ClinicalTrials.gov record
Melphalan and Dexamethasone With or Without Bortezomib in Treating Patients With Previously Untreated Systemic Light-Chain Amyloidosis
ClinicalTrials.gov ID: NCT01078454
Public ClinicalTrials.gov record NCT01078454. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
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
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT01078454
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 11 participants
Conditions and interventions
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Nov 2010 (Type not available)
- Primary completion
- Nov 12, 2012 (Actual)
- Completion
- Nov 27, 2012 (Actual)
- Last update posted
- Feb 1, 2022
2010 – 2012
United States locations
- U.S. sites
- 209
- U.S. states
- 25
- U.S. cities
- 143
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Mayo Clinic in Arizona | Scottsdale | Arizona | 85259 | — |
| University of Arkansas for Medical Sciences | Little Rock | Arkansas | 72205 | — |
| The Medical Center of Aurora | Aurora | Colorado | 80012 | — |
| Boulder Community Hospital | Boulder | Colorado | 80301 | — |
| Penrose-Saint Francis Healthcare | Colorado Springs | Colorado | 80907 | — |
| Porter Adventist Hospital | Denver | Colorado | 80210 | — |
| Exempla Saint Joseph Hospital | Denver | Colorado | 80218 | — |
| Presbyterian - Saint Lukes Medical Center - Health One | Denver | Colorado | 80218 | — |
| Rose Medical Center | Denver | Colorado | 80220 | — |
| Colorado Cancer Research Program CCOP | Denver | Colorado | 80224-2522 | — |
| Swedish Medical Center | Englewood | Colorado | 80113 | — |
| Saint Mary's Hospital and Regional Medical Center | Grand Junction | Colorado | 81502 | — |
| North Colorado Medical Center | Greeley | Colorado | 80631 | — |
| Saint Anthony Hospital | Lakewood | Colorado | 80228 | — |
| Littleton Adventist Hospital | Littleton | Colorado | 80122 | — |
| Sky Ridge Medical Center | Lone Tree | Colorado | 80124 | — |
| Longmont United Hospital | Longmont | Colorado | 80501 | — |
| McKee Medical Center | Loveland | Colorado | 80539 | — |
| Parker Adventist Hospital | Parker | Colorado | 80138 | — |
| Saint Mary Corwin Medical Center | Pueblo | Colorado | 81004 | — |
| North Suburban Medical Center | Thornton | Colorado | 80229 | — |
| Exempla Lutheran Medical Center | Wheat Ridge | Colorado | 80033 | — |
| Eastern Connecticut Hematology and Oncology Associates | Norwich | Connecticut | 06360 | — |
| Beebe Medical Center | Lewes | Delaware | 19958 | — |
| Christiana Care Health System-Christiana Hospital | Newark | Delaware | 19718 | — |
| Mayo Clinic in Florida | Jacksonville | Florida | 32224-9980 | — |
| Cleveland Clinic Florida - Weston | Weston | Florida | 33331 | — |
| Emory University/Winship Cancer Institute | Atlanta | Georgia | 30322 | — |
| Oncare Hawaii Inc-POB II | Honolulu | Hawaii | 96813 | — |
| Queen's Medical Center | Honolulu | Hawaii | 96813 | — |
| Straub Clinic and Hospital | Honolulu | Hawaii | 96813 | — |
| University of Hawaii | Honolulu | Hawaii | 96813 | — |
| OnCare Hawaii-Liliha | Honolulu | Hawaii | 96817-3169 | — |
| Kuakini Medical Center | Honolulu | Hawaii | 96817 | — |
| Oncare Hawaii Inc-Kuakini | Honolulu | Hawaii | 96817 | — |
| Kapiolani Medical Center for Women and Children | Honolulu | Hawaii | 96826 | — |
| Castle Medical Center | Kailua | Hawaii | 96734 | — |
| Wilcox Memorial Hospital and Kauai Medical Clinic | Lihue | Hawaii | 96766 | — |
| Oncare Hawaii Inc-Pali Momi | ‘Aiea | Hawaii | 96701 | — |
| Pali Momi Medical Center | ‘Aiea | Hawaii | 96701 | — |
| Illinois CancerCare-Bloomington | Bloomington | Illinois | 61701 | — |
| Saint Joseph Medical Center | Bloomington | Illinois | 61701 | — |
| Graham Hospital Association | Canton | Illinois | 61520 | — |
| Illinois CancerCare-Canton | Canton | Illinois | 61520 | — |
| Illinois CancerCare-Carthage | Carthage | Illinois | 62321 | — |
