This phase II trial tests how well giving granulocyte colony stimulating factor (G-CSF) with or without plerixafor works to prevent engraftment syndrome in patients undergoing autologous hematopoietic stem cell transplantation (HSCT) for multiple myeloma or lymphoma. Colony-stimulating factors, such as G-CSF and plerixafor, may increase the production of blood cells and help move stem cells from the bone marrow to the blood. The stem cells can then be collected, stored, and given back to the patient. They can also contribute to engraftment syndrome which is an inflammatory condition that occurs in patients undergoing HSCT. It is characterized by symptoms such as fever, diarrhea, rash, and swelling during the white blood cell recovery process. Giving G-CSF and limiting the use of plerixafor may lower the risk of engraftment syndrome for patients undergoing HSCT for multiple myeloma or lymphoma.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT07188090.
Locations matching your search criteria
United States
Pennsylvania
Philadelphia
Thomas Jefferson University HospitalStatus: Active
Contact: Xia Bi
Phone: 215-955-8874
PRIMARY OBJECTIVE:
I. To evaluate whether limiting the use of Plerixafor during stem cell mobilization can reduce the incidence of engraftment syndrome, compared to our historical incidence of 54%, where seventy patients with multiple myeloma or lymphoma were treated with autologous HSCT after stem cell mobilization with GCSF plus plerixafor from 2017-2021 at our institution.
SECONDARY OBJECTIVES:
I. Efficacy of stem cell mobilization.
II. Time to neutrophil and platelet engraftment.
III. Number of collection days.
IV. Length of hospital stay.
V. Disease response.
VI. Cell composition.
VII. Cytokine analysis.
OUTLINE:
Patients receive G-CSF on day -4 and undergo apheresis for peripheral blood stem collection on day 0. If less than 1.7 x 10^6 CD34+ cells/kg is collected after the first day or the target number of stem cells is not reached after two days of apheresis, patients receive plerixafor subcutaneously (SC) and undergo additional apheresis until collection goal is reached. Treatment given in the absence of disease progression or unacceptable toxicity. Patients undergo blood sample collection on study.
After completion of study treatment, patients are followed up on day 10 and 28 post HSCT, up to 90 days.
Trial PhasePhase II
Trial Typesupportive care
Lead OrganizationThomas Jefferson University Hospital
Principal InvestigatorXia Bi
