Patients are enrolled to screening (Reg Step 1) prior to or after ASCT but prior to Reg Step 2. Patients are followed until they will begin Maintenance and then registered to Reg Step 2 (first randomization). Patients are randomized between Lenalidomide for 2 years and Lenalidomide + Daratumumab/rHuPH20. After 2 years of Maintenance, MRD is assessed to guide further therapy. MRD-positive patients will continue with the assigned treatment. MRD-negative patients will be further randomized (Reg Step 3) to either continue or discontinue the assigned treatment. Patients are treated for up to 7 years from Step 2 reg and followed for up to 15 years.
SparkCures ID | 1019 |
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Trial Phase | Phase 3 |
Enrollment | 1100 Patients |
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The following criteria is a partial list of reasons why patients may or may not be eligible to participate in this clinical trial. Further evaluation with a medical professional will be required to determine full eligibility.
The following criteria is provided for health care professionals.
Registration Step 1 Except where otherwise indicated below that test is required in a shorter timeframe, all tests for establishing baseline disease status must be completed within 60 days prior to registration. All test results must be documented on the Baseline Tumor Assessment Form for Multiple Myeloma and the Onstudy Form.
Inclusion Criteria
Exclusion Criteria
Registration Step 2 - First Randomization (Post-ASCT, Pre-Maintenance)
Inclusion Criteria:
Exclusion Criteria:
Registration Step 3 - Second Randomization (Post 24 Months Maintenance)
Inclusion Criteria:
The following is a listing of trial locations that are open and accepting patients.
SparkCures Verified Accurate, up-to-date information. Learn more
Anchorage, AK
Anchorage, AK
Anchorage, AK
Anchorage, AK
Fort Smith, AR
Little Rock, AR
Antioch, CA
Berkeley, CA
Dublin, CA
Fremont, CA
Fresno, CA
Linda, CA
Modesto, CA
Oakland, CA
Redwood City, CA
Richmond, CA
Roseville, CA
Sacramento, CA
Sacramento, CA
Sacramento, CA
San Francisco, CA
San Jose, CA
San Leandro, CA
San Rafael, CA
Santa Clara, CA
Santa Rosa, CA
South San Francisco, CA
Stockton, CA
Truckee, CA
Vacaville, CA
Vallejo, CA
Walnut Creek, CA
Centennial, CO
Colorado Springs, CO
Colorado Springs, CO
Colorado Springs, CO
Denver, CO
Denver, CO
Durango, CO
Durango, CO
Lafayette, CO
Lakewood, CO
Lone Tree, CO
Longmont, CO
Longmont, CO
Parker, CO
Pueblo, CO
Lewes, DE
Newark, DE
Rehoboth Beach, DE
Seaford, DE
Wilmington, DE
Gainesville, FL
Orlando, FL
Tampa, FL
Atlanta, GA
Atlanta, GA
Aiea, HI
Honolulu, HI
Honolulu, HI
Honolulu, HI
Honolulu, HI
Honolulu, HI
Honolulu, HI
Honolulu, HI
Honolulu, HI
Honolulu, HI
Honolulu, HI
Ames, IA
Ames, IA
Boone, IA