| Memorial Hospital | Carthage | Illinois | 62321 | — |
| Decatur Memorial Hospital | Decatur | Illinois | 62526 | — |
| Eureka Hospital | Eureka | Illinois | 61530 | — |
| Illinois CancerCare-Eureka | Eureka | Illinois | 61530 | — |
| Illinois CancerCare Galesburg | Galesburg | Illinois | 61401 | — |
| Illinois CancerCare-Havana | Havana | Illinois | 62644 | — |
| Mason District Hospital | Havana | Illinois | 62644 | — |
| Illinois CancerCare-Kewanee Clinic | Kewanee | Illinois | 61443 | — |
| Illinois CancerCare-Macomb | Macomb | Illinois | 61455 | — |
| Mcdonough District Hospital | Macomb | Illinois | 61455 | — |
| Holy Family Medical Center | Monmouth | Illinois | 61462 | — |
| Illinois CancerCare-Monmouth | Monmouth | Illinois | 61462 | — |
| Bromenn Regional Medical Center | Normal | Illinois | 61761 | — |
| Community Cancer Center Foundation | Normal | Illinois | 61761 | — |
| Illinois CancerCare-Community Cancer Center | Normal | Illinois | 61761 | — |
| Illinois CancerCare-Ottawa Clinic | Ottawa | Illinois | 61350 | — |
| Ottawa Regional Hospital and Healthcare Center | Ottawa | Illinois | 61350 | — |
| Pekin Cancer Treatment Center | Pekin | Illinois | 61554 | — |
| Illinois CancerCare-Pekin | Pekin | Illinois | 61603 | — |
| Methodist Medical Center of Illinois | Peoria | Illinois | 61603 | — |
| Proctor Hospital | Peoria | Illinois | 61614 | — |
| Illinois CancerCare-Peoria | Peoria | Illinois | 61615 | — |
| Illinois Oncology Research Association CCOP | Peoria | Illinois | 61615 | — |
| OSF Saint Francis Medical Center | Peoria | Illinois | 61637 | — |
| Illinois CancerCare-Peru | Peru | Illinois | 61354 | — |
| Illinois Valley Hospital | Peru | Illinois | 61354 | — |
| Illinois CancerCare-Princeton | Princeton | Illinois | 61356 | — |
| Perry Memorial Hospital | Princeton | Illinois | 61356 | — |
| Illinois CancerCare-Spring Valley | Spring Valley | Illinois | 61362 | — |
| Memorial Medical Center | Springfield | Illinois | 62781-0001 | — |
| Saint Francis Hospital and Health Centers | Beech Grove | Indiana | 46107 | — |
| Indiana University Medical Center | Indianapolis | Indiana | 46202 | — |
| Reid Hospital and Health Care Services | Richmond | Indiana | 47374 | — |
| McFarland Clinic PC-William R Bliss Cancer Center | Ames | Iowa | 50010 | — |
| University of Iowa Hospitals and Clinics | Iowa City | Iowa | 52242 | — |
| Siouxland Hematology Oncology Associates | Sioux City | Iowa | 51101 | — |
| Mercy Medical Center-Sioux City | Sioux City | Iowa | 51104 | — |
| Saint Luke's Regional Medical Center | Sioux City | Iowa | 51104 | — |
| Union Hospital of Cecil County | Elkton | Maryland | 21921 | — |
| Tufts Medical Center | Boston | Massachusetts | 02111 | — |
| Boston Medical Center | Boston | Massachusetts | 02118 | — |
| University of Michigan | Ann Arbor | Michigan | 48109 | — |
| Wayne State University/Karmanos Cancer Institute | Detroit | Michigan | 48201 | — |
| Green Bay Oncology - Escanaba | Escanaba | Michigan | 49431 | — |
| Green Bay Oncology - Iron Mountain | Iron Mountain | Michigan | 49801 | — |
| Borgess Medical Center | Kalamazoo | Michigan | 49001 | — |
| Bronson Methodist Hospital | Kalamazoo | Michigan | 49007 | — |
| West Michigan Cancer Center | Kalamazoo | Michigan | 49007 | — |
| Providence Hospital | Southfield | Michigan | 48075 | — |
| Fairview Ridges Hospital | Burnsville | Minnesota | 55337 | — |
| Mercy Hospital | Coon Rapids | Minnesota | 55433 | — |
| Fairview-Southdale Hospital | Edina | Minnesota | 55435 | — |
| Unity Hospital | Fridley | Minnesota | 55432 | — |
| Hutchinson Area Health Care | Hutchinson | Minnesota | 55350 | — |
| Minnesota Oncology Hematology PA-Maplewood | Maplewood | Minnesota | 55109 | — |
| Saint John's Hospital - Healtheast | Maplewood | Minnesota | 55109 | — |
| Abbott-Northwestern Hospital | Minneapolis | Minnesota | 55407 | — |
| Hennepin County Medical Center | Minneapolis | Minnesota | 55415 | — |
