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Bortezomib in Treating Patients With Newly Diagnosed High-Risk Stage III Multiple Myeloma Clinical Trials Data presented on Clinical Trials Search is not meant to be a substitute for qualified health advice, visits or treatment with a real mD. We are not doctors. Always consult your doctor about Bortezomib in Treating Patients With Newly Diagnosed High-Risk Stage III Multiple Myeloma conditions. Clinical Trials Search.org is a site devoted to listing clinical research studies in human subjects. Bortezomib in Treating Patients With Newly Diagnosed High-Risk Stage III Multiple Myeloma Clinical research trials and Bortezomib in Treating Patients With Newly Diagnosed High-Risk Stage III Multiple Myeloma healthcare trials happen in many of places across the United States. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally assess the effectivity of new drugs. The purpose of the studies / projects is to solve particular human medical questions. Clinical trials are a popular way for doctors, government agencies, and private sector companies to discover cures for all varieties of conditions, such as Bortezomib in Treating Patients With Newly Diagnosed High-Risk Stage III Multiple Myeloma. Bortezomib in Treating Patients With Newly Diagnosed High-Risk Stage III Multiple Myeloma Clinical Trials and other clinical trials allow volunteers to have health treatment alternatives before they are available to the masses. Some times the human subjects obtain treatment for without cost, and sometimes they are compensated for their time. Occasionally there is a cost for a Bortezomib in Treating Patients With Newly Diagnosed High-Risk Stage III Multiple Myeloma clinical trial. Test subjects oftentimes receive the most effective healthcare possible for their Bortezomib in Treating Patients With Newly Diagnosed High-Risk Stage III Multiple Myeloma condition. Dangers are a reality, however, and may include extra or frequent physician visits, healthcare dangers (possibly life-jeopardising), and/or the treatment being uneffective. Trials are federally governed with rigorous guidelines to protect clinical trials patients.
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Home > "B" Clinical Trials Conditions > Bortezomib in Treating Patients With Newly Diagnosed High-Risk Stage III Multiple Myeloma  Bortezomib in Treating Patients With Newly Diagnosed High-Risk Stage III Multiple Myeloma
Bortezomib in Treating Patients With Newly Diagnosed High-Risk Stage III Multiple Myeloma
For Condition: stage 3 multiple myeloma
Status: Recruiting
Sponsor(s): Eastern Cooperative Oncology Group , National Cancer Institute (NCI)
Synopsis: RATIONALE: Bortezomib may stop the growth of cancer cells by blocking the enzymes necessary for their growth. PURPOSE: Phase II trial to study the effectiveness of bortezomib in treating patients who have newly diagnosedhigh-riskstage III multiple myeloma.
Details: 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:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry 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) - Meets at least 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
Total Enrollment:
Location and Contact Information:
Overall Study Official:
DavidVesole, , Medical College of Wisconsin
CCOP - Michigan Cancer Research Consortium *Recruiting*
Ann Arbor, Michigan, 48106
United States
Recruiting Philip Stella 734-712-2000
Medical College of Wisconsin Cancer Center *Recruiting*
Milwaukee, Wisconsin, 53226-3596
United States
Recruiting David Vesole 414-805-4646
CCOP - Northern New Jersey *Recruiting*
Hackensack, New Jersey, 07601
United States
Recruiting Richard Rosenbluth 201-996-5917
Vanderbilt-Ingram Cancer Center at Vanderbilt Medical Center *Recruiting*
Nashville, Tennessee, 37232-6307
United States
Recruiting David Johnson 615-343-9454
Midlands Cancer Center at Midlands Community Hospital *Recruiting*
Papillion, Nebraska, 68128-4157
