A Study to Compare the Combinations of Nivolumab, Elotuzumab, Pomalidomide, and Dexamethasone in Patients with Multiple Myeloma

What we are studying

The purpose of this study is to test the effectiveness (how well the drug works), safety, and tolerability of an investigational drug called nivolumab (also known as BMS-936558). Nivolumab is an antibody (a type of human protein) that is being tested to see if it will allow the body’s immune system to work against tumor cells. It has been approved by the FDA for the treatment of metastatic melanoma (a type of skin cancer), and specific types of previously treated advanced lung and kidney cancers. The effectiveness of nivolumab in relapsed or refractory multiple myeloma (rrMM) will be determined by comparing the change in tumor burden and progression free survival of subjects who receive nivolumab combined pomalidomide and dexamethasone compared with those who receive pomalidomide and dexamethasone only. Pomalidomide is an approved treatment for multiple myeloma often given in combination with dexamethasone, a steroid. The combination of pomalidomide and dexamethasone is an accepted standard of care therapy. This study will also examine the tumor burden and progression free survival of subjects given nivolumab combined with elotuzumab, pomalidomide, and dexamethasone. Elotuzumab is a manufactured protein directed against a target found on multiple myeloma cells. It is an approved treatment for multiple myeloma patients whose disease worsens after the initial treatment.

Who is Eligible

  • Genders:
    • Men
    • Women
  • Races:
    • White
    • African American
    • Asian
    • American Indian or Alaska Native
    • Native Hawaiian or Pacific Islander
    • Other
  • All Ethnicities
  • Ages 18+

Eligibility Criteria

  • Must be willing and able to comply to study procedures
  • Must given voluntary written consent
  • Cannot be pregnant or breastfeeding
  • Must have received at least 2 prior treatments
  • Documentation of disease
  • Males cannot donate sperm for up to 180 days after treatment
  • Cannot donate blood up to 90 days after treatment
  • Cannot have active infection
  • Autoimmune disease
  • Leukemia
  • Hepatitis B
  • Hepatits C
  • HIV (human immunodeficiency virus) or AIDS (acquired immunodeficiency virus)

What is involved

  • Physical examination
  • Vital signs
  • Laboratory assessments
  • ECG
  • Bone marrow aspiration/biopsy
  • CT/MRI
  • Study questionnaires

Compensation

The participant will receive $53 for every completed visit. The study participant will be issued a specially designed debit card for clinical research onto which funds will be loaded at the completion of the visit.

Contact Information

Study Coordinator
Jennifer Thomas, MHA, BSN, RN
Email
[email protected]
Phone
-6914
Principal Investigator
Cesar Rodriguez Valdes, MD

Disclaimer: The information on this website is for general informational purposes only and SHOULD NOT be relied upon as a substitute for sound professional medical advice, evaluation or care from your physician or other qualified health care provider.