Des Moines, IA
Des Moines, IA
Des Moines, IA
Des Moines, IA
Fort Dodge, IA
Fort Dodge, IA
Jefferson, IA
Marshalltown, IA
West Des Moines, IA
West Des Moines, IA
Boise, ID
Boise City, ID
Coeur d'Alene, ID
Fruitland, ID
Meridian, ID
Post Falls, ID
Sandpoint, ID
Twin Falls, ID
Bloomington, IL
Burr Ridge, IL
Canton, IL
Carbondale, IL
Carterville, IL
Carthage, IL
Centralia, IL
Dixon, IL
Effingham, IL
Eureka, IL
Galesburg, IL
Galesburg, IL
Kewanee, IL
Macomb, IL
Melrose Park, IL
Mount Vernon, IL
Pekin, IL
Peoria, IL
Peoria, IL
Princeton, IL
Springfield, IL
Springfield, IL
Swansea, IL
Indianapolis, IN
Garden City, KS
Great Bend, KS
Kansas City, KS
Bardstown, KY
Corbin, KY
Lexington, KY
Lexington, KY
Lexington, KY
Louisville, KY
Louisville, KY
Louisville, KY
Louisville, KY
Shepherdsville, KY
Baton Rouge, LA
New Orleans, LA
Boston, MA
Burlington, MA
Worcester, MA
Bangor, ME
Ann Arbor, MI
Battle Creek, MI
Farmington Hills, MI
Flint, MI
Grand Rapids, MI
Grand Rapids, MI
Kalamazoo, MI
Kalamazoo, MI
Kalamazoo, MI
Muskegon, MI
Niles, MI
Reed City, MI
St. Joseph, MI
St. Joseph, MI
Traverse City, MI
Brainerd, MN
Burnsville, MN
Cambridge, MN
Coon Rapids, MN
Deer River, MN
Duluth, MN
Duluth, MN
Duluth, MN
Edina, MN
Fergus Falls, MN
Fridley, MN
Hibbing, MN
Maple Grove, MN
Maplewood, MN
Maplewood, MN
Minneapolis, MN
Minneapolis, MN
Minneapolis, MN
Monticello, MN
New Ulm, MN
Princeton, MN
Robbinsdale, MN
Rochester, MN
Shakopee, MN
St. Cloud, MN
St. Louis Park, MN
St. Louis Park, MN
St. Paul, MN
St. Paul, MN
Stillwater, MN
Virginia, MN
Waconia, MN
Willmar, MN
Woodbury, MN
Wyoming, MN
Ballwin, MO
Bolivar, MO
Bonne Terre, MO
Branson, MO
Cape Girardeau, MO
Cape Girardeau, MO
Creve Coeur, MO
Jefferson City, MO
Joplin, MO
Rolla, MO
Saint Peters, MO
Sainte Genevieve, MO
Springfield, MO
Springfield, MO
St. Joseph, MO
St. Joseph, MO
St. Louis, MO
St. Louis, MO
St. Louis, MO
St. Louis, MO
St. Louis, MO
Sullivan, MO
Sunset Hills, MO
Washington, MO
Anaconda, MT
Billings, MT
Bozeman, MT
Great Falls, MT
Great Falls, MT
Kalispell, MT
Missoula, MT
Missoula, MT
Charlotte, NC
Clinton, NC
Goldsboro, NC
Jacksonville, NC
Pinehurst, NC
Pinehurst, NC
Grand Island, NE
Kearney, NE
Papillion, NE
Camden, NJ
Paramus, NJ
Albuquerque, NM
Rochester, NY
Stony Brook, NY
Belpre, OH
Centerville, OH
Chardon, OH
Chillicothe, OH
Cincinnati, OH
Cincinnati, OH
Cincinnati, OH
Cleveland, OH
Cleveland, OH
Cleveland, OH
Columbus, OH
Columbus, OH
Columbus, OH
Columbus, OH
Columbus, OH
Columbus, OH
Dayton, OH
Dayton, OH
Delaware, OH
Findlay, OH
Forestville, OH
Franklin, OH
Greenville, OH
Kettering, OH
Lancaster, OH
Lima, OH
Mansfield, OH
Marietta, OH
Marion, OH
Mayfield Heights, OH
Middletown, OH
Mount Vernon, OH
Newark, OH
Newark, OH
Portsmouth, OH
Sidney, OH
Springfield, OH
Strongsville, OH
Toledo, OH
Westerville, OH
