttemberg, 89081
Local Institution - 0014
Würzburg, 97080
India11 sites
Local Institution - 0161
Bengaluru, Karnataka, 560027
Local Institution - 0230
Chandigarh, 160012
Local Institution - 0174
Chennai, Tamil Nadu, 600036
Local Institution - 0167
Gurgaon, Haryana, 122001
Local Institution - 0165
Hyderabad, Telangana, 500033
Local Institution - 0310
Hyderabad, Telangana, 500068
Local Institution - 0164
Hyderabad, Telangana, 500084
Local Institution - 0261
Mohali, Punjab, 160055
Local Institution - 0168
Mumbai, Maharashtra, 400012
Local Institution - 0170
New Delhi, National Capital Territory of Delhi, 110085
Local Institution - 0171
Thane, Maharashtra, 400602
Australia10 sites
Local Institution - 0024
Adelaide, South Australia, 5000
Local Institution - 0131
Bendigo, Victoria, 3550
Local Institution - 0077
Camperdown, New South Wales, 2050
Local Institution - 0224
East Melbourne, Victoria, 3002
Local Institution - 0160
Gosford, New South Wales, 2250
Local Institution - 0127
Heidelberg, Victoria, 3084
Local Institution - 0025
Melbourne, Victoria, 3065
Local Institution - 0263
Port Macquarie, New South Wales, 2444
Local Institution - 0078
St Leonards, New South Wales, 2065
Local Institution - 0026
Sydney, New South Wales, 2010
Spain10 sites
Local Institution - 0126
Badalona, Barcelona [Barcelona], 08916
Local Institution - 0092
Barcelona, Barcelona [Barcelona], 08035
Local Institution - 0107
Granada, 18012
Local Institution - 0038
L'Hospitalet Del Llobregat, Barcelona [Barcelona], 08908
Local Institution - 0200
Madrid, Madrid, Comunidad de, 28009
Local Institution - 0047
Madrid, 28015
Local Institution - 0108
Majadahonda, Madrid, Comunidad de, 28222
Local Institution - 0105
Málaga, 29010
Local Institution - 0201
San Cristóbal de La Laguna, Santa Cruz De Tenerife, 38320
Local Institution - 0037
Valencia, Valenciana, Comunitat, 46010
Italy8 sites
Local Institution - 0189
Bologna, 40138
Local Institution - 0148
Catanzaro, 88100
Local Institution - 0147
Lecce, 73100
Local Institution - 0145
Meldola, Emilia-Romagna, 47014
Local Institution - 0143
Milan, Lombardy, 20122
Local Institution - 0144
Pisa, 56100
Local Institution - 0142
Rozzano, Milano, 20089
Local Institution - 0146
Udine, 33100
Argentina6 sites
Local Institution - 0079
ABB, Buenos Aires F.D., C1199ABB
Local Institution - 0150
Buenos Aires, 1431
Local Institution - 0008
Ciudad Autónoma de Buenos Aires, Buenos Aires, C1426ANZ
Local Institution - 0151
Córdoba, 5000
Local Institution - 0182
Rosario, Santa Fe Province, 2000
Local Institution - 0319
San Miguel de Tucumán, Tucumán Province, 4000
Taiwan6 sites
Local Institution - 0274
Chiayi City, Chiayi, 613
Local Institution - 0012
Kaohsiung City, 82445
Local Institution - 0177
Kaohsiung Niao Sung Dist, Kaohsiung, 83301
Local Institution - 0001
Taichung, 407
Local Institution - 0002
Tainan, 704
Local Institution - 0162
Taipei, 11217
United Kingdom6 sites
Local Institution - 0273
Birmingham, B9 5SS
Local Institution - 0067
Cringleford, England, NR4 7UY
Local Institution - 0196
Glasgow, Glasgow City, G12 0YN
Local Institution - 0080
Leeds, LS9 7TF
Local Institution - 0139
Plymouth, Devon, Pl6 8DH
Local Institution - 0040
Taunton, TA1 5DA
Brazil5 sites
Local Institution - 0076
Porto Alegre, Rio Grande do Sul, 90470-340
Local Institution - 0075
Rio de Janeiro, 20775-001
Local Institution - 0121
Salvador, Estado de Bahia, 41253-190
Local Institution - 0085
São Paulo, São Paulo, 01509-010
Local Institution - 0073
São Paulo, 04537-080
Colombia5 sites
Local Institution - 0154
Bogota, Cundinamarca, 111151
Local Institution - 0155
Cali, 760035
Local Institution - 0153
Medellín, Antioquia, 05034
Local Institution - 0324
