A Study to Evaluate CC-92480, Bortezomib and Dexamethasone (480Vd) Versus Pomalidomide, Bortezomib and Dexamethasone (PVd) in Participants With Relapsed or Refractory Multiple Myeloma (RRMM)

Overview

The purpose of this study is to compare the efficacy and safety of CC-92480, bortezomib and dexamethasone (480Vd) versus pomalidomide, bortezomib and dexamethasone (PVd) in participants with relapsed or refractory multiple myeloma (RRMM) who received between 1 to 3 prior lines of therapy and who have had prior lenalidomide exposure.

Full Title of Study: “A Phase 3, Two-Stage, Randomized, Multicenter, Open-Label Study Comparing CC-92480, Bortezomib and Dexamethasone (480Vd) Versus Pomalidomide, Bortezomib and Dexamethasone (PVd) in Subjects With Relapsed or Refractory Multiple Myeloma (RRMM)”

Study Type

• Study Type: Interventional
• Study Design
  • Allocation: Randomized
  • Intervention Model: Parallel Assignment
  • Primary Purpose: Treatment
  • Masking: None (Open Label)
• Study Primary Completion Date: November 3, 2025

Interventions

• Drug: CC-92480
  • Specified dose on specified days
• Drug: Pomalidomide
  • Specified dose on specified days
• Drug: Bortezomib
  • Specified dose on specified days
• Drug: Dexamethasone
  • Specified dose on specified days

Arms, Groups and Cohorts

• Experimental: 480Vd (CC-92480, bortezomib and dexamethasone)
• Experimental: PVd (pomalidomide, bortezomib and dexamethasone)

Clinical Trial Outcome Measures

Primary Measures

• Progression-free Survival (PFS)
  • Time Frame: From date of randomization to date of disease progression or death due to any cause (Up to approximately 5 years)

Secondary Measures

• Recommended CC- 92480 dose
  • Time Frame: Up to 12 Months
  • Stage 1 only
• Plasma concentrations of CC-92480
  • Time Frame: Up to 134 Days
  • Stage 1 only
• Overall Survival (OS)
  • Time Frame: From date of randomization to date of death due to any cause (Up to approximately 5 years)
• Overall Response Rate (ORR)
  • Time Frame: Up to approximately 5 years
• Percentage of participants with Complete Response Rate (CRR) or better as assessed by the International Myeloma Working Group (IMWG) Uniform Response Criteria for Multiple Myeloma
  • Time Frame: Up to approximately 5 Years
• Percentage of participants with Very Good Partial Response Rate (VGPRR) or better as assessed by the IMWG Uniform Response Criteria for Multiple Myeloma
  • 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 European Organization for Research and Treatment of Cancer – Quality of Life C30 questionnaire (EORTC QLQ-C30) scores
  • 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.
• Change from baseline in European Organization for Research and Treatment of Cancer – Quality of Life Multiple Myeloma Module (EORTC QLQ-MY20) score
  • 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.

Participating in This Clinical Trial

Inclusion Criteria

• Participant has documented diagnosis of MM and measurable disease, defined as any of the following: – M-protein ≥ 0.5 grams per deciliter (g/dL) by serum protein electrophoresis (sPEP) or – M-protein ≥ 200 milligrams (mg) per 24-hour urine collection by urine protein electrophoresis (uPEP) – For participants without measurable disease in sPEP or uPEP: serum free light chain (sFLC) levels > 100 mg/L (10 mg/dL) involved light chain and an abnormal kappa/lambda FLC ratio. – Participants received 1 to 3 prior lines of antimyeloma therapy. – Participants achieved minimal response [MR] or better to at least 1 prior antimyeloma therapy. Exclusion Criteria:

• Participant has had progression during treatment or within 60 days of the last dose of a proteasome inhibitor. – For participants with prior treatment of a bortezomib containing regimen, the best response achieved was not a minimal response (MR) or better, or participant discontinued bortezomib due to toxicity. – Participant has had prior treatment with CC-92480 or pomalidomide. Other protocol-defined criteria apply.

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

• Lead Sponsor
  • Bristol-Myers Squibb
• Provider of Information About this Clinical Study
  • Sponsor
• Overall Official(s)
  • Bristol-Myers Squibb, Study Director, Bristol-Myers Squibb
• Overall Contact(s)
  • BMS Study Connect Contact Center www.BMSStudyConnect.com, 855-907-3286, Clinical.Trials@bms.com