Brief Summary
The purpose of the study is to compare Mezigdomide (CC-92480/BMS-986348) with carfilzomib and dexamethasone (MeziKD) against carfilzomib and dexamethasone (Kd) in the treatment of RRMM: SUCCESSOR-2.
Brief Title
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)
Categories
Central Contacts
Central Contact Role
Contact
Central Contact Phone
855-907-3286
Central Contact Email
Clinical.Trials@bms.com
Central Contact Role
Contact
Completion Date
Completion Date Type
Estimated
Conditions
Relapsed or Refractory Multiple Myeloma
Eligibility Criteria
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.
- 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.
Inclusion Criteria
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.
Inclusion/
- 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.
Inclusion/
Gender
All
Gender Based
false
Keywords
BMS-986348
CC-92480
Carfilzomib
Dexamethasone
Multiple Myeloma
Mezigdomide
Healthy Volunteers
No
Last Update Post Date
Last Update Post Date Type
Actual
Last Update Submit Date
Minimum Age
18 Years
NCT Id
NCT05552976
Org Class
Industry
Org Full Name
Bristol-Myers Squibb
Org Study Id
CA057-008
Overall Status
Recruiting
Phases
Phase 3
Primary Completion Date
Primary Completion Date Type
Estimated
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
Primary Outcomes
Outcome Measure
Progression-free Survival (PFS)
Outcome Time Frame
Up to approximately 5 years
Secondary Outcomes
Outcome Description
Stage 1 only
Outcome Time Frame
Up to 12 months
Outcome Measure
Recommended Mezigdomide Dose
Outcome Description
Stage 1 only
Outcome Time Frame
Up to 176 days
Outcome Measure
Plasma concentrations of Mezigdomide in Combination with Carfilzomib and Dexamethasone
Outcome Time Frame
Up to approximately 5 years
Outcome Measure
Overall Survival (OS)
Outcome Time Frame
Up to approximately 5 years
Outcome Measure
Overall Response (OR)
Outcome Description
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.
Outcome Time Frame
Up to approximately 5 years
Outcome Measure
Rate Of Very Good Partial Response (VGPR) Or Better (VGPRR)
Outcome Description
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.
Outcome Time Frame
Up to approximately 5 years
Outcome Measure
Complete Response (CR) Or Better (CRR)
Outcome Time Frame
Up to approximately 5 years
Outcome Measure
Time To Response (TTR)
Outcome Time Frame
Up to approximately 5 years
Outcome Measure
Duration Of Response (DOR)
Outcome Time Frame
Up to approximately 5 years
Outcome Measure
Time To Progression (TTP)
Outcome Time Frame
Up to approximately 5 years
Outcome Measure
Time To Next Treatment (TTNT)
Outcome Time Frame
Up to approximately 5 years
Outcome Measure
Progression-free Survival 2 (PFS-2)
Outcome Time Frame
Up to approximately 5 years
Outcome Measure
Minimal Residual Disease (MRD) Negativity Rate
Outcome Time Frame
Up to approximately 5 years
Outcome Measure
Number Of Participants With Adverse Events (AEs)
Outcome Description
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.
Outcome Time Frame
Up to approximately 5 years
Outcome Measure
Change From Baseline in the European Organization for Research and Treatment of Cancer - Quality of Life C30 Questionnaire (EORTC QLQ-C30)
Outcome Description
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.
Outcome Time Frame
Up to approximately 5 years
Outcome Measure
Change From Baseline in the European Quality of Life Multiple Myeloma Module (EORTC QLQ-MY20)
See Also Links
Start Date
Start Date Type
Actual
Status Verified Date
First Post Date
First Post Date Type
Actual
First Submit Date
First Submit QC Date
Std Ages
Adult
Older Adult
Maximum Age Number (converted to Years and rounded down)
999
Minimum Age Number (converted to Years and rounded down)
18
Investigators
Investigator Type
Principal Investigator
Investigator Name
Ridhi Gupta
Investigator Email
ridgupta@montefiore.org