History of Changes for Study: NCT05552976

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 (SUCCESSOR-2) (SUCCESSOR-2)

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Study Record Versions

Version	Submitted Date	Changes
1	September 21, 2022	None (earliest Version on record)
2	October 26, 2022	Recruitment Status, Contacts/Locations, Study Status and References
3	October 28, 2022	Contacts/Locations and Study Status
4	October 31, 2022	Study Status and Contacts/Locations
5	November 3, 2022	Study Status and Contacts/Locations
6	November 4, 2022	Contacts/Locations and Study Status
7	November 4, 2022	Contacts/Locations and Study Status
8	November 10, 2022	Contacts/Locations and Study Status
9	November 15, 2022	Contacts/Locations and Study Status
10	November 17, 2022	Contacts/Locations and Study Status
11	December 8, 2022	Contacts/Locations and Study Status
12	January 27, 2023	Contacts/Locations, Study Status, Eligibility and Study Identification
13	February 8, 2023	Contacts/Locations, Study Status and IPDSharing
14	February 13, 2023	Contacts/Locations and Study Status
15	February 15, 2023	Contacts/Locations and Study Status
16	February 17, 2023	Contacts/Locations and Study Status
17	February 21, 2023	Contacts/Locations and Study Status
18	February 23, 2023	Contacts/Locations and Study Status
19	February 27, 2023	Contacts/Locations and Study Status
20	March 3, 2023	Study Status and Contacts/Locations
21	March 7, 2023	Contacts/Locations and Study Status
22	March 8, 2023	Contacts/Locations and Study Status
23	March 17, 2023	Contacts/Locations and Study Status
24	March 21, 2023	Contacts/Locations and Study Status
25	March 23, 2023	Contacts/Locations and Study Status
26	March 24, 2023	Contacts/Locations and Study Status
27	March 27, 2023	Contacts/Locations and Study Status
28	March 28, 2023	Contacts/Locations and Study Status
29	March 29, 2023	Contacts/Locations and Study Status
30	March 30, 2023	Contacts/Locations and Study Status
31	April 3, 2023	Study Status and Contacts/Locations
32	April 5, 2023	Contacts/Locations and Study Status
33	April 11, 2023	Contacts/Locations and Study Status
34	April 13, 2023	Contacts/Locations and Study Status
35	April 17, 2023	Contacts/Locations and Study Status
36	April 19, 2023	Contacts/Locations and Study Status
37	April 21, 2023	Contacts/Locations and Study Status
38	April 25, 2023	Contacts/Locations and Study Status
39	April 28, 2023	Contacts/Locations and Study Status
40	May 1, 2023	Study Status and Contacts/Locations
41	May 8, 2023	Contacts/Locations and Study Status
42	May 9, 2023	Contacts/Locations and Study Status
43	May 12, 2023	Contacts/Locations and Study Status
44	May 15, 2023	Contacts/Locations and Study Status
45	May 17, 2023	Contacts/Locations and Study Status
46	May 19, 2023	Contacts/Locations and Study Status
47	May 22, 2023	Contacts/Locations and Study Status
48	May 24, 2023	Contacts/Locations and Study Status
49	May 25, 2023	Contacts/Locations and Study Status
50	May 26, 2023	Contacts/Locations and Study Status
51	May 30, 2023	Contacts/Locations and Study Status
52	May 31, 2023	Contacts/Locations and Study Status
53	June 2, 2023	Study Status and Contacts/Locations
54	June 6, 2023	Contacts/Locations and Study Status
55	June 7, 2023	Contacts/Locations and Study Status
56	June 12, 2023	Study Status and Contacts/Locations
57	June 15, 2023	Contacts/Locations and Study Status
58	June 20, 2023	Contacts/Locations and Study Status
59	June 30, 2023	Contacts/Locations and Study Status
60	July 5, 2023	Study Status and Contacts/Locations
61	July 11, 2023	Contacts/Locations and Study Status
62	July 12, 2023	Contacts/Locations and Study Status
63	July 19, 2023	Contacts/Locations and Study Status
64	July 25, 2023	Contacts/Locations and Study Status
65	July 26, 2023	Contacts/Locations and Study Status
66	July 27, 2023	Contacts/Locations and Study Status
67	July 28, 2023	Contacts/Locations and Study Status
68	August 7, 2023	Contacts/Locations and Study Status
69	August 9, 2023	Contacts/Locations and Study Status
70	August 16, 2023	Contacts/Locations and Study Status
71	August 18, 2023	Contacts/Locations and Study Status
72	August 24, 2023	Contacts/Locations and Study Status
73	August 25, 2023	Contacts/Locations and Study Status
74	September 6, 2023	Contacts/Locations and Study Status
75	September 7, 2023	Contacts/Locations and Study Status
76	September 12, 2023	Contacts/Locations and Study Status
77	September 15, 2023	Contacts/Locations and Study Status
78	September 19, 2023	Contacts/Locations and Study Status
79	September 21, 2023	Contacts/Locations and Study Status
80	September 22, 2023	Contacts/Locations and Study Status
81	October 2, 2023	Arms and Interventions, Study Status, Study Identification, Contacts/Locations, Eligibility, Outcome Measures, Conditions and Study Description
82	October 4, 2023	Arms and Interventions, Study Identification, Contacts/Locations, Eligibility, Outcome Measures, Study Description and Study Status
83	October 13, 2023	Arms and Interventions, Contacts/Locations, Study Identification, Eligibility, Outcome Measures, Study Description and Study Status
84	October 18, 2023	Contacts/Locations and Study Status
85	October 19, 2023	Contacts/Locations and Study Status
86	October 26, 2023	Contacts/Locations and Study Status
87	October 30, 2023	Contacts/Locations and Study Status
88	October 31, 2023	Contacts/Locations and Study Status
89	November 3, 2023	Study Status and Contacts/Locations
90	November 10, 2023	Contacts/Locations and Study Status
91	November 15, 2023	Contacts/Locations and Study Status
92	November 29, 2023	Contacts/Locations and Study Status
93	November 30, 2023	Contacts/Locations and Study Status
94	December 3, 2023	Contacts/Locations and Study Status
95	December 6, 2023	Contacts/Locations and Study Status
96	December 14, 2023	Contacts/Locations, References and Study Status
97	January 2, 2024	Contacts/Locations and Study Status
98	January 5, 2024	Contacts/Locations and Study Status
99	January 12, 2024	Contacts/Locations and Study Status
100	January 30, 2024	Contacts/Locations, References and Study Status
101	February 20, 2024	Contacts/Locations, Study Status, References and Eligibility
102	March 18, 2024	Contacts/Locations and Study Status
103	April 10, 2024	Contacts/Locations and Study Status
104	May 1, 2024	Contacts/Locations and Study Status

