A Study to Evaluate Mezigdomide, Bortezomib and Dexamethasone (MEZIVd) Versus Pomalidomide, Bortezomib and Dexamethasone (PVd) in Participants With Relapsed or Refractory Multiple Myeloma (RRMM)
- Conditions
- Relapsed or Refractory Multiple Myeloma
- Interventions
- Registration Number
- NCT05519085
- Lead Sponsor
- Celgene
- Brief Summary
The purpose of this study is to compare the efficacy and safety of mezigdomide (CC-92480), bortezomib and dexamethasone (MeziVd) 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 810
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description MeziVd (mezigdomide, bortezomib and dexamethasone) Bortezomib - MeziVd (mezigdomide, bortezomib and dexamethasone) mezigdomide - MeziVd (mezigdomide, bortezomib and dexamethasone) Dexamethasone - PVd (pomalidomide, bortezomib and dexamethasone) Pomalidomide - PVd (pomalidomide, bortezomib and dexamethasone) Bortezomib - PVd (pomalidomide, bortezomib and dexamethasone) Dexamethasone -
- Primary Outcome Measures
Name Time Method Progression-free Survival (PFS) From date of randomization to date of disease progression or death due to any cause (Up to approximately 5 years)
- Secondary Outcome Measures
Name Time Method Recommended mezigdomide dose Up to 12 Months Stage 1 only
Plasma concentrations of mezigdomide Up to 134 Days Stage 1 only
Overall Survival (OS) From date of randomization to date of death due to any cause (Up to approximately 5 years) Overall Response (OR) Up to approximately 5 years OR is defined as the number of participants who achieve best response of partial response (PR) or better according to the International Myeloma Working Group (IMWG) Response Criteria for Multiple Myeloma
Complete Response (CR) or better Up to approximately 5 Years Defined as the number of participants who achieve best response of complete response (CR) or better according to the IMWG Uniform Response Criteria for Multiple Myeloma
Very Good Partial Response (VGPR) or better Up to approximately 5 years Defined as the number of participants who achieve best response of very good partial response (VGPR) 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 Up to approximately 5 years Defined as the number of participants who achieve complete response (CR) or better and MRD negativity (defined as less than 1 in 10\^5 nucleated cells \[by next generation flow cytometry\] in bone marrow aspirate)
Number of participants with Adverse Events (AEs) 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 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 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.
Trial Locations
- Locations (263)
Cancer and Blood Specialty Clinic
🇺🇸Los Alamitos, California, United States
Sharp Memorial Hospital
🇺🇸San Diego, California, United States
Local Institution - 0273
🇺🇸West Hollywood, California, United States
Local Institution - 0381
🇺🇸Aurora, Colorado, United States
UConn Health
🇺🇸Farmington, Connecticut, United States
Local Institution - 0208
🇺🇸New Haven, Connecticut, United States
Advanced Research
🇺🇸Coral Springs, Florida, United States
Florida Cancer Specialists - South
🇺🇸Fort Myers, Florida, United States
Florida Cancer Specialists - North
🇺🇸Saint Petersburg, Florida, United States
Florida Cancer Specialists - East
🇺🇸West Palm Beach, Florida, United States
Scroll for more (253 remaining)Cancer and Blood Specialty Clinic🇺🇸Los Alamitos, California, United StatesVu Quang Phan, Site 0366Contact562-735-0602