AzTrials
AzTrials

Stage I Multiple MyelomaPhase 3NCT00522392

Bortezomib and Dexamethasone With or Without Lenalidomide in Treating Patients With Multiple Myeloma Previously Treated With Dexamethasone

A Phase 3 study testing bortezomib, lenalidomide and dexamethasone in people with Stage I Multiple Myeloma and Stage II Multiple Myeloma, run by National Cancer Institute (NCI) at 276 sites in 2 countries.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

This randomized phase III trial compares bortezomib, dexamethasone, and lenalidomide with bortezomib and dexamethasone to see how well they work in treating patients with multiple myeloma previously treated with dexamethasone. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
bortezomib, lenalidomide and dexamethasone
Could I receive a placebo?
No, everyone receives an active treatment
How many people
48 participants
Where
276 sitesin 2 countries
Study dates
Sep 2007to Jul 2014
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Symptomatic multiple myeloma, that was symptomatic at time of initial diagnosis, but may be asymptomatic at the time of registration based on induction therapy
  • For the original diagnosis of myeloma, patients must have met the following criteria at one point in their disease course: bone marrow plasmacytosis (>10% plasma cells or sheets of plasma cells) or a biopsy proven plasmacytoma, and evidence of end-organ damage due to multiple myeloma including anemia, hypercalcemia, bone disease (lytic bone lesions or pathologic fractures) or renal dysfunction.
  • Patients may have prior exposure to bortezomib
  • Patients must have received a minimum of 1 cycle, maximum of 6 cycles, of a dexamethasone-based regimen; patient must not have experienced progressive disease on such therapy
  • The following induction regimens were considered adequate for enrollment: dexamethasone alone; vincristine, doxorubicin and dexamethasone; thalidomide and dexamethasone; lenalidomide and dexamethasone; liposomal doxorubicin and dexamethasone; the combination of any of the above agents and dexamethasone; or cyclophosphamide, lenalidomide and dexamethasone
  • Patients must have received the minimum cumulative dose of dexamethasone of 160 mg (sum of induction treatment) with no maximum dose specified
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  • Patients must have been offered and refused front-line stem cell transplant OR not have been eligible for front-line stem cell transplant.
  • Bone marrow aspiration and/or biopsy must be obtained =< 28 days prior to randomization
  • All tests below must be performed =< 28 days prior to randomization:
  • Kappa free light chain mg/dL
  • Lambda free light chain mg/dL
  • Serum M-protein by serum protein electrophoresis (SPEP)
  • Urine M-protein light chain excretion by urine protein electrophoresis (UPEP)
  • Adequate laboratory levels within 7 days prior to randomization: hemoglobin > 7 g/dL, platelet count > 75,000 cells/mm^3, absolute neutrophil count > 1000 cells/mm^3, creatinine < 2.5 mg/dL, creatinine clearance (measured or calculated) >= 60 mL/min, direct bilirubin =< 1.5 mg/dL, serum glutamate pyruvate transaminase (SGPT) (alanine aminotransferase [ALT]) and serum glutamic oxaloacetic transaminase (SGOT) (aspartate aminotransferase [AST]) =< 2.5 times the upper limit of normal
  • Patients may be receiving bisphosphonates or erythropoietin growth factors (erythropoietic agents) for multiple myeloma
  • Prior palliative and/or localized radiation therapy is permitted, provided at least 14 days have passed from date of last radiation therapy to date of randomization
  • Patients must be willing and able to take prophylaxis with either aspirin at 325 mg/day or alternative prophylaxis with either low molecular weight heparin or coumadin (patients with prior deep vein thrombosis [DVT] are eligible provided they remain on the anticoagulation regimen that was prescribed for treatment of the DVT throughout the protocol therapy)
  • Patients must be competent to understand the study as explained in the consent form
  • Eastern Cooperative Oncology Group (ECOG) performance status 0, 1, or 2
  • Sexually active males must be willing to use a condom (even if they have undergone a prior vasectomy) while having intercourse with any woman, while taking lenalidomide, and for 4 weeks after stopping treatment
  • Patients with a history of prior malignancy are eligible provided there is no active malignancy and a low expectation of recurrence within 6 months
  • Age >=18 years