Comparison Format:

Merged
Side-by-Side

Study Identification


Unique Protocol ID:	CA057-008
Brief Title:	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 (SUCCESSOR-2) (SUCCESSOR-2)
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)
Secondary IDs:

Study Status


Record Verification:	September 2022
Overall Status:	Not yet recruiting
Study Start:	September 30, 2022
Primary Completion:	February 4, 2026 [Anticipated]
Study Completion:	July 25, 2029 [Anticipated]

First Submitted:	September 21, 2022
First Submitted that Met QC Criteria:	September 21, 2022
First Posted:	September 23, 2022 [Actual]

Last Update Submitted that Met QC Criteria:	September 21, 2022
Last Update Posted:	September 23, 2022 [Actual]

Sponsor/Collaborators


Sponsor:	Bristol-Myers Squibb
Responsible Party:	Sponsor
Collaborators:

Oversight


U.S. FDA-regulated Drug:	Yes
U.S. FDA-regulated Device:	No
Data Monitoring:	Yes

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.
Detailed Description:

Conditions


Conditions:	Relapsed or Refractory Multiple Myeloma
Keywords:	BMS-986348 CC-92480 Carfilzomib Dexamethasone Multiple Myeloma

Study Design


Study Type:	Interventional
Primary Purpose:	Treatment
Study Phase:	Phase 3
Interventional Study Model:	Parallel Assignment
	This is a two-stage inferentially seamless design.
Number of Arms:	2
Masking:	None (Open Label)
Allocation:	Randomized
Enrollment:	525 [Anticipated]

