Phase 1b/2, Multicenter, Open-label Study of Oprozomib and Dexamethasone in Patients With Relapsed and/or Refractory Multiple Myeloma
Interventional
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Determine the MTD (Phase 1b)
Phase 1b- Determine the Maximum Tolerated Dose (MTD) of oprozomib given orally, once daily, on 2 different schedules: 5 consecutive days every 14 days (bimonthly) or 2 consecutive days every 7 days (weekly) for a 14-day treatment cycle, both schedules given in combination with dexamethasone
6 weeks to 18 months
Yes
United States: Food and Drug Administration
2012-001
NCT01832727
May 2013
December 2015
Name | Location |
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Center for Cancer and Blood Disorders | Bethesda, Maryland 20817 |