Randomized Phase III Trial of Lenalidomide Versus Observation Alone in Patients With Asymptomatic High-Risk Smoldering Multiple Myeloma
PRIMARY OBJECTIVES:
I. Study the risk of grade 3-4 non-hematologic adverse events in patients with asymptomatic
high-risk smoldering multiple myeloma treated with lenalidomide. (Phase II) II. Compare the
progression-free survival (PFS) of patients with asymptomatic high-risk smoldering multiple
myeloma treated with lenalidomide versus observation alone. (Phase III)
SECONDARY OBJECTIVES:
I. Assess the response of patients treated with lenalidomide. (Phase II) II. Determine and
compare the response rate, time to progression, 1-year PFS probability, and the overall
survival of patients treated with lenalidomide versus observation alone. (Phase III) III.
Estimate the incidence of adverse events of these regimens in these patients. (Phase III)
TERTIARY OBJECTIVES:
I. Describe the cohort in terms of GEP and cytogenetic risk classification and evaluate
baseline immune and MRI parameters. (Phase II) II. Evaluate the impact of therapy within
GEP-defined risk groups and GEP as a prognostic marker. (Phase III) III. Study the effects
of lenalidomide on laboratory markers of immune function. (Phase III) IV. Study the
prognostic value of MRI-detected asymptomatic bone disease on clinical outcome. (Phase III
V. Evaluate the prognostic effect of baseline high-risk cytogenetic abnormalities on
clinical outcome. (Phase III)
QUATERNARY OBJECTIVES:
I. To compare QOL change between treatment and observation arms based on the functional
(FWB) and physical (PWB) well-being components of the FACT-General (G) patient-reported
outcome (PRO) measure from registration (prior to initiation of treatment) up to cycle 24.
II. To examine the impact of differential treatment response (PFS), if observed, on QOL
based on the FACT FWB+PWB up to cycle 48.
III. To obtain prospective data on Myeloma specific QOL attributes, utilizing and evaluating
the Multiple Myeloma Subscale (MMS).
OUTLINE: This is a multicenter study.
PHASE II: Patients receive lenalidomide orally (PO) once daily (QD) on days 1-21. Treatment
repeats every 28 days for 6 courses in the absence of disease progression or unacceptable
toxicity.
PHASE III: Patients are randomized to 1 of 2 treatment arms.
ARM I: Patients receive lenalidomide PO QD on days 1-21. Courses repeat every 28 days in the
absence of disease progression or unacceptable toxicity.
ARM II: Patients receive standard of care and undergo observation in the absence of disease
progression.
Peripheral blood, bone marrow aspirate, and bone marrow core biopsy samples are collected
for gene expression profiling, immune function, and cytogenetic abnormalities. Patients
complete the Functional Assessment of Cancer Therapy (FACT) Physical Well-Being (PWB), and
FACT Functional Well-Being (FWB) questionnaires at baseline and periodically during study.
After completion of study therapy, patients are followed up periodically for 10 years.
Interventional
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Grade 3 or higher non-hematologic toxicity based on AdEERS expedited reporting (Phase II)
The difference in rates of all Grade 3 or higher toxicities will be evaluated for all randomized patients using the Fisher's Exact Test.
