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
Fort Smith, AR
Gainesville, FL
Ames, IA
Ames, IA
Boone, IA
Fort Dodge, IA
Jefferson, IA
Marshalltown, IA
Bloomington, IL
Burr Ridge, IL
Canton, IL
Carbondale, IL
Carterville, IL
Carthage, IL
Centralia, IL
Decatur, IL
Decatur, IL
Dixon, IL
Effingham, IL
Eureka, IL
Galesburg, IL
Galesburg, IL
Kewanee, IL
Macomb, IL
Maywood, IL
Melrose Park, IL
Mount Vernon, IL
Orland Park, IL
Ottawa, IL
Pekin, IL
Peoria, IL
Peoria, IL
Peru, IL
Peru, IL
Princeton, IL
Springfield, IL
Springfield, IL
Springfield, IL
Swansea, IL
Burnsville, MN
Cambridge, MN
Coon Rapids, MN
Edina, MN
Fridley, MN
Maple Grove, MN
Maplewood, MN
Maplewood, MN
Minneapolis, MN
Minneapolis, MN
Minneapolis, MN
Monticello, MN
New Ulm, MN
Princeton, MN
Robbinsdale, MN
Shakopee, MN
St. Louis Park, MN
St. Paul, MN
St. Paul, MN
Stillwater, MN
Waconia, MN
Willmar, MN
Woodbury, MN
Wyoming, MN
Ballwin, MO
Bonne Terre, MO
Branson, MO
Cape Girardeau, MO
Cape Girardeau, MO
Creve Coeur, MO
Creve Coeur, MO
Jefferson City, MO
Joplin, MO
Rolla, MO
Rolla, MO
Saint Peters, MO
Sainte Genevieve, MO
Springfield, MO
Springfield, MO
St. Joseph, MO
St. Louis, MO
St. Louis, MO
St. Louis, MO
St. Louis, MO
Sullivan, MO
Sunset Hills, MO
Washington, MO
Pinehurst, NC
Omaha, NE
Oklahoma City, OK
Oklahoma City, OK
Tulsa, OK
Charleston, SC
Greenville, SC
Greenville, SC
New Richmond, WI
Fort Smith, AR
Gainesville, FL
Bloomington, IL
Burr Ridge, IL
Canton, IL
Carbondale, IL
Carterville, IL
Carthage, IL
Centralia, IL
Decatur, IL
Decatur, IL
Dixon, IL
Effingham, IL
Eureka, IL
Galesburg, IL
Galesburg, IL
Kewanee, IL
Macomb, IL
Maywood, IL
Melrose Park, IL
Mount Vernon, IL
Orland Park, IL
Ottawa, IL
Pekin, IL
Peoria, IL
Peoria, IL
Peru, IL
Peru, IL
Princeton, IL
Springfield, IL
Springfield, IL
Springfield, IL
Swansea, IL
Ames, IA
Ames, IA
Boone, IA
Fort Dodge, IA
Jefferson, IA
Marshalltown, IA
Burnsville, MN
Cambridge, MN
Coon Rapids, MN
Edina, MN
Fridley, MN
Maple Grove, MN
Maplewood, MN
Maplewood, MN
Minneapolis, MN
Minneapolis, MN
Minneapolis, MN
Monticello, MN
New Ulm, MN
Princeton, MN
Robbinsdale, MN
Shakopee, MN
St. Louis Park, MN
St. Paul, MN
St. Paul, MN
Stillwater, MN
Waconia, MN
Willmar, MN
Woodbury, MN
Wyoming, MN
SparkCures Verified Accurate, up-to-date information. Learn more
Ballwin, MO
Bonne Terre, MO
Branson, MO
Cape Girardeau, MO
Cape Girardeau, MO
Creve Coeur, MO
Creve Coeur, MO
Jefferson City, MO
Joplin, MO
Rolla, MO
Rolla, MO
Saint Peters, MO
Sainte Genevieve, MO
Springfield, MO
Springfield, MO
St. Joseph, MO
St. Louis, MO
St. Louis, MO
St. Louis, MO
St. Louis, MO
Sullivan, MO
Sunset Hills, MO
Washington, MO
Omaha, NE
SparkCures Verified Accurate, up-to-date information. Learn more
Pinehurst, NC
Oklahoma City, OK
Oklahoma City, OK
Tulsa, OK
Charleston, SC
Greenville, SC
Greenville, SC
New Richmond, WI
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