Arms and Interventions

Arms	Assigned Interventions
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) [ Time Frame: Up to approximately 5 years ]
Secondary Outcome Measures:
1.	Recommended CC-92480 Dose [ Time Frame: Up to 12 months ] Stage 1 only
2.	Plasma concentrations of CC-92480 in Combination with Carfilzomib and Dexamethasone [ Time Frame: Up to 176 days ] Stage 1 only
3.	Overall Survival (OS) [ Time Frame: Up to approximately 5 years ]
4.	Overall Response Rate (ORR) [ Time Frame: Up to approximately 5 years ]
5.	Rate Of Very Good Partial Response (VGPR) Or Better (VGPRR) [ Time Frame: 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) [ Time Frame: 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) [ Time Frame: Up to approximately 5 years ]
8.	Duration Of Response (DOR) [ Time Frame: Up to approximately 5 years ]
9.	Time To Progression (TTP) [ Time Frame: Up to approximately 5 years ]
10.	Time To Next Treatment (TTNT) [ Time Frame: Up to approximately 5 years ]
11.	Progression-free Survival 2 (PFS-2) [ Time Frame: Up to approximately 5 years ]
12.	Minimal Residual Disease (MRD) Negativity Rate [ Time Frame: Up to approximately 5 years ]
13.	Number Of Participants With Adverse Events (AEs) [ Time Frame: 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) [ Time Frame: 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) [ Time Frame: 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


Minimum Age:	18 Years
Maximum Age:
Sex:	All
Gender Based:
Accepts Healthy Volunteers:	No
Criteria:	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 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/Locations


Central Contact Person:	BMS Study Connect Contact Center www.BMSStudyConnect.com Telephone: 855-907-3286 Email: Clinical.Trials@bms.com
Study Officials:	Bristol-Myers Squibb Study Director Bristol-Myers Squibb
Locations:	United States, Ohio
	Riverside Methodist Hospital Columbus, Ohio, United States, 43214 Contact:Contact: Yvonne Efebera, Site 0172 216-965-8569
	United States, South Carolina
	Charleston Oncology, P.A. Charleston, South Carolina, United States, 29414 Contact:Contact: George Geils, Site 0173 843-577-6957
	Argentina
	Local Institution - 0150 Buenos Aires, Argentina, 1431 Contact:Contact: Site 0150
	Local Institution - 0079 Ciudad Autónoma de Buenos Aires, Argentina, C1199ABB Contact:Contact: Site 0079
	Local Institution - 0151 Córdoba, Argentina, 5000 Contact:Contact: Site 0151
	Argentina, Santa Fe
	Local Institution - 0182 Rosario, Santa Fe, Argentina, S2000DEJ Contact:Contact: Site 0182
	Australia
	Local Institution - 0160 Gosford, Australia, 2250 Contact:Contact: Site 0160
	Australia, Queensland
	Local Institution - 0041 Brisbane, Queensland, Australia, 4029
	Australia, Victoria
	Local Institution - 0131 Bendigo, Victoria, Australia, 3550 Contact:Contact: Site 0131
	China
	Local Institution - 0059 Taiyuan, China, 030032 Contact:Contact: Site 0059
	China, Beijing
	Local Institution - 0057 Beijing, Beijing, China, 100020 Contact:Contact: Site 0057
	Local Institution - 0061 Beijing, Beijing, China, 100020 Contact:Contact: Site 0061
	Local Institution - 0056 Beijing, Beijing, China, 100730 Contact:Contact: Site 0056
	China, Fujian
	Local Institution - 0123 Fuzhou, Fujian, China, 350001 Contact:Contact: Site 0123
	China, Guangdong
	Local Institution - 0138 Guangzhou, Guangdong, China, 510060 Contact:Contact: Site 0138
	China, Henan
	Local Institution - 0051 Zhengzhou, Henan, China, 450008 Contact:Contact: Site 0051
	China, Hunan
	Local Institution - 0071 Changsha, Hunan, China, 410013 Contact:Contact: Site 0071
	Local Institution - 0103 Changsha, Hunan, China, 410013 Contact:Contact: Site 0103
	China, Jiangsu
	Local Institution - 0111 Nantong, Jiangsu, China, 226001 Contact:Contact: Site 0111
	Local Institution - 0104 Suzhou, Jiangsu, China, 215006 Contact:Contact: Site 0104
	Local Institution - 0069 Wuxi, Jiangsu, China, 214023 Contact:Contact: Site 0069
	China, Jilin
	Local Institution - 0052 Changchun, Jilin, China, 130021 Contact:Contact: Site 0052
