NCT03317899

Stem Cell Transplant With or Without Tbo-filgrastim in Treating Patients With Multiple Myeloma or Non-Hodgkin Lymphoma

A Randomized Controlled Trial Evaluating the Use of G-CSF After Plerixafor-Mobilized Autologous Stem Cell Transplant (Auto HSCT)

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 77 (actual)
• Sponsor: Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This phase II trial studies how well stem cell transplant with or without tbo-filgrastim works in treating patients with multiple myeloma or non-Hodgkin lymphoma. Eliminating the use of tbo-filgrastim after transplant may still help maintain a similar time to discharge.

Detailed description

PRIMARY OBJECTIVE: I. To demonstrate non-inferiority in the number of days to discharge readiness after a granulocyte colony-stimulating factor (G-CSF) + plerixafor-mobilized autologous stem cell transplant in patients receiving versus not receiving post-transplant growth factor support. SECONDARY OBJECTIVE: I. To compare days to absolute neutrophil count (ANC) \> 500, days to platelet engraftment, febrile days, days of febrile neutropenia, documented infections, and number of antibiotic days in patients receiving versus not receiving post-transplant growth factor support. EXPLORATORY OBJECTIVE: I. To evaluate immunological recovery (lymphocyte number including CD 3/4 and CD3/8 T cell subsets) at day + 60 in patients receiving versus not receiving post-transplant growth factor support.

Conditions

• Non-Hodgkin's Lymphoma
• Plasma Cell Myeloma

Interventions

Type	Name	Description
PROCEDURE	Hematopoietic Cell Transplantation	Undergo auto HSCT
DRUG	Tbo-filgrastim	Given subcutaneously
OTHER	Laboratory Biomarker Analysis	Correlative Studies

Timeline

• Start date: 2017-10-12
• Primary completion: 2021-06-01
• Completion: 2022-11-16
• First posted: 2017-10-23
• Last updated: 2025-12-17
• Results posted: 2025-12-17

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study