Piedecuesta, Santander Department, 681017
Local Institution - 0156
Valledupar, Cesar Department, 200001
Hungary5 sites
Local Institution - 0042
Budapest, 1088
Local Institution - 0019
Budapest, 1097
Local Institution - 0043
Debrecen, Hajdú-Bihar, 4032
Local Institution - 0094
Nyíregyháza, Szabolcs-Szatmár-Bereg, 4400
Local Institution - 0036
Pécs, Baranya, 7624
Romania5 sites
Local Institution - 0284
Brasov, 500052
Local Institution - 0282
Bucharest, Bucharest, 022328
Local Institution - 0302
Bucharest, 022328
Local Institution - 0287
Bucharest, 030171
Local Institution - 0306
Sibiu, 557260
Denmark4 sites
Local Institution - 0032
Aarhus, Central Jutland, 8200
Local Institution - 0129
Odense, Region Syddanmark, 5000
Local Institution - 0065
Roskilde, Region Sjælland, 4000
Local Institution - 0125
Vejle, 7100
Austria3 sites
Local Institution - 0020
Linz, 4020
Local Institution - 0266
Vienna, State of Vienna, 1060
Local Institution - 0017
Vienna, 1090
Bulgaria3 sites
Local Institution - 0305
Plovdiv, 4002
Local Institution - 0309
Sofia, 1407
Local Institution - 0304
Sofia, 1431
Canada3 sites
Local Institution - 0183
Halifax, Nova Scotia, B3H 2Y9
Local Institution - 0275
London, Ontario, N6A 5W9
Local Institution - 0184
Toronto, Ontario, M5G 2M9
Greece3 sites
Local Institution - 0135
Athens, Attikí, 11528
Local Institution - 0136
Pátrai, Achaḯa, 26504
Local Institution - 0134
Thessaloniki, Thessaloníki, 570 10
Israel3 sites
Local Institution - 0264
Holon, Central District, 5810001
Local Institution - 0277
Jerusalem, 9112001
Local Institution - 0267
Tsrifin, Central District, 70300
Norway3 sites
Local Institution - 0049
Bergen, Hordaland, 5021
Local Institution - 0081
Oslo, 0450
Local Institution - 0112
Stavanger, Rogaland, 4021
South Korea3 sites
Local Institution - 0238
Seoul, Seoul-teukbyeolsi [Seoul], 03080
Local Institution - 0239
Seoul, Seoul-teukbyeolsi [Seoul], 06351
Local Institution - 0240
Seoul, Seoul-teukbyeolsi [Seoul], 06591
Netherlands2 sites
Local Institution - 0113
Breda, North Brabant, 4818 CK
Local Institution - 0194
Enschede, 7512 KZ
Singapore2 sites
Local Institution - 0158
Singapore, Central Singapore, 119074
Local Institution - 0159
Singapore, Central Singapore, 169608
About this study
Official title: 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.
- Conditions
- Relapsed or Refractory Multiple Myeloma
- Being tested
- Mezigdomide, Carfilzomib, Dexamethasone
- Keywords
- BMS-986348, CC-92480, Carfilzomib, Dexamethasone, Multiple Myeloma, Mezigdomide
- Medical subject headings
- Recurrence, Multiple Myeloma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MezigdomideDrug
Also called BMS-986348, CC-92480
Specified dose on specified days
CarfilzomibDrug
Also called Kyprolis
Specified dose on specified days
DexamethasoneDrug
Also called Decadron, Dex
Specified dose on specified days
| Study group | Role | What they receive |
|---|---|---|
| MeziKd (Mezigdomide + Carfilzomib + Dexamethasone) | Experimental | Not described Receives: Drug: Mezigdomide; Drug: Carfilzomib; Drug: Dexamethasone |
| Kd (Carfilzomib + Dexamethasone) | Active comparator | Not described Receives: Drug: Carfilzomib; Drug: Dexamethasone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-free Survival (PFS)
Measured: Up to approximately 5 years
Secondary outcomes (15)
Recommended Mezigdomide Dose
Stage 1 only
Measured: Up to 12 months
Plasma concentrations of Mezigdomide in Combination with Carfilzomib and Dexamethasone
Stage 1 only
Measured: Up to 176 days
Overall Survival (OS)
Measured: Up to approximately 5 years
Overall Response (OR)
Measured: 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.
