AbbVie: Ph 1b Open of Eftozanermin Alfa (Relapsed/Refractory Multiple Myeloma) - Clinical Trial

What is the Purpose of this Study?

We are doing this study to find out if an experimental drug called eftozanermin alfa (the study drug) is a safe and effective treatment for multiple myeloma. We want to know if combining the study drug with two drugs approved for cancer treatment, dexamethasone and bortezomib, can be a potential treatment option for people with multiple myeloma.

What is the Condition Being Studied?

Relapsed or Refractory Multiple Myeloma

Who Can Participate in the Study?

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.

Age Group
Adults

What is Involved?

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

You will proceed to the study drug period if you are eligible after screening. During this period, you will receive up to 12 treatment cycles of the study drug + bortezomib and dexamethasone. Cycles 1-8 will last for 21 days, and cycles 9-12 will last for 35 days.

During cycles 1-8, you will:
- Get the study drug as an infusion (IV) on Days 1 & 8 of each cycle
- Get bortezomib as an infusion or injection (shot under the skin) on Days 1, 4, 8, & 11 of each cycle
- Take dexamethasone by mouth on Days 1, 2, 4, 5, 8, 9, 11, and 12 of each cycle

During cycles 9-12, you will:
- Get the study drug on Days 1, 8, 15, & 22 of each cycle
- Get bortezomib on Days 1 & 22 of each cycle
- Take dexamethasone on Days 15, 16, 22, & 23 of each cycle

When the study drug period ends, you will come back to our clinic a few more times for check-ups.

Study Details

Full Title
A Phase 1b, Open-Label of Eftozanermin Alfa (ABBV-621) in combination with Bortezomib and Dexamethasone in Subjects with Relapsed or Refractory Multiple Myeloma
Principal Investigator
Cellular Therapy Specialist
Protocol Number
IRB: PRO00106199
NCT: NCT04570631
Phase
Phase I
ClinicalTrials.gov
Enrollment Status
Open for Enrollment
Participate
Contact the Duke Recruitment Innovation Center
MyResearchPartners@duke.edu
or
919-681-5698