This is a single arm open label trial to test the tolerability of the combination of monocyte derived DCs loaded with KRN7000 (DC-KRN7000) and Lenalidomide (LEN) in patients with asymptomatic myeloma. Phase I component of the study will evaluate the optimal dose of LEN, with particular emphasis on safety. After an interim analysis of these data, a single dose level will be chosen for phase II component in additional patients.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
6
10 mg/day in cohort 1, and 25 mg/day in cohort 2. LEN is administered orally in standard 21 day cycles starting one week before each DC injection and ending 14 days after each DC injection. All patients will receive a total of three cycles of LEN.
10 million DCs injected intravenously
Yale University School of Medicine
New Haven, Connecticut, United States
Number of Dose Limiting Toxicities (DLTs)
Time frame: upon completion of treatment
Number of Natural Killer Cells(NKT)that make IFNγ in Vitro
Time frame: upon completion of treatment
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