Measured: Up to approximately 5 years
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.
Measured: Up to approximately 5 years
Time To Response (TTR)
Measured: Up to approximately 5 years
Duration Of Response (DOR)
Measured: Up to approximately 5 years
Time To Progression (TTP)
Measured: Up to approximately 5 years
Time To Next Treatment (TTNT)
Measured: Up to approximately 5 years
Progression-free Survival 2 (PFS-2)
Measured: Up to approximately 5 years
Minimal Residual Disease (MRD) Negativity Rate
Measured: Up to approximately 5 years
Number Of Participants With Adverse Events (AEs)
Measured: 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.
Measured: 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.
Measured: Up to approximately 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2022
- Study start10 Jan 2023
- Primary completion28 Sep 2026 (estimated)
- Study completion25 Jul 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Relapsed or Refractory Multiple MyelomaStudies of the same condition, open and under way.
- More trials run by Bristol-Myers SquibbThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This is a two-stage inferentially seamless design.
- Masking
- None (open label)
- Enrolment
- 606 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bristol-Myers Squibb
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Bristol-Myers Squibb, Study director, Bristol-Myers Squibb
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05552976
- Sponsor's protocol ID
- CA057-008
- Acronym
- SUCCESSOR-2
- Status last verified
- Sep 2026
- First submitted
- 21 Sep 2022
- Last updated
- 24 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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
Publications
Dimopoulos MA, Schjesvold F, Fu C, Hartley-Brown MA, Gomez C, Reece D, Mikala G, Alkharabsheh O, Parrish C, de Queiroz Crusoe E, Galvez K, Idrobo H, White D, Gupta R, Lee C, Liu CJ, Quach H, Wang Y, Cerchione C, Forsyth C, Hungria V, Kalaskar P, Graklanov V, Ho PJ, Klaiber-Hakimi M, Kwong YL, Louzada M, Mazumder A, Miles O, Nagarajan C, Prasad SVSS, Raab MS, Varga G, von der Heyde E, Xia Z, Ochoa PA, Oriol A, Yuda J, Kuroda J, Gong J, Zhou Z, Maciag P, Yu B, Rocci A, Koo P, Katz J, Richardson PG; SUCCESSOR-2 Trial Investigators. Mezigdomide, carfilzomib, and dexamethasone versus carfilzomib and dexamethasone in patients with relapsed or refractory multiple myeloma (SUCCESSOR-2): a phase 3, open-label, randomised controlled trial. Lancet. 2026 Jul 18;408(10551):219-233. doi: 10.1016/S0140-6736(26)01088-3. Epub 2026 Jun 14.
PubMed 42289183
Study at a glance
From the registry record, last updated by the sponsor on 24 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT05552976
- Acronym / sponsor ID
- SUCCESSOR-2 / CA057-008
- Conditions
- Relapsed or Refractory Multiple Myeloma
- Keywords
- BMS-986348, CC-92480, Carfilzomib, Dexamethasone, Multiple Myeloma, Mezigdomide
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 606 participants (actual)
- Lead sponsor
- Bristol-Myers SquibbIndustry (pharma, biotech, devices)
- Study start
- 10 Jan 2023 (actual)
- Primary completion
- 28 Sep 2026 (estimated)
- Study completion
- 25 Jul 2029 (estimated)
- First posted
- 23 Sep 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This is a two-stage inferentially seamless design.
| Arm | Type | Receives |
|---|---|---|
| MeziKd (Mezigdomide + Carfilzomib + Dexamethasone) | Experimental | Drug: Mezigdomide, Drug: Carfilzomib, Drug: Dexamethasone |
| Kd (Carfilzomib + Dexamethasone) | Active comparator | Drug: Carfilzomib, Drug: Dexamethasone |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Participant has documented diagnosis of multiple myeloma and measurable disease, defined as any of the following:.
