Relapsed or Refractory Multiple Myeloma
Conditions
Keywords
BMS-986348, CC-92480, Carfilzomib, Dexamethasone, Multiple Myeloma, Mezigdomide
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.
Interventions
DRUGMezigdomide
Specified dose on specified days
DRUGCarfilzomib
Specified dose on specified days
DRUGDexamethasone
Specified dose on specified days
Sponsors
Bristol-Myers Squibb
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
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.
Intervention model description
This is a two-stage inferentially seamless design.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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/
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression-free Survival (PFS) | Up to approximately 5 years |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Recommended Mezigdomide Dose | Up to 12 months | Stage 1 only |
| Plasma concentrations of Mezigdomide in Combination with Carfilzomib and Dexamethasone | Up to 176 days | Stage 1 only |
| Overall Survival (OS) | Up to approximately 5 years | — |
| Overall Response (OR) | Up to approximately 5 years | — |
| 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. |
| 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. |
| 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 | — |
| Progression-free Survival 2 (PFS-2) | 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 | — |
| 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. |
| 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. |
Countries
Argentina, Australia, Austria, Brazil, Bulgaria, Canada, China, Colombia, Denmark, Germany, Greece, Hong Kong, Hungary, India, Israel, Italy, Japan, Netherlands, Norway, Puerto Rico, Romania, Singapore, South Korea, Spain, Taiwan, United Kingdom, United States
Contacts
STUDY_DIRECTORBristol-Myers Squibb
Bristol-Myers Squibb
Outcome results
None listed