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NCT03374085PHASE1, PHASE2TERMINATED

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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Key Facts

Study type
INTERVENTIONAL
Conditions
Multiple Myeloma
Interventions
CC-92480, Dexamethasone
Enrollment
200 participants
Primary completion
Aug 2025
Study completion
Oct 2025
First posted
Dec 2017
Last updated
Feb 2026

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

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✦ Analyst Commentary

Expert commentary on why this trial matters and what to watch for.

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Source

Open on ClinicalTrials.gov