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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.
First Received: January 9, 2004   Last Updated: 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: Treatment, Open Label
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

  Hide Study Locations
Locations
United States, Alabama
University of Alabama at Birmingham Comprehensive Cancer Center
Birmingham, Alabama, United States, 35294-3300
United States, Arizona
CCOP - Mayo Clinic Scottsdale Oncology Program
Scottsdale, Arizona, United States, 85259-5404
United States, California
City of Hope Comprehensive Cancer Center
Duarte, California, United States, 91010-3000
Stanford Cancer Center at Stanford University Medical Center
Stanford, California, United States, 94305-5216
Veterans Affairs Medical Center - Palo Alto
Palo Alto, California, United States, 94304-1290
United States, Colorado
CCOP - Colorado Cancer Research Program, Incorporated
Denver, Colorado, United States, 80224
United States, Delaware
CCOP - Christiana Care Health Services
Newark, Delaware, United States, 19713
United States, District of Columbia
MBCCOP - Howard University Cancer Center
Washington, District of Columbia, United States, 20060
United States, Florida
H. Lee Moffitt Cancer Center and Research Institute at University of South Florida
Tampa, Florida, United States, 33612-9497
Martin Memorial Cancer Center
Stuart, Florida, United States, 34994
University of Florida Shands Cancer Center
Gainesville, Florida, United States, 32610-0277
Veterans Affairs Medical Center - Gainesville
Gainesville, Florida, United States, 32608-1197
Veterans Affairs Medical Center - Miami
Miami, Florida, United States, 33125
Veterans Affairs Medical Center - Tampa (Haley)
Tampa, Florida, United States, 33612
United States, Georgia
Veterans Affairs Medical Center - Atlanta (Decatur)
Decatur, Georgia, United States, 30033
Winship Cancer Institute of Emory University
Atlanta, Georgia, United States, 30322
United States, Illinois
CCOP - Carle Cancer Center
Urbana, Illinois, United States, 61801
Robert H. Lurie Comprehensive Cancer Center at Northwestern University
Chicago, Illinois, United States, 60611
CCOP - Evanston
Evanston, Illinois, United States, 60201
CCOP - Illinois Oncology Research Association
Peoria, Illinois, United States, 61615-7828
Decatur Memorial Hospital Cancer Care Institute
Decatur, Illinois, United States, 62526
Hinsdale Hematology Oncology Associates
Hinsdale, Illinois, United States, 60521
CCOP - Central Illinois
Decatur, Illinois, United States, 62526
Swedish-American Regional Cancer Center
Rockford, Illinois, United States, 61104-2315
Veterans Affairs Medical Center - Lakeside Chicago
Chicago, Illinois, United States, 60611-4494
United States, Indiana
CCOP - Northern Indiana CR Consortium
South Bend, Indiana, United States, 46601
Indiana University Cancer Center
Indianapolis, Indiana, United States, 46202-5289
Veterans Affairs Medical Center - Indianapolis (Roudebush)
Indianapolis, Indiana, United States, 46202
United States, Iowa
Burgess Health Center
Onawa, Iowa, United States, 51040
CCOP - Cedar Rapids Oncology Project
Cedar Rapids, Iowa, United States, 52403-1206
CCOP - Iowa Oncology Research Association
Des Moines, Iowa, United States, 50309-1016
John Stoddard Cancer Center at Iowa Lutheran Hospital
Des Moines, Iowa, United States, 50316-2301
John Stoddard Cancer Center at Iowa Methodist Medical Center
Des Moines, Iowa, United States, 50309
Mercy Cancer Center at Mercy Medical Center - Des Moines
Des Moines, Iowa, United States, 50314
United States, Kansas
CCOP - Wichita
Wichita, Kansas, United States, 67214-3882
Veterans Affairs Medical Center - Wichita
Wichita, Kansas, United States, 67218
United States, Louisiana
CCOP - Ochsner
New Orleans, Louisiana, United States, 70121
MBCCOP - LSU Health Sciences Center
New Orleans, Louisiana, United States, 70112
United States, Massachusetts
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02215
Cancer Center at Tufts - New England Medical Center
Boston, Massachusetts, United States, 02111
United States, Michigan
CCOP - Kalamazoo
Kalamazoo, Michigan, United States, 49007-3731
CCOP - Michigan Cancer Research Consortium
Ann Arbor, Michigan, United States, 48106
West Michigan Cancer Center
Kalamazoo, Michigan, United States, 49007-3731
United States, Minnesota
CCOP - Duluth
Duluth, Minnesota, United States, 55805
CCOP - Metro-Minnesota
Saint Louis Park, Minnesota, United States, 55416
Mayo Clinic Cancer Center
Rochester, Minnesota, United States, 55905
