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

Primary Purpose

Light Chain Deposition Disease, Primary Systemic Amyloidosis

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
melphalan
dexamethasone
bortezomib
Sponsored by
National Cancer Institute (NCI)
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Light Chain Deposition Disease focused on measuring Melphalan, Dexamethasone, Bortezomib, Systemic Light-chain (AL) Amyloidosis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)
    • Difference between involved and uninvolved free light chain be >4.0mg/dL provided the kappa to lambda free light chain (FLC) 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 echocardiogram in the absence of a history of hypertension or valvular heart disease or in the presence of unexplained low voltage (< 0.5 mV) by electrocardiogram
    • 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
  • 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

  • Amyloid cardiac biomarker stage I or II disease

    • The amyloid cardiac staging system is based on NT-proBNP and troponin-T levels. If troponin T (cTnT) is not available at local institution then troponin I (cTnI) may be used. Thresholds for cTnT, cTnI, and NT-proBNP are < 0.035 ug/L, < 0.1 ug/L, and < 332 ng/L, respectively. Stage I patients have both troponin-T (or I) and NT-proBNP below the threshold. Stage II patients have either troponin-T (I) or NT-proBNP above the threshold. Stage III patients have troponin-T (or I) and simultaneous NT-proBNP above the threshold. Stage III patients are further classified as "better risk" if NT-proBNP is over 332 ng/L but less than 6000 ng/L
  • Negative pregnancy test
  • Fertile patients must use effective contraception
  • The absence of supine systolic blood pressure < 100 mmHg and difficult to manage symptomatic orthostatic hypotension
  • Absolute neutrophil count (ANC) > 1,500/mm^3
  • Platelet count > 140,000/mm^3
  • Hemoglobin > 10 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%

  • 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

  • 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

Exclusion Criteria:

  • Pregnant or nursing
  • Clinically overt myeloma (hypercalcemia or lytic bone lesions)
  • Prior chemotherapy or radiotherapy for the treatment of myeloma or systemic light-chain amyloidosis
  • History of sustained ventricular tachycardias
  • Cardiac syncope
  • Uncompensated New York Heart Association (NYHA) class III or IV congestive heart failure
  • Uncontrolled infection
  • 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
  • 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
  • Hypersensitivity to bortezomib, boron, or mannitol
  • Grade 2 or higher peripheral neuropathy

Sites / Locations

  • Mayo Clinic in Arizona
  • University of Arkansas for Medical Sciences
  • The Medical Center of Aurora
  • Boulder Community Hospital
  • Penrose-Saint Francis Healthcare
  • Porter Adventist Hospital
  • Exempla Saint Joseph Hospital
  • Presbyterian - Saint Lukes Medical Center - Health One
  • Rose Medical Center
  • Colorado Cancer Research Program CCOP
  • Swedish Medical Center
  • Saint Mary's Hospital and Regional Medical Center
  • North Colorado Medical Center
  • Saint Anthony Hospital
  • Littleton Adventist Hospital
  • Sky Ridge Medical Center
  • Longmont United Hospital
  • McKee Medical Center
  • Parker Adventist Hospital
  • Saint Mary Corwin Medical Center
  • North Suburban Medical Center
  • Exempla Lutheran Medical Center
  • Eastern Connecticut Hematology and Oncology Associates
  • Beebe Medical Center
  • Christiana Care Health System-Christiana Hospital
  • Mayo Clinic in Florida
  • Cleveland Clinic Florida - Weston
  • Emory University/Winship Cancer Institute
  • Oncare Hawaii Inc-Pali Momi
  • Pali Momi Medical Center
  • Oncare Hawaii Inc-POB II
  • Queen's Medical Center
  • Straub Clinic and Hospital
  • University of Hawaii
  • OnCare Hawaii-Liliha
  • Kuakini Medical Center
  • Oncare Hawaii Inc-Kuakini
  • Kapiolani Medical Center for Women and Children
  • Castle Medical Center
  • Wilcox Memorial Hospital and Kauai Medical Clinic
  • Illinois CancerCare-Bloomington
  • Saint Joseph Medical Center
  • Graham Hospital Association
  • Illinois CancerCare-Canton
  • Illinois CancerCare-Carthage
  • Memorial Hospital
  • Decatur Memorial Hospital
  • Eureka Hospital
  • Illinois CancerCare-Eureka
  • Illinois CancerCare Galesburg
  • Illinois CancerCare-Havana
  • Mason District Hospital
  • Illinois CancerCare-Kewanee Clinic
  • Illinois CancerCare-Macomb
  • Mcdonough District Hospital
  • Holy Family Medical Center
  • Illinois CancerCare-Monmouth
  • Bromenn Regional Medical Center
  • Community Cancer Center Foundation
  • Illinois CancerCare-Community Cancer Center
  • Illinois CancerCare-Ottawa Clinic
  • Ottawa Regional Hospital and Healthcare Center
  • Pekin Cancer Treatment Center
  • Illinois CancerCare-Pekin
  • Methodist Medical Center of Illinois
  • Proctor Hospital
  • Illinois CancerCare-Peoria
  • Illinois Oncology Research Association CCOP
  • OSF Saint Francis Medical Center
  • Illinois CancerCare-Peru
  • Illinois Valley Hospital
  • Illinois CancerCare-Princeton
  • Perry Memorial Hospital
  • Illinois CancerCare-Spring Valley
  • Memorial Medical Center
  • Saint Francis Hospital and Health Centers
  • Indiana University Medical Center
  • Reid Hospital and Health Care Services
  • McFarland Clinic PC-William R Bliss Cancer Center
  • University of Iowa Hospitals and Clinics
  • Siouxland Hematology Oncology Associates
  • Mercy Medical Center-Sioux City
  • Saint Luke's Regional Medical Center
  • Union Hospital of Cecil County
  • Tufts Medical Center
  • Boston Medical Center
  • University of Michigan
  • Wayne State University/Karmanos Cancer Institute
  • Green Bay Oncology - Escanaba
  • Green Bay Oncology - Iron Mountain
  • Borgess Medical Center
  • Bronson Methodist Hospital
  • West Michigan Cancer Center
  • Providence Hospital
  • Fairview Ridges Hospital
  • Mercy Hospital
  • Fairview-Southdale Hospital
  • Unity Hospital
  • Hutchinson Area Health Care
  • Minnesota Oncology Hematology PA-Maplewood
  • Saint John's Hospital - Healtheast
  • Abbott-Northwestern Hospital
  • Hennepin County Medical Center
  • New Ulm Medical Center
  • North Memorial Medical Health Center
  • Mayo Clinic
  • Metro-Minnesota CCOP
  • Park Nicollet Clinic - Saint Louis Park
  • Regions Hospital
  • United Hospital
  • Saint Francis Regional Medical Center
  • Lakeview Hospital
  • Ridgeview Medical Center
  • Rice Memorial Hospital
  • Minnesota Oncology and Hematology PA-Woodbury
  • University of Mississippi Medical Center
  • Washington University School of Medicine
  • Montana Cancer Consortium CCOP
  • Saint Vincent Healthcare
  • Hematology-Oncology Centers of the Northern Rockies PC
  • Billings Clinic
  • Bozeman Deaconess Cancer Center
  • Bozeman Deaconess Hospital
  • Saint James Community Hospital and Cancer Treatment Center
  • Benefis Healthcare- Sletten Cancer Institute
  • Great Falls Clinic
  • Northern Montana Hospital
  • Saint Peter's Community Hospital
  • Glacier Oncology PLLC
  • Kalispell Medical Oncology
  • Kalispell Regional Medical Center
  • Montana Cancer Specialists
  • Saint Patrick Hospital - Community Hospital
  • Cooper Hospital University Medical Center
  • The Jewish Hospital
  • Case Western Reserve University
  • MetroHealth Medical Center
  • Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University Medical Center
  • Grandview Hospital
  • Good Samaritan Hospital - Dayton
  • Miami Valley Hospital
  • Samaritan North Health Center
  • Dayton CCOP
  • Blanchard Valley Hospital
  • Atrium Medical Center-Middletown Regional Hospital
  • Wayne Hospital
  • Kettering Medical Center
  • Upper Valley Medical Center
  • Clinton Memorial Hospital
  • Greene Memorial Hospital
  • Clackamas Radiation Oncology Center
  • Providence Milwaukie Hospital
  • Providence Newberg Medical Center
  • Providence Willamette Falls Medical Center
  • Providence Portland Medical Center
  • Western Oncology Research Consortium
  • Adventist Medical Center
  • Providence Saint Vincent Medical Center
  • Geisinger Medical Center
  • Geisinger Medical Center-Cancer Center Hazelton
  • Fox Chase Cancer Center
  • Geisinger Medical Group
  • Geisinger Wyoming Valley
  • Cancer Care Center at Island Hospital
  • PeaceHealth Saint Joseph Medical Center
  • Harrison HealthPartners Hematology and Oncology-Bremerton
  • Highline Medical Center-Main Campus
  • Swedish Cancer Institute-Issaquah
  • Columbia Basin Hematology and Oncology PLLC
  • Skagit Valley Hospital
  • Harrison HealthPartners Hematology and Oncology-Poulsbo
  • Harborview Medical Center
  • Minor and James Medical PLLC
  • Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium
  • Group Health Cooperative-Seattle
  • Swedish Medical Center-First Hill
  • The Polyclinic
  • University of Washington Medical Center
  • United General Hospital
  • Cancer Care Northwest - Spokane South
  • Evergreen Hematology and Oncology PS
  • PeaceHealth Southwest Medical Center
  • Compass Oncology Vancouver
  • Wenatchee Valley Medical Center
  • Marshfield Clinic-Chippewa Center
  • Marshfield Clinic Cancer Center at Sacred Heart
  • Green Bay Oncology at Saint Vincent Hospital
  • Saint Vincent Hospital
  • Green Bay Oncology Limited at Saint Mary's Hospital
  • Saint Mary's Hospital
  • Gundersen Lutheran
  • Holy Family Memorial Hospital
  • Bay Area Medical Center
  • Marshfield Clinic
  • Marshfield Clinic-Minocqua Center
  • D N Greenwald Center
  • Oconomowoc Memorial Hospital-ProHealth Care Inc
  • Green Bay Oncology - Oconto Falls
  • Marshfield Clinic at James Beck Cancer Center
  • Marshfield Clinic-Rice Lake Center
  • Saint Nicholas Hospital
  • Marshfield Clinic Cancer Care at Saint Michael's Hospital
  • Green Bay Oncology - Sturgeon Bay
  • Waukesha Memorial Hospital - ProHealth Care
  • Diagnostic and Treatment Center
  • Marshfield Clinic - Weston Center
  • Marshfield Clinic - Wisconsin Rapids Center
  • Rocky Mountain Oncology
  • Welch Cancer Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

ARM A (Mel-Dex)

ARM B (B-Mel-Dex)

Arm Description

Patients receive melphalan 0.22 mg/kg orally (PO) and dexamethasone 40 mg PO on days 1-4 every 4 weeks. Treatment repeats every 4 weeks for up to 9 courses in the absence of disease progression or unacceptable toxicity.

Patients receive melphalan 0.22 mg/kg PO and dexamethasone 40 mg PO on days 1-4 and bortezomib 1.3 mg/m^2 intravenously (IV) on days 1, 4, 8, and 11 every 4 weeks. Treatment repeats every 4 weeks for 2 cycles. Patients then receive melphalan PO and dexamethasone PO on days 1-4 and bortezomib IV on days 1, 8, 15, and 22 every 5 weeks. Treatment repeats every 5 weeks for up to 6 cycles in the absence of disease progression or unacceptable toxicity.

Outcomes

Primary Outcome Measures

Proportion of Patients With Hematologic Overall Response (Partial Response [PR]+ Very Good PR [VGPR]+ Amyloid Complete Response [ACR]+ Stringent Complete Response [sCR]) After 3 Months (3 Cycles) of Therapy
sCR: ACR and no clonal cells in bone marrow (BM) ACR: Negative serum/urine immunofixation (IF), <5% plasma cells in BM, and normal serum FLC ratio VGPR: 1. PR and any of the following; 2. serum/urine M-protein detectable by IF but not measurable (NM) on electrophoresis (EP); (3) ≥90% reduction in serum M-component and urine M-protein <100 mg/24 hr if baseline serum measurable; (4) urine M-component <100 mg/24 hr and NM serum M-protein on serum protein EP if baseline urine measurable; (5) ≥90% drop in the difference between involved and uninvolved FLC levels if only FLC measurable PR: (1) ≥50% drop of serum M-protein and 24-hr urinary M-protein drop by ≥90% or to <200 mg/24 hr if baseline serum/urine measurable; or (2) ≥50% drop of serum M-protein if only serum measurable at baseline; or (3) 24-hr urinary M-protein drop by ≥90% or to <200 mg/24 hr if baseline urine measurable; or (4) ≥ 50% drop in the difference between involved and uninvolved FLC if only FLC measu

Secondary Outcome Measures

Full Information

First Posted
February 27, 2010
Last Updated
January 12, 2022
Sponsor
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT01078454
Brief Title
Melphalan and Dexamethasone With or Without Bortezomib in Treating Patients With Previously Untreated Systemic Light-Chain Amyloidosis
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
Study Type
Interventional

2. Study Status

Record Verification Date
January 2022
Overall Recruitment Status
Completed
Study Start Date
November 2010 (undefined)
Primary Completion Date
November 12, 2012 (Actual)
Study Completion Date
November 27, 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National Cancer Institute (NCI)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.
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 amyloid cardiac stage (stage I/II vs. better risk stage III) and are randomized to 1 of 2 treatment arms. ARM A (Mel-Dex): Patients receive melphalan 0.22 mg/kg orally (PO) and dexamethasone 40 mg PO on days 1-4 every 4 weeks. Treatment repeats every 4 weeks for up to 9 courses in the absence of disease progression or unacceptable toxicity. ARM B (B-Mel-Dex): Patients receive melphalan 0.22 mg/kg PO and dexamethasone 40 mg PO on days 1-4 and bortezomib 1.3 mg/m2 intravenously (IV) on days 1, 4, 8, and 11 every 4 weeks. Treatment repeats every 4 weeks for 2 cycles. Patients then receive melphalan PO and dexamethasone PO on days 1-4 and bortezomib IV on days 1, 8, 15, and 22 every 5 weeks. Treatment repeats every 5 weeks for up to 6 cycles 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Light Chain Deposition Disease, Primary Systemic Amyloidosis
Keywords
Melphalan, Dexamethasone, Bortezomib, Systemic Light-chain (AL) Amyloidosis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
11 (Actual)

8. Arms, Groups, and Interventions

Arm Title
ARM A (Mel-Dex)
Arm Type
Experimental
Arm Description
Patients receive melphalan 0.22 mg/kg orally (PO) and dexamethasone 40 mg PO on days 1-4 every 4 weeks. Treatment repeats every 4 weeks for up to 9 courses in the absence of disease progression or unacceptable toxicity.
Arm Title
ARM B (B-Mel-Dex)
Arm Type
Experimental
Arm Description
Patients receive melphalan 0.22 mg/kg PO and dexamethasone 40 mg PO on days 1-4 and bortezomib 1.3 mg/m^2 intravenously (IV) on days 1, 4, 8, and 11 every 4 weeks. Treatment repeats every 4 weeks for 2 cycles. Patients then receive melphalan PO and dexamethasone PO on days 1-4 and bortezomib IV on days 1, 8, 15, and 22 every 5 weeks. Treatment repeats every 5 weeks for up to 6 cycles in the absence of disease progression or unacceptable toxicity.
Intervention Type
Drug
Intervention Name(s)
melphalan
Other Intervention Name(s)
L-PAM, L-phenylalanine mustard, L-sarcolysin, Alkeran, NSC #8806
Intervention Description
Given PO
Intervention Type
Drug
Intervention Name(s)
dexamethasone
Other Intervention Name(s)
Decadron, Hexadrol, Dexameth, Dexone, DXM
Intervention Description
Given PO
Intervention Type
Drug
Intervention Name(s)
bortezomib
Other Intervention Name(s)
Velcade®, PS-341, MLN-341, LDP-341
Intervention Description
Given IV
Primary Outcome Measure Information:
Title
Proportion of Patients With Hematologic Overall Response (Partial Response [PR]+ Very Good PR [VGPR]+ Amyloid Complete Response [ACR]+ Stringent Complete Response [sCR]) After 3 Months (3 Cycles) of Therapy
Description
sCR: ACR and no clonal cells in bone marrow (BM) ACR: Negative serum/urine immunofixation (IF), <5% plasma cells in BM, and normal serum FLC ratio VGPR: 1. PR and any of the following; 2. serum/urine M-protein detectable by IF but not measurable (NM) on electrophoresis (EP); (3) ≥90% reduction in serum M-component and urine M-protein <100 mg/24 hr if baseline serum measurable; (4) urine M-component <100 mg/24 hr and NM serum M-protein on serum protein EP if baseline urine measurable; (5) ≥90% drop in the difference between involved and uninvolved FLC levels if only FLC measurable PR: (1) ≥50% drop of serum M-protein and 24-hr urinary M-protein drop by ≥90% or to <200 mg/24 hr if baseline serum/urine measurable; or (2) ≥50% drop of serum M-protein if only serum measurable at baseline; or (3) 24-hr urinary M-protein drop by ≥90% or to <200 mg/24 hr if baseline urine measurable; or (4) ≥ 50% drop in the difference between involved and uninvolved FLC if only FLC measu
Time Frame
Assessed at 3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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) Difference between involved and uninvolved free light chain be >4.0mg/dL provided the kappa to lambda free light chain (FLC) 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 echocardiogram in the absence of a history of hypertension or valvular heart disease or in the presence of unexplained low voltage (< 0.5 mV) by electrocardiogram 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 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 Amyloid cardiac biomarker stage I or II disease The amyloid cardiac staging system is based on NT-proBNP and troponin-T levels. If troponin T (cTnT) is not available at local institution then troponin I (cTnI) may be used. Thresholds for cTnT, cTnI, and NT-proBNP are < 0.035 ug/L, < 0.1 ug/L, and < 332 ng/L, respectively. Stage I patients have both troponin-T (or I) and NT-proBNP below the threshold. Stage II patients have either troponin-T (I) or NT-proBNP above the threshold. Stage III patients have troponin-T (or I) and simultaneous NT-proBNP above the threshold. Stage III patients are further classified as "better risk" if NT-proBNP is over 332 ng/L but less than 6000 ng/L Negative pregnancy test Fertile patients must use effective contraception The absence of supine systolic blood pressure < 100 mmHg and difficult to manage symptomatic orthostatic hypotension Absolute neutrophil count (ANC) > 1,500/mm^3 Platelet count > 140,000/mm^3 Hemoglobin > 10 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% 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 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 Exclusion Criteria: Pregnant or nursing Clinically overt myeloma (hypercalcemia or lytic bone lesions) Prior chemotherapy or radiotherapy for the treatment of myeloma or systemic light-chain amyloidosis History of sustained ventricular tachycardias Cardiac syncope Uncompensated New York Heart Association (NYHA) class III or IV congestive heart failure Uncontrolled infection 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 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 Hypersensitivity to bortezomib, boron, or mannitol Grade 2 or higher peripheral neuropathy
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Angela Dispenzieri, M.D.
Organizational Affiliation
Mayo Clinic
Official's Role
Study Chair
Facility Information:
Facility Name
Mayo Clinic in Arizona
City
Scottsdale
State/Province
Arizona
ZIP/Postal Code
85259
Country
United States
Facility Name
University of Arkansas for Medical Sciences
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72205
Country
United States
Facility Name
The Medical Center of Aurora
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80012
Country
United States
Facility Name
Boulder Community Hospital
City
Boulder
State/Province
Colorado
ZIP/Postal Code
80301
Country
United States
Facility Name
Penrose-Saint Francis Healthcare
City
Colorado Springs
State/Province
Colorado
ZIP/Postal Code
80907
Country
United States
Facility Name
Porter Adventist Hospital
City
Denver
State/Province
Colorado
ZIP/Postal Code
80210
Country
United States
Facility Name
Exempla Saint Joseph Hospital
City
Denver
State/Province
Colorado
ZIP/Postal Code
80218
Country
United States
Facility Name
Presbyterian - Saint Lukes Medical Center - Health One
City
Denver
State/Province
Colorado
ZIP/Postal Code
80218
Country
United States
Facility Name
Rose Medical Center
City
Denver
State/Province
Colorado
ZIP/Postal Code
80220
Country
United States
Facility Name
Colorado Cancer Research Program CCOP
City
Denver
State/Province
Colorado
ZIP/Postal Code
80224-2522
Country
United States
Facility Name
Swedish Medical Center
City
Englewood
State/Province
Colorado
ZIP/Postal Code
80113
Country
United States
Facility Name
Saint Mary's Hospital and Regional Medical Center
City
Grand Junction
State/Province
Colorado
ZIP/Postal Code
81502
Country
United States
Facility Name
North Colorado Medical Center
City
Greeley
State/Province
Colorado
ZIP/Postal Code
80631
Country
United States
Facility Name
Saint Anthony Hospital
City
Lakewood
State/Province
Colorado
ZIP/Postal Code
80228
Country
United States
Facility Name
Littleton Adventist Hospital
City
Littleton
State/Province
Colorado
ZIP/Postal Code
80122
Country
United States
Facility Name
Sky Ridge Medical Center
City
Lone Tree
State/Province
Colorado
ZIP/Postal Code
80124
Country
United States
Facility Name
Longmont United Hospital
City
Longmont
State/Province
Colorado
ZIP/Postal Code
80501
Country
United States
Facility Name
McKee Medical Center
City
Loveland
State/Province
Colorado
ZIP/Postal Code
80539
Country
United States
Facility Name
Parker Adventist Hospital
City
Parker
State/Province
Colorado
ZIP/Postal Code
80138
Country
United States
Facility Name
Saint Mary Corwin Medical Center
City
Pueblo
State/Province
Colorado
ZIP/Postal Code
81004
Country
United States
Facility Name
North Suburban Medical Center
City
Thornton
State/Province
Colorado
ZIP/Postal Code
80229
Country
United States
Facility Name
Exempla Lutheran Medical Center
City
Wheat Ridge
State/Province
Colorado
ZIP/Postal Code
80033
Country
United States
Facility Name
Eastern Connecticut Hematology and Oncology Associates
City
Norwich
State/Province
Connecticut
ZIP/Postal Code
06360
Country
United States
Facility Name
Beebe Medical Center
City
Lewes
State/Province
Delaware
ZIP/Postal Code
19958
Country
United States
Facility Name
Christiana Care Health System-Christiana Hospital
City
Newark
State/Province
Delaware
ZIP/Postal Code
19718
Country
United States
Facility Name
Mayo Clinic in Florida
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32224-9980
Country
United States
Facility Name
Cleveland Clinic Florida - Weston
City
Weston
State/Province
Florida
ZIP/Postal Code
33331
Country
United States
Facility Name
Emory University/Winship Cancer Institute
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30322
Country
United States
Facility Name
Oncare Hawaii Inc-Pali Momi
City
'Aiea
State/Province
Hawaii
ZIP/Postal Code
96701
Country
United States
Facility Name
Pali Momi Medical Center
City
'Aiea
State/Province
Hawaii
ZIP/Postal Code
96701
Country
United States
Facility Name
Oncare Hawaii Inc-POB II
City
Honolulu
State/Province
Hawaii
ZIP/Postal Code
96813
Country
United States
Facility Name
Queen's Medical Center
City
Honolulu
State/Province
Hawaii
ZIP/Postal Code
96813
Country
United States
Facility Name
Straub Clinic and Hospital
City
Honolulu
State/Province
Hawaii
ZIP/Postal Code
96813
Country
United States
Facility Name
University of Hawaii
City
Honolulu
State/Province
Hawaii
ZIP/Postal Code
96813
Country
United States
Facility Name
OnCare Hawaii-Liliha
City
Honolulu
State/Province
Hawaii
ZIP/Postal Code
96817-3169
Country
United States
Facility Name
Kuakini Medical Center
City
Honolulu
State/Province
Hawaii
ZIP/Postal Code
96817
Country
United States
Facility Name
Oncare Hawaii Inc-Kuakini
City
Honolulu
State/Province
Hawaii
ZIP/Postal Code
96817
Country
United States
Facility Name
Kapiolani Medical Center for Women and Children
City
Honolulu
State/Province
Hawaii
ZIP/Postal Code
96826
Country
United States
Facility Name
Castle Medical Center
City
Kailua
State/Province
Hawaii
ZIP/Postal Code
96734
Country
United States
Facility Name
Wilcox Memorial Hospital and Kauai Medical Clinic
City
Lihue
State/Province
Hawaii
ZIP/Postal Code
96766
Country
United States
Facility Name
Illinois CancerCare-Bloomington
City
Bloomington
State/Province
Illinois
ZIP/Postal Code
61701
Country
United States
Facility Name
Saint Joseph Medical Center
City
Bloomington
State/Province
Illinois
ZIP/Postal Code
61701
Country
United States
Facility Name
Graham Hospital Association
City
Canton
State/Province
Illinois
ZIP/Postal Code
61520
Country
United States
Facility Name
Illinois CancerCare-Canton
City
Canton
State/Province
Illinois
ZIP/Postal Code
61520
Country
United States
Facility Name
Illinois CancerCare-Carthage
City
Carthage
State/Province
Illinois
ZIP/Postal Code
62321
Country
United States
Facility Name
Memorial Hospital
City
Carthage
State/Province
Illinois
ZIP/Postal Code
62321
Country
United States
Facility Name
Decatur Memorial Hospital
City
Decatur
State/Province
Illinois
ZIP/Postal Code
62526
Country
United States
Facility Name
Eureka Hospital
City
Eureka
State/Province
Illinois
ZIP/Postal Code
61530
Country
United States
Facility Name
Illinois CancerCare-Eureka
City
Eureka
State/Province
Illinois
ZIP/Postal Code
61530
Country
United States
Facility Name
Illinois CancerCare Galesburg
City
Galesburg
State/Province
Illinois
ZIP/Postal Code
61401
Country
United States
Facility Name
Illinois CancerCare-Havana
City
Havana
State/Province
Illinois
ZIP/Postal Code
62644
Country
United States
Facility Name
Mason District Hospital
City
Havana
State/Province
Illinois
ZIP/Postal Code
62644
Country
United States
Facility Name
Illinois CancerCare-Kewanee Clinic
City
Kewanee
State/Province
Illinois
ZIP/Postal Code
61443
Country
United States
Facility Name
Illinois CancerCare-Macomb
City
Macomb
State/Province
Illinois
ZIP/Postal Code
61455
Country
United States
Facility Name
Mcdonough District Hospital
City
Macomb
State/Province
Illinois
ZIP/Postal Code
61455
Country
United States
Facility Name
Holy Family Medical Center
City
Monmouth
State/Province
Illinois
ZIP/Postal Code
61462
Country
United States
Facility Name
Illinois CancerCare-Monmouth
City
Monmouth
State/Province
Illinois
ZIP/Postal Code
61462
Country
United States
Facility Name
Bromenn Regional Medical Center
City
Normal
State/Province
Illinois
ZIP/Postal Code
61761
Country
United States
Facility Name
Community Cancer Center Foundation
City
Normal
State/Province
Illinois
ZIP/Postal Code
61761
Country
United States
Facility Name
Illinois CancerCare-Community Cancer Center
City
Normal
State/Province
Illinois
ZIP/Postal Code
61761
Country
United States
Facility Name
Illinois CancerCare-Ottawa Clinic
City
Ottawa
State/Province
Illinois
ZIP/Postal Code
61350
Country
United States
Facility Name
Ottawa Regional Hospital and Healthcare Center
City
Ottawa
State/Province
Illinois
ZIP/Postal Code
61350
Country
United States
Facility Name
Pekin Cancer Treatment Center
City
Pekin
State/Province
Illinois
ZIP/Postal Code
61554
Country
United States
Facility Name
Illinois CancerCare-Pekin
City
Pekin
State/Province
Illinois
ZIP/Postal Code
61603
Country
United States
Facility Name
Methodist Medical Center of Illinois
City
Peoria
State/Province
Illinois
ZIP/Postal Code
61603
Country
United States
Facility Name
Proctor Hospital
City
Peoria
State/Province
Illinois
ZIP/Postal Code
61614
Country
United States
Facility Name
Illinois CancerCare-Peoria
City
Peoria
State/Province
Illinois
ZIP/Postal Code
61615
Country
United States
Facility Name
Illinois Oncology Research Association CCOP
City
Peoria
State/Province
Illinois
ZIP/Postal Code
61615
Country
United States
Facility Name
OSF Saint Francis Medical Center
City
Peoria
State/Province
Illinois
ZIP/Postal Code
61637
Country
United States
Facility Name
Illinois CancerCare-Peru
City
Peru
State/Province
Illinois
ZIP/Postal Code
61354
Country
United States
Facility Name
Illinois Valley Hospital
City
Peru
State/Province
Illinois
ZIP/Postal Code
61354
Country
United States
Facility Name
Illinois CancerCare-Princeton
City
Princeton
State/Province
Illinois
ZIP/Postal Code
61356
Country
United States
Facility Name
Perry Memorial Hospital
City
Princeton
State/Province
Illinois
ZIP/Postal Code
61356
Country
United States
Facility Name
Illinois CancerCare-Spring Valley
City
Spring Valley
State/Province
Illinois
ZIP/Postal Code
61362
Country
United States
Facility Name
Memorial Medical Center
City
Springfield
State/Province
Illinois
ZIP/Postal Code
62781-0001
Country
United States
Facility Name
Saint Francis Hospital and Health Centers
City
Beech Grove
State/Province
Indiana
ZIP/Postal Code
46107
Country
United States
Facility Name
Indiana University Medical Center
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202
Country
United States
Facility Name
Reid Hospital and Health Care Services
City
Richmond
State/Province
Indiana
ZIP/Postal Code
47374
Country
United States
Facility Name
McFarland Clinic PC-William R Bliss Cancer Center
City
Ames
State/Province
Iowa
ZIP/Postal Code
50010
Country
United States
Facility Name
University of Iowa Hospitals and Clinics
City
Iowa City
State/Province
Iowa
ZIP/Postal Code
52242
Country
United States
Facility Name
Siouxland Hematology Oncology Associates
City
Sioux City
State/Province
Iowa
ZIP/Postal Code
51101
Country
United States
Facility Name
Mercy Medical Center-Sioux City
City
Sioux City
State/Province
Iowa
ZIP/Postal Code
51104
Country
United States
Facility Name
Saint Luke's Regional Medical Center
City
Sioux City
State/Province
Iowa
ZIP/Postal Code
51104
Country
United States
Facility Name
Union Hospital of Cecil County
City
Elkton
State/Province
Maryland
ZIP/Postal Code
21921
Country
United States
Facility Name
Tufts Medical Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02111
Country
United States
Facility Name
Boston Medical Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02118
Country
United States
Facility Name
University of Michigan
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109
Country
United States
Facility Name
Wayne State University/Karmanos Cancer Institute
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48201
Country
United States
Facility Name
Green Bay Oncology - Escanaba
City
Escanaba
State/Province
Michigan
ZIP/Postal Code
49431
Country
United States
Facility Name
Green Bay Oncology - Iron Mountain
City
Iron Mountain
State/Province
Michigan
ZIP/Postal Code
49801
Country
United States
Facility Name
Borgess Medical Center
City
Kalamazoo
State/Province
Michigan
ZIP/Postal Code
49001
Country
United States
Facility Name
Bronson Methodist Hospital
City
Kalamazoo
State/Province
Michigan
ZIP/Postal Code
49007
Country
United States
Facility Name
West Michigan Cancer Center
City
Kalamazoo
State/Province
Michigan
ZIP/Postal Code
49007
Country
United States
Facility Name
Providence Hospital
City
Southfield
State/Province
Michigan
ZIP/Postal Code
48075
Country
United States
Facility Name
Fairview Ridges Hospital
City
Burnsville
State/Province
Minnesota
ZIP/Postal Code
55337
Country
United States
Facility Name
Mercy Hospital
City
Coon Rapids
State/Province
Minnesota
ZIP/Postal Code
55433
Country
United States
Facility Name
Fairview-Southdale Hospital
City
Edina
State/Province
Minnesota
ZIP/Postal Code
55435
Country
United States
Facility Name
Unity Hospital
City
Fridley
State/Province
Minnesota
ZIP/Postal Code
55432
Country
United States
Facility Name
Hutchinson Area Health Care
City
Hutchinson
State/Province
Minnesota
ZIP/Postal Code
55350
Country
United States
Facility Name
Minnesota Oncology Hematology PA-Maplewood
City
Maplewood
State/Province
Minnesota
ZIP/Postal Code
55109
Country
United States
Facility Name
Saint John's Hospital - Healtheast
City
Maplewood
State/Province
Minnesota
ZIP/Postal Code
55109
Country
United States
Facility Name
Abbott-Northwestern Hospital
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55407
Country
United States
Facility Name
Hennepin County Medical Center
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55415
Country
United States
Facility Name
New Ulm Medical Center
City
New Ulm
State/Province
Minnesota
ZIP/Postal Code
56073
Country
United States
Facility Name
North Memorial Medical Health Center
City
Robbinsdale
State/Province
Minnesota
ZIP/Postal Code
55422
Country
United States
Facility Name
Mayo Clinic
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
Facility Name
Metro-Minnesota CCOP
City
Saint Louis Park
State/Province
Minnesota
ZIP/Postal Code
55416
Country
United States
Facility Name
Park Nicollet Clinic - Saint Louis Park
City
Saint Louis Park
State/Province
Minnesota
ZIP/Postal Code
55416
Country
United States
Facility Name
Regions Hospital
City
Saint Paul
State/Province
Minnesota
ZIP/Postal Code
55101
Country
United States
Facility Name
United Hospital
City
Saint Paul
State/Province
Minnesota
ZIP/Postal Code
55102
Country
United States
Facility Name
Saint Francis Regional Medical Center
City
Shakopee
State/Province
Minnesota
ZIP/Postal Code
55379
Country
United States
Facility Name
Lakeview Hospital
City
Stillwater
State/Province
Minnesota
ZIP/Postal Code
55082
Country
United States
Facility Name
Ridgeview Medical Center
City
Waconia
State/Province
Minnesota
ZIP/Postal Code
55387
Country
United States
Facility Name
Rice Memorial Hospital
City
Willmar
State/Province
Minnesota
ZIP/Postal Code
56201
Country
United States
Facility Name
Minnesota Oncology and Hematology PA-Woodbury
City
Woodbury
State/Province
Minnesota
ZIP/Postal Code
55125
Country
United States
Facility Name
University of Mississippi Medical Center
City
Jackson
State/Province
Mississippi
ZIP/Postal Code
39216
Country
United States
Facility Name
Washington University School of Medicine
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Facility Name
Montana Cancer Consortium CCOP
City
Billings
State/Province
Montana
ZIP/Postal Code
59101
Country
United States
Facility Name
Saint Vincent Healthcare
City
Billings
State/Province
Montana
ZIP/Postal Code
59101
Country
United States
Facility Name
Hematology-Oncology Centers of the Northern Rockies PC
City
Billings
State/Province
Montana
ZIP/Postal Code
59102
Country
United States
Facility Name
Billings Clinic
City
Billings
State/Province
Montana
ZIP/Postal Code
59107-7000
Country
United States
Facility Name
Bozeman Deaconess Cancer Center
City
Bozeman
State/Province
Montana
ZIP/Postal Code
59715
Country
United States
Facility Name
Bozeman Deaconess Hospital
City
Bozeman
State/Province
Montana
ZIP/Postal Code
59715
Country
United States
Facility Name
Saint James Community Hospital and Cancer Treatment Center
City
Butte
State/Province
Montana
ZIP/Postal Code
59701
Country
United States
Facility Name
Benefis Healthcare- Sletten Cancer Institute
City
Great Falls
State/Province
Montana
ZIP/Postal Code
59405
Country
United States
Facility Name
Great Falls Clinic
City
Great Falls
State/Province
Montana
ZIP/Postal Code
59405
Country
United States
Facility Name
Northern Montana Hospital
City
Havre
State/Province
Montana
ZIP/Postal Code
59501
Country
United States
Facility Name
Saint Peter's Community Hospital
City
Helena
State/Province
Montana
ZIP/Postal Code
59601
Country
United States
Facility Name
Glacier Oncology PLLC
City
Kalispell
State/Province
Montana
ZIP/Postal Code
59901
Country
United States
Facility Name
Kalispell Medical Oncology
City
Kalispell
State/Province
Montana
ZIP/Postal Code
59901
Country
United States
Facility Name
Kalispell Regional Medical Center
City
Kalispell
State/Province
Montana
ZIP/Postal Code
59901
Country
United States
Facility Name
Montana Cancer Specialists
City
Missoula
State/Province
Montana
ZIP/Postal Code
59802
Country
United States
Facility Name
Saint Patrick Hospital - Community Hospital
City
Missoula
State/Province
Montana
ZIP/Postal Code
59802
Country
United States
Facility Name
Cooper Hospital University Medical Center
City
Camden
State/Province
New Jersey
ZIP/Postal Code
08103
Country
United States
Facility Name
The Jewish Hospital
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45236
Country
United States
Facility Name
Case Western Reserve University
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44106
Country
United States
Facility Name
MetroHealth Medical Center
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44109
Country
United States
Facility Name
Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University Medical Center
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210
Country
United States
Facility Name
Grandview Hospital
City
Dayton
State/Province
Ohio
ZIP/Postal Code
45405
Country
United States
Facility Name
Good Samaritan Hospital - Dayton
City
Dayton
State/Province
Ohio
ZIP/Postal Code
45406
Country
United States
Facility Name
Miami Valley Hospital
City
Dayton
State/Province
Ohio
ZIP/Postal Code
45409
Country
United States
Facility Name
Samaritan North Health Center
City
Dayton
State/Province
Ohio
ZIP/Postal Code
45415
Country
United States
Facility Name
Dayton CCOP
City
Dayton
State/Province
Ohio
ZIP/Postal Code
45420
Country
United States
Facility Name
Blanchard Valley Hospital
City
Findlay
State/Province
Ohio
ZIP/Postal Code
45840
Country
United States
Facility Name
Atrium Medical Center-Middletown Regional Hospital
City
Franklin
State/Province
Ohio
ZIP/Postal Code
45005-1066
Country
United States
Facility Name
Wayne Hospital
City
Greenville
State/Province
Ohio
ZIP/Postal Code
45331
Country
United States
Facility Name
Kettering Medical Center
City
Kettering
State/Province
Ohio
ZIP/Postal Code
45429
Country
United States
Facility Name
Upper Valley Medical Center
City
Troy
State/Province
Ohio
ZIP/Postal Code
45373
Country
United States
Facility Name
Clinton Memorial Hospital
City
Wilmington
State/Province
Ohio
ZIP/Postal Code
45177
Country
United States
Facility Name
Greene Memorial Hospital
City
Xenia
State/Province
Ohio
ZIP/Postal Code
45385
Country
United States
Facility Name
Clackamas Radiation Oncology Center
City
Clackamas
State/Province
Oregon
ZIP/Postal Code
97015
Country
United States
Facility Name
Providence Milwaukie Hospital
City
Milwaukie
State/Province
Oregon
ZIP/Postal Code
97222
Country
United States
Facility Name
Providence Newberg Medical Center
City
Newberg
State/Province
Oregon
ZIP/Postal Code
97132
Country
United States
Facility Name
Providence Willamette Falls Medical Center
City
Oregon City
State/Province
Oregon
ZIP/Postal Code
97045
Country
United States
Facility Name
Providence Portland Medical Center
City
Portland
State/Province
Oregon
ZIP/Postal Code
97213
Country
United States
Facility Name
Western Oncology Research Consortium
City
Portland
State/Province
Oregon
ZIP/Postal Code
97213
Country
United States
Facility Name
Adventist Medical Center
City
Portland
State/Province
Oregon
ZIP/Postal Code
97216
Country
United States
Facility Name
Providence Saint Vincent Medical Center
City
Portland
State/Province
Oregon
ZIP/Postal Code
97225
Country
United States
Facility Name
Geisinger Medical Center
City
Danville
State/Province
Pennsylvania
ZIP/Postal Code
17822-2001
Country
United States
Facility Name
Geisinger Medical Center-Cancer Center Hazelton
City
Hazleton
State/Province
Pennsylvania
ZIP/Postal Code
18201
Country
United States
Facility Name
Fox Chase Cancer Center
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19111
Country
United States
Facility Name
Geisinger Medical Group
City
State College
State/Province
Pennsylvania
ZIP/Postal Code
16801
Country
United States
Facility Name
Geisinger Wyoming Valley
City
Wilkes-Barre
State/Province
Pennsylvania
ZIP/Postal Code
18711
Country
United States
Facility Name
Cancer Care Center at Island Hospital
City
Anacortes
State/Province
Washington
ZIP/Postal Code
98221
Country
United States
Facility Name
PeaceHealth Saint Joseph Medical Center
City
Bellingham
State/Province
Washington
ZIP/Postal Code
98225
Country
United States
Facility Name
Harrison HealthPartners Hematology and Oncology-Bremerton
City
Bremerton
State/Province
Washington
ZIP/Postal Code
98310
Country
United States
Facility Name
Highline Medical Center-Main Campus
City
Burien
State/Province
Washington
ZIP/Postal Code
98166
Country
United States
Facility Name
Swedish Cancer Institute-Issaquah
City
Issaquah
State/Province
Washington
ZIP/Postal Code
98029
Country
United States
Facility Name
Columbia Basin Hematology and Oncology PLLC
City
Kennewick
State/Province
Washington
ZIP/Postal Code
99336
Country
United States
Facility Name
Skagit Valley Hospital
City
Mount Vernon
State/Province
Washington
ZIP/Postal Code
98274
Country
United States
Facility Name
Harrison HealthPartners Hematology and Oncology-Poulsbo
City
Poulsbo
State/Province
Washington
ZIP/Postal Code
98370
Country
United States
Facility Name
Harborview Medical Center
City
Seattle
State/Province
Washington
ZIP/Postal Code
98104
Country
United States
Facility Name
Minor and James Medical PLLC
City
Seattle
State/Province
Washington
ZIP/Postal Code
98104
Country
United States
Facility Name
Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium
City
Seattle
State/Province
Washington
ZIP/Postal Code
98109
Country
United States
Facility Name
Group Health Cooperative-Seattle
City
Seattle
State/Province
Washington
ZIP/Postal Code
98112
Country
United States
Facility Name
Swedish Medical Center-First Hill
City
Seattle
State/Province
Washington
ZIP/Postal Code
98122-4307
Country
United States
Facility Name
The Polyclinic
City
Seattle
State/Province
Washington
ZIP/Postal Code
98122
Country
United States
Facility Name
University of Washington Medical Center
City
Seattle
State/Province
Washington
ZIP/Postal Code
98195
Country
United States
Facility Name
United General Hospital
City
Sedro-Woolley
State/Province
Washington
ZIP/Postal Code
98284
Country
United States
Facility Name
Cancer Care Northwest - Spokane South
City
Spokane
State/Province
Washington
ZIP/Postal Code
99202
Country
United States
Facility Name
Evergreen Hematology and Oncology PS
City
Spokane
State/Province
Washington
ZIP/Postal Code
99218
Country
United States
Facility Name
PeaceHealth Southwest Medical Center
City
Vancouver
State/Province
Washington
ZIP/Postal Code
98664
Country
United States
Facility Name
Compass Oncology Vancouver
City
Vancouver
State/Province
Washington
ZIP/Postal Code
98684
Country
United States
Facility Name
Wenatchee Valley Medical Center
City
Wenatchee
State/Province
Washington
ZIP/Postal Code
98801
Country
United States
Facility Name
Marshfield Clinic-Chippewa Center
City
Chippewa Falls
State/Province
Wisconsin
ZIP/Postal Code
54729
Country
United States
Facility Name
Marshfield Clinic Cancer Center at Sacred Heart
City
Eau Claire
State/Province
Wisconsin
ZIP/Postal Code
54701
Country
United States
Facility Name
Green Bay Oncology at Saint Vincent Hospital
City
Green Bay
State/Province
Wisconsin
ZIP/Postal Code
54301-3526
Country
United States
Facility Name
Saint Vincent Hospital
City
Green Bay
State/Province
Wisconsin
ZIP/Postal Code
54301
Country
United States
Facility Name
Green Bay Oncology Limited at Saint Mary's Hospital
City
Green Bay
State/Province
Wisconsin
ZIP/Postal Code
54303
Country
United States
Facility Name
Saint Mary's Hospital
City
Green Bay
State/Province
Wisconsin
ZIP/Postal Code
54303
Country
United States
Facility Name
Gundersen Lutheran
City
La Crosse
State/Province
Wisconsin
ZIP/Postal Code
54601
Country
United States
Facility Name
Holy Family Memorial Hospital
City
Manitowoc
State/Province
Wisconsin
ZIP/Postal Code
54221
Country
United States
Facility Name
Bay Area Medical Center
City
Marinette
State/Province
Wisconsin
ZIP/Postal Code
54143
Country
United States
Facility Name
Marshfield Clinic
City
Marshfield
State/Province
Wisconsin
ZIP/Postal Code
54449
Country
United States
Facility Name
Marshfield Clinic-Minocqua Center
City
Minocqua
State/Province
Wisconsin
ZIP/Postal Code
54548
Country
United States
Facility Name
D N Greenwald Center
City
Mukwonago
State/Province
Wisconsin
ZIP/Postal Code
53149
Country
United States
Facility Name
Oconomowoc Memorial Hospital-ProHealth Care Inc
City
Oconomowoc
State/Province
Wisconsin
ZIP/Postal Code
53066-3896
Country
United States
Facility Name
Green Bay Oncology - Oconto Falls
City
Oconto Falls
State/Province
Wisconsin
ZIP/Postal Code
54154
Country
United States
Facility Name
Marshfield Clinic at James Beck Cancer Center
City
Rhinelander
State/Province
Wisconsin
ZIP/Postal Code
54501
Country
United States
Facility Name
Marshfield Clinic-Rice Lake Center
City
Rice Lake
State/Province
Wisconsin
ZIP/Postal Code
54868
Country
United States
Facility Name
Saint Nicholas Hospital
City
Sheboygan
State/Province
Wisconsin
ZIP/Postal Code
53081
Country
United States
Facility Name
Marshfield Clinic Cancer Care at Saint Michael's Hospital
City
Stevens Point
State/Province
Wisconsin
ZIP/Postal Code
54481
Country
United States
Facility Name
Green Bay Oncology - Sturgeon Bay
City
Sturgeon Bay
State/Province
Wisconsin
ZIP/Postal Code
54235
Country
United States
Facility Name
Waukesha Memorial Hospital - ProHealth Care
City
Waukesha
State/Province
Wisconsin
ZIP/Postal Code
53188
Country
United States
Facility Name
Diagnostic and Treatment Center
City
Weston
State/Province
Wisconsin
ZIP/Postal Code
54476
Country
United States
Facility Name
Marshfield Clinic - Weston Center
City
Weston
State/Province
Wisconsin
ZIP/Postal Code
54476
Country
United States
Facility Name
Marshfield Clinic - Wisconsin Rapids Center
City
Wisconsin Rapids
State/Province
Wisconsin
ZIP/Postal Code
54494
Country
United States
Facility Name
Rocky Mountain Oncology
City
Casper
State/Province
Wyoming
ZIP/Postal Code
82609
Country
United States
Facility Name
Welch Cancer Center
City
Sheridan
State/Province
Wyoming
ZIP/Postal Code
82801
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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