| New Ulm Medical Center | New Ulm | Minnesota | 56073 | — |
| North Memorial Medical Health Center | Robbinsdale | Minnesota | 55422 | — |
| Mayo Clinic | Rochester | Minnesota | 55905 | — |
| Metro-Minnesota CCOP | Saint Louis Park | Minnesota | 55416 | — |
| Park Nicollet Clinic - Saint Louis Park | Saint Louis Park | Minnesota | 55416 | — |
| Regions Hospital | Saint Paul | Minnesota | 55101 | — |
| United Hospital | Saint Paul | Minnesota | 55102 | — |
| Saint Francis Regional Medical Center | Shakopee | Minnesota | 55379 | — |
| Lakeview Hospital | Stillwater | Minnesota | 55082 | — |
| Ridgeview Medical Center | Waconia | Minnesota | 55387 | — |
| Rice Memorial Hospital | Willmar | Minnesota | 56201 | — |
| Minnesota Oncology and Hematology PA-Woodbury | Woodbury | Minnesota | 55125 | — |
| University of Mississippi Medical Center | Jackson | Mississippi | 39216 | — |
| Washington University School of Medicine | St Louis | Missouri | 63110 | — |
| Montana Cancer Consortium CCOP | Billings | Montana | 59101 | — |
| Saint Vincent Healthcare | Billings | Montana | 59101 | — |
| Hematology-Oncology Centers of the Northern Rockies PC | Billings | Montana | 59102 | — |
| Billings Clinic | Billings | Montana | 59107-7000 | — |
| Bozeman Deaconess Cancer Center | Bozeman | Montana | 59715 | — |
| Bozeman Deaconess Hospital | Bozeman | Montana | 59715 | — |
| Saint James Community Hospital and Cancer Treatment Center | Butte | Montana | 59701 | — |
| Benefis Healthcare- Sletten Cancer Institute | Great Falls | Montana | 59405 | — |
| Great Falls Clinic | Great Falls | Montana | 59405 | — |
| Northern Montana Hospital | Havre | Montana | 59501 | — |
| Saint Peter's Community Hospital | Helena | Montana | 59601 | — |
| Glacier Oncology PLLC | Kalispell | Montana | 59901 | — |
| Kalispell Medical Oncology | Kalispell | Montana | 59901 | — |
| Kalispell Regional Medical Center | Kalispell | Montana | 59901 | — |
| Montana Cancer Specialists | Missoula | Montana | 59802 | — |
| Saint Patrick Hospital - Community Hospital | Missoula | Montana | 59802 | — |
| Cooper Hospital University Medical Center | Camden | New Jersey | 08103 | — |
| The Jewish Hospital | Cincinnati | Ohio | 45236 | — |
| Case Western Reserve University | Cleveland | Ohio | 44106 | — |
| MetroHealth Medical Center | Cleveland | Ohio | 44109 | — |
| Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University Medical Center | Columbus | Ohio | 43210 | — |
| Grandview Hospital | Dayton | Ohio | 45405 | — |
| Good Samaritan Hospital - Dayton | Dayton | Ohio | 45406 | — |
| Miami Valley Hospital | Dayton | Ohio | 45409 | — |
| Samaritan North Health Center | Dayton | Ohio | 45415 | — |
| Dayton CCOP | Dayton | Ohio | 45420 | — |
| Blanchard Valley Hospital | Findlay | Ohio | 45840 | — |
| Atrium Medical Center-Middletown Regional Hospital | Franklin | Ohio | 45005-1066 | — |
| Wayne Hospital | Greenville | Ohio | 45331 | — |
| Kettering Medical Center | Kettering | Ohio | 45429 | — |
| Upper Valley Medical Center | Troy | Ohio | 45373 | — |
| Clinton Memorial Hospital | Wilmington | Ohio | 45177 | — |
| Greene Memorial Hospital | Xenia | Ohio | 45385 | — |
| Clackamas Radiation Oncology Center | Clackamas | Oregon | 97015 | — |
| Providence Milwaukie Hospital | Milwaukie | Oregon | 97222 | — |
| Providence Newberg Medical Center | Newberg | Oregon | 97132 | — |
| Providence Willamette Falls Medical Center | Oregon City | Oregon | 97045 | — |
| Providence Portland Medical Center | Portland | Oregon | 97213 | — |
| Western Oncology Research Consortium | Portland | Oregon | 97213 | — |
| Adventist Medical Center | Portland | Oregon | 97216 | — |
| Providence Saint Vincent Medical Center | Portland | Oregon | 97225 | — |
| Geisinger Medical Center | Danville | Pennsylvania | 17822-2001 | — |
| Geisinger Medical Center-Cancer Center Hazelton | Hazleton | Pennsylvania | 18201 | — |
| Fox Chase Cancer Center | Philadelphia | Pennsylvania | 19111 | — |