6 months
Yes
Sagar Lonial
Principal Investigator
Eastern Cooperative Oncology Group
United States: Food and Drug Administration
NCI-2011-02057
NCT01169337
October 2010
Name | Location |
---|---|
Albert Einstein College of Medicine | Bronx, New York 10461 |
Mayo Clinic | Rochester, Minnesota 55905 |
University of Mississippi Medical Center | Jackson, Mississippi 39216-4505 |
Fox Chase Cancer Center | Philadelphia, Pennsylvania 19111 |
Hurley Medical Center | Flint, Michigan 48503 |
Pennsylvania Hospital | Philadelphia, Pennsylvania 19107 |
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 |
Bronson Methodist Hospital | Kalamazoo, Michigan 49007 |
West Michigan Cancer Center | Kalamazoo, Michigan 49007-3731 |
Borgess Medical Center | Kalamazooaa, Michigan 49001 |
Fairview Ridges Hospital | Burnsville, Minnesota 55337 |
Hutchinson Area Health Care | Hutchinson, Minnesota 55350 |
United Hospital | St. Paul, Minnesota 55102 |
Ridgeview Medical Center | Waconia, Minnesota 55387 |
Geisinger Medical Center | Danville, Pennsylvania 17822-0001 |
Avera Cancer Institute | Sioux Falls, South Dakota 57105 |
Rapid City Regional Hospital | Rapid City, South Dakota 57709 |
Marshfield Clinic | Marshfield, Wisconsin 54449 |
Methodist Medical Center of Illinois | Peoria, Illinois 61636 |
Newark Beth Israel Medical Center | Newark, New Jersey 07112 |
Jackson-Madison County General Hospital | Jackson, Tennessee 38301 |
Waukesha Memorial Hospital | Waukesha, Wisconsin 53188 |
Illinois Masonic Medical Center | Chicago, Illinois 60657 |
Wesley Medical Center | Wichita, Kansas 67214 |
Ochsner Clinic Foundation | New Orleans, Louisiana 70121 |
University of Oklahoma Health Sciences Center | Oklahoma City, Oklahoma 73104 |
Great Falls Clinic | Great Falls, Montana 59405 |
MetroHealth Medical Center | Cleveland, Ohio 44109 |
Montefiore Medical Center | Bronx, New York 10467-2490 |
North Colorado Medical Center | Greeley, Colorado 80631 |
McKee Medical Center | Loveland, Colorado 80539 |
Bozeman Deaconess Hospital | Bozeman, Montana 59715 |
Kalispell Medical Oncology | Kalispell, Montana 59901 |
Kalispell Regional Medical Center | Kalispell, Montana 59901 |
Adena Regional Medical Center | Chillicothe, Ohio 54601 |
Grady Memorial Hospital | Delaware, Ohio 43015 |
Fairfield Medical Center | Lancaster, Ohio 43130 |
Avera McKennan Hospital and University Health Center | Sioux Falls, South Dakota 57105 |
Welch Cancer Center | Sheridan, Wyoming 82801 |
Paoli Memorial Hospital | Paoli, Pennsylvania 19301-1792 |
Beebe Medical Center | Lewes, Delaware 19958 |
Memorial Hospital | Carthage, Illinois 62321 |
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 |
Creighton University Medical Center | Omaha, Nebraska 68131-2197 |
Iredell Memorial Hospital | Statesville, North Carolina 28677 |
Bismarck Cancer Center | Bismarck, North Dakota 58501 |
Grandview Hospital | Dayton, Ohio 45405 |
Providence Milwaukie Hospital | Milwaukie, Oregon 97222 |
Bryn Mawr Hospital | Bryn Mawr, Pennsylvania 19010 |
Danville Regional Medical Center | Danville, Virginia 24541 |
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 |
Holy Family Medical Center | Des Plaines, Illinois 60016 |
Saint Joseph Medical Center | Joliet, Illinois 60435 |
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 |
Rice Memorial Hospital | Willmar, Minnesota 56201 |
Geisinger Medical Group | State College, Pennsylvania 16801 |
Swedish American Hospital | Rockford, Illinois 61104 |
Miami Valley Hospital | Dayton, Ohio 45409 |
Eastern Connecticut Hematology and Oncology Associates | Norwich, Connecticut 06360 |
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 |
