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IIT: PhIb/II ABC294640 in R/R Multiple Myeloma - Clinical Trial

What is the Purpose of this Study?

We are doing this study to learn about any side effects and to figure out the dosage of the study drug, ABC294640 (Yeliva).

What is the Condition Being Studied?

Refractory or Relapsed Multiple Myeloma

Who Can Participate in the Study?

Adults with symptomatic multiple myeloma (MM) that is relapsed or refractory and who:
- Have been previously treated with a proteasome inhibitor
- Have been previously treated with an immmunomodulatory drug
- Have measurable disease
- Have received other treatment more than 2-4 weeks prior
- Have acceptable liver function
- Have sufficient blood cell numbers

Age Group
Adults

What is Involved?

If you choose to join the study, you will:
- Have a screening visit that will include questions, physical examination, blood work, urinalysis, bone marrow biopsy and aspirate (within 2 weeks of starting study drug), bone skeletal survey
- Once your eligibility is confirmed, you will take Yeliva by mouth twice daily with or without a light meal. Your study doctor will tell you what dose of Yeliva you will get.
- You will come back to the clinic weekly for the first cycle (each cycle is 28 days) and every other week for following cycles to:
-- Receive study drug
-- Have a physical examination
-- Answer questions about your medications and how you are doing
-- Have blood work
-- Review your patient diary and pill count
-- Have urinalysis and other tests (only at some visits)
-- Answer questions about any adverse events you may be experienciing
-- Follow up at end of treatment
-- Bone marrow biopsy at the beginning of cycle 4

Study Details

Full Title
A Phase Ib/II Safety and Efficacy Study of ABC294640 in Patients with Refractory or Relapsed Multiple Myeloma Who Have Previously Been Treated with Proteasome Inhibitors and Immunomodulatory Drugs.
Principal Investigator
Cell Therapy and Hematologic Malignancies Specialist
Protocol Number
IRB:PRO00062304
NCT:NCT02757326
Phase
Phase I/II
ClinicalTrials.gov
Contact the Duke Recruitment Innovation Center
studyrecruitment@duke.edu
or
919-681-5698