CA057-001

About this trial

To determine the safety and effectiveness of CC-92480 in combination with bortezomib and dexamethasone as compared to pomalidomide in combination with bortezomib and dexamethasone in people who have Multiple Myeloma that is not responsive after treatment or has returned after a period of treatment.

Patient Profile

Inclusion Criteria •Subject has documented diagnosis of MM and measurable disease, defined as: —M-protein ≥ 0.5 g/dL by serum protein electrophoresis (sPEP), or ≥ 200 mg/24-hour urine collection by urine protein electrophoresis (uPEP) or, —For subjects 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 •Subject has received 1 to 3 prior anti-myeloma lines of therapy •Subject must have received prior treatment with a lenalidomide containing regimen •Subject achieved a minimal response [MR] or better to at least 1 prior antimyeloma therapy •Subject must have documented disease progression during or after their last antimyeloma regimen •Subject has an Eastern Cooperative Oncology Group (ECOG) performance status score of 0, 1 or 2.

Where’s this trial being run?

Cork University Hospital, St James’s Hospital, and University Hospital Galway

Can I join this study / trial?

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Questions?

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Questions

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Summary Data

Name:	CA057-001
Number:	CA057-001
Full Title:	A Phase 3, Two-Stage, Randomized, Multicenter, Open-Label Study Comparing CC-92480, Bortezomib And Dexamethasone (480Vd) Versus Pomalidomide, Bortezomib And Dexamethasone (PVd) In Subjects With Relapsed Or Refractory Multiple Myeloma (RRMM)

Principal Investigator:	Prof Patrick Hayden
Type:	Industry Sponsored
Sponsor:	Bristol-Myers Squibb International Corporation
Recruitment Started:	Global: 22-Sep-2022 Ireland:

Global Recruitment Target:	950
Ireland Recruitment Target:	13