This study will use the drug daratumumab in patients who did not achieve at least a very good
partial response (VGPR) and are already planned to have an Autologous Stem Cell Transplant
(ASCT). Daratumumab will be given before the stem cell collection to attempt to get rid of
any multiple myeloma cells that may be present in the stem cell collection and after the ASCT
to get rid of any multiple myeloma cells that may be remaining.
This is a single arm, two-stage, phase II study to evaluate the rate of Complete Response
(CR) post-Autologous Stem Cell Transplant (ASCT) in Multiple Myeloma (MM) subjects who failed
to achieve at least a Very Good Partial Response (VGPR) post initial induction therapy for
newly diagnosed disease, and for whom an ASCT is planned. Subjects will be treated with four
weekly doses of daratumumab before mobilization for Hematopoietic Progenitor Cells (HPC)
collection, followed by high dose chemotherapy and ASCT and four weekly doses of daratumumab
after ASCT. A two-stage design will be implemented. Twenty three (23) subjects will be
enrolled in the first stage, and if at least 12 of the 23 subjects have at least a CR after
ASCT, an additional 16 subjects will be enrolled in the second stage (a total of 39
If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.
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