Melphalan and Dexamethasone With or Without Bortezomib in Treating Patients With Previously Untreated Systemic Light-Chain Amyloidosis

This study has been terminated.
(Administratively complete.)
Sponsor:
Information provided by (Responsible Party):
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT01078454
First received: February 27, 2010
Last updated: March 18, 2013
Last verified: March 2013
  Purpose

This randomized phase III trial is studying melphalan and dexamethasone to see how well they work with or without bortezomib in treating patients with previously untreated systemic amyloidosis. Drugs used in chemotherapy, such as melphalan and dexamethasone, work in different ways to stop the growth of plasma cells, either by killing the cells or by stopping them from dividing. Bortezomib may stop the growth of plasma cells by blocking some of the enzymes needed for cell growth. It is not yet known whether giving melphalan together with dexamethasone is more effective with or without bortezomib in treating systemic amyloidosis


Condition Intervention Phase
Light Chain Deposition Disease
Primary Systemic Amyloidosis
Drug: melphalan
Drug: dexamethasone
Drug: bortezomib
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Randomized Phase III Trial of Melphalan and Dexamethasone (MDex) Versus Bortezomib, Melphalan and Dexamethasone (BMDex) for Untreated Patients With Systemic Light-Chain (AL) Amyloidosis Ineligible for Autologous Stem-Cell Transplantation

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Hematologic overall response (PR+VGPR+ACR+sCR) [ Time Frame: 84 days (3 courses) ] [ Designated as safety issue: No ]
    Will be performed using Mantel-Haenszel test stratified on cardiac stage with an overall one-side type I error of 2.5%. The Mantel-Haenszel estimator is used to estimate the common odds ratio (BMDex/MDex), and a two-sided 95% confidence interval is also calculated.

  • Change in the FACT-Ntx TOI mean change score [ Time Frame: Baseline and 84 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Complete hematologic response rate [ Time Frame: 84 days ] [ Designated as safety issue: No ]
    Will be compared using the Mantel-Haenszel test stratified on cardiac stage. Exact conditional inference will be performed for these analyses.

  • Partial response [ Time Frame: At completion of treatment ] [ Designated as safety issue: No ]
    Will be compared using the Mantel-Haenszel test stratified on cardiac stage. Exact conditional inference will be performed for these analyses.

  • Organ response rate [ Time Frame: Up to 12 months ] [ Designated as safety issue: No ]
    Will be compared using the Mantel-Haenszel test stratified on cardiac stage. Exact conditional inference will be performed for these analyses.

  • Time to hematologic response [ Time Frame: From confirmed hematologic response until progression or death of any cause, assessed up to 5 years ] [ Designated as safety issue: No ]
    These distributions in each of the arms will be estimated using the method of Kaplan and Meier. The comparison between the two arms will be performed by using one-sided stratified log-rank test.

  • Time to organ response [ Time Frame: From confirmed organ improvement first observed date to confirmed organ progressive disease first observed date or death of any cause, assessed up to 5 years ] [ Designated as safety issue: No ]
    These distributions in each of the arms will be estimated using the method of Kaplan and Meier. The comparison between the two arms will be performed by using one-sided stratified log-rank test.

  • Progression free survival [ Time Frame: From randomization until disease progression or death of any cause, assessed up to 5 years ] [ Designated as safety issue: No ]
    These distributions in each of the arms will be estimated using the method of Kaplan and Meier. The comparison between the two arms will be performed by using one-sided stratified log-rank test.

  • Overall survival [ Time Frame: Up to 5 years ] [ Designated as safety issue: No ]
    These distributions in each of the arms will be estimated using the method of Kaplan and Meier. The comparison between the two arms will be performed by using one-sided stratified log-rank test.

  • Treatment-related mortality [ Time Frame: Up to 5 years ] [ Designated as safety issue: No ]
    A two-sided 95% confidence interval on the common odds ratio (BMDex/MDex) is computed by using the exact inference, to quantify the treatment effect on the treatment-related mortality rate.

