mezigdomide
DrugSpecified dose on specified days
Other names: BMS-986348, CC-92480
NCT Number: NCT05552976
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.
This study is active but is not currently recruiting participants.
Notify Me18 year and older
All sexes
Interventional
Phase 3
Local Institution - 0008, Ciudad Autónoma de Buenos Aires, Buenos Aires, Argentina
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
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.
Exclusion criteria
Specified dose on specified days
Other names: BMS-986348, CC-92480
Specified dose on specified days
Other names: Kyprolis
Specified dose on specified days
Other names: Decadron, Dex
Time frame: Up to approximately 5 years
Time frame: Up to 12 months
Stage 1 only
Time frame: Up to 176 days
Stage 1 only
Time frame: Up to approximately 5 years
Time frame: Up to approximately 5 years
Time frame: Up to approximately 5 years
VGPRR will be calculated as the percentage of participants who achieve best response of VGPR or better according to the International Myeloma Working Group (IMWG) Uniform Response Criteria for Multiple Myeloma.
Time frame: Up to approximately 5 years
CRR will be calculated as the percentage of participants who achieve best response of CR or better according to the IMWG Uniform Response Criteria for Multiple Myeloma.
Time frame: Up to approximately 5 years
Time frame: Up to approximately 5 years
Time frame: Up to approximately 5 years
Time frame: Up to approximately 5 years
Time frame: Up to approximately 5 years
Time frame: Up to approximately 5 years
Time frame: Up to approximately 5 years
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.
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.
Bristol-Myers Squibb
Industry
A Phase 3, Two-stage, Randomized, Multicenter, Open-label Study Comparing Mezigdomide (CC-92480/BMS-986348), Carfilzomib, and Dexamethasone (MeziKD) Versus Carfilzomib and Dexamethasone (Kd) in Participants With Relapsed or Refractory Multiple Myeloma (RRMM): SUCCESSOR-2
Acronym: SUCCESSOR-2
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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