PD and Safety of TG-0054 Combined With G-CSF in Multiple Myeloma, Non-Hodgkin Lymphoma and Hodgkin Disease Patients

Multiple Myeloma Clinical Trial

Official title:

A Phase II, Open-Label Study to Evaluate the Hematopoietic Stem Cell Mobilization of TG-0054 Combined With G-CSF in Patients With Multiple Myeloma, Non-Hodgkin Lymphoma or Hodgkin Disease

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02104427
• Other study ID #: TG-0054-04
• Status: Completed
• Phase: Phase 2
• Start date: February 2015
• Est. completion date: November 2015

Study information

• Verified date: April 2021
• Source: GPCR Therapeutics, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This is a phase II study to evaluate the efficacy and safety of TG-0054 combined with G-CSF in mobilizing hematopoietic stem cells in patients with multiple myeloma, non-Hodgkin lymphoma or Hodgkin disease.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: November 2015
• Est. primary completion date: November 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• Male or female 18 to 75 years of age inclusive;

• Patients with confirmed pathology diagnosis of MM, NHL or HD;

• Potential candidate for autologous stem cell transplantation at Investigator's discretion;

• > 4 weeks since last cycle of chemotherapy prior to the study drug administration;

• Total dose of melphalan received ? 200 mg in the most recent chemotherapy treatment;

• Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1;

• Recovered from all acute toxic effects of prior chemotherapy at Investigator's discretion;

• White blood cell (WBC) count ? 3.0*10^9/L on screening laboratory assessments;

• Absolute neutrophil count ? 1.5*10^9/L on screening laboratory assessments;

• Platelet count ? 100*10^9/L on screening laboratory assessments;

• Serum creatinine ? 2.2 mg/dL on screening laboratory assessments;

• Aspartate aminotransferase (AST), alanine aminotransferase (ALT), and total bilirubin < 2 x upper limit of normal (ULN) on screening laboratory assessments;

• Negative for human immunodeficiency virus (HIV);

• Adequate cardiac and pulmonary function to undergo leukapheresis at Investigator's discretion;

• For females, one of the following criteria must be fulfilled:

1. At least one year post-menopausal, or

2. Surgically sterile, or

3. Willing to use a double-barrier method [intrauterine device (IUD) plus condom, spermicidal gel plus condom] of contraception from study Day 1 until 28 days after the last dose of TG-0054;

• Males must be willing to use a reliable form of contraception (use of a condom or a partner fulfilling the above criteria) from study Day 1 until 28 days after the last dose of TG-0054;

• Able to provide the signed informed consent.

Exclusion Criteria:

• Received radiation therapy to the pelvis;

• Received > 6 cycles of lenalidomide;

• Evidence of bone marrow involvement of lymphoma in NHL patients;

• Failed previous stem cell collection [failed to collect 2.0*10^6 CD34+ cells/kg within 4 leukapheresis sessions after receiving granulocyte colony-stimulating factor (G-CSF)];

• Patients who have undergone previous stem cell transplantation procedure;

• Received G-CSF within 2 weeks prior to the study drug administration;

• History of other cancer within the past 5 years excluding MM, NHL, HD, basal cell or squamous cell carcinoma of the skin;

• History of other hematologic disorders including bleeding or thromboembolic disease being treated with anti-coagulant;

• History of poor and uncontrollable cardiovascular or pulmonary disease such as myocardial infarction, cardiac arrhythmias, transient ischemic attack, stroke or Chronic Obstructive Pulmonary Disease (COPD) patients hospitalized more than two times a year due to underlying disease;

• Diagnosis of sickle cell anemia or documented sickle cell trait;

• Patients with proliferative retinopathy;

• Uncontrollable malignancy with MM, NHL or HD, or carcinomatous meningitis, at Investigator's discretion;

• Any infection required antibiotic treatment or unexplained fever above 38 °C within 3 days prior to dosing;

• Pregnant or breast-feeding;

• Prisoners or subjects who are compulsorily detained (involuntarily incarcerated) for treatment of either a psychiatric or physical (e.g., infectious disease) illness must not be enrolled into this study;

• Received any other investigational drug within 1 month before entering the study;

• Received prior treatment with TG-0054 but withdrew early from this study.

Related Conditions & MeSH terms

• Hodgkin Disease
• Lymphoma
• Lymphoma, Non-Hodgkin
• Multiple Myeloma
• Neoplasms, Plasma Cell
• Non-Hodgkin Lymphoma

Intervention

Drug:
• TG-0054 combined with G-CSF

Locations

Country	Name	City	State
United States	Tennessee Oncology, PLLC	Nashville	Tennessee
United States	Stony Brook University Hospital	Stony Brook	New York

Sponsors (1)

Lead Sponsor	Collaborator
GPCR Therapeutics, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of Patients From Whom a Total Number of CD34+ Cells =5.0 x 10^6 Cells/kg Was Collected Within the First 4 Leukapheresis Sessions	The primary efficacy endpoint was the proportion of patients from whom a total number of CD34+ cells =5.0 x 10^6 cells/kg was collected within the first 4 leukapheresis sessions. For the primary efficacy endpoint, each patient's CD34+ cell number was calculated as the sum of CD34+ cell numbers collected from (up to) the first 4 leukapheresis sessions.	Day 5 to Day 8
Secondary	Proportion of Patients From Whom a Total Number of CD34+ Cells =2.5 x 10^6 Cells/kg Was Collected Within the First 4 Leukapheresis Sessions	The secondary efficacy endpoint was the proportion of patients from whom a total number of CD34+ cells =2.5 x 10^6 cells/kg was collected within the first 4 leukapheresis sessions. Each patient's CD34+ cell number was calculated as the sum of CD34+ cell numbers collected from (up to) the first 4 leukapheresis sessions.	Day 5 to Day 8
Secondary	Proportion of Patients Who Mobilized the Targeted Total Number of CD34+ Cells (=6.0 x 10^6 Cells/kg) Within 5 Leukapheresis Sessions	The secondary efficacy endpoint was the proportion of patients from whom a total number of CD34+ cells =6.0 x 10^6 cells/kg was collected within 5 leukapheresis sessions. Each patient's CD34+ cell number was calculated as the sum of CD34+ cell numbers collected from (up to) 5 leukapheresis sessions.	Day 5 to Day 9
Secondary	the Pharmacodynamics (PD) Following Treatment With TG-0054 When Combined With G-CSF	determine circulating CD34+ cell counts in peripheral blood	Day 5 (1st leukapheresis session) to Day 6 (2nd leukapheresis session)