This research is being done to find out if altering the immune system by giving activated marrow infiltrating lymphocytes (MILs) can improve outcomes for multiple myeloma patients who receive a standard autologous stem cell transplant.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
102
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Baltimore, Maryland, United States
Feasibility of MILs as Assessed by the Ability to Harvest, Expand, and Infuse the MILs Product
Feasibility is defined as the ability to harvest, expand, and infuse the MILs product within 120 days. After treating 60 patients with MILs, we will declare MILs not feasible if we can only harvest, expand, and deliver MILs to 40 or fewer patients.
Time frame: 120 days
Toxicity as Determined by Total Number of Grade 3 or Higher Adverse Events
Total number of adverse events grade 3 or higher that occur from MILs harvest through 60 days after transplant.
Time frame: 60 days from aMILs harvest until day 60 after transplant
Overall Survival (OS)
OS assessed by number of participants alive at the end of follow up period.
Time frame: 3 years
Progression-free Survival (PFS)
Median PFS time equals the time of randomization (in months) until disease progression, death from any cause, or protocol deviation due to lenalidomide dosing (above 10mg), whichever occurs first.
Time frame: 5 years
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