B-Cell Targeted Carfilzomib Desensitization

Conditions

• Transplants and Implants

Eligibility Criteria

Sex

ALL

Age

18 Years - 65 Years

Healthy Volunteers

Not accepted

Interventions

• Carfilzomib — DRUG
  Carfilzomib will be administered for desensitization per study protocol.
• Rituximab — DRUG
  Rituximab will be administered for desensitization per study protocol.

Study Details

The primary purpose of this study is to provide a preliminary evaluation of the safety and potential efficacy of carfilzomib in reducing HLA antibody levels in highly sensitized kidney transplant candidates.

Key Dates

Start date

Dec 31, 2014

Status verified

Jun 2020

Primary completion

Jun 30, 2021

Completion

Sep 30, 2021

Study Design

Enrollment

32 participants (estimated)

Allocation

NON_RANDOMIZED

Intervention model

SEQUENTIAL

Primary purpose

TREATMENT

Arms

• Experimental: Group A (5-8 patients) - Carfilzomib
  Two cycles of carfilzomib desensitization given.
• Experimental: Group B (5-8 patients) - Carfilzomib/plasmapheresis
  Two cycles of carfilzomib desensitization given with weekly plasmapheresis prior to carfilzomib therapy
• Experimental: Group C (5-8 patients) - Rituximab/Carfilzomib/plasmapheresis
  1 dose of rituximab prior to two cycles of carfilzomib desensitization given with weekly plasmapheresis prior to carfilzomib therapy
• Experimental: Group D (5-8 patients) - Rituximab/Carfilzomib/plasmapheresis
  1 dose of rituximab prior to three cycles of carfilzomib desensitization given with weekly plasmapheresis prior to carfilzomib therapy

Primary Outcome Measure

Safety of carfilzomib will be assessed by incidence of grade 3 and above non-hematologic toxicities, incidence of grade 4 hematologic toxicities and incidence of all grades of peripheral neuropathy [ Time Frame: 6 months ]

Central Contacts

• E. Steve Woodle, MD
  513-558-6001
  [email protected]

Locations (2)

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