Testing a disease specific treatment with ixazomib, lenalidomide, dexamethasone, and zoledronic acid versus zoledronic acid after radiation therapy in people with a plasma cell disorder known as solitary plasmacytoma of bone.

What we are studying

The purpose of this study is to compare any good and bad effects of using a combination of lenalidomide, ixazomib, dexamethasone and zoledronic acid along with the radiation therapy to using radiation therapy and zoledronic acid alone. The addition of lenalidomide, ixazomib, dexamethasone and zoledronic acid to the usual radiation could prevent it from returning but it could also cause side effects. This study will allow the researchers to know whether this different approach is better, the same, or worse than the usual approach. The cancer drugs lenalidomide, dexamethasone, and zoledronic acid are approved by the FDA for use in multiple myeloma but not for this disease. Ixazomib is not FDA approved and is experimental.

Who we are studying

  • Men and Women
  • Races:
    • White
    • African American
    • Asian
    • American Indian or Alaska Native
    • Native Hawaiian or Pacific Islander
    • Other
  • All Ethnicities
  • Ages 18 - 80

Eligibility Criteria

  • Subjects should be post radiation therapy documentation of a bone marrow aspirate and biopsy

What is involved

  • Study participants will be randomized to Group 1- ixazomib; lenalidomide; dexamethasone; and zoledronic acid or
  • Group 2 - zoledronic acid.
  • Study participants will be asked to keep a medication diary.
  • Study participants will receive treatment for 6 months.

Compensation

Parking will be validated for all study related visits.

Contact Information

Study Coordinator
Scarlett Hutchins
Email
snhutche@wakehealth.edu
Phone
336-713-6915

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.