Celgene_CA057-001 CC92480 (Multiple Myeloma)

Purpose of this Study

We are doing this study to find out if an experimental drug called CC-92480 (the study drug) is a safe and effective treatment for multiple myeloma. We also want to figure out the most appropriate dose and schedule for giving the study drug to multiple myeloma patients.

Who Can Participate?

Eligibility

Adults ages 18+ who:
  • Have multiple myeloma that is not responding to therapy; OR
  • Have multiple myeloma that has come back after previous therapy
For more information about who can join this study, please contact the study team 919-668-0613.

What is Involved?

Description

This study has three periods: a screening period, the study drug period, and a follow-up period. If you choose to join this study, during the screening period you will:
  • Have a physical exam
  • Have blood draws
  • Give urine samples
  • Have imaging tests (X-Ray, MRI/CT/PET scans)
  • Have a bone marrow biopsy
If you are eligible to join the study, you will take the study drug as directed by the study doctor. You will continue taking the study drug for as long as you and the study doctor believe that you are benefitting from it. After you stop taking the study drug, we will keep in touch with you to see how you are doing.

Study Details

Full Title

Celgene: CA057-001 - 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

Cristina
Gasparetto

Protocol Number

PRO00112328

NCT ID

NCT05519085

Phase

III

Enrollment Status

Open to Enrollment
ClinicalTrials.gov