United States
Recruiting James Mailliard 402-593-3000
Veterans Affairs Medical Center - Minneapolis *Recruiting*
Minneapolis, Minnesota, 55417-2399
United States
Recruiting Markus Gapany 612-725-2000 ext. 3459
CCOP - Metro-Minnesota *Recruiting*
St. Louis Park, Minnesota, 55416
United States
Recruiting Patrick Flynn 952-993-15175
CCOP - Illinois Oncology Research Association *Recruiting*
Peoria, Illinois, 61602
United States
Recruiting John Kugler 309-636-3605
CCOP - Northern Indiana CR Consortium *Recruiting*
South Bend, Indiana, 46601
United States
Recruiting Rafat Ansari 574-284-7977
Instituto de Enfermedades Neoplasicas *Recruiting*
Lima, , 34
Peru
Recruiting Carlos Vallejos-Sologuren 51-14-499-137
Cancer Institute of New Jersey *Recruiting*
New Brunswick, New Jersey, 08903
United States
Recruiting Joseph Aisner 732-235-7464
CCOP - Oklahoma *Recruiting*
Tulsa, Oklahoma, 74136
United States
Recruiting James Lockhart 918-491-5878
CCOP - Sioux Community Cancer Consortium *Recruiting*
Sioux Falls, South Dakota, 57104
United States
Recruiting Loren Tschetter 605-328-8044
MBCCOP - Howard University Cancer Center *Recruiting*
Washington D.C., District of Columbia, 20060
United States
Recruiting Lucile Adams-Campbell 202-806-7697
CCOP - Southern Nevada Cancer Research Foundation *Recruiting*
Las Vegas, Nevada, 89106
United States
Recruiting John Ellerton 702-384-0013
Veterans Affairs Medical Center - Tampa (Haley) *Recruiting*
Tampa, Florida, 33612
United States
Recruiting Julie Kish 813-972-2000
MBCCOP - San Juan *Recruiting*
San Juan, , 00921-3201
Puerto Rico
Recruiting Luis Baez-Diaz 787-641-3693
NYU School of Medicine's Kaplan Comprehensive Cancer Center *Recruiting*
New York City, New York, 10016
United States
Recruiting Howard Hochster 212-652-1912
Veterans Affairs Medical Center - Milwaukee (Zablocki) *Recruiting*
Milwaukee, Wisconsin, 53295
United States
Recruiting Mohammed Raheem 414-384-2000
MetroHealth Medical Center *Recruiting*
Cleveland, Ohio, 44109
United States
Recruiting Edward Mansour 216-778-4394
CCOP - Carle Cancer Center *Recruiting*
Urbana, Illinois, 61801
United States
Recruiting Kendrith Rowland 217-383-4083
University of Alabama at Birmingham Comprehensive Cancer Center *Recruiting*
Birmingham, Alabama, 35294-3300
United States
Recruiting Carla Falkson 205-975-2691
CCOP - Mayo Clinic Scottsdale Oncology Program *Recruiting*
Scottsdale, Arizona, 85259-5404
United States
Recruiting Tom Fitch 480-301-9875
John Stoddard Cancer Center at Iowa Methodist Medical Center *Recruiting*
Des Moines, Iowa, 50309
United States
Recruiting Roscoe Morton 515-241-4245
CCOP - Duluth *Recruiting*
Duluth, Minnesota, 55805
United States
Recruiting Robert Dalton 218-786-8364
Beth Israel Deaconess Medical Center *Recruiting*
Boston, Massachusetts, 02215
United States
Recruiting Michael Atkins 617-667-1930
Veterans Affairs Medical Center - Gainesville *Recruiting*
Gainesville, Florida, 32608-1197
United States
Recruiting Dean McCarley 352-374-6016
Veterans Affairs Medical Center - Miami *Recruiting*
Miami, Florida, 33125
United States
Recruiting Niramol Savaraj 305-324-3143
CCOP - Evanston *Recruiting*
Evanston, Illinois, 60201
United States
Recruiting Gershon Locker 847-570-2518
Pretoria Academic Hospital *Recruiting*
Pretoria, , 0001
South Africa
Recruiting Coenraad Slabber 27-12-354-1054
Winship Cancer Institute of Emory University *Recruiting*
Atlanta, Georgia, 30322
United States
Recruiting William Wood 404-778-5180
Albert Einstein Clinical Cancer Center *Recruiting*
Bronx, New York, 10461
United States
Recruiting Joseph Sparano 718-904-2555
Stanford Cancer Center at Stanford University Medical Center *Recruiting*
Stanford, California, 94305-5216
United States
Recruiting Harlan Pinto 650-725-9057
Cleveland Clinic Taussig Cancer Center *Recruiting*
Cleveland, Ohio, 44195
United States
Recruiting Robert Dreicer 216-445-4623
Westmead Hospital *Recruiting*
Westmead, New South Wales, 2145
Australia
Recruiting Richard Kefford 61-2-9845-6033
