Know Cancer

or
forgot password

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


Phase 3
18 Years
N/A
Open (Enrolling)
Both
Stage I Multiple Myeloma, Stage II Multiple Myeloma, Stage III Multiple Myeloma

Thank you

Trial Information

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


PRIMARY OBJECTIVES:

I. To compare the progression-free survival (PFS) of patients with previously treated
symptomatic multiple myeloma treated with consolidation therapy comprising bortezomib and
dexamethasone with vs without lenalidomide.

SECONDARY OBJECTIVES:

I. To determine the incremental ability of these regimens in attaining a complete response
or a very good partial response (VGPR) in these patients.

II. To compare the overall survival of patients treated with these regimens. III. To compare
the toxicity of these regimens in these patients. IV. To compare the quality of life of
these patients. V. To examine the impact of differential treatment response, if observed, on
quality of life of these patients.

VI. To obtain prospective data on multiple myeloma specific quality of life attributes.

OUTLINE: Patients are stratified according to prior induction therapy with lenalidomide and
dexamethasone (yes vs no) and whether or not they are in complete response after induction
therapy at study registration (yes vs no). Patients are randomized to 1 of 2 treatment arms.

ARM I: Patients receive bortezomib IV on days 1, 4, 8, and 11, oral lenalidomide once a day
on days 1-14, and oral dexamethasone once a day on days 1-4. Treatment repeats every 21 days
for 8 courses in the absence of disease progression or unacceptable toxicity.

ARM II: Patients receive bortezomib IV on days 1, 4, 8, and 11 and oral dexamethasone once a
day on days 1-4. Treatment repeats every 21 days for 8 courses in the absence of disease
progression or unacceptable toxicity.

Quality of life is assessed periodically. 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.


Inclusion Criteria:



- Diagnosis of symptomatic multiple myeloma

- Must meet the following criteria at one point in the course of the disease for the
original diagnosis of myeloma:

- Bone marrow plasmacytosis with > 10% plasma cells or sheets of plasma cells or
biopsy proven plasmacytoma

- Must have symptomatic disease that prompted the initiation of therapy (e.g.,
anemia, hypercalcemia, bone disease, or renal dysfunction)

- Must have completed a minimum of 1 and a maximum of 6 courses of a
dexamethasone-based regimen within the past 8 weeks, including any of the following:

- 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

- Cyclophosphamide, lenalidomide, and dexamethasone

- Received a minimum cumulative dose of 160 mg of dexamethasone (no maximum dose
specified)

- Must have not experienced progressive disease on the dexamethasone-based regimen

- Patients diagnosed with only smoldering myeloma or monoclonal gammopathy of
undetermined significance are not eligible

- ECOG performance status 0-2

- Hemoglobin > 7 g/dL

- Platelet count > 75,000/mm^3

- Absolute neutrophil count > 1,000/mm^3 (without the use of growth factors to increase
ANC)

- Creatinine < 2.5 mg/dL and creatinine clearance (measured or calculated) ≥ 60 mL/min

- Direct bilirubin < 1.5 mg/dL

- ALT and AST < 2.5 times upper limit of normal

- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use effective double-method contraception for 4 weeks prior to,
during, and for 4 weeks after completion of study therapy

- No active uncontrolled seizure disorder

- No seizure within the past 6 months

- No concurrent uncontrolled illness that would limit compliance with the study,
including any of the following:

- Uncontrolled hypertension

- Symptomatic congestive heart failure

- Unstable angina

- Uncontrolled cardiac arrhythmia

- Uncontrolled psychiatric illness or social situation

- History of Steven Johnson syndrome

- No peripheral neuropathy ≥ grade 2

- No active uncontrolled infection

- Patients with a history of prior malignancy are eligible provided there is no active
malignancy AND there is a low expectation of recurrence within 6 months

- Must be willing and able to receive prophylaxis with aspirin (325 mg/day) or
alternative prophylaxis with low molecular weight heparin or coumadin

- Patients with prior DVT are eligible provided they remain on the anticoagulation
regimen that was prescribed for treatment of the DVT throughout study therapy

- Concurrent bisphosphonates or growth factors (e.g., granulocyte and/or erythropoietic
agents) for multiple myeloma allowed

- At least 14 days since prior palliative and/or localized radiotherapy

- Prior bortezomib allowed

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

PFS of two consolidation regimens

Outcome Description:

PFS in each of the arms will be estimated using the method of Kaplan and Meier. PFS between the two arms will be compared using one-sided stratified log-rank test.

Outcome Time Frame:

Time from consolidation randomization until progression or death of any cause, assessed up to 10 years

Safety Issue:

No

Principal Investigator

Rafael Fonseca

Investigator Role:

Principal Investigator

Investigator Affiliation:

Eastern Cooperative Oncology Group

Authority:

United States: Food and Drug Administration

Study ID:

NCI-2009-00521

NCT ID:

NCT00522392

Start Date:

August 2007

Completion Date:

Related Keywords:

  • Stage I Multiple Myeloma
  • Stage II Multiple Myeloma
  • Stage III Multiple Myeloma
  • Multiple Myeloma
  • Neoplasms, Plasma Cell

Name

Location

Mayo Clinic Rochester, Minnesota  55905
Abington Memorial Hospital Abington, Pennsylvania  19001
University of Washington Medical Center Seattle, Washington  98195-6043
Hurley Medical Center Flint, Michigan  48503
Boulder Community Hospital Boulder, Colorado  80301-9019
Porter Adventist Hospital Denver, Colorado  80210
Rose Medical Center Denver, Colorado  80220
Swedish Medical Center Englewood, Colorado  80110
Sky Ridge Medical Center Lone Tree, Colorado  80124
North Suburban Medical Center Thornton, Colorado  80229
Fairview Ridges Hospital Burnsville, Minnesota  55337
Hutchinson Area Health Care Hutchinson, Minnesota  55350
Meeker County Memorial Hospital Lichfield, Minnesota  55355
United Hospital St. Paul, Minnesota  55102
Ridgeview Medical Center Waconia, Minnesota  55387
Geisinger Medical Center Danville, Pennsylvania  17822-0001
Rapid City Regional Hospital Rapid City, South Dakota  57709
Marshfield Clinic Marshfield, Wisconsin  54449
Stanford University Stanford, California  94305
Methodist Medical Center of Illinois Peoria, Illinois  61636
Reading Hospital and Medical Center Reading, Pennsylvania  19612-6052
Virginia Piper Cancer Institute Minneapolis, Minnesota  55407
Wesley Medical Center Wichita, Kansas  67214
Iowa Methodist Medical Center Des Moines, Iowa  50309
Iowa Lutheran Hospital Des Moines, Iowa  50316-2301
University of Wisconsin Hospital and Clinics Madison, Wisconsin  53792-0001
Great Falls Clinic Great Falls, Montana  59405
Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium Seattle, Washington  98109
Montefiore Medical Center Bronx, New York  10467-2490
North Colorado Medical Center Greeley, Colorado  80631
McKee Medical Center Loveland, Colorado  80539
Northern Rockies Radiation Oncology Center Billings, Montana  59101
Bozeman Deaconess Hospital Bozeman, Montana  59715
Kalispell Medical Oncology Kalispell, Montana  59901
Kalispell Regional Medical Center Kalispell, Montana  59901
Grady Memorial Hospital Delaware, Ohio  43015
Fairfield Medical Center Lancaster, Ohio  43130
Harborview Medical Center Seattle, Washington  98104
Welch Cancer Center Sheridan, Wyoming  82801
Paoli Memorial Hospital Paoli, Pennsylvania  19301-1792
University Medical Center of Southern Nevada Las Vegas, Nevada  89102
Beebe Medical Center Lewes, Delaware  19958
Memorial Hospital Carthage, Illinois  62321
Galesburg Cottage Hospital Galesburg, Illinois  61401
Galesburg Clinic Galesburg, Illinois  61401
Mason District Hospital Havana, Illinois  62644
McDonough District Hospital Macomb, Illinois  61455
BroMenn Regional Medical Center Normal, Illinois  61761
Proctor Hospital Peoria, Illinois  61614
Perry Memorial Hospital Princeton, Illinois  61356
Valley Cancer Center Spring Valley, Illinois  61362
Community Cancer Center of Monroe Monroe, Michigan  48162
Saint Francis Medical Center Cape Girardeau, Missouri  63701
MeritCare Medical Group Fargo, North Dakota  58122
Wood County Oncology Center Bowling Green, Ohio  43402
Grandview Hospital Dayton, Ohio  45405
Fremont Memorial Hospital Fremont, Ohio  43420
Lima Memorial Hospital Lima, Ohio  45804
Northwest Ohio Oncology Center Maumee, Ohio  43537
Firelands Regional Medical Center Sandusky, Ohio  44870
Mercy Medical Center Springfield, Ohio  45504
Mercy Hospital of Tiffin Tiffin, Ohio  44883
Fulton County Health Center Wauseon, Ohio  43567
Bryn Mawr Hospital Bryn Mawr, Pennsylvania  19010
Exempla Lutheran Medical Center Wheat Ridge, Colorado  80033
Eureka Hospital Eureka, Illinois  61530
Mercy Hospital Coon Rapids, Minnesota  55433
Graham Hospital Association Canton, Illinois  61520
Saint Joseph Medical Center Joliet, Illinois  60435
Pekin Hospital Pekin, Illinois  61554
Medical Oncology and Hematology Associates Des Moines, Iowa  50309
Bixby Medical Center Adrian, Michigan  49221
Saint Joseph Mercy Hospital Ann Arbor, Michigan  48106
Fairview-Southdale Hospital Edina, Minnesota  55435
Abbott-Northwestern Hospital Minneapolis, Minnesota  55407
Regions Hospital Saint Paul, Minnesota  55101
Saint Francis Regional Medical Center Shakopee, Minnesota  55379
Mary Imogene Bassett Hospital Cooperstown, New York  13326
Saint Luke's Hospital Maumee, Ohio  43537
Lancaster General Hospital Lancaster, Pennsylvania  17604-3555
Geisinger Medical Group State College, Pennsylvania  16801
Franciscan Skemp Healthcare La Crosse, Wisconsin  54601-4796
Center for Cancer Care and Research St. Louis, Missouri  63141
Miami Valley Hospital Dayton, Ohio  45409
Lawrence Memorial Hospital Lawrence, Kansas  66044
Bozeman Deaconess Cancer Center Bozeman, Montana  59715
Northern Montana Hospital Havre, Montana  59501
Mary Rutan Hospital Bellefontaine, Ohio  43311
Wayne Hospital Greenville, Ohio  45331
Fisher-Titus Medical Center Norwalk, Ohio  44857
Clinton Memorial Hospital Wilmington, Ohio  45177
Adventist Medical Center Portland, Oregon  97216
Wenatchee Valley Medical Center Wenatchee, Washington  98801-2028
Marshfield Clinic Cancer Care at Regional Cancer Center Eau Claire, Wisconsin  54701
UW Cancer Center Johnson Creek Johnson Creek, Wisconsin  53038
Saint Joseph's Hospital Marshfield, Wisconsin  54449
Marshfield Clinic - Weston Center Weston, Wisconsin  54476
Marshfield Clinic - Wisconsin Rapids Center Wisconsin Rapids, Wisconsin  54494
Longmont United Hospital Longmont, Colorado  80501
Genesys Regional Medical Center Grand Blanc, Michigan  48439-8066
Greene Memorial Hospital Xenia, Ohio  45385
Union Hospital of Cecil County Elkton MD, Maryland  21921
Mayo Clinic in Arizona Scottsdale, Arizona  85259-5404
Mayo Clinic in Florida Jacksonville, Florida  32224
Memorial Medical Center Springfield, Illinois  62781
Doylestown Hospital Doylestown, Pennsylvania  18901
McLeod Regional Medical Center Florence, South Carolina  29501
Guardian Oncology and Center for Wellness Missoula, Montana  59804
Woodwinds Health Campus Woodbury, Minnesota  55125
Hennepin County Medical Center Minneapolis, Minnesota  
Case Western Reserve University Cleveland, Ohio  44106
Toledo Clinic Oregon, Ohio  43616
Riverside Methodist Hospital Columbus, Ohio  43214
Licking Memorial Hospital Newark, Ohio  43055-2899
Presbyterian - Saint Lukes Medical Center - Health One Denver, Colorado  80218
Kaiser Permanente Sacramento, California  
Montana Cancer Consortium CCOP Billings, Montana  59101
Metro-Minnesota CCOP St. Louis Park, Minnesota  
University of New Mexico Albuquerque, New Mexico  87131
Decatur Memorial Hospital Decatur, Illinois  62526
Lankenau Hospital Wynnewood, Pennsylvania  19096
Montana Cancer Specialists Missoula, Montana  59807-7877
OSF Saint Francis Medical Center Peoria, Illinois  61637
Northbay Cancer Center Fairfield, California  94533
The Medical Center of Aurora Aurora, Colorado  80012
Penrose-Saint Francis Healthcare Colorado Springs, Colorado  80907
Saint Anthony Central Hospital Denver, Colorado  80204
Exempla Saint Joseph Hospital Denver, Colorado  80218
Colorado Cancer Research Program CCOP Denver, Colorado  80224-2522
Saint Mary's Hospital and Regional Medical Center Grand Junction, Colorado  81502
Saint Mary Corwin Medical Center Pueblo, Colorado  81004
John B Amos Cancer Center Columbus, Georgia  31904
Saint Anthony's Health Alton, Illinois  62002
Cancer Institute at Alexian Brothers Elk Grove Village, Illinois  60007
Saint Francis Hospital Evanston, Illinois  60202
Intercommunity Cancer Center Galesburg, Illinois  61401
Hopedale Medical Complex - Hospital Hopedale, Illinois  61747
Joliet Oncology-Hematology Associates Limited Joliet, Illinois  60435
Stoffel, Thomas J MD (UIA Investigator) Moline, Illinois  61265
Garneau, Stewart C MD (UIA Investigator) Moline, Illinois  61265
Sharis, Christine M MD (UIA Investigator) Moline, Illinois  61265
Porubcin, Michael MD (UIA Investigator) Moline, Illinois  61265
Good Samaritan Regional Medical Center Mt. Vernon, Illinois  62864
Community Cancer Center Foundation 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 Oncology Research Association CCOP Peoria, Illinois  61615
Illinois Valley Hospital Peru, Illinois  61354
Saint Margaret's Hospital Spring Valley, Illinois  61362
Carle Clinic-Urbana Main Urbana, Illinois  61801
Saint Francis Hospital and Health Centers Beech Grove, Indiana  46107
Reid Hospital and Health Care Services Richmond, Indiana  47374
McFarland Clinic Ames, Iowa  50010
Constantinou, Costas L MD (UIA Investigator) Bettendorf, Iowa  52722
Iowa Oncology Research Association CCOP Des Moines, Iowa  50309
Mercy Capitol Des Moines, Iowa  50307
Mercy Medical Center - Des Moines Des Moines, Iowa  50314
Medical Oncology and Hematology Associates-Des Moines Des Moines, Iowa  50309
Mercy Medical Center-Sioux City Sioux City, Iowa  51104
Saint Luke's Regional Medical Center Sioux City, Iowa  51104
Siouxland Hematology - Oncology Associates Sioux City, Iowa  51101
Covenant Medical Center Waterloo, Iowa  50702
Hickman Cancer Center Adrian, Michigan  49221
Michigan Cancer Research Consortium Community Clinical Oncology Program Ann Arbor, Michigan  48106
Oakwood Hospital Dearborn, Michigan  48123
Saint John Hospital and Medical Center Detroit, Michigan  48236
Green Bay Oncology - Escanaba Escanaba, Michigan  49431
Green Bay Oncology - Iron Mountain Iron Mountain, Michigan  49801
Allegiance Health Jackson, Michigan  49201
Sparrow Hospital Lansing, Michigan  48912
Saint Mary Mercy Hospital Livonia, Michigan  48154
Mercy Memorial Hospital Monroe, Michigan  48162
Saint Joseph Mercy Oakland Pontiac, Michigan  48341-2985
Saint Joseph Mercy Port Huron Port Huron, Michigan  48060
Saint Mary's of Michigan Saginaw, Michigan  48601
Saint John Macomb-Oakland Hospital Warren, Michigan  48093
Merit Care Clinic Bemidji Bemidji, Minnesota  56601
Saint Mary's Medical Center Duluth, Minnesota  55805
Miller-Dwan Hospital Duluth, Minnesota  55805
Duluth Clinic CCOP Duluth, Minnesota  55805
Unity Hospital Fridley, Minnesota  55432
Saint John's Hospital - Healtheast Maplewood, Minnesota  55109
Minnesota Oncology Hematology PA-Maplewood Maplewood, Minnesota  55109
North Memorial Medical Health Center Robbinsdale, Minnesota  55422
Park Nicollet Clinic - Saint Louis Park Saint Louis Park, Minnesota  55416
Saint Joseph's Hospital - Healtheast Saint Paul, Minnesota  55102
Minnesota Oncology and Hematology PA-Woodbury Woodbury, Minnesota  55125
Southeast Missouri Hospital Cape Girardeau, Missouri  63701
Saint Louis-Cape Girardeau CCOP Saint Louis, Missouri  63141
Missouri Baptist Medical Center Saint Louis, Missouri  63131
Saint John's Mercy Medical Center Saint Louis, Missouri  63141
Saint Louis Cancer and Breast Institute Saint Louis, Missouri  63109
Ozark Health Ventures LLC dba Cancer Research for The Ozarks Springfield Springfield, Missouri  65802
Saint John's Hospital Springfield, Missouri  65804
Hematology-Oncology Centers of the Northern Rockies PC Billings, Montana  59101
Saint Vincent Healthcare Billings, Montana  59101
Billings Clinic Billings, Montana  59107-7000
Saint James Community Hospital and Cancer Treatment Center Butte, Montana  59701
Berdeaux, Donald MD (UIA Investigator) Great Falls, Montana  59405
Saint Peter's Community Hospital Helena, Montana  59601
Glacier Oncology PLLC Kalispell, Montana  59901
Community Medical Hospital Missoula, Montana  59801
Saint Patrick Hospital - Community Hospital Missoula, Montana  59802
Good Samaritan Hospital Kearney, Nebraska  68847
Nevada Cancer Research Foundation CCOP Las Vegas, Nevada  89106
Cooper Hospital University Medical Center Camden, New Jersey  08103
Veterans Adminstration New Jersey Health Care System East Orange, New Jersey  07018-1095
Fox Chase Cancer Center at Virtua Memorial Hospital of Burlington County Mount Holly, New Jersey  08060
Virtua West Jersey Hospital Voorhees Voorhees, New Jersey  08043
Adirondack Cancer Center Glens Falls, New York  12801
Orange Regional Medical Center Middletown, New York  10940
Meritcare Hospital Fargo, North Dakota  58122
Doctors Hospital Columbus, Ohio  43228
Grant Medical Center Columbus, Ohio  43215
Mount Carmel Health Center West Columbus, Ohio  43222
Good Samaritan Hospital - Dayton Dayton, Ohio  45406
Dayton CCOP Dayton, Ohio  45429
Samaritan North Health Center Dayton, Ohio  45415
Veteran Affairs Medical Center Dayton, Ohio  45428
Hematology Oncology Center Incorporated Elyria, Ohio  44035
Blanchard Valley Hospital Findlay, Ohio  45840
Atrium Medical Center-Middletown Regional Hospital Franklin, Ohio  45005-1066
Kettering Medical Center Kettering, Ohio  45429
Marietta Memorial Hospital Marietta, Ohio  45750
Toledo Radiation Oncology at Northwest Ohio Onocolgy Center Maumee, Ohio  43537
Bayview Oncology Associates Oregon, Ohio  43616
Saint Charles Hospital Oregon, Ohio  43616
North Coast Cancer Care Sandusky, Ohio  44870
Flower Memorial Hospital Sylvania, Ohio  43560
Toledo Community Hospital Oncology Program CCOP Toledo, Ohio  43617
Mercy Cancer Center at Saint Anne Mercy Hospital Toledo, Ohio  43623
University of Toledo Toledo, Ohio  43614
The Toledo Hospital Toledo, Ohio  43606
Saint Vincent Mercy Medical Center Toledo, Ohio  43608
Upper Valley Medical Center Troy, Ohio  45373
Saint Ann's Hospital Westerville, Ohio  43081
Genesis HealthCare System Zanesville, Ohio  43701
Geisinger South Wilkes Barre-Hazelton Cancer Center Hazleton, Pennsylvania  18201
Pottstown Memorial Medical Center Pottstown, Pennsylvania  19464
Geisinger Wyoming Valley Wilkes-Barre, Pennsylvania  18711
Mainline Health CCOP Wynnewood, Pennsylvania  19096
Fredericksburg Oncology Inc Fredericksburg, Virginia  22401
Saint Joseph Hospital Bellingham, Washington  98225
Harrison Bremerton Hematology and Oncology Bremerton, Washington  98310
Columbia Basin Hematology and Oncology PLLC Kennewick, Washington  99336
Minor and James Medical PLLC Seattle, Washington  98104
The Polyclinic Seattle, Washington  98122
Swedish Medical Center-First Hill Seattle, Washington  98122-4307
Wheeling Hospital Wheeling, West Virginia  26003
Sacred Heart Hospital Eau Claire, Wisconsin  54701
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
Green Bay Oncology at Saint Vincent Hospital Green Bay, Wisconsin  54301-3526
Bay Area Medical Center Marinette, Wisconsin  54143
Marshfield Clinic-Minocqua Center Minocqua, Wisconsin  54548
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 Michael's Hospital Stevens Point, Wisconsin  54481
Green Bay Oncology - Sturgeon Bay Sturgeon Bay, Wisconsin  54235
Marshfield Clinic-Wausau Center Wausau, Wisconsin  54401
Christiana Healthcare Services - Christian Hospital Newark, Delaware  19718
Harbin Clinic Medical Oncology and Clinical Research Rome, Georgia  30165
University of Missouri - Ellis Fischel Columbia, Missouri  65203
University of Tennessee - Knoxville Knoxville, Tennessee  37920
Marshfield Clinic-Chippewa Center Chippewa Falls, Wisconsin  54729
State University of New York Downstate Medical Center Brooklyn, New York  11203
Capital Regional Medical Center Jefferson City, Missouri  65101
Doctors Carrol, Sheth, Raghavan Louisville, Kentucky  40215
Kings County Hospital Brooklyn, New York  11203
Gundersen Lutheran La Crosse, Wisconsin  54601
University Hospital of Brooklyn Brooklyn, New York  11203
The Schiffler Cancer Center of Wheeling Hospital Wheeling, West Virginia  26003