- Myeloma-protein (M-protein) ≥ 0.5 grams/deciliter (g/dL) by serum protein electrophoresis (sPEP), or.
- M-protein ≥ 200 milligrams (mg)/24-hour urine collection by urine protein electrophoresis (uPEP) or,.
- 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).
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MezigdomideAlso: BMS-986348, CC-92480Specified dose on specified days | Drug | MeziKd (Mezigdomide + Carfilzomib + Dexamethasone) |
| CarfilzomibAlso: KyprolisSpecified dose on specified days | Drug | Kd (Carfilzomib + Dexamethasone), MeziKd (Mezigdomide + Carfilzomib + Dexamethasone) |
| DexamethasoneAlso: Decadron, DexSpecified dose on specified days | Drug | Kd (Carfilzomib + Dexamethasone), MeziKd (Mezigdomide + Carfilzomib + Dexamethasone) |
Primary outcome
Progression-free Survival (PFS)
Time frame: Up to approximately 5 years
15 secondary outcomes
Recommended Mezigdomide Dose
Time frame: Up to 12 months
Plasma concentrations of Mezigdomide in Combination with Carfilzomib and Dexamethasone
Time frame: Up to 176 days
Overall Survival (OS)
Time frame: Up to approximately 5 years
Overall Response (OR)
Time frame: Up to approximately 5 years
Rate Of Very Good Partial Response (VGPR) Or Better (VGPRR)
Time frame: Up to approximately 5 years
Complete Response (CR) Or Better (CRR)
Time frame: Up to approximately 5 years
Time To Response (TTR)
Time frame: Up to approximately 5 years
Duration Of Response (DOR)
Time frame: Up to approximately 5 years
Time To Progression (TTP)
Time frame: Up to approximately 5 years
Time To Next Treatment (TTNT)
Time frame: Up to approximately 5 years
Progression-free Survival 2 (PFS-2)
Time frame: Up to approximately 5 years
Minimal Residual Disease (MRD) Negativity Rate
Time frame: Up to approximately 5 years
Number Of Participants With Adverse Events (AEs)
Time frame: 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)
Time frame: Up to approximately 5 years
Change From Baseline in the European Quality of Life Multiple Myeloma Module (EORTC QLQ-MY20)
Time frame: Up to approximately 5 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Sep 2026.
- Derived from this study: PubMed 42289183Dimopoulos MA, Schjesvold F, Fu C, Hartley-Brown MA, Gomez C, Reece D, Mikala G, Alkharabsheh O, Parrish C, de Queiroz Crusoe E, Galvez K, Idrobo H, White D, Gupta R, Lee C, Liu CJ, Quach H, Wang Y, Cerchione C, Forsyth C, Hungria V, Kalaskar P, Graklanov V, Ho PJ, Klaiber-Hakimi M, Kwong YL, Louzada M, Mazumder A, Miles O, Nagarajan C, Prasad SVSS, Raab MS, Varga G, von der Heyde E, Xia Z, Ochoa PA, Oriol A, Yuda J, Kuroda J, Gong J, Zhou Z, Maciag P, Yu B, Rocci A, Koo P, Katz J, Richardson PG; SUCCESSOR-2 Trial Investigators. Mezigdomide, carfilzomib, and dexamethasone versus carfilzomib and dexamethasone in patients with relapsed or refractory multiple myeloma (SUCCESSOR-2): a phase 3, open-label, randomised controlled trial. Lancet. 2026 Jul 18;408(10551):219-233. doi: 10.1016/S0140-6736(26)01088-3. Epub 2026 Jun 14.
- BMS Clinical Trial InformationLink provided by the sponsor.
- BMS Clinical Trial Patient RecruitingLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. 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
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bristol-Myers Squibb study director
Bristol-Myers Squibb
204 sites in 27 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Mezigdomide, Carfilzomib and Dexamethasone in people with Relapsed or Refractory Multiple Myeloma, run by Bristol-Myers Squibb at 204 sites in 27 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 24 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 204 sites in United States, China, Japan, Germany, India and 22 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression-free Survival (PFS) (time frame: Up to approximately 5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05552976, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Sep 2026.