Who cannot join

  • More than 8 weeks from the last day of last cycle of induction treatment
  • Active, uncontrolled seizure disorder; seizures in the last 6 months
  • Uncontrolled inter-current illness that would limit compliance with the study including uncontrolled hypertension, symptomatic congestive heart failure, unstable angina, uncontrolled cardiac arrhythmia, uncontrolled psychiatric illness or social situation, prior history of Stevens Johnson syndrome
  • Grade 2 or higher peripheral neuropathy by Common Terminology Criteria for Adverse Events (CTCAE) version 3.0
  • Active, uncontrolled infection
  • Smoldering myeloma or monoclonal gammopathy of undetermined significance
  • Pregnant or nursing women were not eligible. Women of child-bearing potential unwilling to use a dual method of contraception and men who were unwilling to use a condom were not eligible

Trial locations and contacts

276 sites in 2 countries.

276 sites in 2 countries

United States275 sites

  • Abington Memorial Hospital

    Abington, Pennsylvania, 19001

  • Bixby Medical Center

    Adrian, Michigan, 49221

  • Hickman Cancer Center

    Adrian, Michigan, 49221

  • University of New Mexico Cancer Center

    Albuquerque, New Mexico, 87106

  • Saint Anthony's Health

    Alton, Illinois, 62002

  • McFarland Clinic PC-William R Bliss Cancer Center

    Ames, Iowa, 50010

  • Saint Joseph Mercy Hospital

    Ann Arbor, Michigan, 48106-0995

  • Michigan Cancer Research Consortium Community Clinical Oncology Program

    Ann Arbor, Michigan, 48106

  • The Medical Center of Aurora

    Aurora, Colorado, 80012

  • Saint Francis Hospital and Health Centers

    Beech Grove, Indiana, 46107

  • Mary Rutan Hospital

    Bellefontaine, Ohio, 43311

  • PeaceHealth Saint Joseph Medical Center

    Bellingham, Washington, 98225

  • Sanford Clinic North-Bemidgi

    Bemidji, Minnesota, 56601

  • Constantinou, Costas L MD (UIA Investigator)

    Bettendorf, Iowa, 52722

  • Montana Cancer Consortium CCOP

    Billings, Montana, 59101

  • Northern Rockies Radiation Oncology Center

    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

  • Saint Joseph Medical Center

    Bloomington, Illinois, 61701

  • Boulder Community Hospital

    Boulder, Colorado, 80301

  • Toledo Clinic Cancer Centers-Bowling Green

    Bowling Green, Ohio, 43402

  • Bozeman Deaconess Cancer Center

    Bozeman, Montana, 59715

  • Bozeman Deaconess Hospital

    Bozeman, Montana, 59715

  • Harrison HealthPartners Hematology and Oncology-Bremerton

    Bremerton, Washington, 98310

  • Kings County Hospital

    Brooklyn, New York, 11203

  • State University of New York Downstate Medical Center

    Brooklyn, New York, 11203

  • University Hospital of Brooklyn

    Brooklyn, New York, 11203

  • Bryn Mawr Hospital

    Bryn Mawr, Pennsylvania, 19010

  • Fairview Ridges Hospital

    Burnsville, Minnesota, 55337

  • Saint James Community Hospital and Cancer Treatment Center

    Butte, Montana, 59701

  • Cooper Hospital University Medical Center

    Camden, New Jersey, 08103

  • Graham Hospital Association

    Canton, Illinois, 61520

  • Mercy Medical Center

    Canton, Ohio, 44708

  • Southeast Missouri Hospital

    Cape Girardeau, Missouri, 63701

  • Saint Francis Medical Center

    Cape Girardeau, Missouri, 63703

  • Memorial Hospital

    Carthage, Illinois, 62321

  • Marshfield Clinic-Chippewa Center

    Chippewa Falls, Wisconsin, 54729

  • Case Western Reserve University

    Cleveland, Ohio, 44106

  • Penrose-Saint Francis Healthcare

    Colorado Springs, Colorado, 80907

  • University of Missouri - Ellis Fischel

    Columbia, Missouri, 65212

  • John B Amos Cancer Center

    Columbus, Georgia, 31904

  • Riverside Methodist Hospital

    Columbus, Ohio, 43214

  • Grant Medical Center

    Columbus, Ohio, 43215

  • Mount Carmel Health Center West

    Columbus, Ohio, 43222

  • Doctors Hospital

    Columbus, Ohio, 43228

  • Mercy Hospital

    Coon Rapids, Minnesota, 55433

  • Mary Imogene Bassett Hospital

    Cooperstown, New York, 13326

  • Geisinger Medical Center

    Danville, Pennsylvania, 17822-2001

  • 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

  • Veteran Affairs Medical Center

    Dayton, Ohio, 45428

  • Oakwood Hospital

    Dearborn, Michigan, 48124

  • Decatur Memorial Hospital

    Decatur, Illinois, 62526

  • Grady Memorial Hospital

    Delaware, Ohio, 43015

  • 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

  • Mercy Capitol

    Des Moines, Iowa, 50307

  • Iowa Methodist Medical Center

    Des Moines, Iowa, 50309

  • Iowa Oncology Research Association CCOP

    Des Moines, Iowa, 50309

  • Medical Oncology and Hematology Associates-Des Moines

    Des Moines, Iowa, 50309

  • Medical Oncology and Hematology Associates-Laurel

    Des Moines, Iowa, 50314

  • Mercy Medical Center - Des Moines

    Des Moines, Iowa, 50314

  • Iowa Lutheran Hospital

    Des Moines, Iowa, 50316

  • Saint John Hospital and Medical Center

    Detroit, Michigan, 48236

  • Doylestown Hospital

    Doylestown, Pennsylvania, 18901

  • Essentia Health Duluth Clinic CCOP

    Duluth, Minnesota, 55805

  • Essentia Health Saint Mary's Medical Center

    Duluth, Minnesota, 55805

  • Miller-Dwan Hospital

    Duluth, Minnesota, 55805

  • Veterans Adminstration New Jersey Health Care System

    East Orange, New Jersey, 07018-1095

  • Marshfield Clinic Cancer Center at Sacred Heart

    Eau Claire, Wisconsin, 54701

  • Sacred Heart Hospital

    Eau Claire, Wisconsin, 54701

  • Fairview-Southdale Hospital

    Edina, Minnesota, 55435

  • Alexian Brothers Medical and Cancer Center

    Elk Grove Village, Illinois, 60007

  • Union Hospital of Cecil County

    Elkton MD, Maryland, 21921

  • Hematology Oncology Center Incorporated

    Elyria, Ohio, 44035

  • Swedish Medical Center

    Englewood, Colorado, 80113

  • Green Bay Oncology - Escanaba

    Escanaba, Michigan, 49431

  • Eureka Hospital

    Eureka, Illinois, 61530

  • Saint Francis Hospital

    Evanston, Illinois, 60202

  • Northbay Cancer Center

    Fairfield, California, 94533

  • Sanford Clinic North-Fargo

    Fargo, North Dakota, 58122

  • Sanford Medical Center-Fargo

    Fargo, North Dakota, 58122

  • Blanchard Valley Hospital

    Findlay, Ohio, 45840

  • Hurley Medical Center

    Flint, Michigan, 48502

  • Genesys Regional Medical Center-West Flint Campus

    Flint, Michigan, 48532

  • McLeod Regional Medical Center

    Florence, South Carolina, 29506

  • Atrium Medical Center-Middletown Regional Hospital

    Franklin, Ohio, 45005-1066

  • Fredericksburg Oncology Inc

    Fredericksburg, Virginia, 22401

  • Fremont Memorial Hospital

    Fremont, Ohio, 43420

  • Unity Hospital

    Fridley, Minnesota, 55432

  • Galesburg Cottage Hospital

    Galesburg, Illinois, 61401

  • Illinois CancerCare Galesburg

    Galesburg, Illinois, 61401

  • Western Illinois Cancer Treatment Center

    Galesburg, Illinois, 61401

  • Adirondack Cancer Center

    Glens Falls, New York, 12801

  • Saint Mary's Hospital and Regional Medical Center

    Grand Junction, Colorado, 81502

  • Berdeaux, Donald MD (UIA Investigator)

    Great Falls, Montana, 59405

  • Great Falls Clinic

    Great Falls, Montana, 59405

  • North Colorado Medical Center

    Greeley, Colorado, 80631

  • 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

  • Wayne Hospital

    Greenville, Ohio, 45331

  • Mason District Hospital

    Havana, Illinois, 62644

  • Northern Montana Hospital

    Havre, Montana, 59501

  • Geisinger Medical Center-Cancer Center Hazleton

    Hazleton, Pennsylvania, 18201

  • Saint Peter's Community Hospital

    Helena, Montana, 59601

  • Hopedale Medical Complex - Hospital

    Hopedale, Illinois, 61747

  • Hutchinson Area Health Care

    Hutchinson, Minnesota, 55350

  • Green Bay Oncology - Iron Mountain

    Iron Mountain, Michigan, 49801

  • Allegiance Health

    Jackson, Michigan, 49201

  • Mayo Clinic in Florida

    Jacksonville, Florida, 32224-9980

  • Capital Regional Medical Center

    Jefferson City, Missouri, 65101

  • UW Cancer Center Johnson Creek

    Johnson Creek, Wisconsin, 53038

  • Joliet Oncology-Hematology Associates Limited

    Joliet, Illinois, 60435

  • Glacier Oncology PLLC

    Kalispell, Montana, 59901

  • Kalispell Medical Oncology

    Kalispell, Montana, 59901

  • Kalispell Regional Medical Center

    Kalispell, Montana, 59901

  • Good Samaritan Hospital

    Kearney, Nebraska, 68847

  • Columbia Basin Hematology and Oncology PLLC

    Kennewick, Washington, 99336

  • Kettering Medical Center

    Kettering, Ohio, 45429

  • University of Tennessee - Knoxville

    Knoxville, Tennessee, 37920

  • Gundersen Lutheran

    La Crosse, Wisconsin, 54601

  • Mayo Clinic Health System-Franciscan Healthcare

    La Crosse, Wisconsin, 54601

  • Saint Anthony Hospital

    Lakewood, Colorado, 80228

  • Fairfield Medical Center

    Lancaster, Ohio, 43130

  • Lancaster General Hospital

    Lancaster, Pennsylvania, 17604

  • Sparrow Hospital

    Lansing, Michigan, 48912

  • University Medical Center of Southern Nevada

    Las Vegas, Nevada, 89102

  • Nevada Cancer Research Foundation CCOP

    Las Vegas, Nevada, 89106

  • Lawrence Memorial Hospital

    Lawrence, Kansas, 66044

  • Beebe Medical Center

    Lewes, Delaware, 19958

  • Lima Memorial Hospital

    Lima, Ohio, 45804

  • Meeker County Memorial Hospital

    Litchfield, Minnesota, 55355

  • Saint Mary Mercy Hospital

    Livonia, Michigan, 48154

  • Sky Ridge Medical Center

    Lone Tree, Colorado, 80124

  • Longmont United Hospital

    Longmont, Colorado, 80501

  • Doctors Carrol, Sheth, Raghavan

    Louisville, Kentucky, 40215

  • McKee Medical Center

    Loveland, Colorado, 80539

  • Mcdonough District Hospital

    Macomb, Illinois, 61455

  • University of Wisconsin Hospital and Clinics

    Madison, Wisconsin, 53792

  • Minnesota Oncology Hematology PA-Maplewood

    Maplewood, Minnesota, 55109

  • Saint John's Hospital - Healtheast

    Maplewood, Minnesota, 55109

  • Marietta Memorial Hospital

    Marietta, Ohio, 45750

  • Bay Area Medical Center

    Marinette, Wisconsin, 54143

  • Marshfield Clinic

    Marshfield, Wisconsin, 54449

  • Saint Joseph's Hospital

    Marshfield, Wisconsin, 54449

  • Saint Luke's Hospital

    Maumee, Ohio, 43537

  • Toledo Clinic Cancer Centers-Maumee

    Maumee, Ohio, 43537

  • Toledo Radiation Oncology at Northwest Ohio Onocolgy Center

    Maumee, Ohio, 43537

  • Orange Regional Medical Center

    Middletown, New York, 10940

  • Abbott-Northwestern Hospital

    Minneapolis, Minnesota, 55407

  • Virginia Piper Cancer Institute

    Minneapolis, Minnesota, 55407

  • Hennepin County Medical Center

    Minneapolis, Minnesota, 55415

  • Marshfield Clinic-Minocqua Center

    Minocqua, Wisconsin, 54548

  • Community Medical Hospital

    Missoula, Montana, 59801

  • Montana Cancer Specialists

    Missoula, Montana, 59802

  • Saint Patrick Hospital - Community Hospital

    Missoula, Montana, 59802

  • Guardian Oncology and Center for Wellness

    Missoula, Montana, 59804

  • Garneau, Stewart C MD (UIA Investigator)

