Bortezomib (Velcade) Post Allogenic Peripheral Blood Stem Cell Transplantation for Myeloma
Information source: M.D. Anderson Cancer Center
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Multiple Myeloma
Intervention: Bortezomib (Drug)
Phase: Phase 2
Status: Active, not recruiting
Sponsored by: M.D. Anderson Cancer Center Official(s) and/or principal investigator(s):
Sergio A. Giralt, MD, Principal Investigator, Affiliation: U.T.M.D. Anderson Cancer Center
Summary
Primary Objective:
1. To determine the antimyeloma effect of bortezomib after allogeneic transplantation for
patients with multiple myeloma.
Secondary Objective
1. To determine the toxicity profile of bortezomib in patients with multiple myeloma
undergoing allogeneic progenitor cell transplantation.
Clinical Details
Official title: A Phase II Trial of Bortezomib (Velcade) After Allogenic Peripheral Blood Stem Cell or Bone Marrow Transplantation for Patients With Multiple Myeloma
Study design: Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Primary outcome: To learn if Bortezomib (Velcade) can help to control the disease in patients who have received a stem cell transplant from a related or unrelated donor and whose disease has either not gone into complete remission or whose disease has come back.
Secondary outcome: The safety of this treatment will also be studied.
Detailed description:
Bortezomib (velcade) is a new drug that works by blocking a structure in the cells called
proteasome. This proteasome acts like a system that eliminates abnormal or old proteins from
the cells. Cancer cells may be sensitive to drugs like bortezomib (velcade), because tumor
cells have more abnormal proteins than normal cells. Bortezomib (velcade) enters the tumor
cells and affects the way they divide. When cancer cells cannot divide, they die.
You will have blood (about 2 tablespoons) and bone marrow testing done about every 2-3 months
to determine your response and tolerance to treatment. To collect a bone marrow sample, an
area of the hip or chest bone is numbed with anesthetic and a small amount of bone marrow is
withdrawn through a large needle.
You will receive bortezomib (velcade) as an infusion into a vein over 5-10 minutes twice a
week for 2 weeks. You will then rest for 10 to 17 days. This 21-28 day period makes up 1
cycle. You will complete up to a total of 4 cycles. Courses 2 and 3 might be given under
supervision of your local physician however the principal investigator will do necessary
treatment dose adjustments and new set of treatment orders will be provided to your
physician. Treatment evaluations will be under the supervision of the principal
investigator.
You will have a physical exam and routine blood tests (about 2 tablespoons) before each dose
of bortezomib (velcade). Blood (about 2 tablespoons) and urine tests to determine response to
treatment will be performed once a month, as well as blood tests to look at side effects of
treatment will be performed at least once a week and more frequently if medically necessary.
You will be taken off study if the disease gets worse or intolerable side effects occur. You
will be called every 3 months for at least 1 year after the last dose of bortezomib (velcade)
to see how you are doing.
This is an investigational study. Bortezomib (velcade) is commercially available and
indicated for the treatment of myeloma. A total of 28 patients will participate in this
study. All will be enrolled at M. D. Anderson.
Eligibility
Minimum age: N/A.
Maximum age: 70 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Patients with Multiple Myeloma at least 3 months post allogeneic transplant who either
failed to achieve a complete remission or are relapsing.
- Allograft performed from a related donor who is HLA-compatible (5/6 or 6/6), or class
I serologic match and class II molecular matched unrelated donor).
- Zubrod PS<2, life expectancy is not severely limited by concomitant illness.
- Patient willing and able to sign informed consent.
- Patients less than 70 years of age.
Exclusion Criteria:
- Active CNS disease.
- Uncontrolled acute or chronic GVHD.
Locations and Contacts
U.T.M.D. Anderson Cancer Center, Houston, Texas 77030, United States
Additional Information
Starting date: January 2004
Last updated: June 6, 2008
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