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Active (not recruiting) Phase 3 NCT05552976

A Study to Evaluate Mezigdomide in Combination With Carfilzomib and Dexamethasone (MeziKD) Versus Carfilzomib and Dexamethasone (Kd) in Participants With Relapsed or Refractory Multiple Myeloma (SUCCESSOR-2)

Phase 3 – large-scale trial before approval
Conditions: Relapsed or Refractory Multiple Myeloma

Sponsor: Bristol-Myers Squibb

trial.available_in: БГ
Overview
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.
Who can participate
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/Exclusion criteria apply.
Locations 25
Argentina (1)
Local Institution - 0008
Ciudad Autónoma de Buenos Aires , Buenos Aires
Australia (1)
Local Institution - 0077
Camperdown , New South Wales
Brazil (1)
Local Institution - 0121
Salvador , Estado de Bahia
Bulgaria (1)
Local Institution - 0305
Plovdiv
Canada (1)
Local Institution - 0183
Halifax , Nova Scotia
China (1)
Local Institution - 0318
Hefei , Anhui
Colombia (1)
Local Institution - 0153
Medellín , Antioquia
Denmark (1)
Local Institution - 0032
Aarhus , Central Jutland
Greece (1)
Local Institution - 0136
Pátrai , Achaḯa
Hong Kong (1)
Local Institution - 0178
Hksar
Hungary (1)
Local Institution - 0036
Pécs , Baranya
India (1)
Local Institution - 0167
Gurgaon , Haryana
Israel (1)
Local Institution - 0264
Holon , Central District
Italy (1)
Local Institution - 0145
Meldola , Emilia-Romagna
Japan (1)
Local Institution - 0269
Nagoya , Aichi-ken
Netherlands (1)
Local Institution - 0113
Breda , North Brabant
Norway (1)
Local Institution - 0049
Bergen , Hordaland
Puerto Rico (1)
Local Institution - 0316
San Juan
Romania (1)
Local Institution - 0282
Bucharest , Bucharest
Singapore (1)
Local Institution - 0158
Singapore , Central Singapore
South Korea (1)
Local Institution - 0238
Seoul , Seoul-teukbyeolsi [Seoul]
Spain (1)
Local Institution - 0126
Badalona , Barcelona [Barcelona]
Taiwan (1)
Local Institution - 0274
Chiayi City , Chiayi
United Kingdom (1)
Local Institution - 0139
Plymouth , Devon
United States (1)
Local Institution - 0046
Mobile , Alabama
Technical details
Status
Active (not recruiting)
Phase
Phase 3
Study type
INTERVENTIONAL
Sex
Male and female
Minimum age
18 Years
Healthy volunteers
No
Start date
10.01.2023
Completion date
25.07.2029
Registry ID
NCT05552976
Source
anzctr
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Information is automatically extracted from ClinicalTrials.gov. Consult your doctor before taking action.