Clincosm LogoSign in Get a demo

SUCCESSOR-2: A Study to Evaluate CC-92480 in Combination With Carfilzomib and Dexamethasone (480Kd) Versus Carfilzomib and Dexamethasone (Kd) in Participants With Relapsed or Refractory Multiple Myeloma

Sponsor
Bristol-Myers Squibb (Industry)
Overall Status
Recruiting
CT.gov ID
NCT05552976
Collaborator
(none)
525
Enrollment
131
Locations
2
Arms
78.5
Anticipated Duration (Months)
4
Patients Per Site
0.1
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of the study is to compare CC-92480 (BMS-986348) with carfilzomib and dexamethasone (480Kd) against carfilzomib and dexamethasone (Kd) in the treatment of RRMM.

Condition or Disease Intervention/Treatment Phase
Phase 3

Study Design

Study Type:
Interventional
Anticipated Enrollment :
525 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
This is a two-stage inferentially seamless design.This is a two-stage inferentially seamless design.
Masking:
None (Open Label)
Masking Description:
This is an open-label study; however, any review of aggregate study data by the Sponsor will be performed in a blinded manner.
Primary Purpose:
Treatment
Official Title:
A Phase 3, Two-stage, Randomized, Multicenter, Open-label Study Comparing CC-92480 (BMS-986348), Carfilzomib, and Dexamethasone (480Kd) Versus Carfilzomib and Dexamethasone (Kd) in Participants With Relapsed or Refractory Multiple Myeloma (RRMM)
Actual Study Start Date :
Jan 10, 2023
Anticipated Primary Completion Date :
Feb 4, 2026
Anticipated Study Completion Date :
Jul 25, 2029

Arms and Interventions

Arm Intervention/Treatment
Experimental: 480Kd (CC-92480 + Carfilzomib + Dexamethasone)

Drug: CC-92480
Specified dose on specified days
Other Names:
  • BMS-986348
  • Mezigdomide

    • Drug: Carfilzomib
    Specified dose on specified days
    Other Names:
  • Kyprolis

    • Drug: Dexamethasone
    Specified dose on specified days
    Other Names:
  • Decadron
  • Dex

    		•
    Active Comparator: Kd (Carfilzomib + Dexamethasone)

    Drug: Carfilzomib
    Specified dose on specified days
    Other Names:
  • Kyprolis

    • Drug: Dexamethasone
    Specified dose on specified days
    Other Names:
  • Decadron
  • Dex

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Progression-free Survival (PFS) [Up to approximately 5 years]

    Secondary Outcome Measures

    1. Recommended CC-92480 Dose [Up to 12 months]

      Stage 1 only

    2. Plasma concentrations of CC-92480 in Combination with Carfilzomib and Dexamethasone [Up to 176 days]

      Stage 1 only

    3. Overall Survival (OS) [Up to approximately 5 years]

    4. Overall Response Rate (ORR) [Up to approximately 5 years]

    5. Rate Of Very Good Partial Response (VGPR) Or Better (VGPRR) [Up to approximately 5 years]

      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.

    6. Rate Of Complete Response (CR) Or Better (CRR) [Up to approximately 5 years]

      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.

    7. Time To Response (TTR) [Up to approximately 5 years]

    8. Duration Of Response (DOR) [Up to approximately 5 years]

    9. Time To Progression (TTP) [Up to approximately 5 years]

    10. Time To Next Treatment (TTNT) [Up to approximately 5 years]

    11. Progression-free Survival 2 (PFS-2) [Up to approximately 5 years]

    12. Minimal Residual Disease (MRD) Negativity Rate [Up to approximately 5 years]

    13. Number Of Participants With Adverse Events (AEs) [Up to approximately 5 years]

    14. Mean Change From Baseline in the European Organization for Research and Treatment of Cancer - Quality of Life C30 Questionnaire (EORTC QLQ-C30) [Up to approximately 5 years]

      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.

    15. Mean Change From Baseline in the European Quality of Life Multiple Myeloma Module (EORTC QLQ-MY20) [Up to approximately 5 years]

      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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • 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.

    • 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 CC-92480 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.