    Moline, Illinois, 61265

  • Porubcin, Michael MD (UIA Investigator)

    Moline, Illinois, 61265

  • Sharis, Christine M MD (UIA Investigator)

    Moline, Illinois, 61265

  • Stoffel, Thomas J MD (UIA Investigator)

    Moline, Illinois, 61265

  • Community Cancer Center of Monroe

    Monroe, Michigan, 48162

  • Mercy Memorial Hospital

    Monroe, Michigan, 48162

  • Fox Chase Cancer Center at Virtua Memorial Hospital of Burlington County

    Mount Holly, New Jersey, 08060

  • Good Samaritan Regional Health Center

    Mount Vernon, Illinois, 62864

  • Christiana Care Health System-Christiana Hospital

    Newark, Delaware, 19718

  • Licking Memorial Hospital

    Newark, Ohio, 43055

  • Bromenn Regional Medical Center

    Normal, Illinois, 61761

  • Community Cancer Center Foundation

    Normal, Illinois, 61761

  • Fisher-Titus Medical Center

    Norwalk, Ohio, 44857

  • Green Bay Oncology - Oconto Falls

    Oconto Falls, Wisconsin, 54154

  • Saint Charles Hospital

    Oregon, Ohio, 43616

  • Toledo Clinic Cancer Centers-Oregon

    Oregon, Ohio, 43616

  • Illinois CancerCare-Ottawa Clinic

    Ottawa, Illinois, 61350

  • Ottawa Regional Hospital and Healthcare Center

    Ottawa, Illinois, 61350

  • Paoli Memorial Hospital

    Paoli, Pennsylvania, 19301

  • Pekin Cancer Treatment Center

    Pekin, Illinois, 61554

  • Pekin Hospital

    Pekin, Illinois, 61554

  • Methodist Medical Center of Illinois

    Peoria, Illinois, 61603

  • Proctor Hospital

    Peoria, Illinois, 61614

  • Illinois Oncology Research Association CCOP

    Peoria, Illinois, 61615

  • OSF Saint Francis Medical Center

    Peoria, Illinois, 61637

  • Illinois Valley Hospital

    Peru, Illinois, 61354

  • Valley Radiation Oncology

    Peru, Illinois, 61354

  • Saint Joseph Mercy Oakland

    Pontiac, Michigan, 48341-2985

  • Saint Joseph Mercy Port Huron

    Port Huron, Michigan, 48060

  • Adventist Medical Center

    Portland, Oregon, 97216

  • Pottstown Memorial Medical Center

    Pottstown, Pennsylvania, 19464

  • Perry Memorial Hospital

    Princeton, Illinois, 61356

  • Saint Mary Corwin Medical Center

    Pueblo, Colorado, 81004

  • Rapid City Regional Hospital

    Rapid City, South Dakota, 57701

  • Marshfield Clinic at James Beck Cancer Center

    Rhinelander, Wisconsin, 54501

  • Marshfield Clinic-Rice Lake Center

    Rice Lake, Wisconsin, 54868

  • Reid Hospital and Health Care Services

    Richmond, Indiana, 47374

  • North Memorial Medical Health Center

    Robbinsdale, Minnesota, 55422

  • Mayo Clinic

    Rochester, Minnesota, 55905

  • Harbin Clinic Medical Oncology and Clinical Research

    Rome, Georgia, 30165

  • Saint Mary's of Michigan

    Saginaw, Michigan, 48601

  • 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

  • Saint Joseph's Hospital - Healtheast

    Saint Paul, Minnesota, 55102

  • United Hospital

    Saint Paul, Minnesota, 55102

  • Kaiser Permanente

    San Diego, California, 92120

  • Firelands Regional Medical Center

    Sandusky, Ohio, 44870

  • North Coast Cancer Care

    Sandusky, Ohio, 44870

  • Mayo Clinic in Arizona

    Scottsdale, Arizona, 85259

  • 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

  • Swedish Medical Center-First Hill

    Seattle, Washington, 98122-4307

  • The Polyclinic

    Seattle, Washington, 98122

  • University of Washington Medical Center

    Seattle, Washington, 98195

  • Saint Francis Regional Medical Center

    Shakopee, Minnesota, 55379

  • Welch Cancer Center

    Sheridan, Wyoming, 82801

  • 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

