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A Phase II Trial of Bortezomib (Velcade) After Allogenic Peripheral Blood Stem Cell or Bone Marrow Transplantation for Patients With Multiple Myeloma


Phase 2
N/A
70 Years
Not Enrolling
Both
Multiple Myeloma

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Trial Information

A Phase II Trial of Bortezomib (Velcade) After Allogenic Peripheral Blood Stem Cell or Bone Marrow Transplantation for Patients With Multiple Myeloma


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bone marrow is withdrawn through a large needle.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.


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 Points Scale (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 Central Nervous System (CNS) disease.

- Uncontrolled acute or chronic Graft-versus-host disease (GVHD).

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Number of Participants with Complete Response (CR)

Outcome Description:

Response rate (CR), evaluated within 6 weeks of beginning treatment, assessed using The European Group for Blood and Bone Marrow Transplant/International Bone Marrow Transplant Registry (EBMT/IBMTR) response criteria of Complete Response (CR), Minimal Response (MR), No Change (NC), or Progressive Disease (PD).

Outcome Time Frame:

6 weeks from beginning treatment

Safety Issue:

No

Principal Investigator

Sergio A. Giralt, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

M.D. Anderson Cancer Center

Authority:

United States: Institutional Review Board

Study ID:

2003-0751

NCT ID:

NCT00504634

Start Date:

January 2004

Completion Date:

May 2010

Related Keywords:

  • Multiple Myeloma
  • Multiple Myeloma
  • Post Allogeneic Transplantation
  • Bortezomib
  • Velcade
  • PS-341
  • Multiple Myeloma
  • Neoplasms, Plasma Cell

Name

Location
UT MD Anderson Cancer Center Houston, Texas  77030