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Bortezomib (Velcade) Post Allogenic Peripheral Blood Stem Cell Transplantation for Myeloma
This study is ongoing, but not recruiting participants.
First Received: July 18, 2007   Last Updated: October 23, 2008   History of Changes
Sponsored by: M.D. Anderson Cancer Center
Information provided by: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT00504634
  Purpose

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.


Condition Intervention Phase
Multiple Myeloma
Drug: Bortezomib
Phase II

Study Type: Interventional
Study Design: Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Official Title: A Phase II Trial of Bortezomib (Velcade) After Allogenic Peripheral Blood Stem Cell or Bone Marrow Transplantation for Patients With Multiple Myeloma

Resource links provided by NLM:


Further study details as provided by M.D. Anderson Cancer Center:

Primary Outcome Measures:
  • 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. [ Time Frame: 5 Years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • The safety of this treatment will also be studied. [ Time Frame: 5 Years ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 28
Study Start Date: January 2004
Estimated Primary Completion Date: January 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
1: Experimental
Bortezomib
Drug: Bortezomib
1 mg/m^2 IV On Days 1, 4, 8, and 11.

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

Ages Eligible for Study:   up to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00504634

Locations
United States, Texas
U.T.M.D. Anderson Cancer Center
Houston, Texas, United States, 77030
Sponsors and Collaborators
M.D. Anderson Cancer Center
Investigators
Principal Investigator: Sergio A. Giralt, MD U.T.M.D. Anderson Cancer Center
  More Information

Additional Information:
No publications provided

Responsible Party: U.T.M.D. Anderson Cancer Center ( Sergio A. Giralt, MD/Professor )
Study ID Numbers: 2003-0751
Study First Received: July 18, 2007
Last Updated: October 23, 2008
ClinicalTrials.gov Identifier: NCT00504634     History of Changes
Health Authority: United States: Institutional Review Board

Keywords provided by M.D. Anderson Cancer Center:
Multiple Myeloma
Post Allogeneic Transplantation
Bortezomib
Velcade
PS-341

Study placed in the following topic categories:
Immunoproliferative Disorders
Blood Protein Disorders
Hematologic Diseases
Blood Coagulation Disorders
Bortezomib
Vascular Diseases
Paraproteinemias
Hemostatic Disorders
Multiple Myeloma
Protease Inhibitors
Hemorrhagic Disorders
Lymphoproliferative Disorders
Neoplasms, Plasma Cell

Additional relevant MeSH terms:
Neoplasms by Histologic Type
Immunoproliferative Disorders
Molecular Mechanisms of Pharmacological Action
Immune System Diseases
Antineoplastic Agents
Blood Protein Disorders
Hematologic Diseases
Bortezomib
Vascular Diseases
Enzyme Inhibitors
Paraproteinemias
Hemostatic Disorders
Pharmacologic Actions
Protease Inhibitors
Multiple Myeloma
Neoplasms
Hemorrhagic Disorders
Therapeutic Uses
Cardiovascular Diseases
Lymphoproliferative Disorders
Neoplasms, Plasma Cell

ClinicalTrials.gov processed this record on September 11, 2009