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

NCT03317899 | Completed Phase 2 Results DMC FDA Drug

• 2 other identifiers: 17D.404JT 10928
• Study Type: interventional
• Target: 77
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Non-Hodgkin's Lymphoma; Plasma Cell Myeloma

Outcome Measures

Primary Outcomes (1)

• Number of Days to Discharge

  Will compare days to discharge readiness between the two groups.

  Up to 60 days

Secondary Outcomes (9)

• Median Days Post Autologous Hematopoietic Cell Transplantation (Auto HSCT) to Neutrophil Engraftment

  Up to 60 days

• Median Days Post Auto HSCT to Platelet Engraftment

  Up to 60 days

• Percentage of Participants With Engraftment Syndrome

  Up to 60 days

• Median Number of Febrile Days During the Auto HSCT Inpatient Stay

  Up to 60 days

• Median Number of Days of Febrile Neutropenia During the Auto HSCT Inpatient Stay

  Up to 60 days

Study Arms (2)

Group I (auto HSCT tbo-filgrastim)

EXPERIMENTAL

Beginning on day 3 after auto Hematopoietic Cell Transplantation (HSCT), patients receive tbo-filgrastim SC daily for 12-14 days.

Procedure: Hematopoietic Cell Transplantation; Drug: Tbo-filgrastim; Other: Laboratory Biomarker Analysis

Group II (auto HSCT)

EXPERIMENTAL

Patients undergo auto Hematopoietic Cell Transplantation (HSCT).

Procedure: Hematopoietic Cell Transplantation; Other: Laboratory Biomarker Analysis

Interventions

Tbo-filgrastim DRUG

Given subcutaneously

Also known as: Filgrastim Biosimilar Tbo-filgrastim, Filgrastim XM02, Granix

Group I (auto HSCT tbo-filgrastim)

Laboratory Biomarker Analysis OTHER

Correlative Studies

Group I (auto HSCT tbo-filgrastim); Group II (auto HSCT)

Hematopoietic Cell Transplantation PROCEDURE

Undergo auto HSCT

Group I (auto HSCT tbo-filgrastim); Group II (auto HSCT)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Undergoing autologous stem cell transplant for one of the following diagnoses:
• Multiple myeloma
• Non-Hodgkin lymphoma
• Karnofsky performance status of \>= 70%
• Patients must meet the Thomas Jefferson University Hospital (TJUH) bone marrow transplant (BMT) standard of procedure (SOP) guidelines for "Patient Criteria for Autologous HSCT"
• Left ventricular ejection fraction (LVEF) of ≥ 40%
• Adjusted Carbon monoxide diffusing capability (DLCO) \> 45% of predicted corrected for hemoglobin
• Serum bilirubin \< 1.8
• Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) \< 2.5 X upper limit of normal
• Serum creatinine =\< 2.0 mg/dl and/or creatinine clearance of \> 40 ml/min (excludes multiple myeloma patients receiving high dose melphalan conditioning)
• Willingness to use contraception if childbearing potential
• Has the ability to give informed consent, or for cognitively or decisionally impaired individuals (vulnerable population), the availability of a family member or guardian to give consent and assist in the consent process
• Life expectancy of \> 12 months (exclusive of the disease for which the auto HSCT is being performed)
• Patients must have undergone stem cell mobilization with the combination of G-CSF and plerixafor as per TJUH BMT SOP guidelines
• Collection of an adequate number of CD34+ stem cells, i.e. \>= 4-6 x 10\^6/kg from apheresis

You may not qualify if:

• Uncontrolled human immunodeficiency virus (HIV)
• Uncontrolled bacterial infection
• Active central nervous system (CNS) disease
• Pregnancy or lactation
• Evidence of another malignancy, exclusive of a skin cancer that requires only local treatment

Sponsors & Collaborators

• Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University: lead

Study Sites (1)

Sidney Kimmel Cancer Center at Thomas Jefferson University

Philadelphia, Pennsylvania, 19107, United States

Location

Related Links

• Sidney Kimmel Cancer Center
• Thomas Jefferson University Hospital

MeSH Terms

Conditions

Lymphoma, Non-Hodgkin; Multiple Myeloma

Interventions

Stem Cell Transplantation; Filgrastim; Granulocyte Colony-Stimulating Factor

Condition Hierarchy (Ancestors)

Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Neoplasms, Plasma Cell; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Paraproteinemias; Blood Protein Disorders; Hematologic Diseases; Hemorrhagic Disorders

Intervention Hierarchy (Ancestors)

Cell Transplantation; Cell- and Tissue-Based Therapy; Biological Therapy; Therapeutics; Transplantation; Surgical Procedures, Operative; Colony-Stimulating Factors; Glycoproteins; Glycoconjugates; Carbohydrates; Hematopoietic Cell Growth Factors; Cytokines; Intercellular Signaling Peptides and Proteins; Peptides; Amino Acids, Peptides, and Proteins; Proteins; Biological Factors

Results Point of Contact

• Title: Dolores Grosso
• Organization: Thomas Jefferson University

dag104@jefferson.edu

848-256-5751

Study Officials

• Dolores Grosso, DNP

  Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 18, 2017
• First Posted: October 23, 2017
• Study Start: October 12, 2017
• Primary Completion: June 1, 2021
• Study Completion: November 16, 2022
• Last Updated: December 17, 2025
• Results First Posted: December 17, 2025

Record last verified: 2025-09

Locations

US (1)