	China, Liaoning
	Local Institution - 0096 Shenyang, Liaoning, China, 110001 Contact:Contact: Site 0096
	Local Institution - 0176 Shenyang, Liaoning, China, 110004 Contact:Contact: Site 0176
	China, Shaanxi
	Local Institution - 0060 Xi'an, Shaanxi, China, 710126 Contact:Contact: Site 0060
	China, Shandong
	Local Institution - 0072 Jinan, Shandong, China, 250014 Contact:Contact: Site 0072
	China, Shanghai
	Local Institution - 0118 Shanghai, Shanghai, China, 0 Contact:Contact: Site 0118
	China, Tianjin
	Local Institution - 0091 Tianjin, Tianjin, China, 300020 Contact:Contact: Site 0091
	China, Yunnan
	Local Institution - 0058 Kunming, Yunnan, China, 650101 Contact:Contact: Site 0058
	China, Zhejiang
	Local Institution - 0050 Hangzhou, Zhejiang, China, 310003 Contact:Contact: Site 0050
	Colombia, Antioquia
	Local Institution - 0153 Medellin, Antioquia, Colombia, 05034 Contact:Contact: Site 0153
	Colombia, Cesar
	Local Institution - 0156 Valledupar, Cesar, Colombia, 200001 Contact:Contact: Site 0156
	Colombia, Cundinamarca
	Local Institution - 0154 Bogota, Cundinamarca, Colombia, 111151 Contact:Contact: Site 0154
	Colombia, Valle Del Cauca
	Local Institution - 0155 Cali, Valle Del Cauca, Colombia, 0 Contact:Contact: Site 0155
	Germany, Saxony
	Local Institution - 0030 Leipzig, Saxony, Germany, 04103 Contact:Contact: Site 0030
	Hong Kong
	Local Institution - 0178 Hong Kong, Hong Kong, 0 Contact:Contact: Site 0178
	India
	Local Institution - 0171 Thane, India, 400602 Contact:Contact: Site 0171
	India, Delhi
	Local Institution - 0170 New Delhi, Delhi, India, 110085 Contact:Contact: Site 0170
	India, Haryana
	Local Institution - 0167 Gurgaon, Haryana, India, 122001 Contact:Contact: Site 0167
	India, Karnataka
	Local Institution - 0161 Bengaluru, Karnataka, India, 560027 Contact:Contact: Site 0161
	India, Maharashtra
	Local Institution - 0168 Mumbai, Maharashtra, India, 400012 Contact:Contact: Site 0168
	India, Tamil Nadu
	Local Institution - 0174 Chennai, Tamil Nadu, India, 600036 Contact:Contact: Site 0174
	India, Telangana
	Local Institution - 0165 Hyderabad, Telangana, India, 500033 Contact:Contact: Site 0165
	Local Institution - 0164 Hyderabad, Telangana, India, 500082 Contact:Contact: Site 0164
	India, West Bengal
	Local Institution - 0163 Kolkata, West Bengal, India, 700014 Contact:Contact: Site 0163
	Singapore, Central Singapore
	Local Institution - 0158 Singapore, Central Singapore, Singapore, 119074 Contact:Contact: Site 0158
	Local Institution - 0159 Singapore, Central Singapore, Singapore, 169608 Contact:Contact: Site 0159
	Taiwan
	Local Institution - 0012 Kaohsiung, Taiwan, 82445 Contact:Contact: Site 0012
	Local Institution - 0162 Taipei, Taiwan, 11217 Contact:Contact: Site 0162
	Taiwan, Kaohsiung
	Local Institution - 0177 Kaohsiung City, Kaohsiung, Taiwan, 83301 Contact:Contact: Site 0177

IPDSharing


Plan to Share IPD:	Yes BMS will provide access to individual anonymized participant data upon request from qualified researchers, and subject to certain criteria. Additional information regarding Bristol Myers Squibb's data sharing policy and process can be found at: https://www.bms.com/researchers-and-partners/clinical-trials-and-research/disclosurecommitment.html
	Supporting Information: Study Protocol Statistical Analysis Plan (SAP) Clinical Study Report (CSR)
	Time Frame: See Plan Description
	Access Criteria: See Plan Description
	URL: https://www.bms.com/researchers-and-partners/clinical-trials-and-research/disclosurecommitment.html

References


Citations:
Links:	URL: https://www.bms.com/researchers-and-partners/clinical-trials-and-research.html Description: BMS Clinical Trial Information
	URL: https://www.bmsstudyconnect.com/s/US/English/USenHome Description: BMS Clinical Trial Patient Recruiting
	URL: https://www.bms.com/researchers-and-partners/clinical-trials-and-research.html Description: Investigator Inquiry Form
	URL: https://www.fda.gov/Safety/MedWatch/SafetyInformation/default.htm Description: FDA Safety Alerts and Recalls
Available IPD/Information: