Leukemia Clinical Trial
Official title:
Phase II Study of Subcutaneous Bortezomib for Patients With Low or Intermediate-1 Risk Myelodysplastic Syndrome
The goal of this clinical research study is to learn if bortezomib can help to control MDS.
The safety of this drug will also be studied.
Bortezomib is designed to block a protein that causes cells to grow. This may cause cancer
cells to die.
Study Drug Administration:
If you are found to be eligible to take part in this study, you will receive bortezomib as an
injection under the skin on Days 1, 4, 8, and 11 of each 21-day cycle.
Study Visits:
At each visit, you will be asked about any drugs you may be taking and any side effects you
may be having.
One (1) time a week during Cycle 1, blood (about 2 tablespoons) will be drawn for routine
tests.
On Day 21 of Cycles 1 and 3, you will have a bone marrow aspiration and/or biopsy to check
the status of the disease and for cytogenetic testing.
On Day 1 of Cycles 2 and beyond, blood (about 2 tablespoons) will be drawn for routine tests.
If your doctor thinks it is needed, you may have additional bone aspirations and/or biopsies
to check the status of the disease and/or for cytogenetic testing.
Length of Treatment:
You may continue taking the study drug for as long as the doctor thinks it is in your best
interest. You will no longer be able to take the study drug if the disease gets worse, if
intolerable side effects occur, if you are able to have an allogeneic stem cell transplant (a
stem cell transplant from a donor), or if you are unable to follow study directions.
Your participation on the study will be over once you have completed the end-of- treatment
visit.
End-of-Treatment Visit:
At 30 days after your last dose of study drug:
- You will be asked about any drugs you may be taking and any side effects you may have
had.
- Blood (about 2 tablespoons) will be drawn for routine tests.
- If your doctor thinks it is needed, you will have a bone marrow aspirate and/or biopsy
to check the status of the disease and for cytogenetic testing.
This is an investigational study. Bortezomib is FDA approved and commercially available to
treat multiple myeloma and mantle cell lymphoma. Giving it to patients with MDS is
investigational.
Up to 40 participants will be enrolled in this study. All will take part at MD Anderson.
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