Knox Community Hospital | Mount Vernon, Ohio 43050 |
Clinton Memorial Hospital | Wilmington, Ohio 45177 |
Marshfield Clinic - Weston Center | Weston, Wisconsin 54476 |
Diagnostic and Treatment Center | Weston, Wisconsin 54476 |
Marshfield Clinic - Wisconsin Rapids Center | Wisconsin Rapids, Wisconsin 54494 |
Rocky Mountain Oncology | Casper, Wyoming 82609 |
Longmont United Hospital | Longmont, Colorado 80501 |
Greene Memorial Hospital | Xenia, Ohio 45385 |
Union Hospital of Cecil County | Elkton MD, Maryland 21921 |
Cancer Centers of the Carolinas - Grove Commons | Greenville, South Carolina 29605 |
Cancer Centers of the Carolinas - Seneca | Seneca, South Carolina 29672 |
Cancer Centers of the Carolinas - Spartanburg | Spartanburg, South Carolina 29307 |
Mayo Clinic in Arizona | Scottsdale, Arizona 85259-5404 |
Manchester Memorial Hospital | Manchester, Connecticut 06040-4188 |
Memorial Medical Center | Springfield, Illinois 62781 |
Wellmont Holston Valley Hospital and Medical Center | Kingsport, Tennessee 37662 |
Northwest Cancer Specialists | Vancouver, Washington 98664 |
Hennepin County Medical Center | Minneapolis, Minnesota |
Holy Cross Hospital | Fort Lauderdale, Florida 33308 |
Case Western Reserve University | Cleveland, Ohio 44106 |
Emory University | Atlanta, Georgia 30322 |
Riverside Methodist Hospital | Columbus, Ohio 43214 |
Licking Memorial Hospital | Newark, Ohio 43055-2899 |
Providence Portland Medical Center | Portland, Oregon 97213-3635 |
Mid Dakota Clinic | Bismarck, North Dakota 58501 |
Columbus CCOP | Columbus, Ohio 43206 |
Presbyterian - Saint Lukes Medical Center - Health One | Denver, Colorado 80218 |
University of Texas Southwestern Medical Center | Dallas, Texas |
Montana Cancer Consortium CCOP | Billings, Montana 59101 |
Alegent Health Immanuel Medical Center | Omaha, Nebraska 68122 |
Alegent Health Bergan Mercy Medical Center | Omaha, Nebraska 68124 |
Columbia Saint Mary's Hospital - Ozaukee | Mequon, Wisconsin 53097 |
Metro-Minnesota CCOP | St. Louis Park, Minnesota |
Providence Hospital | Southfield, Michigan 48075 |
Cancer Centers of the Carolinas - Easley | Easley, South Carolina 29640 |
Lakeview Hospital | Stillwater, Minnesota 55082 |
Decatur Memorial Hospital | Decatur, Illinois 62526 |
Lankenau Hospital | Wynnewood, Pennsylvania 19096 |
Montana Cancer Specialists | Missoula, Montana 59807-7877 |
Florida Hospital | Orlando, Florida 32803 |
Southeast Cancer Center | Cape Girardeau, Missouri 63703 |
Clackamas Radiation Oncology Center | Clackamas, Oregon 97015 |
Providence Newberg Medical Center | Newberg, Oregon 97132 |
Parker Adventist Hospital | Parker, Colorado 80138 |
OSF Saint Francis Medical Center | Peoria, Illinois 61637 |
Northside Hospital | Atlanta, Georgia 30342 |
Palo Alto Medical Foundation-Camino Division | Mountain View, California 94040 |
Palo Alto Medical Foundation Heath Care | Palo Alto, California 94301 |
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 |
Danbury Hospital | Danbury, Connecticut 06810 |
Saint Francis Hospital and Medical Center | Hartford, Connecticut 06105 |
Middlesex Hospital | Middletown, Connecticut 06457 |
The Hospital of Central Connecticut | New Britain, Connecticut 06050 |
Phoebe Putney Memorial Hospital | Albany, Georgia 31703 |
Veterans Administration Medical Center | Decatur, Georgia 30033 |
Saint Joseph's-Candler Health System | Savannah, Georgia 31405 |
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 CancerCare-Peoria | Peoria, Illinois 61615 |
Illinois Valley Hospital | Peru, Illinois 61354 |
Saint Francis Hospital and Health Centers | Beech Grove, Indiana 46107 |
Reid Hospital and Health Care Services | Richmond, Indiana 47374 |