  • Rates of grade 3 or higher toxicities using NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 [ Time Frame: Up to 5 years ] [ Designated as safety issue: Yes ]
    The toxicity comparison will use the Fisher's exact test. A two-sided 95% confidence interval on the odds ratio (BMDex/MDex) will be also computed.

  • FACT-Ntx TOI score [ Time Frame: Up to 9 months ] [ Designated as safety issue: No ]
  • Total score of the FACT/GOG-Ntx subscale [ Time Frame: Up to 9 months ] [ Designated as safety issue: No ]

Enrollment: 98
Study Start Date: November 2010
Estimated Primary Completion Date: November 2022 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm I (melphalan and dexamethasone)
Patients receive melphalan PO and dexamethasone PO on days 1-4. Treatment repeats every 28 days for up to 9 courses in the absence of disease progression or unacceptable toxicity.
Drug: melphalan
Given PO
Other Names:
  • Alkeran
  • CB-3025
  • L-PAM
  • L-phenylalanine mustard
  • L-Sarcolysin
Drug: dexamethasone
Given PO
Other Names:
  • Aeroseb-Dex
  • Decaderm
  • Decadron
  • DM
  • DXM
Experimental: Arm II (melphalan, dexamethasone, and bortezomib)
Patients receive melphalan PO and dexamethasone PO on days 1-4 and bortezomib intravenously (IV) on days 1, 4, 8, and 11. Treatment repeats every 28 days for 2 courses. Patients then receive melphalan PO and dexamethasone PO on days 1-4 and bortezomib IV on days 1, 8, 15, and 22. Treatment repeats every 35 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.
Drug: melphalan
Given PO
Other Names:
  • Alkeran
  • CB-3025
  • L-PAM
  • L-phenylalanine mustard
  • L-Sarcolysin
Drug: dexamethasone
Given PO
Other Names:
  • Aeroseb-Dex
  • Decaderm
  • Decadron
  • DM
  • DXM
Drug: bortezomib
Given IV
Other Names:
  • LDP 341
  • MLN341
  • VELCADE

Detailed Description:

PRIMARY OBJECTIVES:

I. To compare hematologic overall response (partial response [PR], very good PR, amyloid complete hematologic response [ACR], and stringent complete response [sCR]) after 3 courses of therapy in patients with previously untreated systemic light-chain amyloidosis treated with melphalan and dexamethasone with vs without bortezomib.

SECONDARY OBJECTIVES:

I. To evaluate the ACR rate after 3 courses of therapy and at completion of therapy.

II. To evaluate organ response rates after 3 courses of therapy and at 6, 9, and 12 months.

III. To evaluate treatment-related mortality. IV. To evaluate toxicity. V. To evaluate progression-free and overall survival. VI. To evaluate PR or better at completion of therapy. VII. To evaluate time to hematologic and organ response. VIII. To evaluate the duration of hematologic and organ response. IX. To assess quality of life (QOL) at baseline, at 3, 6, and 9 months during the therapy, at completion of therapy, and 3 and 6 months after therapy.

TERTIARY OBJECTIVES:

I. To determine the prognostic impact of t(11;14) translocation and cyclin D1 overexpression on response and overall survival.

II. (Correlative) To compare sCR rates and to determine the impact of sCR on the outcomes.

III. (Correlative) To perform a descriptive analysis of amyloid typing and proteomic composition of amyloid tissues.

OUTLINE: This is a multicenter study. Patients are stratified according to cardiac stage (I vs II) and are randomized to 1 of 2 treatment arms.

ARM I: Patients receive melphalan orally (PO) and dexamethasone PO on days 1-4. Treatment repeats every 28 days for up to 9 courses in the absence of disease progression or unacceptable toxicity.

ARM II: Patients receive melphalan PO and dexamethasone PO on days 1-4 and bortezomib intravenously (IV) on days 1, 4, 8, and 11. Treatment repeats every 28 days for 2 courses. Patients then receive melphalan PO and dexamethasone PO on days 1-4 and bortezomib IV on days 1, 8, 15, and 22. Treatment repeats every 35 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.

Blood, urine, bone marrow, and fat samples may be collected periodically for laboratory analysis. Health-related quality of life is assessed periodically before, during, and after therapy. After completion of study treatment, patients are followed up periodically for 5 years.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Histologically confirmed diagnosis of systemic light-chain amyloidosis

    • Histologic diagnosis of disease must be confirmed by pathology (positive Congo red stain with green birefringence on polarized light microscopy)
  • Genetic testing must be negative for transthyretin mutations associated with hereditary amyloidosis (required in patients who are African-American or who present with peripheral neuropathy as the dominant organ involvement)
  • Measurable disease, defined by >= 1 of the following:

    • Serum M-protein >= 1 g/dL by serum protein electrophoresis (SPEP)
    • Serum kappa or lambda free light chain of >= 7.5 mg/dL allowed provided the kappa to lambda free light chain ratio is abnormal
  • Symptomatic organ involvement* (heart, kidney, liver/gastrointestinal tract, peripheral nervous system, or soft tissue), defined as any of the following:

    • NOTE: *Carpal tunnel syndrome skin purpura or the presence of vascular amyloid on a bone marrow biopsy alone are not sufficient to meet criteria for "symptomatic organ involvement"
    • Renal involvement is defined as proteinuria (predominantly albumin) > 0.5 g/day by 24-hour urine collection
    • Cardiac involvement is defined as the presence of a mean left ventricular wall thickness of > 12 mm by ECHO in the absence of a history of hypertension or valvular heart disease or in the presence of unexplained low voltage (< 0.5 mV) by ECG
    • Hepatic involvement is defined as hepatomegaly or an alkaline phosphatase > 1.5 times upper limit of normal (ULN)
    • Peripheral nerve involvement is defined by clinical history or abnormal sensory and/or motor findings on neurologic exam
    • Gastrointestinal (GI) involvement is defined as gross GI bleeding or diarrhea (at least 4 stools per day over baseline); a positive GI biopsy is not sufficient to document clinical involvement
    • Autonomic nerve involvement is defined as orthostasis, symptoms of nausea or dysgeusia, gastric atony by gastric emptying scan, diarrhea, or constipation
    • Soft tissue and lymphatic involvement may be ascertained based on classic physical exam findings (macroglossia, shoulder pad sign, raccoon eyes, carpal tunnel syndrome, synovial enlargement, firm enlarged lymph nodes) or biopsy
  • Amyloid cardiac biomarker stage I or II disease

    • Staging defined by NT-proBNP and troponin T cut-offs of < 332 pg/mL and < 0.035 ng/mL, respectively, as thresholds: stage I, both under threshold; stage II, either troponin or NT-proBNP (but not both) over threshold (if troponin T is not available at local institution, troponin I may be used, but the threshold must be < 0.1 ng/mL)
  • No clinically overt myeloma (hypercalcemia or lytic bone lesions)
  • Ineligible for autologous stem cell transplantation with melphalan 200 mg/m^2 or refuses to undergo transplantation
  • Eastern Cooperative Oncology Group (ECOG) performance status 0-2
  • Absolute neutrophil count (ANC) > 1,500/mm^3
  • Platelet count > 140,000/mm^3
  • Hemoglobin > 11 g/dL
  • Total bilirubin < 2.5 mg/dL
  • Alkaline phosphatase < 5 times upper limit of normal (ULN)
  • Aspartate aminotransferase (AST) < 3 times ULN
  • Creatinine clearance > 30 mL/min
  • Bone marrow plasma cells < 30%
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception
  • No repetitive ventricular arrhythmias on 24-hour Holter electrocardiogram (ECG) (in spite of antiarrhythmic treatment)
  • The absence of supine systolic blood pressure < 100 mmHg and difficult to managesymptomatic orthostatic hypotension
  • No symptomatic orthostatic hypotension that is difficult to manage
  • No cardiac syncope
  • No uncompensated NYHA class III or IV congestive heart failure
  • No uncontrolled infection
  • No active malignancy within the past 5 years except for adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, or adequately treated stage I cancer currently in complete remission
  • No serious medical or psychiatric illness likely to interfere with study participation, including recent myocardial infarction (within the past 6 months) or poorly controlled diabetes mellitus
  • No peripheral neuropathy >= grade 2
  • Human immunodeficiency virus (HIV)-positivity allowed provided the following criteria are met:

    • No history of acquired immunodeficiency syndrome (AIDS)-defining events including history of CD4 cell count < 200/mm^3
    • Current CD4 cell count >= 350/mm^3
    • Not receiving zidovudine or stavudine
    • No secondary amyloidosis
  • No known hypersensitivity to bortezomib, boron, or mannitol
  • No prior chemotherapy or radiotherapy for the treatment of myeloma or systemic light-chain amyloidosis
  • More than 3 weeks since radiotherapy

    • Enrollment of subjects who require radiotherapy (which must be localized in field size) should be deferred until the radiotherapy is completed and 3 weeks have elapsed since the last date of therapy
  • More than 14 days since prior and no concurrent participation in clinical trials with other investigational agents not included in this trial
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01078454

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Locations
United States, Arizona
Mayo Clinic in Arizona
Scottsdale, Arizona, United States, 85259
United States, Arkansas
University of Arkansas for Medical Sciences
Little Rock, Arkansas, United States, 72205
United States, Colorado
The Medical Center of Aurora
Aurora, Colorado, United States, 80012
Boulder Community Hospital
Boulder, Colorado, United States, 80301
Penrose-Saint Francis Healthcare
Colorado Springs, Colorado, United States, 80907
Colorado Cancer Research Program CCOP
Denver, Colorado, United States, 80224-2522
Rose Medical Center
Denver, Colorado, United States, 80220
Presbyterian - Saint Lukes Medical Center - Health One
Denver, Colorado, United States, 80218
Saint Anthony Central Hospital
Denver, Colorado, United States, 80204
Porter Adventist Hospital
Denver, Colorado, United States, 80210
Exempla Saint Joseph Hospital
Denver, Colorado, United States, 80218
Swedish Medical Center
Englewood, Colorado, United States, 80110
Saint Mary's Hospital and Regional Medical Center
Grand Junction, Colorado, United States, 81502
North Colorado Medical Center
Greeley, Colorado, United States, 80631
Littleton Adventist Hospital
Littleton, Colorado, United States, 80122
Sky Ridge Medical Center
Lone Tree, Colorado, United States, 80124
Longmont United Hospital
Longmont, Colorado, United States, 80501
McKee Medical Center
Loveland, Colorado, United States, 80539
Parker Adventist Hospital
Parker, Colorado, United States, 80138
Saint Mary Corwin Medical Center
Pueblo, Colorado, United States, 81004
North Suburban Medical Center
Thornton, Colorado, United States, 80229
Exempla Lutheran Medical Center
Wheat Ridge, Colorado, United States, 80033
United States, Connecticut
Eastern Connecticut Hematology and Oncology Associates
Norwich, Connecticut, United States, 06360
United States, Delaware
Beebe Medical Center
Lewes, Delaware, United States, 19958
Christiana Care Health System-Christiana Hospital
Newark, Delaware, United States, 19718
United States, Florida
Mayo Clinic in Florida
Jacksonville, Florida, United States, 32224-9980
Cleveland Clinic Florida - Weston
Weston, Florida, United States, 33331
United States, Georgia
Emory University
Atlanta, Georgia, United States, 30322
United States, Hawaii
Kapiolani Medical Center at Pali Momi
Aiea, Hawaii, United States, 96701
Oncare Hawaii Inc - Kapiolani Medical Center at Pali Momi
Aiea, Hawaii, United States, 96701
Straub Clinic and Hospital
Honolulu, Hawaii, United States, 96813
OnCare Hawaii-Liliha
Honolulu, Hawaii, United States, 96817-3169
Oncare Hawaii Inc-Kuakini
Honolulu, Hawaii, United States, 96817
Queen's Medical Center
Honolulu, Hawaii, United States, 96813
Kuakini Medical Center
Honolulu, Hawaii, United States, 96817
Kapiolani Medical Center for Women and Children
Honolulu, Hawaii, United States, 96826
Oncare Hawaii Inc-POB II
Honolulu, Hawaii, United States, 96813
University of Hawaii
Honolulu, Hawaii, United States, 96813
Castle Medical Center
Kailua, Hawaii, United States, 96734
Wilcox Memorial Hospital and Kauai Medical Clinic
Lihue, Hawaii, United States, 96766
United States, Illinois
Saint Joseph Medical Center
Bloomington, Illinois, United States, 61701
Illinois CancerCare-Bloomington
Bloomington%, Illinois, United States, 61701
Illinois CancerCare-Canton
Canton, Illinois, United States, 61520
Graham Hospital Association
Canton, Illinois, United States, 61520
Illinois CancerCare-Carthage
Carthage, Illinois, United States, 62321
Memorial Hospital
Carthage, Illinois, United States, 62321
Decatur Memorial Hospital
Decatur, Illinois, United States, 62526
Illinois CancerCare-Eureka
Eureka, Illinois, United States, 61530
Eureka Hospital
Eureka, Illinois, United States, 61530
Galesburg Clinic
Galesburg, Illinois, United States, 61401
Illinois CancerCare-Havana
Havana, Illinois, United States, 62644
Mason District Hospital
Havana, Illinois, United States, 62644
Illinois CancerCare-Kewanee Clinic
Kewanee, Illinois, United States, 61443
Mcdonough District Hospital
Macomb, Illinois, United States, 61455
Illinois CancerCare-Macomb
Macomb, Illinois, United States, 61455
Illinois CancerCare-Monmouth
Monmouth, Illinois, United States, 61462
Holy Family Medical Center
Monmouth, Illinois, United States, 61462
Illinois CancerCare-Community Cancer Center
Normal, Illinois, United States, 61761
Community Cancer Center Foundation
Normal, Illinois, United States, 61761
Bromenn Regional Medical Center
Normal, Illinois, United States, 61761
Illinois CancerCare-Ottawa Clinic
Ottawa, Illinois, United States, 61350
Ottawa Regional Hospital and Healthcare Center
Ottawa, Illinois, United States, 61350
Pekin Cancer Treatment Center
Pekin, Illinois, United States, 61554
Illinois CancerCare-Pekin
Pekin, Illinois, United States, 61603
Illinois CancerCare-Peoria
Peoria, Illinois, United States, 61615
Proctor Hospital
Peoria, Illinois, United States, 61614
OSF Saint Francis Medical Center
Peoria, Illinois, United States, 61637
Methodist Medical Center of Illinois
Peoria, Illinois, United States, 61603
Illinois Oncology Research Association CCOP
Peoria, Illinois, United States, 61615
Illinois CancerCare-Peru
Peru, Illinois, United States, 61354
Illinois Valley Hospital
Peru, Illinois, United States, 61354
Perry Memorial Hospital
Princeton, Illinois, United States, 61356
Illinois CancerCare-Princeton
Princeton, Illinois, United States, 61356
Illinois CancerCare-Spring Valley
Spring Valley, Illinois, United States, 61362
Memorial Medical Center
Springfield, Illinois, United States, 62781-0001
United States, Indiana
Saint Francis Hospital and Health Centers
Beech Grove, Indiana, United States, 46107
Indiana University Medical Center
Indianapolis, Indiana, United States, 46202
Reid Hospital and Health Care Services
Richmond, Indiana, United States, 47374
United States, Iowa
McFarland Clinic
Ames, Iowa, United States, 50010
University of Iowa Hospitals and Clinics
Iowa City, Iowa, United States, 52242
Saint Luke's Regional Medical Center
Sioux City, Iowa, United States, 51104
Mercy Medical Center-Sioux City
Sioux City, Iowa, United States, 51104
Siouxland Hematology Oncology Associates
Sioux City, Iowa, United States, 51101
United States, Maryland
Union Hospital of Cecil County
Elkton MD, Maryland, United States, 21921
United States, Massachusetts
Tufts Medical Center
Boston, Massachusetts, United States, 02111
Boston Medical Center
Boston, Massachusetts, United States, 02118
United States, Michigan
University of Michigan University Hospital
Ann Arbor, Michigan, United States, 48109
Wayne State University
Detroit, Michigan, United States, 48202
Green Bay Oncology - Escanaba
Escanaba, Michigan, United States, 49431
Green Bay Oncology - Iron Mountain
Iron Mountain, Michigan, United States, 49801
West Michigan Cancer Center
Kalamazoo, Michigan, United States, 49007
Bronson Methodist Hospital
Kalamazoo, Michigan, United States, 49007
Borgess Medical Center
Kalamazoo, Michigan, United States, 49001
Providence Hospital
Southfield, Michigan, United States, 48075
United States, Minnesota
Fairview Ridges Hospital
Burnsville, Minnesota, United States, 55337
Mercy Hospital
Coon Rapids, Minnesota, United States, 55433
Fairview-Southdale Hospital
Edina, Minnesota, United States, 55435
Unity Hospital
Fridley, Minnesota, United States, 55432
Hutchinson Area Health Care
Hutchinson, Minnesota, United States, 55350
Saint John's Hospital - Healtheast
Maplewood, Minnesota, United States, 55109
Minnesota Oncology Hematology PA-Maplewood
Maplewood, Minnesota, United States, 55109
Abbott-Northwestern Hospital
Minneapolis, Minnesota, United States, 55407
Hennepin County Medical Center
Minneapolis, Minnesota, United States, 55415
New Ulm Medical Center
New Ulm, Minnesota, United States, 56073
North Memorial Medical Health Center
Robbinsdale, Minnesota, United States, 55422
Mayo Clinic
Rochester, Minnesota, United States, 55905
Metro-Minnesota CCOP
Saint Louis Park, Minnesota, United States, 55416
Park Nicollet Clinic - Saint Louis Park
Saint Louis Park, Minnesota, United States, 55416
Regions Hospital
Saint Paul, Minnesota, United States, 55101
United Hospital
Saint Paul, Minnesota, United States, 55102
Saint Francis Regional Medical Center
Shakopee, Minnesota, United States, 55379
Lakeview Hospital
Stillwater, Minnesota, United States, 55082
Ridgeview Medical Center
Waconia, Minnesota, United States, 55387
Rice Memorial Hospital
Willmar, Minnesota, United States, 56201
Minnesota Oncology and Hematology PA-Woodbury
Woodbury, Minnesota, United States, 55125
United States, Mississippi
University of Mississippi Medical Center
Jackson, Mississippi, United States, 39216
United States, Missouri
Washington University School of Medicine
Saint Louis, Missouri, United States, 63110
United States, Montana
Montana Cancer Consortium CCOP
Billings, Montana, United States, 59101
Saint Vincent Healthcare
Billings, Montana, United States, 59101
Billings Clinic
Billings, Montana, United States, 59107-7000
Hematology-Oncology Centers of the Northern Rockies PC
Billings, Montana, United States, 59102
Bozeman Deaconess Hospital
Bozeman, Montana, United States, 59715
Bozeman Deaconess Cancer Center
Bozeman, Montana, United States, 59715
Saint James Community Hospital and Cancer Treatment Center
Butte, Montana, United States, 59701
Benefis Healthcare- Sletten Cancer Institute
Great Falls, Montana, United States, 59405
Great Falls Clinic
Great Falls, Montana, United States, 59405
Northern Montana Hospital