| Geisinger Medical Group | State College | Pennsylvania | 16801 | — |
| Geisinger Wyoming Valley | Wilkes-Barre | Pennsylvania | 18711 | — |
| Cancer Care Center at Island Hospital | Anacortes | Washington | 98221 | — |
| PeaceHealth Saint Joseph Medical Center | Bellingham | Washington | 98225 | — |
| Harrison HealthPartners Hematology and Oncology-Bremerton | Bremerton | Washington | 98310 | — |
| Highline Medical Center-Main Campus | Burien | Washington | 98166 | — |
| Swedish Cancer Institute-Issaquah | Issaquah | Washington | 98029 | — |
| Columbia Basin Hematology and Oncology PLLC | Kennewick | Washington | 99336 | — |
| Skagit Valley Hospital | Mount Vernon | Washington | 98274 | — |
| Harrison HealthPartners Hematology and Oncology-Poulsbo | Poulsbo | Washington | 98370 | — |
| Harborview Medical Center | Seattle | Washington | 98104 | — |
| Minor and James Medical PLLC | Seattle | Washington | 98104 | — |
| Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium | Seattle | Washington | 98109 | — |
| Group Health Cooperative-Seattle | Seattle | Washington | 98112 | — |
| Swedish Medical Center-First Hill | Seattle | Washington | 98122-4307 | — |
| The Polyclinic | Seattle | Washington | 98122 | — |
| University of Washington Medical Center | Seattle | Washington | 98195 | — |
| United General Hospital | Sedro-Woolley | Washington | 98284 | — |
| Cancer Care Northwest - Spokane South | Spokane | Washington | 99202 | — |
| Evergreen Hematology and Oncology PS | Spokane | Washington | 99218 | — |
| PeaceHealth Southwest Medical Center | Vancouver | Washington | 98664 | — |
| Compass Oncology Vancouver | Vancouver | Washington | 98684 | — |
| Wenatchee Valley Medical Center | Wenatchee | Washington | 98801 | — |
| Marshfield Clinic-Chippewa Center | Chippewa Falls | Wisconsin | 54729 | — |
| Marshfield Clinic Cancer Center at Sacred Heart | Eau Claire | Wisconsin | 54701 | — |
| Green Bay Oncology at Saint Vincent Hospital | Green Bay | Wisconsin | 54301-3526 | — |
| Saint Vincent Hospital | Green Bay | Wisconsin | 54301 | — |
| Green Bay Oncology Limited at Saint Mary's Hospital | Green Bay | Wisconsin | 54303 | — |
| Saint Mary's Hospital | Green Bay | Wisconsin | 54303 | — |
| Gundersen Lutheran | La Crosse | Wisconsin | 54601 | — |
| Holy Family Memorial Hospital | Manitowoc | Wisconsin | 54221 | — |
| Bay Area Medical Center | Marinette | Wisconsin | 54143 | — |
| Marshfield Clinic | Marshfield | Wisconsin | 54449 | — |
| Marshfield Clinic-Minocqua Center | Minocqua | Wisconsin | 54548 | — |
| D N Greenwald Center | Mukwonago | Wisconsin | 53149 | — |
| Oconomowoc Memorial Hospital-ProHealth Care Inc | Oconomowoc | Wisconsin | 53066-3896 | — |
| Green Bay Oncology - Oconto Falls | Oconto Falls | Wisconsin | 54154 | — |
| Marshfield Clinic at James Beck Cancer Center | Rhinelander | Wisconsin | 54501 | — |
| Marshfield Clinic-Rice Lake Center | Rice Lake | Wisconsin | 54868 | — |
| Saint Nicholas Hospital | Sheboygan | Wisconsin | 53081 | — |
| Marshfield Clinic Cancer Care at Saint Michael's Hospital | Stevens Point | Wisconsin | 54481 | — |
| Green Bay Oncology - Sturgeon Bay | Sturgeon Bay | Wisconsin | 54235 | — |
| Waukesha Memorial Hospital - ProHealth Care | Waukesha | Wisconsin | 53188 | — |
| Diagnostic and Treatment Center | Weston | Wisconsin | 54476 | — |
| Marshfield Clinic - Weston Center | Weston | Wisconsin | 54476 | — |
| Marshfield Clinic - Wisconsin Rapids Center | Wisconsin Rapids | Wisconsin | 54494 | — |
| Rocky Mountain Oncology | Casper | Wyoming | 82609 | — |
| Welch Cancer Center | Sheridan | Wyoming | 82801 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT01078454, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Feb 1, 2022 · Synced Oct 22, 2026
Related: full search, browse by condition, browse by drug or therapy, browse by sponsor, browse by U.S. city.
Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT01078454 live on ClinicalTrials.gov.