McFarland Clinic | Ames, Iowa 50010 |
Hematology Oncology Associates-Quad Cities | Bettendorf, Iowa 52722 |
Genesis Medical Center - East Campus | Davenport, Iowa 52803 |
Mercy Medical Center-Sioux City | Sioux City, Iowa 51104 |
Saint Luke's Regional Medical Center | Sioux City, Iowa 51104 |
Ochsner Clinic Foundation-Baton Rouge | Baton Rouge, Louisiana 70809 |
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 |
Allegiance Health | Jackson, Michigan 49201 |
Sparrow Hospital | Lansing, Michigan 48912 |
Saint Mary Mercy Hospital | Livonia, Michigan 48154 |
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 |
Miller-Dwan Hospital | 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 |
Minnesota Oncology and Hematology PA-Woodbury | Woodbury, Minnesota 55125 |
Kansas City Veterans Affairs Medical Center | Kansas City, Missouri 64128 |
Missouri Baptist Medical Center | Saint Louis, Missouri 63131 |
Ozark Health Ventures LLC dba Cancer Research for The Ozarks Springfield | Springfield, Missouri 65802 |
Saint John's Hospital | Springfield, Missouri 65804 |
Cox Medical Center | Springfield, Missouri 65807 |
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 |
Benefis Healthcare- Sletten Cancer Institute | Great Falls, Montana 59405 |
Saint Peter's Community Hospital | Helena, Montana 59601 |
Glacier Oncology PLLC | Kalispell, Montana 59901 |
Saint Patrick Hospital - Community Hospital | Missoula, Montana 59802 |
Lincoln Medical Education Foundation Cancer Resource Center | Lincoln, Nebraska 68510 |
Missouri Valley Cancer Consortium CCOP | Omaha, Nebraska 68106 |
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 |
Wayne Memorial Hospital | Goldsboro, North Carolina 27534 |
Kinston Medical Specialists PA | Kinston, North Carolina 28501 |
Saint Alexius Medical Center | Bismarck, North Dakota 58501 |
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 |
Blanchard Valley Hospital | Findlay, Ohio 45840 |
Atrium Medical Center-Middletown Regional Hospital | Franklin, Ohio 45005-1066 |
Kettering Medical Center | Kettering, Ohio 45429 |
Saint Rita's Medical Center | Lima, Ohio 45801 |
Marietta Memorial Hospital | Marietta, Ohio 45750 |
Upper Valley Medical Center | Troy, Ohio 45373 |
Saint Ann's Hospital | Westerville, Ohio 43081 |
Genesis HealthCare System | Zanesville, Ohio 43701 |
Providence Saint Vincent Medical Center | Portland, Oregon 97225 |
Columbia River Oncology Program | Portland, Oregon 97225 |
Saint Luke's Hospital | Bethlehem, Pennsylvania 18015 |
Pottstown Memorial Medical Center | Pottstown, Pennsylvania 19464 |
Geisinger Wyoming Valley | Wilkes-Barre, Pennsylvania 18711 |
Greenville CCOP | Greenville, South Carolina 29615 |
Greenville Memorial Hospital | Greenville, South Carolina 29605 |
Conklin Regional Cancer Center | Aberdeen, South Dakota 57401 |
Southwest VA Regional Cancer Center | Norton, Virginia 24273 |
Aurora BayCare Medical Center | Green Bay, Wisconsin 54311-6519 |
Dean Hematology and Oncology Clinic | Madison, Wisconsin 53717 |
Vince Lombardi Cancer Clinic-Marinette | Marinette, Wisconsin 54143 |
Marshfield Clinic-Minocqua Center | Minocqua, Wisconsin 54548 |
Oconomowoc Memorial Hospital-ProHealth Care Inc | Oconomowoc, Wisconsin 53066-3896 |
Marshfield Clinic at James Beck Cancer Center | Rhinelander, Wisconsin 54501 |
Marshfield Clinic-Rice Lake Center | Rice Lake, Wisconsin 54868 |
University of California Medical Center At Irvine-Orange Campus | Orange, California 92868 |
Jupiter Medical Center | Jupiter, Florida 33458 |
Rutland Regional Medical Center | Rutland, Vermont 05701 |
University of Illinois | Chicago, Illinois 60612 |
