A Phase II, Open-Label, Multi-Center Study to Evaluate the Safety, Pharmacokinetics, and Hematopoietic Stem Cell Mobilization of TG-0054 in Patients With Multiple Myeloma, Non-Hodgkin Lymphoma or Hodgkin Disease

GPCR Therapeutics, Inc.6 sites in 1 country19 target enrollmentFebruary 2010

ConditionsMultiple Myeloma Non-Hodgkin Lymphoma Hodgkin Disease

InterventionsTG-0054 (2.24 mg/kg)TG-0054 (3.14 mg/kg)

DrugsTG-0054 (2.24 mg/kg)TG-0054 (3.14 mg/kg)

Overview

Phase: Phase 2
Intervention: TG-0054 (2.24 mg/kg)
Conditions: Multiple Myeloma
Sponsor: GPCR Therapeutics, Inc.
Enrollment: 19
Locations: 6
Primary Endpoint: Number of Patients Who Achieved Mobilization Success of Hematopoietic Stem Cells in Patients With Multiple Myeloma (MM), Non-Hodgkin Lymphoma (NHL) or Hodgkin Disease (HD).
Status: Completed
Last Updated: 4 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

A phase II study to evaluate the safety, pharmacokinetics, and hematopoietic stem cell mobilization of TG-0054 in patients with multiple myeloma, non-Hodgkin lymphoma or Hodgkin disease.

Registry

clinicaltrials.gov

Start Date

February 2010

End Date

October 2011

Last Updated

4 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

GPCR Therapeutics, Inc.

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Male or female 18 to 70 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
•≦ 2 prior regimens of cytotoxic chemotherapy (rituximab, thalidomide, and bortezomib will not be considered as cytotoxic chemotherapy)
•\> 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 x 109/L on screening laboratory assessments
•Absolute neutrophil count ≧ 1.5 x 109/L on screening laboratory assessments

Exclusion Criteria

•Received radiation therapy around the pelvic or spinal area within 6 months prior to the study drug administration
•\>10% bone marrow involvement of lymphoma in NHL patients
•Failed previous stem cell collection \[failed to collect 2 x 106 CD34+ cells/kg within 4 apheresis sessions after receiving granulocyte colony-stimulating factor (G-CSF)\]
•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
•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
•Uncontrollable malignancy with MM, NHL or HD, or carcinomatous meningitis, at Investigator's discretion

Arms & Interventions

TG-0054 (2.24 mg/kg)

TG-0054: 2.24 mg/kg TG-0054 administrated via 15-min IV infusion(allow a maximum of six leukapheresis sessions)

Intervention: TG-0054 (2.24 mg/kg)

TG-0054 (3.14 mg/kg)

TG-0054: 3.14 mg/kg TG-0054 administrated via 15-min IV infusion(allow a maximum of six leukapheresis sessions)

Intervention: TG-0054 (3.14 mg/kg)

Outcomes

Primary Outcomes

Number of Patients Who Achieved Mobilization Success of Hematopoietic Stem Cells in Patients With Multiple Myeloma (MM), Non-Hodgkin Lymphoma (NHL) or Hodgkin Disease (HD).

Time Frame: 1 week

Patients who met the target CD34+ cell collection of ≧2 x 106 cells/kg after two apheresis sessions were classified as achieving mobilization success.

Secondary Outcomes

Fold Increase of Circulating CD34+ Cell Counts in Peripheral Blood.(Baseline, 3 hours and 6 hours after infusion)
Time at Which Maximum Plasma Concentration is Observed (Tmax) of TG-0054 in 12 Consented Patients With MM, NHL or HD.(36 hrs after infusion)
Terminal Elimination Half-life (t1/2) of TG-0054 in 12 Consented Patients With MM, NHL or HD.(36 hrs after infusion)
Terminal Elimination Rate Constant (λz) of TG-0054 in 12 Consented Patients With MM, NHL or HD.(36 hrs after infusion)
The Area Under the Plasma Concentration Time Curve (AUC) From 0 Hours to Infinity of TG-0054 in 12 Consented Patients With MM, NHL or HD.(36 hrs after infusion)
Clearance (CL) of TG-0054 in 12 Consented Patients With MM, NHL or HD.(36 hrs after infusion)
Volume of Distribution at the Terminal State (Vz) of TG-0054 in 12 Consented Patients With MM, NHL or HD.(36 hrs after infusion)
Maximum Plasma Concentration (Cmax) of TG-0054 in 12 Consented Patients With MM, NHL or HD.(36 hrs after infusion)
The Area Under the Plasma Concentration Time Curve (AUC) From 0 Hours to Time t of TG-0054 in 12 Consented Patients With MM, NHL or HD.(36 hrs after infusion)
Volume of Distribution at Steady State (Vss) of TG-0054 in 12 Consented Patients With MM, NHL or HD.(36 hrs after infusion)
Circulating CD34+ Cell Counts in Peripheral Blood.(Baseline, 3 hours and 6 hours after infusion)