CA057-001: Phase 3 Two-Stage Randomized Multi-centre Open-Label Study Comparing 480Vd vs PVd in RRMM
Research type
Research Study
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)
IRAS ID
1005632
Contact name
GSM-CT Representative
Contact email
Sponsor organisation
Celgene Corporation
Eudract number
2021-001957-30
Clinicaltrials.gov Identifier
Research summary
This is a Phase 3 multicentre study of investigational drug CC-92480 in patients ≥18 years with relapsed or refractory multiple myeloma (RRMM). This study will compare treatment regimen CC-92480, Bortezomib and Dexamethasone (480Vd) versus Pomalidomide, Bortezomib and Dexamethasone (PVd). CC-92480 and Pomalidomide are oral medications that work in several ways to help the body’s defence system cause the breakdown of cancer cells. CC-92480 is a new drug not yet approved. Pomalidomide, bortezomib and dexamethasone are approved drugs commonly used in MM treatment. Bortezomib is given by injection beneath the skin and dexamethasone is a steroid taken by mouth or given into a vein.
760 patients will take part in this study world-wide, 20 in the UK. Patients and Doctors will know what treatment they are on.
The study has 2 stages. In stage 1 three different dose levels of CC-92480 will be tested in the 480Vd treatment regimen and will be compared to PVd treatment regimen in 140 patients.
In Stage 2, one of the three dose levels of CC-92480 from stage 1 will be selected for further testing. The 480Vd treatment regimen will be compared to the PVd treatment regimen to further evaluate the safety and see if it is effective in 620 patients.
During the study, patients will have the following procedures: physical exams, body scans (CT/MRI), bone marrow aspirations/biopsies, ECG, vital signs (blood pressure, heart rate and temperature), blood & urine sampling and pregnancy testing. Patients will receive study drug until they withdraw their consent, no longer tolerate the study drug, or their disease worsens. Patients will have a follow-up visit about 28 days from last dose. Long-term follow-up will be every 4 months (in clinic/by phone) for at least 5 years or until death, lost to follow-up, or the end of the trial.REC name
East Midlands - Leicester Central Research Ethics Committee
REC reference
22/EM/0195
Date of REC Opinion
12 Oct 2022
REC opinion
Further Information Favourable Opinion