This phase II trial investigates how well romiplostim works in treating low platelet counts following chemotherapy and stem cell transplant in patients with blood cancer. Platelets are made when the liver produces a hormone that travels to the bone marrow. Once the hormone is in the bone marrow, it finds a specific protein on the surface of cells called megakaryocytes. Megakaryocytes are responsible for making platelets. The more this hormone binds to the megakaryocytes, the more platelets are made. Romiplostim acts like the hormone produced in the liver because it finds the same proteins on the surface of megakaryocytes and helps increase the production of platelets. Romiplostim may be able to stimulate the cells in bone marrow to make more platelets in the blood, which may decrease the amount of platelet transfusions needed during hospital admission.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT04478123.
PRIMARY OBJECTIVE:
I. To evaluate whether receiving romiplostim after high-dose therapy and autologous hematopoietic cell transplantation (HDT-AHCT) decreases the number of days requiring platelet transfusions or grade 4 Common Terminology Criteria for Adverse Events (CTCAE) thrombocytopenia following HDT-AHCT.
SECONDARY OBJECTIVES:
I. To evaluate whether romiplostim can reduce the number of platelet transfusions issued during the AHCT admission.
II. To evaluate whether romiplostim can reduce the time to platelet engraftment after HDT-AHCT.
III. To evaluate whether romiplostim can reduce the length of stay of AHCT.
IV. The safety profile of romiplostim will be assessed in this patient population during the course of the study.
OUTLINE:
Patients undergo standard of care AHCT on day 0 and then receive romiplostim subcutaneously (SC) weekly beginning day 1 until platelet count is > 50,000/mcL, without any platelet transfusions in the prior 48 hours. Treatment with romiplostim may continue for up to a total of 6 doses in the absence of unacceptable toxicity, even if platelets have not corrected by day 42.
After completion of study treatment, patients are followed up at 7 days, and then at 30, 60, and 100 days after completion of AHCT.
Lead OrganizationMemorial Sloan Kettering Cancer Center
Principal InvestigatorMichael Scordo
