Plasma Cell Leukemia Clinical Trial
Official title:
Phase 1 Study of Daratumumab When Given in Combination With Bortezomib, Dexamethasone, Doxil, and Lenalidomide in Patients With Plasma Cell Leukemia
This phase I trial studies side effects of daratumumab, bortezomib, dexamethasone, pegylated liposomal doxorubicin hydrochloride, and lenalidomide in treating participants with plasma cell leukemia. Monoclonal antibodies, such as daratumumab, may interfere with the ability of cancer cells to grow and spread. Bortezomib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as, dexamethasone, pegylated liposomal doxorubicin hydrochloride, and lenalidomide, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving daratumumab, bortezomib, dexamethasone, pegylated liposomal doxorubicin hydrochloride, and lenalidomide in treating participants with plasma cell leukemia.
PRIMARY OBJECTIVES:
I. To determine the maximum tolerated dose(s) (MTD)/recommended phase 2 dose(s) (RP2D) of,
bortezomib and pegylated liposomal doxorubicin hydrochloride (doxil) when given in
combination with fixed dose daratumumab, lenalidomide, and dexamethasone.
SECONDARY OBJECTIVES:
I. To assess the tolerability and safety of the planned regimen, by evaluation of toxicities
including: type, frequency, severity, attribution, time course and duration.
II. To estimate and assess overall response rate, response duration, and survival
probabilities (overall and progression-free).
EXPLORATORY OBJECTIVES:
I. Quantify CD38+ cells from the peripheral blood mononuclear cells (PBMC) fraction,
including T, natural killer (NK), and monocytic subsets.
II. Assess possible changes in CD38 expression, as well as the co-receptor marker CD31,
overall and by response status (responder/non-responder).
III. Assess cytokine levels in peripheral blood plasma. IV. Quantify CD38+ cells from the
bone marrow CD-138 negative fractions and acellular fractions, including T, NK, and monocytic
subsets.
V. Assess possible changes in CD38 expression, as well as the co-receptor marker CD31,
overall and by response status (responder/non-responder).
VI. Assess cytokine levels in the bone marrow acellular fraction. VII. Investigate CD38
cellular localization in plasma cells and extracellular vesicles from blood plasma.
VIII. Assess messenger ribonucleic acid (mRNA) expression in the peripheral blood mononuclear
cell (PBMC), the bone marrow CD138-negative fraction, the T cell fraction, and plasma cells.
IX. Investigate epigenetic changes in CD38 mRNA expression.
OUTLINE:
Participants receive daratumumab intravenously (IV) on days 1, 8, 15, and 22, dexamethasone
IV/orally (PO) on days 1, 2, 8, 9, 15, 16, 22, and 23, pegylated liposomal doxorubicin
hydrochloride IV on day 8, lenalidomide PO daily on days 1-14, and bortezomib subcutaneously
(SC) on days 1, 4, 8, and 11 of courses 1 and 2. Participants then receive daratumumab IV on
days 1, and 15, dexamethasone IV/PO on days 1, 2, 8, 9, 15, 16, 22, and 23, pegylated
liposomal doxorubicin hydrochloride IV on day 8, lenalidomide PO daily on days 1-14, and
bortezomib SC on days 1, 4, 8, and 11 of courses 3 and 4. Courses repeat every 28 days for up
to 4 courses in the absence of disease progression or unacceptable toxicity. Participants may
receive up to 8 courses at the discretion of treating physician.
After completion of study treatment, participants are followed up at 30 days and then every 3
months for 18 months.
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