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Bortezomib in Treating Patients With Newly Diagnosed High-Risk Stage III Multiple Myeloma
This study is ongoing, but not recruiting participants.
Study NCT00075881   Information provided by National Cancer Institute (NCI)
First Received: January 9, 2004   Last Updated: July 23, 2008   History of Changes

January 9, 2004
July 23, 2008
January 2004
 
 
 
Complete list of historical versions of study NCT00075881 on ClinicalTrials.gov Archive Site
 
 
 
Bortezomib in Treating Patients With Newly Diagnosed High-Risk Stage III Multiple Myeloma
Phase II Study Of PS-341 For Patients With High-Risk, Newly Diagnosed Multiple Myeloma

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.

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.

Phase II
Interventional
Treatment, Open Label
Multiple Myeloma and Plasma Cell Neoplasm
Drug: bortezomib
 
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Active, not recruiting
 
 
 

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States,   Australia,   Peru,   Puerto Rico,   South Africa
 
NCT00075881
 
CDR0000349450, ECOG-E2A02
Eastern Cooperative Oncology Group
National Cancer Institute (NCI)
Study Chair: Angela Dispenzieri, MD Mayo Clinic
National Cancer Institute (NCI)
November 2005

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP