Patients are randomized between Lenalidomide for 2 years and Lenalidomide + Daratumumab/rHuPH20.
This trial is currently open and accepting patients.
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.
The following criteria is a partial list of reasons why patients may be eligible to participate in this clinical trial. Further evaluation with a medical professional is required.
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:
Phase 3
Enrollment: 1,100 patients (estimated)
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Burbank, CA
Los Angeles, CA
Orange, CA
Santa Maria, CA
Colorado Springs, CO
Denver, CO
Lone Tree, CO
Newark, DE
Miami, FL
Plantation, FL
Springfield, IL
Iowa City, IA
Louisville, KY
New Orleans, LA
Ann Arbor, MI
Canton, MI
Grand Rapids, MI
Grosse Pointe Woods, MI
Grosse Pointe Woods, MI
Kalamazoo, MI
Marlette, MI
Royal Oak, MI
Warren, MI
Las Cruces, NM
Rochester, NY
Chapel Hill, NC
Winston-Salem, NC
Charlotte, NC
Greenville, NC
Monroe, NC
Cleveland, OH
Columbus, OH
Sandusky, OH
Strongsville, OH
Portland, OR
Portland, OR
Philadelphia, PA
Seattle, WA
Tacoma, WA
Tacoma, WA
Madison, WI
Germantown, WI
Green Bay, WI
Milwaukee, WI
Oconto Falls, WI
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