  • Saint Margaret's Hospital

    Spring Valley, Illinois, 61362

  • Memorial Medical Center

    Springfield, Illinois, 62781-0001

  • Ozark Health Ventures LLC dba Cancer Research for The Ozarks Springfield

    Springfield, Missouri, 65802

  • Mercy Hospital Springfield

    Springfield, Missouri, 65804

  • Saint Louis Cancer and Breast Institute-South City

    St Louis, Missouri, 63109

  • Missouri Baptist Medical Center

    St Louis, Missouri, 63131

  • Center for Cancer Care and Research

    St Louis, Missouri, 63141

  • Saint John's Mercy Medical Center

    St Louis, Missouri, 63141

  • Saint Louis-Cape Girardeau CCOP

    St Louis, Missouri, 63141

  • Stanford University Hospitals and Clinics

    Stanford, California, 94305

  • Geisinger Medical Group

    State College, Pennsylvania, 16801

  • Saint Michael's Hospital

    Stevens Point, Wisconsin, 54481

  • Green Bay Oncology - Sturgeon Bay

    Sturgeon Bay, Wisconsin, 54235

  • Flower Hospital

    Sylvania, Ohio, 43560

  • Montefiore Medical Center

    The Bronx, New York, 10467-2490

  • North Suburban Medical Center

    Thornton, Colorado, 80229

  • Mercy Hospital of Tiffin

    Tiffin, Ohio, 44883

  • The Toledo Hospital/Toledo Children's Hospital

    Toledo, Ohio, 43606

  • Saint Vincent Mercy Medical Center

    Toledo, Ohio, 43608

  • University of Toledo

    Toledo, Ohio, 43614

  • Toledo Community Hospital Oncology Program CCOP

    Toledo, Ohio, 43617

  • Mercy Saint Anne Hospital

    Toledo, Ohio, 43623

  • Toledo Clinic Cancer Centers-Toledo

    Toledo, Ohio, 43623

  • Upper Valley Medical Center

    Troy, Ohio, 45373

  • Carle Clinic-Urbana Main

    Urbana, Illinois, 61801

  • Virtua West Jersey Hospital Voorhees

    Voorhees Township, New Jersey, 08043

  • Ridgeview Medical Center

    Waconia, Minnesota, 55387

  • Saint John Macomb-Oakland Hospital

    Warren, Michigan, 48093

  • Covenant Medical Center

    Waterloo, Iowa, 50702

  • Marshfield Clinic-Wausau Center

    Wausau, Wisconsin, 54401

  • Fulton County Health Center

    Wauseon, Ohio, 43567

  • Wenatchee Valley Medical Center

    Wenatchee, Washington, 98801

  • Reading Hospital

    West Reading, Pennsylvania, 19611

  • Saint Ann's Hospital

    Westerville, Ohio, 43081

  • Marshfield Clinic - Weston Center

    Weston, Wisconsin, 54476

  • Exempla Lutheran Medical Center

    Wheat Ridge, Colorado, 80033

  • The Schiffler Cancer Center of Wheeling Hospital

    Wheeling, West Virginia, 26003

  • Wheeling Hospital

    Wheeling, West Virginia, 26003

  • Wesley Medical Center

    Wichita, Kansas, 67214

  • Geisinger Wyoming Valley

    Wilkes-Barre, Pennsylvania, 18711

  • Clinton Memorial Hospital

    Wilmington, Ohio, 45177

  • Marshfield Clinic - Wisconsin Rapids Center

    Wisconsin Rapids, Wisconsin, 54494

  • Minnesota Oncology and Hematology PA-Woodbury

    Woodbury, Minnesota, 55125

  • Woodwinds Health Campus

    Woodbury, Minnesota, 55125

  • Lankenau Hospital

    Wynnewood, Pennsylvania, 19096

  • Mainline Health CCOP

    Wynnewood, Pennsylvania, 19096

  • Greene Memorial Hospital

    Xenia, Ohio, 45385

  • Genesis HealthCare System

    Zanesville, Ohio, 43701

Other trials in United States

South Africa1 site

  • University Of Pretoria

    Pretoria, 0002

Other trials in South Africa

About this study

Official title: Randomized Phase III Trial of Consolidation Therapy With Bortezomib (Velcade®)-Lenalidomide (Revlimid®) -Dexamethasone (VRD) Versus Bortezomib (Velcade®)-Dexamethasone (VD) for Patients With Multiple Myeloma Who Have Completed a Dexamethasone Based Induction Regimen