Havre, Montana, United States, 59501
Saint Peter's Community Hospital
Helena, Montana, United States, 59601
Kalispell Regional Medical Center
Kalispell, Montana, United States, 59901
Kalispell Medical Oncology
Kalispell, Montana, United States, 59901
Glacier Oncology PLLC
Kalispell, Montana, United States, 59901
Saint Patrick Hospital - Community Hospital
Missoula, Montana, United States, 59802
Montana Cancer Specialists
Missoula, Montana, United States, 59802
United States, New Jersey
Cooper Hospital University Medical Center
Camden, New Jersey, United States, 08103
United States, Ohio
The Jewish Hospital
Cincinnati, Ohio, United States, 45236
Case Western Reserve University
Cleveland, Ohio, United States, 44106
MetroHealth Medical Center
Cleveland, Ohio, United States, 44109
Miami Valley Hospital
Dayton, Ohio, United States, 45409
Grandview Hospital
Dayton, Ohio, United States, 45405
Samaritan North Health Center
Dayton, Ohio, United States, 45415
Good Samaritan Hospital - Dayton
Dayton, Ohio, United States, 45406
Dayton CCOP
Dayton, Ohio, United States, 45420
Blanchard Valley Hospital
Findlay, Ohio, United States, 45840
Atrium Medical Center-Middletown Regional Hospital
Franklin, Ohio, United States, 45005-1066
Wayne Hospital
Greenville, Ohio, United States, 45331
Kettering Medical Center
Kettering, Ohio, United States, 45429
Upper Valley Medical Center
Troy, Ohio, United States, 45373
Clinton Memorial Hospital
Wilmington, Ohio, United States, 45177
Greene Memorial Hospital
Xenia, Ohio, United States, 45385
United States, Oregon
Clackamas Radiation Oncology Center
Clackamas, Oregon, United States, 97015
Providence Milwaukie Hospital
Milwaukie, Oregon, United States, 97222
Providence Newberg Medical Center
Newberg, Oregon, United States, 97132
Providence Willamette Falls Medical Center
Oregon City, Oregon, United States, 97045
Providence Portland Medical Center
Portland, Oregon, United States, 97213
Providence Saint Vincent Medical Center
Portland, Oregon, United States, 97225
Columbia River Oncology Program
Portland, Oregon, United States, 97225
United States, Pennsylvania
Geisinger Medical Center
Danville, Pennsylvania, United States, 17822-2001
Geisinger Medical Center-Cancer Center Hazelton
Hazleton, Pennsylvania, United States, 18201
Fox Chase Cancer Center
Philadelphia, Pennsylvania, United States, 19111-2497
Geisinger Medical Group
State College, Pennsylvania, United States, 16801
Geisinger Wyoming Valley
Wilkes-Barre, Pennsylvania, United States, 18711
United States, Washington
Cancer Care Center at Island Hospital
Anacortes, Washington, United States, 98221
PeaceHealth Saint Joseph Medical Center
Bellingham, Washington, United States, 98225
Harrison Bremerton Hematology and Oncology
Bremerton, Washington, United States, 98310
Highline Medical Center-Main Campus
Burien, Washington, United States, 98166
Swedish Cancer Institute-Issaquah
Issaquah, Washington, United States, 98029
Columbia Basin Hematology and Oncology PLLC
Kennewick, Washington, United States, 99336
Skagit Valley Hospital
Mount Vernon, Washington, United States, 98274
Harrison Poulsbo Hematology and Oncology
Poulsbo, Washington, United States, 98370
University of Washington Medical Center
Seattle, Washington, United States, 98195
Harborview Medical Center
Seattle, Washington, United States, 98104
Swedish Medical Center-First Hill
Seattle, Washington, United States, 98122-4307
The Polyclinic
Seattle, Washington, United States, 98122
Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium
Seattle, Washington, United States, 98109
Group Health Cooperative
Seattle, Washington, United States, 98112
Minor and James Medical PLLC
Seattle, Washington, United States, 98104
United General Hospital
Sedro-Woolley, Washington, United States, 98284
Evergreen Hematology and Oncology PS
Spokane, Washington, United States, 99218
Cancer Care Northwest - Spokane South
Spokane, Washington, United States, 99202
PeaceHealth Southwest Medical Center
Vancouver, Washington, United States, 98664
Northwest Cancer Specialists
Vancouver, Washington, United States, 98684
Wenatchee Valley Medical Center
Wenatchee, Washington, United States, 98801
United States, Wisconsin
Marshfield Clinic-Chippewa Center
Chippewa Falls, Wisconsin, United States, 54729
Marshfield Clinic Cancer Care at Regional Cancer Center
Eau Claire, Wisconsin, United States, 54701
Green Bay Oncology at Saint Vincent Hospital
Green Bay, Wisconsin, United States, 54301-3526
Saint Mary's Hospital
Green Bay, Wisconsin, United States, 54303
Saint Vincent Hospital
Green Bay, Wisconsin, United States, 54301
Green Bay Oncology Limited at Saint Mary's Hospital
Green Bay, Wisconsin, United States, 54303
Gundersen Lutheran
La Crosse, Wisconsin, United States, 54601
Holy Family Memorial Hospital
Manitowoc, Wisconsin, United States, 54221
Bay Area Medical Center
Marinette, Wisconsin, United States, 54143
Marshfield Clinic
Marshfield, Wisconsin, United States, 54449
Marshfield Clinic-Minocqua Center
Minocqua, Wisconsin, United States, 54548
Green Bay Oncology - Oconto Falls
Oconto Falls, Wisconsin, United States, 54154
Marshfield Clinic at James Beck Cancer Center
Rhinelander, Wisconsin, United States, 54501
Marshfield Clinic-Rice Lake Center
Rice Lake, Wisconsin, United States, 54868
Saint Nicholas Hospital
Sheboygan, Wisconsin, United States, 53081
Marshfield Clinic Cancer Care at Saint Michael's Hospital
Stevens Point, Wisconsin, United States, 54481
Green Bay Oncology - Sturgeon Bay
Sturgeon Bay, Wisconsin, United States, 54235
Marshfield Clinic - Weston Center
Weston, Wisconsin, United States, 54476
Diagnostic and Treatment Center
Weston, Wisconsin, United States, 54476
Marshfield Clinic - Wisconsin Rapids Center
Wisconsin Rapids, Wisconsin, United States, 54494
United States, Wyoming
Rocky Mountain Oncology
Casper, Wyoming, United States, 82609
Welch Cancer Center
Sheridan, Wyoming, United States, 82801
Sponsors and Collaborators
Investigators
Principal Investigator: Angela Dispenzieri Eastern Cooperative Oncology Group
  More Information

No publications provided

Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT01078454     History of Changes
Other Study ID Numbers: NCI-2011-02010, E4A08, U10CA021115
Study First Received: February 27, 2010
Last Updated: March 18, 2013
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Amyloidosis
Multiple Myeloma
Proteostasis Deficiencies
Metabolic Diseases
Neoplasms, Plasma Cell
Neoplasms by Histologic Type
Neoplasms
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Paraproteinemias
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Lymphoproliferative Disorders
Immunoproliferative Disorders
Immune System Diseases
Dexamethasone acetate
Dexamethasone
Dexamethasone 21-phosphate
Bortezomib
Melphalan
BB 1101
Anti-Inflammatory Agents
Therapeutic Uses
Pharmacologic Actions
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on July 28, 2014