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A Phase II Trial of Bortezomib (Velcade) Plus Prednisone for Initial Therapy of Chronic Graft Versus Host Disease

Phase 2
18 Years
Not Enrolling
Chronic Graft Versus Host Disease

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Trial Information

A Phase II Trial of Bortezomib (Velcade) 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

- 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

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

To determine the overall response rate after a 15 week course of bortezomib plus prednisone in patients with cGVHD

Outcome Time Frame:

2 years

Safety Issue:


Principal Investigator

John Koreth, MBBS, DPhil

Investigator Role:

Principal Investigator

Investigator Affiliation:

Dana-Farber Cancer Institute


United States: Institutional Review Board

Study ID:




Start Date:

December 2008

Completion Date:

January 2013

Related Keywords:

  • Chronic Graft Versus Host Disease
  • cGVHD
  • Velcade
  • bortezomib
  • Graft vs Host Disease



Dana-Farber Cancer Institute Boston, Massachusetts  02115