This randomized phase III trial compares bortezomib, dexamethasone, and lenalidomide with bortezomib and dexamethasone to see how well they work in treating patients with multiple myeloma previously treated with dexamethasone. Bortezomib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as dexamethasone, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Lenalidomide may stimulate the immune system in different ways and stop cancer cells from growing. It is not yet known whether giving bortezomib and dexamethasone is more effective with or without lenalidomide in treating multiple myeloma.

Read the detailed description

PRIMARY OBJECTIVES:

  1. To compare the progression-free survival (PFS) for two consolidation regimens: bortezomib, lenalidomide, and dexamethasone (VRD) versus bortezomib and dexamethasone (VD) only.

SECONDARY OBJECTIVES:

  1. To determine the incremental ability of VRD versus VD in attaining a complete response or a very good partial response (VGPR) in patients receiving induction therapy with a dexamethasone based induction regimen.

II. To compare the overall survival, measured from the time of study entry.

III. Evaluate response rate and PFS according to cytogenetic category (by gene expression and fluorescence in situ hybridization [FISH]).

IV. To evaluate the toxicity of the two regimens.

  1. To compare quality of life (QOL) based on the Functional Assessment of Cancer Therapy (FACT)-Neurotoxicity (Ntx) Trial Outcome Index (TOI) of patients receiving VD to those receiving VRD from registration to 6 months post consolidation treatment.

VI. To examine the impact of differential treatment response (PFS), if observed, on QOL based on the FACT-Ntx TOI up to 12 months post consolidation treatment.

VII. To obtain prospective data on multiple myeloma specific QOL attributes.

OUTLINE: Patients are randomized to 1 of 2 treatment arms.

ARM A: Patients receive bortezomib at 1.3 mg/m2 intravenously (IV) on days 1, 4, 8, and 11, lenalidomide orally (PO) once daily (QD) at 15 mg on days 1-14, and dexamethasone at 40 mg total dose per day PO QD on days 1, 8, and 15. Treatment repeats every 21 days for 8 courses in the absence of disease progression or unacceptable toxicity.

ARM B: Patients receive bortezomib at 1.3 mg/m2 IV on days 1, 4, 8, and 11 and dexamethasone at 40 mg total dose per day PO QD on days 1, 8, and 15. Treatment repeats every 21 days for 8 courses in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed every 3 months for 2 years, every 6 months for 3 years, and then every 12 months for 5 years.

Keywords
Consolidation therapy, First-line therapy, Proteasome inhibitor, Thalidomide analogue, Quality of life
Medical subject headings
Multiple Myeloma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • bortezomibDrug

    Also called PS-341, LDP-341, MLN-341, VELCADE

    Given IV

  • lenalidomideDrug

    Also called CC-5013, CDC-501, Revlimid® (formerly Revimid®)

    Given PO

  • dexamethasoneDrug

    Also called Decadron, Hexadrol, Dexameth, Dexone

    Given PO

Study groups in NCT00522392
Study groupRoleWhat they receive
Arm A (VRD)ExperimentalPatients were given consolidation therapy for 8 cycles (1 cycle = 21 days) with the combination bortezomib, dexamethasone and lenalidomide. Patients received each cycle: the standard dose of bortezomib (1.3 mg/m2) on days 1, 4, 8 and 11; fixed dose of lenalidomide at 15 mg orally on days 1-14; and 3 days of dexamethasone at 40 mg total dose per day given on days 1, 8 and 15. Aspirin 325 mg/day orally on days 1-21 of each cycle was required unless the patient was treated with alternate prophylaxis of either low molecular weight heparin or coumadin.
Receives: Drug: bortezomib; Drug: lenalidomide; Drug: dexamethasone
Arm B (VD)Active comparatorPatients were given consolidation therapy for 8 cycles (1 cycle = 21 days) with the combination bortezomib plus dexamethasone. Patients received each cycle: the standard dose of bortezomib (1.3 mg/m2) on days 1, 4, 8 and 11 and 3 days of dexamethasone at 40 mg total dose per day given on days 1, 8 and 15.
Receives: Drug: bortezomib; Drug: dexamethasone

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Progression-free Survival (PFS)

    Progression-free survival was defined as the time from randomization to the earliest documentation of disease progression (PD) or death. If a patient died without evidence of PD, the patient was considered an event if death occurred within 3 months of the last disease assessment. Patients who died outside of the specified interval or patients who were alive without evidence of PD were censored at the date of last disease assessment.