Westlake, OH
White Oak, OH
Whitehall, OH
Wooster, OH
Zanesville, OH
Lawton, OK
Oklahoma City, OK
Oklahoma City, OK
Clackamas, OR
Coos Bay, OR
Newberg, OR
Portland, OR
Portland, OR
Chadds Ford, PA
Danville, PA
Hershey, PA
Philadelphia, PA
Charleston, SC
Florence, SC
Greenville, SC
Greenville, SC
Sioux Falls, SD
Bryan, TX
Salt Lake City, UT
Bellingham, WA
Bremerton, WA
Burien, WA
Edmonds, WA
Enumclaw, WA
Everett, WA
Federal Way, WA
Lakewood, WA
Longview, WA
Seattle, WA
Seattle, WA
Seattle, WA
Silverdale, WA
Vancouver, WA
Walla Walla, WA
Ashland, WI
Burlington, WI
Cudahy, WI
Eau Claire, WI
Grafton, WI
Green Bay, WI
Kenosha, WI
La Crosse, WI
Marshfield, WI
Milwaukee, WI
Milwaukee, WI
Milwaukee, WI
Minocqua, WI
Mount Pleasant, WI
Mukwonago, WI
New Richmond, WI
Oconomowoc, WI
Oconomowoc, WI
Oshkosh, WI
Rice Lake, WI
Sheboygan, WI
Stevens Point, WI
Two Rivers, WI
Waukesha, WI
Wauwatosa, WI
West Allis, WI
Weston, WI
Morgantown, WV
Cody, WY
Sheridan, WY
The following is a listing of trial locations that are not currently open and accepting patients.
Indianapolis, IN
Bethesda, MD
Toledo, OH
Anchorage, AK
Anchorage, AK
Anchorage, AK
Anchorage, AK
Fort Smith, AR
Little Rock, AR
Antioch, CA
Berkeley, CA
Dublin, CA
Fremont, CA
Fresno, CA
Linda, CA
Modesto, CA
Oakland, CA
Redwood City, CA
Richmond, CA
Roseville, CA
Sacramento, CA
Sacramento, CA
Sacramento, CA
San Francisco, CA
San Jose, CA
San Leandro, CA
San Rafael, CA
Santa Clara, CA
Santa Rosa, CA
South San Francisco, CA
Stockton, CA
Truckee, CA
Vacaville, CA
Vallejo, CA
Walnut Creek, CA
Centennial, CO
Colorado Springs, CO
Colorado Springs, CO
Colorado Springs, CO
Denver, CO
Denver, CO
Durango, CO
Durango, CO
Lafayette, CO
Lakewood, CO
Lone Tree, CO
Longmont, CO
Longmont, CO
Parker, CO
Pueblo, CO
Lewes, DE
Newark, DE
Rehoboth Beach, DE
Seaford, DE
Wilmington, DE
Gainesville, FL
Orlando, FL
Tampa, FL
Atlanta, GA
Atlanta, GA
Aiea, HI
Honolulu, HI
Honolulu, HI
Honolulu, HI
Honolulu, HI
Honolulu, HI
Honolulu, HI
Honolulu, HI
Honolulu, HI
Honolulu, HI
Honolulu, HI
Boise, ID
Boise City, ID
Coeur d'Alene, ID
Fruitland, ID
Meridian, ID
Post Falls, ID
Sandpoint, ID
Twin Falls, ID
Bloomington, IL
Burr Ridge, IL
Canton, IL
Carbondale, IL
Carterville, IL
Carthage, IL
Centralia, IL
Dixon, IL
Effingham, IL
Eureka, IL
Galesburg, IL
Galesburg, IL
Kewanee, IL
Macomb, IL
Melrose Park, IL
Mount Vernon, IL
Pekin, IL
Peoria, IL
Peoria, IL
Princeton, IL
Springfield, IL
Springfield, IL
Swansea, IL
Indianapolis, IN
Indianapolis, IN
SparkCures Verified Accurate, up-to-date information. Learn more
Ames, IA
Ames, IA
Boone, IA
Des Moines, IA
Des Moines, IA
Des Moines, IA
Des Moines, IA
Fort Dodge, IA
Fort Dodge, IA
Jefferson, IA
Marshalltown, IA
West Des Moines, IA
West Des Moines, IA
Garden City, KS
Great Bend, KS
Kansas City, KS
Bardstown, KY