    Additional protocol-defined criteria apply.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 USA Mitchell Cancer Institute Mobile Alabama United States 36604
    2 Kaiser Permanente - Irvine Irvine California United States 92618
    3 Los Angeles Hematology Oncology Medical Group Los Angeles California United States 90017
    4 Innovative Clinical Research Institute Whittier California United States 90603
    5 Augusta University Augusta Georgia United States 30912
    6 Montefiore Medical Center Bronx New York United States 10467
    7 Riverside Methodist Hospital Columbus Ohio United States 43214
    8 Charleston Oncology, P.A. Charleston South Carolina United States 29414
    9 Houston Methodist Hospital Houston Texas United States 77030
    10 Baylor Scott & White Medical Center - Temple Temple Texas United States 76508
    11 Northwest Medical Specialties - Gig Harbor Tacoma Washington United States 98405
    12 Local Institution - 0008 Ciudad Autónoma de Buenos Aires Buenos Aires Argentina C1426ANZ
    13 Local Institution - 0079 ABB Ciudad Autónoma De Buenos Aires Argentina C1199ABB
    14 Local Institution - 0182 Rosario Santa Fe Argentina S2000DEJ
    15 Local Institution - 0150 Buenos Aires Argentina 1431
    16 Local Institution - 0151 Córdoba Argentina 5000
    17 Local Institution - 0077 Camperdown New South Wales Australia 2050
    18 Local Institution - 0078 St Leonards New South Wales Australia 2065
    19 Local Institution - 0026 Sydney New South Wales Australia 2010
    20 Local Institution - 0041 Brisbane Queensland Australia 4029
    21 Local Institution - 0024 Adelaide South Australia Australia 5000
    22 Local Institution - 0131 Bendigo Victoria Australia 3550
    23 Local Institution - 0127 Heidelberg Victoria Australia 3084
    24 Local Institution - 0025 Melbourne Victoria Australia 3065
    25 Local Institution - 0160 Gosford Australia 2250
    26 Local Institution - 0020 Linz Oberösterreich Austria 4020
    27 Local Institution - 0017 Wien Austria 1090
    28 Local Institution - 0119 Wien Austria 1130
    29 Local Institution - 0121 Salvador Bahia Brazil 41253-190
    30 Local Institution - 0076 Porto Alegre Rio Grande Do Sul Brazil 90470-340
    31 Local Institution - 0085 Sao Paulo São Paulo Brazil 01509-010
    32 Local Institution - 0075 Rio de Janeiro Brazil 20775-001
    33 Local Institution - 0073 São Paulo Brazil 04537-080
    34 Local Institution - 0183 Halifax Nova Scotia Canada B3H 2Y9
    35 Local Institution - 0184 Toronto Ontario Canada M5G 2M9
    36 Local Institution - 0186 Montreal Quebec Canada H3T 1E2
    37 Local Institution - 0057 Beijing Beijing China 100020
    38 Local Institution - 0061 Beijing Beijing China 100020
    39 Local Institution - 0056 Beijing Beijing China 100730
    40 Local Institution - 0122 Fuzhou Fujian Fujian China 350001
    41 Local Institution - 0123 Fuzhou Fujian Fujian China 350001
    42 Local Institution - 0138 Guangzhou Guangdong China 510060
    43 Local Institution - 0051 Zhengzhou Henan China 450008
    44 Local Institution - 0071 Changsha Hunan China 410013
    45 Local Institution - 0103 Changsha Hunan China 410013
    46 Local Institution - 0180 Nanjing Jiangsu China 210009
    47 Local Institution - 0111 Nantong Jiangsu China 226001
    48 Local Institution - 0104 Suzhou Jiangsu China 215006
    49 Local Institution - 0069 Wuxi Jiangsu China 214023
    50 Local Institution - 0052 Changchun Jilin China 130021
    51 Local Institution - 0096 Shenyang Liaoning China 110001
    52 Local Institution - 0176 Shenyang Liaoning China 110004
    53 Local Institution - 0060 Xi'an Shaanxi China 710126
    54 Local Institution - 0072 Jinan Shandong China 250014
    55 Local Institution - 0118 Shanghai Shanghai China 0
    56 Local Institution - 0091 Tianjin Tianjin China 300060
    57 Local Institution - 0058 Kunming Yunnan China 650101
    58 Local Institution - 0050 Hangzhou Zhejiang China 310003
    59 Local Institution - 0059 Taiyuan China 030032
    60 Local Institution - 0153 Medellin Antioquia Colombia 05034
    61 Local Institution - 0156 Valledupar Cesar Colombia 200001
    62 Local Institution - 0154 Bogota Cundinamarca Colombia 111151
    63 Local Institution - 0155 Cali Valle Del Cauca Colombia 760035
    64 Local Institution - 0048 Copenhagen Hovedstaden Denmark 2100
    65 Local Institution - 0032 Aarhus Midtjylland Denmark 8200
    66 Local Institution - 0065 Roskilde Sjælland Denmark 4000
    67 Local Institution - 0129 Odense Syddanmark Denmark 5000
    68 Local Institution - 0125 Vejle Syddanmark Denmark 7100
