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Protocol No.A061402
StatusOPEN TO ACCRUAL
Principal InvestigatorAbonour, Rafat
ScopeNational
PhasePhase III
Age GroupAdult
TitleSOLITARY PLASMACYTOMA OF BONE: RANDOMIZED PHASE III TRIAL TO EVALUATE TREATMENT WITH ADJUVANT SYSTEMIC TREATMENT AND ZOLEDRONIC ACID VERSUS ZOLEDRONIC ACID AFTER DEFINITE RADIATION THERAPY
DescriptionThis randomized phase III trial compares ixazomib citrate, lenalidomide, dexamethasone and zoledronic acid with zoledronic acid alone to see how well they work when given after radiation therapy in treating patients with solitary plasmacytoma of bone. Ixazomib citrate may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Lenalidomide may help the immune system kill abnormal blood cells or cancer cells. Dexamethasone is a drug used in chemotherapy that may cause tumor cells to die. Zoledronic acid may prevent bone fractures and reduce bone pain, and may also improve survival. Standard treatment for this cancer is radiation therapy alone. It is not yet known whether ixazomib citrate, lenalidomide, dexamethasone and zoledronic acid or zoledronic acid alone is more effective, and whether adding these treatments after radiation therapy is more effective than radiation therapy alone in treating patients with solitary plasmacytoma of bone.
Key EligibilityIn order to be eligible to take part in this trial, patients must meet the following criteria:

  • Histologic Documentation of Solitary Bone Plasmacytoma
  • Concomitant Treatment: Patients cannot be on systemic treatment with strong inhibitors of CYP1A2 (fluvoxamine, enoxacin), strong inhibitors of CYP3A (clarithromycin, telithromycin, itraconazole, voriconazole, ketoconazole, nefazodone) or strong CYP3A inducers (rifampin, rifapentine, rifabutin, carbamazepine, phenytoin, phenobarbital) within 14 days of registration.
For a full list of participation criteria, please visit ClinicalTrials.gov.
Applicable Disease SitesMultiple Myeloma
Participating InstitutionsIndiana University (IU)
  • Indiana University Hospital / IU Simon Cancer Center
  • Spring Mill Medical Center
Treatment TypeTreatment
ContactPhone: (317) 278-5632
Email: iutrials@iu.edu