CCOP - Kalamazoo *Recruiting*
Kalamazoo, Michigan, 49007-3731
United States
Recruiting Raymond Lord 269-373-7488
Veterans Affairs Medical Center - Omaha *Recruiting*
Omaha, Nebraska, 68105
United States
Recruiting James Mailliard 402-280-5274
CCOP - Merit Care Hospital *Recruiting*
Fargo, North Dakota, 58122
United States
Recruiting Preston Steen 701-234-6161
Mercy Cancer Center at Mercy Medical Center-Des Moines *Recruiting*
Des Moines, Iowa, 50314
United States
Recruiting Roscoe Morton 515-247-3121
Veterans Affairs Medical Center - New York *Recruiting*
New York City, New York, 10010
United States
Recruiting Howard Hochster 212-652-1912
CCOP - Columbus *Recruiting*
Columbus, Ohio, 43206
United States
Recruiting J. Kuebler 614-488-2118
CCOP - Christiana Care Health Services *Recruiting*
Newark, Delaware, 19713
United States
Recruiting Stephen Grubbs 302-623-4100
Mayo Clinic Cancer Center *Recruiting*
Rochester, Minnesota, 55905
United States
Recruiting Thomas Habermann 507-284-2511
Fox Chase Cancer Center *Recruiting*
Philadelphia, Pennsylvania, 19111-2497
United States
Recruiting Lori Goldstein 215-728-2689
CCOP - Marshfield Clinic Research Foundation *Recruiting*
Marshfield, Wisconsin, 54449
United States
Recruiting Tarit Banerjee 715-387-5134
CCOP - MainLine Health *Recruiting*
Wynnewood, Pennsylvania, 19096
United States
Recruiting Paul Gilman 610-645-2057
CCOP - Colorado Cancer Research Program, Incorporated *Recruiting*
Denver, Colorado, 80224
United States
Recruiting Eduardo Pajon 303-777-2663
Veterans Affairs Medical Center - Brooklyn *Recruiting*
Brooklyn, New York, 11209
United States
Recruiting Andrea Wiesel Leaf 718-630-3691
City of Hope Comprehensive Cancer Center *Recruiting*
Duarte, California, 91010-3000
United States
Recruiting Theodore Krontiris 626-301-8164
Veterans Affairs Medical Center - Palo Alto *Recruiting*
Palo Alto, California, 94304-1290
United States
Recruiting Harlan Pinto 650-493-5000 ext. 4948
CCOP - Central Illinois *Recruiting*
Decatur, Illinois, 62526
United States
Recruiting James Wade 217-876-6617
Veterans Affairs Medical Center - Tennessee Valley Healthcare System - Nashville Campus *Recruiting*
Nashville, Tennessee, 37212-2637
United States
Recruiting Kenneth Hande 615-327-4751
University of Wisconsin Comprehensive Cancer Center *Recruiting*
Madison, Wisconsin, 53792-0001
United States
Recruiting James Stewart 608-265-8131
Veterans Affairs Medical Center - Madison *Recruiting*
Madison, Wisconsin, 53705
United States
Recruiting Mark Albertini 608-262-7017
CCOP - Iowa Oncology Research Association *Recruiting*
Des Moines, Iowa, 50309-1016
United States
Recruiting Roscoe Morton 515-244-7586
CCOP - St. Vincent Hospital Cancer Center, Green Bay *Recruiting*
Green Bay, Wisconsin, 54307-3453
United States
Recruiting Gerald Bayer 920-433-8889
Veterans Affairs Medical Center - Atlanta (Decatur) *Recruiting*
Decatur, Georgia, 30033
United States
Recruiting Maria Amarante Ribeiro 404-728-7680
Veterans Affairs Medical Center - East Orange *Recruiting*
East Orange, New Jersey, 07019
United States
Recruiting Basil Kasimis 973-676-1000 ext. 1544
Veterans Affairs Medical Center - Indianapolis (Roudebush) *Recruiting*
Indianapolis, Indiana, 46202
United States
Recruiting Patrick Loehrer 317-554-0000
Iowa Lutheran Hospital *Recruiting*
Des Moines, Iowa, 50316-2301
United States
Recruiting Roscoe Morton 515-663-5612
Veterans Affairs Medical Center - Wichita *Recruiting*
Wichita, Kansas, 67218
United States
Recruiting Shaker Dakhil 316-685-2221
MBCCOP-Our Lady of Mercy Cancer Center *Recruiting*
Bronx, New York, 10466
United States
Recruiting Peter Wiernik 718-920-1100
San Juan City Hospital *Recruiting*
San Juan, , 00936-7344
Puerto Rico
Recruiting Luis Baez-Diaz 787-641-3693
CCOP - Wichita *Recruiting*
Wichita, Kansas, 67214-3882
United States
Recruiting Shaker Dakhil 316-268-5784
Tufts - New England Medical Center *Recruiting*
Boston, Massachusetts, 02111
United States
Recruiting John Erban 617-636-5147
