Study of G-CSF Combined With IL-11 for Improving Blood Cell Recovery After Autologous Stem Cell Transplantation in Adults with Multiple Myeloma or Lymphoma

What this Trial Is About

Researchers are studying the effects of combining two drugs, G-CSF and IL-11, to improve the mobilization of blood stem cells in patients with blood cancers like multiple myeloma or lymphoma. This Phase 2 trial aims to find out if adding IL-11 to the usual G-CSF treatment can increase the number of certain blood-forming stem cells, potentially speeding up recovery after autologous hematopoietic stem cell transplantation auto-HSCT. Previous smaller studies suggested this combination might help patients recover blood cells faster and reduce the need for transfusions. Participants will be randomly assigned to receive either a combination of recombinant human G-CSF 5 micrograms per kilogram per day for 6 days plus recombinant human IL-11 50 micrograms per kilogram per day for 5 days, or G-CSF alone at the same dose and duration. This trial is triple-blinded, meaning that participants, caregivers, and researchers do not know which treatment is given to avoid bias. The study will monitor the time it takes for blood cell recovery and any treatment-related side effects. During the study, participants will be followed daily from the day of stem cell infusion until their blood cells have engrafted or for up to 100 days. Researchers will track the time for granulocyte and platelet recovery, record any adverse events for about 12 months, and assess longer-term outcomes like progression-free survival and overall survival over approximately one year. The total participation period and detailed monitoring will help assess both the safety and effectiveness of the new drug combination.

G-CSF Combined With IL-11 on Hematopoietic Reconstitution After Autologous Hematopoietic Stem Cell Transplantation