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Phase II Study Of PS-341 For Patients With High-Risk, Newly Diagnosed Multiple Myeloma

Phase 2
18 Years
Not Enrolling
Multiple Myeloma, Plasma Cell Neoplasm

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Trial Information

Phase II Study Of PS-341 For Patients With High-Risk, Newly Diagnosed Multiple Myeloma



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


- 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 intravenously (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.

ACTUAL ACCRUAL: A total of 44 patients were accrued for this study.

Inclusion Criteria

Inclusion Criteria

- 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

- Age>=18

- Eastern Cooperative Oncology Group (ECOG) performance status of 0-2 (ECOG performance
status of 3 allowed if secondary to acute bone event [i.e., fracture])

- Adequate hematopoietic,hepatic, renal, cardiovascular function:

- 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)

- Bilirubin ≤ 1.5 times upper limit of normal (ULN)

- Aspartate aminotransferase (AST) ≤ 2.5 times ULN

- Alkaline phosphatase ≤ 2.5 times ULN

- Creatinine clearance ≥ 20 mL/min

- Fertile patients must use effective contraception

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

- Prior or concurrent bisphosphonates allowed

- Concurrent localized radiotherapy allowed upon approval by study chair

Exclusion criteria:

- Pregnant or nursing

- Positive pregnancy test

- Myocardial infarction within the past 6 months

- New York Heart Association class III or IV heart failure

- Uncontrolled angina

- Acute ischemia by electrocardiography (EKG)

- Severe uncontrolled ventricular arrhythmias

- Active conduction system abnormalities by EKG

- Cardiac amyloidosis

- Poorly controlled hypertension

- History of allergic reaction attributable to compounds containing boron or mannitol

- Greater than grade 1 peripheral neuropathy

- Other serious medical or psychiatric illness that would preclude study completion

- Prior biologic therapy for multiple myeloma

- Concurrent biologic therapy

- Concurrent pegfilgrastim

- Prior chemotherapy for multiple myeloma

- Concurrent chemotherapy

- Prior radiotherapy for multiple myeloma

- Less than 4 weeks since prior radiotherapy for plasmacytoma (e.g., solitary

- Other concurrent antineoplastic therapy for multiple myeloma

Type of Study:


Study Design:

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Response Rate on Induction

Outcome Description:

Eastern Cooperative Oncology Group (ECOG) Myeloma Response Criteria that follows the standard European Group for Blood and Bone Marrow Transplant criteria was used to evaluate patient response and progression. Patients who have complete disappearance of an M-protein and no evidence of myeloma in the bone marrow are considered to have complete response. 42 eligible and treated patients were included in the analysis.

Outcome Time Frame:

participants were evaluated prior to each cycle, up to 8 cycles with a median number of 6 cycles. 1 cycle=21 days

Safety Issue:


Principal Investigator

Angela Dispenzieri, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Mayo Clinic


United States: Federal Government

Study ID:




Start Date:

January 2004

Completion Date:

May 2011

Related Keywords:

  • Multiple Myeloma
  • Plasma Cell Neoplasm
  • stage III multiple myeloma
  • high risk, newly diagnosed multiple myeloma
  • Neoplasms
  • Multiple Myeloma
  • Neoplasms, Plasma Cell
  • Plasmacytoma



