Relapsed or Refractory Multiple Myeloma
Conditions
Keywords
Multiple myeloma, RRMM, MeziVd, PVd, CC92480, pomalidomide, bortezomib, dexamethasone, mezigdomide
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.
Interventions
DRUGmezigdomide
Specified dose on specified days
DRUGPomalidomide
Specified dose on specified days
DRUGBortezomib
Specified dose on specified days
DRUGDexamethasone
Specified dose on specified days
Sponsors
Celgene
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
\- Participant has documented diagnosis of MM and measurable disease, defined as any of the following:. i) M-protein ≥ 0.5 grams per deciliter (g/dL) by serum protein electrophoresis (sPEP) or. ii) M-protein ≥ 200 milligrams (mg) per 24-hour urine collection by urine protein electrophoresis (uPEP). iii) 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, except as noted below:. i) Subjects who progressed while being treated with, or within 60 days of last dose of bortezomib maintenance given once every 2 weeks (or less frequently) are not excluded. ii) Participants who progressed while being treated with ixazomib monotherapy maintenance ≥ 6 months prior to the time of starting study treatment are not excluded. * 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 mezigdomide or pomalidomide. * Other protocol-defined Inclusion/
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
Argentina, Australia, Austria, Belgium, Brazil, Canada, Chile, China, Czechia, Finland, France, Germany, Greece, India, Ireland, Israel, Italy, Japan, New Zealand, Poland, Portugal, Puerto Rico, Romania, South Africa, South Korea, Spain, Turkey (Türkiye), United Kingdom, United States
Contacts
CONTACTBMS Clinical Trials Contact Center www.BMSClinicalTrials.com
CONTACTFirst line of the email MUST contain NCT # and Site #.
STUDY_DIRECTORBristol-Myers Squibb
Bristol-Myers Squibb
Outcome results
None listed