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Adjuvant Bortezomib Maintenance Therapy After Autologous Peripheral Stem Cell Transplantation in Treating Patients With Intermediate or Advanced Multiple Myeloma
This study is currently recruiting participants.
Verified by National Cancer Institute (NCI), January 2009
Sponsors and Collaborators: Jonsson Comprehensive Cancer Center
National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00084747
  Purpose

RATIONALE: Bortezomib may stop the growth of cancer cells by blocking the enzymes necessary for their growth. Giving bortezomib as maintenance therapy after autologous stem cell transplantation may kill more cancer cells and prolong remission.

PURPOSE: This phase I/II trial is studying the side effects and best dose of adjuvant bortezomib as maintenance therapy and to see how well it works in treating patients who have undergone stem cell transplantation for intermediate or advanced multiple myeloma.


Condition Intervention Phase
Multiple Myeloma and Plasma Cell Neoplasm
Drug: bortezomib
Procedure: adjuvant therapy
Phase I
Phase II

Genetics Home Reference related topics: aceruloplasminemia hemophilia
MedlinePlus related topics: Cancer Multiple Myeloma
Drug Information available for: Bortezomib
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment
Official Title: Phase I/II Trial of Autologous Peripheral Blood Progenitor Cell Transplantation With VELCADE Maintenance as Treatment for Intermediate- and Advanced-Stage Multiple Myeloma

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Progression-free and overall survival [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Disease progression rate [ Designated as safety issue: No ]
  • Mortality rate [ Designated as safety issue: No ]

Estimated Enrollment: 30
Study Start Date: February 2004
Detailed Description:

OBJECTIVES:

  • Determine response rate, as defined by resolution of bone marrow plasmacytosis and monoclonal paraproteinemia, in the first year after autologous peripheral blood stem cell transplantation in patients with intermediate or advanced multiple myeloma treated with adjuvant bortezomib.
  • Compare progression-free survival of patients treated with adjuvant bortezomib with historical controls treated with autologous transplantation alone.
  • Determine the toxicity of this drug in these patients (phase I).

OUTLINE: This is a multicenter, dose-escalation study.

Patients receive bortezomib IV on days 1, 8, and 15. Treatment repeats every 28 days for 8 courses in the absence of disease progression or unacceptable toxicity.

Cohorts of 3-6 patients receive escalating doses of bortezomib until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity.

Patients are followed every 3 months.

PROJECTED ACCRUAL: A total of 3-30 patients will be accrued for this study within 2 years.

  Eligibility

Ages Eligible for Study:   18 Years to 69 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • Diagnosis of intermediate or advanced multiple myeloma meeting criteria for at least 1 of the following:

    • Intermediate- to high-M-component production rates (immunoglobulin [Ig]G > 5 g/dL or IgA > 3 g/dL or urine M component > 4 g/24 hours)
    • More than one osteolytic bone lesion or radiographic evidence of diffuse osteoporosis
    • β-2 microglobulin > 3
    • Nonsecretory myeloma if bone marrow plasmacytosis is greater than 30%
  • Must have undergone autologous peripheral blood stem cell transplantation within the past 3-4 months

PATIENT CHARACTERISTICS:

Age

  • 18 to 69

Performance status

  • Not specified

Life expectancy

  • Not specified

Hematopoietic

  • Absolute neutrophil count ≥ 1,000/mm^3
  • Platelet count ≥ 30,000/mm^3

Hepatic

  • SGOT or SGPT ≤ 300 IU
  • Bilirubin ≤ 2 mg/dL

Renal

  • Creatinine ≤ 2.0 mg/dL OR
  • Creatinine clearance ≥ 30 mL/min

Cardiovascular

  • No concurrent major cardiac disease that would preclude study participation

Pulmonary

  • No concurrent major pulmonary disease that would preclude study participation

Other

  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception
  • No peripheral neuropathy ≥ grade 2
  • No history of hypersensitivity to bortezomib, boron, or mannitol
  • No concurrent major gastrointestinal or bladder disease that would preclude study participation
  • No concurrent major neurologic or psychiatric disease that would preclude study participation
  • No dementia or significantly altered mental status that would preclude giving informed consent

PRIOR CONCURRENT THERAPY:

Biologic therapy

  • See Disease Characteristics
  • No prior interferon post-transplantation
  • No prior thalidomide post-transplantation

Chemotherapy

  • No prior chemotherapy post-transplantation

Endocrine therapy

  • Not specified

Radiotherapy

  • No prior radiotherapy post-transplantation

Surgery

  • Not specified

Other

  • No prior investigational therapy post-transplantation
  • No prior bortezomib
  • No prior therapy for myeloma post-transplantation
  • No other concurrent anti-myeloma therapy
  • No other concurrent investigational therapy
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00084747

Locations
United States, California
Jonsson Comprehensive Cancer Center at UCLA Recruiting
Los Angeles, California, United States, 90095-1781
Contact: Clinical Trials Office - Jonsson Comprehensive Cancer Center a     888-798-0719        
Sponsors and Collaborators
Jonsson Comprehensive Cancer Center
Investigators
Principal Investigator: Gary J. Schiller, MD Jonsson Comprehensive Cancer Center
  More Information

Clinical trial summary from the National Cancer Institute's PDQ® database  This link exits the ClinicalTrials.gov site

Publications of Results:
Schiller GJ, Sohn JP, Malone P, et al.: Phase I/II trial of bortezomib maintenance following autologous peripheral blood progenitor cell transplantation as treatment for intermediate- and advanced-stage multiple myeloma. [Abstract] Biol Blood Marrow Transplant 13 (2 Suppl 1): A-153, 57, 2007.

Responsible Party: Jonsson Comprehensive Cancer Center at UCLA ( Gary John Schiller )
Study ID Numbers: CDR0000365583, UCLA-0306106, MILLENNIUM-MM2003
Study First Received: June 10, 2004
Last Updated: January 9, 2009
ClinicalTrials.gov Identifier: NCT00084747  
Health Authority: Unspecified

Keywords provided by National Cancer Institute (NCI):
stage II multiple myeloma
stage III multiple myeloma

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
Hemorrhagic Disorders
Multiple myeloma
Lymphoproliferative Disorders
Neoplasms, Plasma Cell

Additional relevant MeSH terms:
Neoplasms
Neoplasms by Histologic Type
Molecular Mechanisms of Pharmacological Action
Immune System Diseases
Antineoplastic Agents
Therapeutic Uses
Enzyme Inhibitors
Cardiovascular Diseases
Pharmacologic Actions
Protease Inhibitors

ClinicalTrials.gov processed this record on January 16, 2009