Bortezomib Plus Prednisone for Initial Therapy of Chronic Graft Versus Host Disease

• Each treatment cycle lasts five weeks, during which time participants will come to the clinic to receive bortezomib intravenously once a week for the first 4 weeks. Prednisone will be taken orally on a daily basis and dose reduction may be initiated after 1 cycle of therapy.
• During all treatment cycles, participants will have the following: physical exam and blood work. At the end of cycle 3 (week 15) the participants cGVHD will be evaluated. These assessments may include an eye examination, a skin examination, a pulmonary function test and/or, a flexion assessment test.
• Participants will receive 3 cycles of bortezomib.

Inclusion criteria

• Recipients of allogeneic stem cell transplantation with myeloablative or non-myeloablative conditioning regimens
• 100 days or more past stem cell transplantation
• Recipients of matched or mismatched, related or unrelated adult donor stem cells
• Must have cGVHD requiring systemic therapy
• No addition or subtraction of other immunosuppressive medications. The dose of immunosuppressive medicines may be adjusted based on the therapeutic range of that drug. However, if cGVHD occurs during a taper of immune suppression, the medication(s) may not be increased back up to therapeutic level, but will continue a the taper dose for the 15 week study duration
• Adequate bone marrow, hepatic and renal function as outlined in the protocol
• Does not require hemodialysis
• 18 years of age or older
• ECOG Performance Status of 0-2 or Karnofsky performance score of 70% or greater
• Life expectancy of more than 3 months

Exclusion criteria

• Systemic steroid therapy in the 4 weeks prior to enrollment
• Active malignant disease after transplantation. Complete resection of basal cell carcinoma or squamous cell carcinoma of the skin, an in situ malignancy, or low-risk prostate cancer after curative therapy will not be considered in this category
• Active uncontrolled infection
• Peripheral neuropathy CTC Grade 1 (or greater) with pain in the 4 weeks before enrollment. Other neurological deficits must be reviewed with the study PI prior to study entry
• Myocardial infarction within 6 months prior to enrollment or has NYHA Class III or IV heart failure, uncontrolled angina, severe uncontrolled ventricular arrhythmias, or electrocardiographic evidence of acute ischemia or active conduction system abnormalities
• Hypersensitivity to bortezomib, boron, or mannitol
• Female subject is pregnant or breast-feeding
• Serious medical or psychiatric illness likely to interfere with participation in this clinical study