Mayo Clinic Cancer Center Rochester, Minnesota  55905
Indiana University Cancer Center Indianapolis, Indiana  46202-5265
University of Minnesota Cancer Center Minneapolis, Minnesota  55455
Fox Chase Cancer Center Philadelphia, Pennsylvania  19111
CCOP - Wichita Wichita, Kansas  67214-3882
CCOP - Missouri Valley Cancer Consortium Omaha, Nebraska  68131
CCOP - Southern Nevada Cancer Research Foundation Las Vegas, Nevada  89106
CCOP - Christiana Care Health Services Wilmington, Delaware  19899
Veterans Affairs Medical Center - Atlanta (Decatur) Decatur, Georgia  30033
CCOP - Illinois Oncology Research Association Peoria, Illinois  61602
CCOP - Carle Cancer Center Urbana, Illinois  61801
Veterans Affairs Medical Center - Indianapolis (Roudebush) Indianapolis, Indiana  46202
CCOP - Iowa Oncology Research Association Des Moines, Iowa  50309-1016
Beth Israel Deaconess Medical Center Boston, Massachusetts  02215
CCOP - Kalamazoo Kalamazoo, Michigan  49007-3731
CCOP - Metro-Minnesota Saint Louis Park, Minnesota  55416
Veterans Affairs Medical Center - East Orange East Orange, New Jersey  07018-1095
CCOP - Northern New Jersey Hackensack, New Jersey  07601
Hahnemann University Hospital Philadelphia, Pennsylvania  19102-1192
Hinsdale Hematology Oncology Associates Hinsdale, Illinois  60521
CCOP - Michigan Cancer Research Consortium Ann Arbor, Michigan  48106
West Michigan Cancer Center Kalamazoo, Michigan  49007-3731
CCOP - Duluth Duluth, Minnesota  55805
Penn State Cancer Institute at Milton S. Hershey Medical Center Hershey, Pennsylvania  17033-0850
Abramson Cancer Center of the University of Pennsylvania Philadelphia, Pennsylvania  19104-4283
Medical College of Wisconsin Cancer Center Milwaukee, Wisconsin  53226
CCOP - Cedar Rapids Oncology Project Cedar Rapids, Iowa  52403-1206
CCOP - Ochsner New Orleans, Louisiana  70121
CCOP - Merit Care Hospital Fargo, North Dakota  58122
CCOP - Sioux Community Cancer Consortium Sioux Falls, South Dakota  57105-1080
University of Alabama at Birmingham Comprehensive Cancer Center Birmingham, Alabama  35294-3300
CCOP - Central Illinois Springfield, Illinois  62526
CCOP - Columbus Columbus, Ohio  43206
CCOP - MainLine Health Wynnewood, Pennsylvania  19096
Veterans Affairs Medical Center - Madison Madison, Wisconsin  53705
University of Wisconsin Comprehensive Cancer Center Madison, Wisconsin  53792
Veterans Affairs Medical Center - Milwaukee (Zablocki) Milwaukee, Wisconsin  53295
CCOP - Evanston Evanston, Illinois  60201
CCOP - Northern Indiana CR Consortium South Bend, Indiana  46601
Cancer Center at Tufts - New England Medical Center Boston, Massachusetts  02111
Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center Lebanon, New Hampshire  03756-0002
MBCCOP - University of New Mexico HSC Albuquerque, New Mexico  87131
MetroHealth's Cancer Care Center at MetroHealth Medical Center Cleveland, Ohio  44106
CCOP - Geisinger Clinic and Medical Center Danville, Pennsylvania  17822-2001
Vanderbilt-Ingram Cancer Center at Vanderbilt Medical Center Nashville, Tennessee  37232-2516
CCOP - Scott and White Hospital Temple, Texas  76508
Veterans Affairs Medical Center - Lakeside Chicago Chicago, Illinois  60611
Veterans Affairs Medical Center - New York New York, New York  10010
CCOP - St. Vincent Hospital Cancer Center, Green Bay Green Bay, Wisconsin  54301
Cleveland Clinic Taussig Cancer Center Cleveland, Ohio  44195
Veterans Affairs Medical Center - Wichita Wichita, Kansas  67218
MBCCOP - LSU Health Sciences Center New Orleans, Louisiana  70112
CCOP - Oklahoma Tulsa, Oklahoma  74136
Veterans Affairs Medical Center - Pittsburgh Pittsburgh, Pennsylvania  15240
Veterans Affairs Medical Center - Miami Miami, Florida  33125
Veterans Affairs Medical Center - Minneapolis Minneapolis, Minnesota  55417
Veterans Affairs Medical Center - Palo Alto Palo Alto, California  94304
City of Hope Comprehensive Cancer Center Duarte, California  91010
John Stoddard Cancer Center at Iowa Methodist Medical Center Des Moines, Iowa  50309
Midlands Cancer Center at Midlands Community Hospital Papillion, Nebraska  68128-4157
CCOP - Colorado Cancer Research Program, Incorporated Denver, Colorado  80224
Hillman Cancer Center at University of Pittsburgh Cancer Institute Pittsburgh, Pennsylvania  15236
Veterans Affairs Medical Center - Brooklyn Brooklyn, New York  11209
Veterans Affairs Medical Center - Tampa (Haley) Tampa, Florida  33612
Stanford Cancer Center at Stanford University Medical Center Stanford, California  94305
Veterans Affairs Medical Center - Tennessee Valley Healthcare System - Nashville Campus Nashville, Tennessee  37212
CCOP - Toledo Community Hospital Toledo, Ohio  43623-3456
University of Florida Shands Cancer Center Gainesville, Florida  32610-0232
Winship Cancer Institute of Emory University Atlanta, Georgia  30322
Albert Einstein Cancer Center at Albert Einstein College of Medicine Bronx, New York  10461
NYU Cancer Institute at New York University Medical Center New York, New York  10016
CCOP - Marshfield Clinic Research Foundation Marshfield, Wisconsin  54449
MBCCOP - Howard University Cancer Center Washington, District of Columbia  20060
Swedish-American Regional Cancer Center Rockford, Illinois  61104-2315
Cancer Institute of New Jersey at UMDNJ - Robert Wood Johnson Medical School New Brunswick, New Jersey  08903
MBCCOP-Our Lady of Mercy Cancer Center Bronx, New York  10466
Robert H. Lurie Comprehensive Cancer Center at Northwestern University Chicago, Illinois  60611
Decatur Memorial Hospital Cancer Care Institute Decatur, Illinois  62526
Veterans Affairs Medical Center - Gainesville Gainesville, Florida  32608-1197
John Stoddard Cancer Center at Iowa Lutheran Hospital Des Moines, Iowa  50316-2301
Mercy Cancer Center at Mercy Medical Center - Des Moines Des Moines, Iowa  50314
Burgess Health Center Onawa, Iowa  51040
Veterans Affairs Medical Center - Omaha Omaha, Nebraska  68105
CCOP - Mayo Clinic Scottsdale Oncology Program Scottsdale, Arizona  85259
H. Lee Moffitt Cancer Center and Research Institute at University of South Florida Tampa, Florida  33612
Martin Memorial Cancer Center Stuart, Florida  34995-9010