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Bortezomib in Treating Patients With Newly Diagnosed High-Risk Stage III Multiple Myeloma
The recruitment status of this study is unknown because the information has not been verified recently.
Verified November 2005 by National Cancer Institute (NCI).   Recruitment status was  Active, not recruiting

First Received on January 9, 2004.   Last Updated on July 23, 2008   History of Changes
Sponsor: Eastern Cooperative Oncology Group
Collaborator: National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00075881
  Purpose

RATIONALE: Bortezomib may stop the growth of cancer cells by blocking the enzymes necessary for their growth.

PURPOSE: This phase II trial is studying how well bortezomib works in treating patients with newly diagnosed high-risk stage III multiple myeloma.


Condition Intervention Phase
Multiple Myeloma and Plasma Cell Neoplasm
Drug: bortezomib
Phase II

Study Type: Interventional
Study Design: Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase II Study Of PS-341 For Patients With High-Risk, Newly Diagnosed Multiple Myeloma

Resource links provided by NLM:


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

Study Start Date: January 2004
Detailed Description:

OBJECTIVES:

Primary

  • Determine the response rate in patients with newly diagnosed high-risk stage III multiple myeloma treated with bortezomib induction therapy.

Secondary

  • Determine the progression-free survival of patients treated with this drug.
  • Determine the response rate and duration of second response in patients who relapse or progress while on maintenance therapy and subsequently receive reinduction therapy with this drug.

OUTLINE: This is a multicenter study.

  • Induction therapy: Patients receive bortezomib IV over 3-5 seconds on days 1, 4, 8, and 11. Treatment repeats every 3 weeks for 8 courses in the absence of disease progression or unacceptable toxicity. Patients who experience disease progression must complete at least 2 courses of induction therapy. Patients who achieve complete remission receive 2 additional courses, but no more than 8 courses total, and then proceed to maintenance therapy.
  • Maintenance therapy: Patients receive bortezomib IV over 3-5 seconds on days 1 and 15. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity. Patients who experience disease progression may return to induction therapy (reinduction therapy).
  • Reinduction therapy: Patients receive bortezomib as in induction therapy. Courses repeat every 3 weeks until second disease progression or unacceptable toxicity.

Patients are followed every 3 months for 2 years and then every 6 months for 4 years from study entry.

PROJECTED ACCRUAL: A total of 44 patients will be accrued for this study within 7 months.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • Diagnosis of multiple myeloma meeting the following criteria:

    • Symptomatic disease diagnosed within the past 30 days
    • Measurable or evaluable disease meeting at least 1 of the following criteria:

      • Serum monoclonal protein ≥ 1 g/dL (measurable disease)
      • Monoclonal light chain in urine protein electrophoresis ≥ 200 mg/24-hour urine collection (measurable disease)
      • Bone marrow plasmacytosis ≥ 30% (evaluable disease)
  • High-risk disease, defined by ≥ 1 of the following criteria:

    • Beta 2-microglobulin ≥ 5.5 μg/mL
    • Plasma cell labeling index ≥ 1%
    • Deletion of chromosome 13 by cytogenetic analysis

PATIENT CHARACTERISTICS:

Age

  • 18 and over

Performance status

  • ECOG 0-2 (ECOG 3 allowed if secondary to acute bone event [i.e., fracture])

Life expectancy

  • Not specified

Hematopoietic

  • Platelet count ≥ 20,000/mm^3 (transfusion allowed)
  • Hemoglobin ≥ 7.0 g/dL (transfusion allowed)
  • Absolute neutrophil count ≥ 500/mm^3 (without growth factor support)

Hepatic

  • Bilirubin ≤ 1.5 times upper limit of normal (ULN)
  • AST ≤ 2.5 times ULN
  • Alkaline phosphatase ≤ 2.5 times ULN

Renal

  • Creatinine clearance ≥ 20 mL/min

Cardiovascular

  • No myocardial infarction within the past 6 months
  • No New York Heart Association class III or IV heart failure
  • No uncontrolled angina
  • No acute ischemia by EKG
  • No severe uncontrolled ventricular arrhythmias
  • No active conduction system abnormalities by EKG
  • No cardiac amyloidosis
  • No poorly controlled hypertension

Other

  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception
  • No history of allergic reaction attributable to compounds containing boron or mannitol
  • No greater than grade 1 peripheral neuropathy
  • No other serious medical or psychiatric illness that would preclude study completion

PRIOR CONCURRENT THERAPY:

Biologic therapy

  • No prior biologic therapy for multiple myeloma
  • No concurrent biologic therapy
  • No concurrent pegfilgrastim

Chemotherapy

  • No prior chemotherapy for multiple myeloma
  • No concurrent chemotherapy

Endocrine therapy

  • Concurrent corticosteroids allowed for treatment of chronic disorders other than multiple myeloma (e.g., rheumatoid arthritis or adrenal insufficiency)

Radiotherapy

  • No prior radiotherapy for multiple myeloma
  • At least 4 weeks since prior radiotherapy for plasmacytoma (e.g., solitary plasmacytoma)
  • No concurrent radiotherapy

    • Concurrent localized radiotherapy allowed upon approval by study chair

Surgery

  • Not specified

Other

  • Prior or concurrent bisphosphonates allowed
  • No other concurrent antineoplastic therapy for multiple myeloma
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00075881

  Show 92 Study Locations
Sponsors and Collaborators
Eastern Cooperative Oncology Group
Investigators
Study Chair: Angela Dispenzieri, MD Mayo Clinic
  More Information

Additional Information:
Publications:
Dispenzieri A, Zhang L, Fonseca R, et al.: Single agent bortezomib is associated with a high response rate in patients with high risk myeloma. A phase II study from the Eastern Cooperative Oncology Group (E2A02). [Abstract] Blood 108 (11): A-3527, 2006.

ClinicalTrials.gov Identifier: NCT00075881     History of Changes
Other Study ID Numbers: CDR0000349450, ECOG-E2A02
Study First Received: January 9, 2004
Last Updated: July 23, 2008
Health Authority: United States: Federal Government

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

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

ClinicalTrials.gov processed this record on February 12, 2012