A Safety, PK and Efficacy Study of CC-92480 Monotherapy and in Combination With Dexamethasone in Subjects With Relapsed and Refractory Multiple Myeloma (RRMM)
A Phase 1/2 Multicenter, Open-label Study to Assess the Safety, Pharmacokinetics and Efficacy of CC-92480 Monotherapy and in Combination With Dexamethasone in Subjects With Relapsed and Refractory Multiple Myeloma
Sponsor: Celgene
No open prediction endpoints
Endpoints are classified and published by ProgramSignal analysts.
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Primary Endpoints (CT.gov)
Adverse Events (AEs)
Time frame: From enrollment until at least 28 days after completion of study treatment
Pharmacokinetics- AUC
Time frame: Up to approximately 28 days
Pharmacokinetics- Cmax
Time frame: Up to approximately 28 days
Pharmacokinetics- Tmax
Time frame: Up to approximately 28 days
Secondary Endpoints
Overall response rate (ORR)
Time to response (TTR)
Duration of response (DOR)
Eligibility Criteria
Inclusion Criteria: 1. Subject is ≥ 18 years of age at the time of signing the informed consent form (ICF). 2. Subject must understand and voluntarily sign an ICF prior to any study-related assessments/procedures being conducted. 3. Subject is willing and able to adhere to the study visit schedule and other protocol requirements. 4. Eastern Cooperative Oncology Group (ECOG) performance status score of 0, 1 or 2. 5. Subjects must have a documented diagnosis of MM and measurable disease at enrollment. Measurable disease is defined as: * M-protein quantities ≥ 0.5 g/dL by sPEP or * ≥ 200 mg/24 hour urine collection by uPEP or * Serum FLC levels \> 100 mg/L (milligrams/liter) involved light chain and an abnormal kappa/lambda (κ/λ) ratio in subjects without measurable serum or urine M-protein or * For subjects with immunoglobulin class A (IgA), myeloma whose disease can only be reliably measured by quantitative immunoglobulin measurement, a serum IgA level ≥ 0.50 g/dL. 6. All …
Read full criteria on CT.gov →✦ Analyst Commentary
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