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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 CenterRochester, Minnesota  55905
Indiana University Cancer CenterIndianapolis, Indiana  46202-5265
University of Minnesota Cancer CenterMinneapolis, Minnesota  55455
Fox Chase Cancer CenterPhiladelphia, Pennsylvania  19111
CCOP - WichitaWichita, Kansas  67214-3882
CCOP - Missouri Valley Cancer ConsortiumOmaha, Nebraska  68131
CCOP - Southern Nevada Cancer Research FoundationLas Vegas, Nevada  89106
CCOP - Christiana Care Health ServicesWilmington, Delaware  19899
Veterans Affairs Medical Center - Atlanta (Decatur)Decatur, Georgia  30033
CCOP - Illinois Oncology Research AssociationPeoria, Illinois  61602
CCOP - Carle Cancer CenterUrbana, Illinois  61801
Veterans Affairs Medical Center - Indianapolis (Roudebush)Indianapolis, Indiana  46202
CCOP - Iowa Oncology Research AssociationDes Moines, Iowa  50309-1016
Beth Israel Deaconess Medical CenterBoston, Massachusetts  02215
CCOP - KalamazooKalamazoo, Michigan  49007-3731
CCOP - Metro-MinnesotaSaint Louis Park, Minnesota  55416
Veterans Affairs Medical Center - East OrangeEast Orange, New Jersey  07018-1095
CCOP - Northern New JerseyHackensack, New Jersey  07601
Hahnemann University HospitalPhiladelphia, Pennsylvania  19102-1192
Hinsdale Hematology Oncology AssociatesHinsdale, Illinois  60521
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West Michigan Cancer CenterKalamazoo, Michigan  49007-3731
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Penn State Cancer Institute at Milton S. Hershey Medical CenterHershey, Pennsylvania  17033-0850
Abramson Cancer Center of the University of PennsylvaniaPhiladelphia, Pennsylvania  19104-4283
Medical College of Wisconsin Cancer CenterMilwaukee, Wisconsin  53226
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CCOP - OchsnerNew Orleans, Louisiana  70121
CCOP - Merit Care HospitalFargo, North Dakota  58122
CCOP - Sioux Community Cancer ConsortiumSioux Falls, South Dakota  57105-1080
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CCOP - Central IllinoisSpringfield, Illinois  62526
CCOP - ColumbusColumbus, Ohio  43206
CCOP - MainLine HealthWynnewood, Pennsylvania  19096
Veterans Affairs Medical Center - MadisonMadison, Wisconsin  53705
University of Wisconsin Comprehensive Cancer CenterMadison, Wisconsin  53792
Veterans Affairs Medical Center - Milwaukee (Zablocki)Milwaukee, Wisconsin  53295
CCOP - EvanstonEvanston, Illinois  60201
CCOP - Northern Indiana CR ConsortiumSouth Bend, Indiana  46601
Cancer Center at Tufts - New England Medical CenterBoston, Massachusetts  02111
Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical CenterLebanon, New Hampshire  03756-0002
MBCCOP - University of New Mexico HSCAlbuquerque, New Mexico  87131
MetroHealth's Cancer Care Center at MetroHealth Medical CenterCleveland, Ohio  44106
CCOP - Geisinger Clinic and Medical CenterDanville, Pennsylvania  17822-2001
Vanderbilt-Ingram Cancer Center at Vanderbilt Medical CenterNashville, Tennessee  37232-2516
CCOP - Scott and White HospitalTemple, Texas  76508
Veterans Affairs Medical Center - Lakeside ChicagoChicago, Illinois  60611
Veterans Affairs Medical Center - New YorkNew York, New York  10010
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Cleveland Clinic Taussig Cancer CenterCleveland, Ohio  44195
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MBCCOP - LSU Health Sciences CenterNew Orleans, Louisiana  70112
CCOP - OklahomaTulsa, Oklahoma  74136
Veterans Affairs Medical Center - PittsburghPittsburgh, Pennsylvania  15240
Veterans Affairs Medical Center - MiamiMiami, Florida  33125
Veterans Affairs Medical Center - MinneapolisMinneapolis, Minnesota  55417
Veterans Affairs Medical Center - Palo AltoPalo Alto, California  94304
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Midlands Cancer Center at Midlands Community HospitalPapillion, Nebraska  68128-4157
CCOP - Colorado Cancer Research Program, IncorporatedDenver, Colorado  80224
Hillman Cancer Center at University of Pittsburgh Cancer InstitutePittsburgh, Pennsylvania  15236
Veterans Affairs Medical Center - BrooklynBrooklyn, New York  11209
Veterans Affairs Medical Center - Tampa (Haley)Tampa, Florida  33612
Stanford Cancer Center at Stanford University Medical CenterStanford, California  94305
Veterans Affairs Medical Center - Tennessee Valley Healthcare System - Nashville CampusNashville, Tennessee  37212
CCOP - Toledo Community HospitalToledo, Ohio  43623-3456
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Albert Einstein Cancer Center at Albert Einstein College of MedicineBronx, New York  10461
NYU Cancer Institute at New York University Medical CenterNew York, New York  10016
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MBCCOP - Howard University Cancer CenterWashington, District of Columbia  20060
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John Stoddard Cancer Center at Iowa Lutheran HospitalDes Moines, Iowa  50316-2301
Mercy Cancer Center at Mercy Medical Center - Des MoinesDes Moines, Iowa  50314
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