Memorial Healthcare System - Joe DiMaggio Children's Hospital | Hollywood, Florida 33021 |
Mount Sinai Medical Center CCOP | Miami Beach, Florida 33140 |
Illinois CancerCare-Bloomington | Bloomington%, Illinois 61701 |
Illinois CancerCare-Canton | Canton, Illinois 61520 |
Illinois CancerCare-Carthage | Carthage, Illinois 62321 |
Illinois CancerCare-Eureka | Eureka, Illinois 61530 |
Illinois CancerCare-Havana | Havana, Illinois 62644 |
Illinois CancerCare-Kewanee Clinic | Kewanee, Illinois 61443 |
Illinois CancerCare-Macomb | Macomb, Illinois 61455 |
Illinois CancerCare-Monmouth | Monmouth, Illinois 61462 |
Illinois CancerCare-Community Cancer Center | Normal, Illinois 61761 |
Illinois CancerCare-Pekin | Pekin, Illinois 61603 |
Illinois CancerCare-Peru | Peru, Illinois 61354 |
Illinois CancerCare-Princeton | Princeton, Illinois 61356 |
Illinois CancerCare-Spring Valley | Spring Valley, Illinois 61362 |
Central Care Cancer Center-Carrie J Babb Cancer Center | Bolivar, Missouri 65613 |
Skaggs Cancer Center | Branson, Missouri 65616 |
Roper Hospital | Charleston, South Carolina 29401 |
Cancer Centers of the Carolinas - Faris | Greenville, South Carolina 29605 |
Cancer Centers of the Carolinas-Greer Medical Oncology | Greer, South Carolina 29650 |
University of Tennessee - Knoxville | Knoxville, Tennessee 37920 |
West Virginia University Charleston | Charleston, West Virginia 25304 |
Marshfield Clinic-Chippewa Center | Chippewa Falls, Wisconsin 54729 |
Vince Lombardi Cancer Clinic-Sheboygan | Sheboygan, Wisconsin 53081 |
Marshfield Clinic Cancer Care at Saint Michael's Hospital | Stevens Point, Wisconsin 54481 |
Aurora Medical Center in Summit | Summit, Wisconsin 53066 |
Vince Lombardi Cancer Clinic | Two Rivers, Wisconsin 54241 |
Ochsner North Shore Medical Center | Covington, Louisiana 70433 |
Capital Region Medical Center-Goldschmidt Cancer Center | Jefferson City, Missouri 65109 |
Comprehensive Cancer Care PC | Saint Louis, Missouri 63141 |
The Mark H Zangmeister Center | Columbus, Ohio 43219 |
Susquehanna Cancer Center | Williamsport, Pennsylvania 17701 |
Gundersen Lutheran | La Crosse, Wisconsin 54601 |
Columbia Saint Mary's Water Tower Medical Commons | Milwaukee, Wisconsin 53211 |
Siouxland Hematology Oncology Associates | Sioux City, Iowa 51101 |
Walter Reed National Military Medical Center | Bethesda, Maryland 20889 |
IU Health Arnett | Lafayette, Indiana |
Carle Foundation - Carle Cancer Center | Urbana, Illinois 61801 |
Eastern Cooperative Oncology Group | Boston, Massachusetts 02215 |
Genesys Regional Medical Center-West Flint Campus | Flint, Michigan 48532 |
Essentia Health Saint Joseph's Medical Center | Brainerd, Minnesota 56401 |
Essentia Health Duluth Clinic CCOP | Duluth, Minnesota 55805 |
Essentia Health Saint Mary's Medical Center | Duluth, Minnesota 55805 |
Sanford Bismarck Medical Center | Bismarck, North Dakota 58501 |
Geisinger Medical Center-Cancer Center Hazelton | Hazleton, Pennsylvania 18201 |
Illinois CancerCare Galesburg | Galesburg, Illinois 61401 |
Aurora Cancer Care-Milwaukee West | Wauwatosa, Wisconsin 53226 |
Christiana Care Health System-Christiana Hospital | Newark, Delaware 19718 |
Springfield Regional Medical Center | Springfield, Ohio 45505 |
Georgia Regents University | Augusta, Georgia 30912 |
Self Regional Healthcare | Greenwood, South Carolina 29646 |
PeaceHealth Southwest Medical Center | Vancouver, Washington 98664 |
Aurora Cancer Care-Southern Lakes | Elkhorn, Wisconsin 53121 |
Ochsner Baptist Medical Center | New Orleans, Louisiana 70115 |
Providence Willamette Falls Medical Center | Oregon City, Oregon 97045 |
Marshfield Clinic Cancer Center at Sacred Heart | Eau Claire, Wisconsin 54701 |