Relapsed or Refractory Multiple Myeloma (RRMM)
Conditions
Interventions
Product Name: CC-92480
Pharmaceutical Form: Capsule, hard
INN or Proposed INN: Mezigdomide
CAS Number: 2259648-80-9
Current Sponsor code: CC-92480
Other descriptive name: CC-92480 0.2mg
Concentration
Sponsors
Celgene Corporation
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: •Subject has documented diagnosis of MM and measurable disease, defined as: —M-protein = 0.5 g/dL by serum protein electrophoresis (sPEP), or = 200 mg/24-hour urine collection by urine protein electrophoresis (uPEP) or, —For subjects 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 •Subject has received 1 to 3 prior anti-myeloma lines of therapy •Subject must have received prior treatment with a lenalidomide containing regimen. For country-specific requirements, see APPENDIX I. •Subject achieved a minimal response [MR] or better to at least 1 prior antimyeloma therapy •Subject must have documented disease progression during or after their last antimyeloma regimen •Subject has an Eastern Cooperative Oncology Group (ECOG) performance status score of 0, 1 or 2. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 418 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 532
Exclusion criteria
Exclusion criteria: •Subject has had prior treatment with mezigdomide or pomalidomide •Subject has had progression during treatment or within 60 days of the last dose of a proteasome inhibitor, except as noted below: a. Subjects who progressed while being treated with, or within 60 days of last dose of bortezomib maintenance given once every 2 weeks or less are not excluded. •Subject discontinued prior treatment with bortezomib due to toxicity •Any of the following laboratory abnormalities: —ANC 13.5 mg/dL (> 3.4 mmol/L) —AST or ALT > 2.5 × ULN —Serum total bilirubin > 1.5 × ULN, or for subjects with documented Gilbert’s syndrome > 3.0 mg/dL
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To compare the progression-free survival (PFS) of mezigdomide, bortezomib and dexamethasone (MeziVd) to that of pomalidomide, bortezomib and dexamethasone (PVd) in subjects with relapsed or refractory multiple myeloma (RRMM);Secondary Objective: - In Stage 1, to determine the dose of mezigdomide in combination with bortezomib and dexamethasone to continue in Stage 2 of the study - In Stage 1, to determine the plasma concentrations of mezigdomide in combination with bortezomib and dexamethasone - To compare overall survival (OS) between MeziVd and PVd in subjects with RRMM - To evaluate additional efficacy parameters in subjects with RRMM treated with MeziVd compared to PVd - To evaluate minimal residual disease (MRD) negativity rate in subjects treated with MeziVd compared to those treated with PVd - To evaluate safety of MeziVd compared to PVd in subjects with RRMM - In subjects randomized to Stage 2, to evaluate cancer-related symptoms and healthrelated quality of life (HRQoL) using the European Organization for Research and Treatment of Cancer - Quality of Life C30 questionnaire (EORTC QLQ-C30) and the European Quality of Life Multiple Myeloma Module (EORTC QLQ-MY20) in subjects treated with MeziVd compared to PVd;Primary end point(s): Progression free Survival (PFS) ;Timepoint(s) of evaluation of this end point: 43 months | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1.Recommended mezigdomide dose 2.Pharmacokinetics 3.Overall Survival (OS) 4.Overall Response Rate (OR) 5.Complete Response Rate (CR) or better 6.Very Good Partial Response Rate (VGPR) or better 7.Time to Response (TTR) 8.Duration of Response (DOR) 9.Time to Progression (TTP) 10.Time to Next Treatment (TTNT) 11.Progression-free survival 2 (PFS-2) 12.Minimal residual disease (MRD) negativity 13.Safety 14.Health Related Quality of Life (HRQoL) Evaluation;Timepoint(s) of evaluation of this end point: 1. 12 Months 2. 12 Months 3. 121 Months 4. 43 Months 5. 43 Months 6. 43 Months 7. 43 Months 8. 43 Months 9. 43 Months 10. 43 Months 11. 121 Months 12. 43 Months 13. 43 Months 14. 43 Months | — |
Countries
Argentina, Australia, Austria, Belgium, Brazil, Canada, China, Czechia, Finland, France, Germany, Greece, Ireland, Israel, Italy, Japan, Korea, Republic of, Norway, Poland, Portugal, Romania, Spain, Turkey, United Kingdom, United States
Contacts
Public ContactGSM-CT
Bristol-Myers Squibb International Corporation
Outcome results
None listed