University of Minnesota Cancer Center *Recruiting*
Minneapolis, Minnesota, 55455
United States
Recruiting George Adams 612-625-2410
Indiana University Cancer Center *Recruiting*
Indianapolis, Indiana, 46202-5289
United States
Recruiting Patrick Loehrer 317-278-7418
Burgess Health Center *Recruiting*
Onawa, Iowa, 51040
United States
Recruiting James Mailliard 712-423-2311
CCOP - Cedar Rapids Oncology Project *Recruiting*
Cedar Rapids, Iowa, 52403-1206
United States
Recruiting Martin Wiesenfeld 319-363-8303
MBCCOP - LSU Health Sciences Center *Recruiting*
New Orleans, Louisiana, 70112
United States
Recruiting Jill Gilbert 504-568-5136
Des Moines General Hospital *Recruiting*
Des Moines, Iowa, 50309
United States
Recruiting Roscoe Morton 515-247-3121
Hillman Cancer Center at University of Pittsburgh Cancer Institute *Recruiting*
Pittsburgh, Pennsylvania, 15236
United States
Recruiting John Kirkwood 412-692-4724
Veterans Affairs Medical Center - Pittsburgh *Recruiting*
Pittsburgh, Pennsylvania, 15240
United States
Recruiting Timothy Carlos 412-688-6248
H. Lee Moffitt Cancer Center and Research Institute *Recruiting*
Tampa, Florida, 33612-9497
United States
Recruiting Cancer Answers 800-456-7121
Robert H. Lurie Comprehensive Cancer Center at Northwestern University *Recruiting*
Chicago, Illinois, 60611
United States
Recruiting Al Benson 312-695-1382
Veterans Affairs Medical Center - Lakeside Chicago *Recruiting*
Chicago, Illinois, 60611-4494
United States
Recruiting Timothy Kuzel 312-469-3748
CCOP - Ochsner *Recruiting*
New Orleans, Louisiana, 70121
United States
Recruiting Carl Kardinal 504-842-3910
Norris Cotton Cancer Center at Dartmouth Medical School *Recruiting*
Lebanon, New Hampshire, 03756-0002
United States
Recruiting Camilo Fadul 603-650-6312
CCOP - Toledo Community Hospital *Recruiting*
Toledo, Ohio, 43623-3456
United States
Recruiting Paul Schaefer 419-843-6147
CCOP - Scott and White Hospital *Recruiting*
Temple, Texas, 76508
United States
Recruiting Lucas Wong 254-724-7048
CCOP - Missouri Valley Cancer Consortium *Recruiting*
Omaha, Nebraska, 68106
United States
Recruiting James Mailliard 402-280-4364
MBCCOP - University of New Mexico HSC *Recruiting*
Albuquerque, New Mexico, 87131
United States
Recruiting Cynthia Cathcart 505-272-5688
Abramson Cancer Center at University of Pennsylvania Medical Center *Recruiting*
Philadelphia, Pennsylvania, 19104
United States
Recruiting Daniel Haller 215-662-6318
CCOP - Geisinger Clinic and Medical Center *Recruiting*
Danville, Pennsylvania, 17822-2001
United States
Recruiting Suresh Nair 570-271-6413
Veterans Affairs Medical Center - San Juan *Recruiting*
San Juan, , 00927-5800
Puerto Rico
Recruiting Luis Baez-Diaz 787-641-3693
Drexel University Hospital *Recruiting*
Philadelphia, Pennsylvania, 19102-1192
United States
Recruiting Pamela Crilley 215-762-8547
Penn State Cancer Institute at Milton S. Hershey Medical Center *Recruiting*
Hershey, Pennsylvania, 17033-0850
United States
Recruiting Witold Rybka 717-531-1050
Additional Information:
Study ID Numbers: CDR0000349450; ECOG-E2A02
Study Start Date:
Record last reviewed: February 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00075881
Other Stage 3 Multiple Myeloma Studies:
1. CC-5013 in Treating Patients With Advanced Multiple Myeloma
2. Bevacizumab With or Without Thalidomide in Treating Patients With Relapsed or Refractory Multiple Myeloma
3. Combination Chemotherapy With or Without Thalidomide in Treating Patients With Multiple Myeloma
4. Combination Chemotherapy in Treating Patients With Stage II or Stage III Multiple Myeloma
5. Chemotherapy Plus Peripheral Stem Cell Transplantation in Treating Patients With Multiple Myeloma
Related Studies:
Other stage 3 multiple myeloma Clinical Trials
Other Minnesota Clinical Trials
Other St. Louis Park Clinical Trials
Bortezomib in Treating Patients With Newly Diagnosed High-Risk Stage III Multiple Myeloma
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