    The PFS results are based on data as of August 2012, while overall survival (OS) was updated in April 2014. Given the early termination and limited sample size, data management efforts to update PFS were not pursued.

    Measured: Assessed every 3 months if patient is < 2 years from study entry, every 6 months if patient is 2-5 years from study entry, every 12 months if patient is 6-10 years from study entry, up to 10 years

Secondary outcomes (3)

  1. Response Rates (Complete Response [CR] or Very Good Partial Response [VGPR])

    CR:

    Patients with complete disappearance of an M-protein and no evidence of myeloma in the bone marrow are considered to have CR. To be considered CR, patients must meet all of the following criteria:

    • Negative immunofixation on the serum and urine at two consecutive times
    • Disappearance of any soft tissue plasmacytomas
    • ≤5% plasma cells in bone marrow
    • If serum and urine M protein are unmeasurable and the immunoglobulin free light chain (FLC) parameter is being used, patients must have a normal ratio of 0.26-1.65 at two consecutive times

    VGPR:

    • Serum and urine M-component detectable by immunofixation but not on electrophoresis OR
    • >=90% reduction in serum M-component plus urine M-component <100 mg per 24 hours (by SPEP and UPEP)
    • If the serum and urine M protein are unmeasurable and the immunoglobulin FLC parameter is being used, a >90% decrease in the difference between involved and uninvolved FLC levels is required in place of the M protein criteria

    Measured: Assessed at the end of each cycle, every 3 months if patient is < 2 years from study entry, every 6 months if patient is 2-5 years from study entry, every 12 months if patient is 6-10 years from study entry, up to 10 years

  2. Overall Survival (OS)

    Overall survival is defined as the time from randomization to death or date of last known alive. The OS results are based on data as of April 2014.

    Measured: Assessed every 3 months if patient is < 2 years from study entry, every 6 months if patient is 2-5 years from study entry, every 12 months if patient is 6-10 years from study entry, up to 10 years

  3. Change in Quality of Life (QOL) From Baseline to 6 Months Post Consolidation as Assessed by the Functional Assessment of Cancer Therapy-Neurotoxicity Trial Outcome Index (FACT-Ntx TOI)

    The combined score on the FACT-Ntx TOI is of interest. The FACT-Ntx TOI has 25 items and the score ranges from 0 (worst possible quality of life) -100 (best possible quality of life). The primary QOL endpoint is defined as the change in the FACT-Ntx TOI score from registration to 6 months post consolidation treatment.

    Measured: Baseline and 6 months post consolidation treatment

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Aug 2007 (estimated)
  2. Study startSep 2007
  3. Primary completionAug 2012
  4. Study completionJul 2014

Why it stopped: Slow accrual

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
48 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00522392
Sponsor's protocol ID
NCI-2009-00521
Other IDs
NCI-2009-00521, E1A05, U10CA021115, U10CA180820
Status last verified
May 2015
First submitted
28 Aug 2007
Last updated
26 Jun 2015
Data monitoring committee
Yes

Publications

  • Fonseca R, Rajkumar SV. Consolidation therapy with bortezomib/lenalidomide/ dexamethasone versus bortezomib/dexamethasone after a dexamethasone-based induction regimen in patients with multiple myeloma: a randomized phase III trial. Clin Lymphoma Myeloma. 2008 Oct;8(5):315-7. doi: 10.3816/CLM.2008.n.046.

    PubMed 18854289

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing bortezomib, lenalidomide and dexamethasone in people with Stage I Multiple Myeloma and Stage II Multiple Myeloma, run by National Cancer Institute (NCI) at 276 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 22 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 26 Jun 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 276 sites in United States, South Africa. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 26 Jun 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Progression-free Survival (PFS) (time frame: Assessed every 3 months if patient is < 2 years from study entry, every 6 months if patient is 2-5 years from study entry, every 12 months if patient is 6-10 years from study entry, up to 10 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00522392, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jun 2015.

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