University of Minnesota Cancer Center
Minneapolis, Minnesota, United States, 55455
Veterans Affairs Medical Center - Minneapolis
Minneapolis, Minnesota, United States, 55417-2399
United States, Nebraska
CCOP - Missouri Valley Cancer Consortium
Omaha, Nebraska, United States, 68106
Midlands Cancer Center at Midlands Community Hospital
Papillion, Nebraska, United States, 68128-4157
Veterans Affairs Medical Center - Omaha
Omaha, Nebraska, United States, 68105
United States, Nevada
CCOP - Southern Nevada Cancer Research Foundation
Las Vegas, Nevada, United States, 89106
United States, New Hampshire
Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, United States, 03756-0002
United States, New Jersey
Cancer Institute of New Jersey at UMDNJ - Robert Wood Johnson Medical School
New Brunswick, New Jersey, United States, 08903
CCOP - Northern New Jersey
Hackensack, New Jersey, United States, 07601
Veterans Affairs Medical Center - East Orange
East Orange, New Jersey, United States, 07018
United States, New Mexico
MBCCOP - University of New Mexico HSC
Albuquerque, New Mexico, United States, 87131
United States, New York
Albert Einstein Cancer Center at Albert Einstein College of Medicine
Bronx, New York, United States, 10461
MBCCOP-Our Lady of Mercy Cancer Center
Bronx, New York, United States, 10466
NYU Cancer Institute at New York University Medical Center
New York, New York, United States, 10016
Veterans Affairs Medical Center - Brooklyn
Brooklyn, New York, United States, 11209
Veterans Affairs Medical Center - New York
New York, New York, United States, 10010
United States, North Dakota
CCOP - Merit Care Hospital
Fargo, North Dakota, United States, 58122
United States, Ohio
CCOP - Columbus
Columbus, Ohio, United States, 43206
CCOP - Toledo Community Hospital
Toledo, Ohio, United States, 43623-3456
Cleveland Clinic Taussig Cancer Center
Cleveland, Ohio, United States, 44195
MetroHealth's Cancer Care Center at MetroHealth Medical Center
Cleveland, Ohio, United States, 44109
United States, Oklahoma
CCOP - Oklahoma
Tulsa, Oklahoma, United States, 74136
United States, Pennsylvania
Abramson Cancer Center of the University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
CCOP - Geisinger Clinic and Medical Center
Danville, Pennsylvania, United States, 17822-2001
CCOP - MainLine Health
Wynnewood, Pennsylvania, United States, 19096
Fox Chase Cancer Center
Philadelphia, Pennsylvania, United States, 19111-2497
Hahnemann University Hospital
Philadelphia, Pennsylvania, United States, 19102-1192
Hillman Cancer Center at University of Pittsburgh Cancer Institute
Pittsburgh, Pennsylvania, United States, 15236
Penn State Cancer Institute at Milton S. Hershey Medical Center
Hershey, Pennsylvania, United States, 17033-0850
Veterans Affairs Medical Center - Pittsburgh
Pittsburgh, Pennsylvania, United States, 15240
United States, South Dakota
CCOP - Sioux Community Cancer Consortium
Sioux Falls, South Dakota, United States, 57104
United States, Tennessee
Vanderbilt-Ingram Cancer Center at Vanderbilt Medical Center
Nashville, Tennessee, United States, 37232-6307
Veterans Affairs Medical Center - Tennessee Valley Healthcare System - Nashville Campus
Nashville, Tennessee, United States, 37212-2637
United States, Texas
CCOP - Scott and White Hospital
Temple, Texas, United States, 76508
United States, Wisconsin
CCOP - Marshfield Clinic Research Foundation
Marshfield, Wisconsin, United States, 54449
CCOP - St. Vincent Hospital Cancer Center, Green Bay
Green Bay, Wisconsin, United States, 54301
Medical College of Wisconsin Cancer Center
Milwaukee, Wisconsin, United States, 53226-3596
University of Wisconsin Comprehensive Cancer Center
Madison, Wisconsin, United States, 53792-0001
Veterans Affairs Medical Center - Madison
Madison, Wisconsin, United States, 53705
Veterans Affairs Medical Center - Milwaukee (Zablocki)
Milwaukee, Wisconsin, United States, 53295
Australia, New South Wales
Westmead Hospital
Westmead, New South Wales, Australia, 2145
Peru
Instituto de Enfermedades Neoplasicas
Lima, Peru, 34
Puerto Rico
MBCCOP - San Juan
San Juan, Puerto Rico, 00921-3201
San Juan City Hospital
San Juan, Puerto Rico, 00936-7344
Veterans Affairs Medical Center - San Juan
San Juan, Puerto Rico, 00927-5800
South Africa
Pretoria Academic Hospital
Pretoria, South Africa, 0001
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.

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

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

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 November 27, 2009