    69 Local Institution - 0030 Leipzig Saxony Germany 04103
    70 Local Institution - 0029 Kiel Schleswig-Holstein Germany 24105
    71 Local Institution - 0007 Berlin Germany 12203
    72 Local Institution - 0015 Heidelberg Germany D-69120
    73 Local Institution - 0102 Köln Germany 50937
    74 Local Institution - 0133 Nürnberg Germany 90419
    75 Local Institution - 0124 Ulm Germany 89081
    76 Local Institution - 0014 Wuerzburg Germany 97080
    77 Local Institution - 0136 Patras Achaḯa Greece 26504
    78 Local Institution - 0135 Athens Attikí Greece 115 28
    79 Local Institution - 0134 Thessaloniki Thessaloníki Greece 570 10
    80 Local Institution - 0178 Hksar Hong Kong 0
    81 Local Institution - 0036 Pécs Baranya Hungary 7624
    82 Local Institution - 0094 Nyiregyhaza Szabolcs-Szatmár-Bereg Hungary 4400
    83 Local Institution - 0042 Budapest Hungary 1085
    84 Local Institution - 0019 Budapest Hungary 1097
    85 Local Institution - 0043 Debrecen Hungary 4032
    86 Local Institution - 0170 New Delhi Delhi India 110085
    87 Local Institution - 0167 Gurgaon Haryana India 122001
    88 Local Institution - 0161 Bengaluru Karnataka India 560027
    89 Local Institution - 0168 Mumbai Maharashtra India 400012
    90 Local Institution - 0171 Thane Maharashtra India 400602
    91 Local Institution - 0174 Chennai Tamil Nadu India 600036
    92 Local Institution - 0165 Hyderabad Telangana India 500033
    93 Local Institution - 0164 Hyderabad Telangana India 500082
    94 Local Institution - 0163 Kolkata West Bengal India 700014
    95 Local Institution - 0145 Meldola Emilia-Romagna Italy 47014
    96 Local Institution - 0143 Milano Lombardia Italy 20122
    97 Local Institution - 0142 Rozzano Milano Italy 20089
    98 Local Institution - 0189 Bologna Italy 40138
    99 Local Institution - 0148 Catanzaro Italy 88100
    100 Local Institution - 0147 Lecce Italy 73100
    101 Local Institution - 0144 Pisa Italy 56100
    102 Local Institution - 0146 Udine Italy 33100
    103 Local Institution - 0194 Enschede Netherlands 7512 KZ
    104 Local Institution - 0049 Bergen Hordaland Norway 5021
    105 Local Institution - 0112 Stavanger Rogaland Norway 4011
    106 Local Institution - 0081 Oslo Norway 0450
    107 Local Institution - 0158 Singapore Central Singapore Singapore 119074
    108 Local Institution - 0159 Singapore Central Singapore Singapore 169608
    109 Local Institution - 0126 Badalona Barcelona [Barcelona] Spain 08916
    110 Local Institution - 0092 Barcelona Barcelona [Barcelona] Spain 08035
    111 Local Institution - 0038 L'Hospitalet Del Llobregat Barcelona [Barcelona] Spain 08908
    112 Local Institution - 0108 Majadahonda Madrid, Comunidad De Spain 28222
    113 Local Institution - 0192 San Cristobal de La laguna Santa Cruz De Tenerife Spain 38320
    114 Local Institution - 0201 San Cristobal de La laguna Santa Cruz De Tenerife Spain 38320
    115 Local Institution - 0037 Valencia Valenciana, Comunitat Spain 46010
    116 Local Institution - 0107 Granada Spain 18012
    117 Local Institution - 0200 Madrid Spain 28007
    118 Local Institution - 0047 Madrid Spain 28015
    119 Local Institution - 0105 Málaga Spain 29010
    120 Local Institution - 0177 Kaohsiung Niao Sung Dist Kaohsiung Taiwan 83301
    121 Local Institution - 0012 Kaohsiung Taiwan 82445
    122 Local Institution - 0001 Taichung Taiwan 407
    123 Local Institution - 0002 Tainan Taiwan 704
    124 Local Institution - 0149 Taipei Taiwan 11217
    125 Local Institution - 0162 Taipei Taiwan 11217
    126 Local Institution - 0139 Plymouth Devon United Kingdom Pl6 8DH
    127 Local Institution - 0067 Cringleford England United Kingdom NR4 7UY
    128 Local Institution - 0039 Birmingham United Kingdom B15 2TH
    129 Local Institution - 0080 Leeds United Kingdom LS9 7TF
    130 Local Institution - 0130 Sheffield United Kingdom S10 2JF
    131 Local Institution - 0040 Taunton United Kingdom TA1 5DA

    Sponsors and Collaborators

    • Bristol-Myers Squibb

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    Bristol-Myers Squibb
    ClinicalTrials.gov Identifier:
    NCT05552976
    Other Study ID Numbers:
    • CA057-008
    First Posted:
    Sep 23, 2022
    Last Update Posted:
    Jan 30, 2023
    Last Verified:
    Jan 1, 2023
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Bristol-Myers Squibb
    BMS-986348
    CC-92480
    Carfilzomib
    Dexamethasone
    Multiple Myeloma
    Additional relevant MeSH terms:
    Multiple Myeloma
    Neoplasms, Plasma Cell
    Dexamethasone

    Study Results

    No Results Posted as of Jan 30, 2023