AzTrials
AzTrials

Multiple MyelomaPhase 2NCT01018979

Safety and PK/PD of TG-0054 in Multiple Myeloma, Non-Hodgkin Lymphoma and Hodgkin Disease Patients

A Phase 2 study testing TG-0054 (2.24 mg/kg) and TG-0054 (3.14 mg/kg) in people with Multiple Myeloma and Non-Hodgkin Lymphoma, run by GPCR Therapeutics, Inc. at 6 sites in Taiwan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 to 70 years
What is being tested?
TG-0054 (2.24 mg/kg) and TG-0054 (3.14 mg/kg)
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
19 participants
Where
6 sitesTaiwan
Study dates
Feb 2010to Oct 2011
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
Show all 21Show fewer
  • 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
  • Platelet count ≧ 100 x 109/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:
  • At least one year post-menopausal, or
  • Surgically sterile, or
  • Willing to use a double-barrier method [intrauterine device (IUD) plus condom, spermicidal gel plus condom] of contraception throughout the study
  • 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

Who cannot join

  • 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
Show all 14Show fewer
  • 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
  • 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

Trial locations and contacts

6 sites in 1 country.

6 sites in 1 country

Taiwan6 sites

  • Chang-Gung Memorial Hospital Chiayi

    Chiayi City

  • Buddist Tzu Chi General Hospital

    Hualien City

  • Kaohsiung Medical University Hospital

    Kaohsiung City

  • Chang-Gung Memorial Hospital Linkou

    Linkou District

  • National Taiwan University Hospital

    Taipei

  • Taipei Veterans General Hospital

    Taipei

Other trials in Taiwan

About this study

Official title: 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

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.

Being tested
TG-0054 (2.24 mg/kg), TG-0054 (3.14 mg/kg)
Medical subject headings
Multiple Myeloma, Lymphoma, Non-Hodgkin, Hodgkin Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • TG-0054 (2.24 mg/kg)Drug

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

  • TG-0054 (3.14 mg/kg)Drug

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

Study groups in NCT01018979
Study groupRoleWhat they receive
TG-0054 (2.24 mg/kg)ExperimentalTG-0054: 2.24 mg/kg TG-0054 administrated via 15-min IV infusion(allow a maximum of six leukapheresis sessions)
Receives: Drug: TG-0054 (2.24 mg/kg)
TG-0054 (3.14 mg/kg)ExperimentalTG-0054: 3.14 mg/kg TG-0054 administrated via 15-min IV infusion(allow a maximum of six leukapheresis sessions)
Receives: Drug: TG-0054 (3.14 mg/kg)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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).

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

    Measured: 1 week

Secondary outcomes (11)

  1. Maximum Plasma Concentration (Cmax) of TG-0054 in 12 Consented Patients With MM, NHL or HD.

    Plasma concentrations of TG-0054 were determinate by validated LC-MS/MS method.

    Measured: 36 hrs after infusion

  2. Fold Increase of Circulating CD34+ Cell Counts in Peripheral Blood.

    Measured: Baseline, 3 hours and 6 hours after infusion

  3. Time at Which Maximum Plasma Concentration is Observed (Tmax) of TG-0054 in 12 Consented Patients With MM, NHL or HD.

    Plasma concentrations of TG-0054 were determinate by validated LC-MS/MS method.

    Measured: 36 hrs after infusion

  4. Terminal Elimination Half-life (t1/2) of TG-0054 in 12 Consented Patients With MM, NHL or HD.

    Plasma concentrations of TG-0054 were determinate by validated LC-MS/MS method.

    Measured: 36 hrs after infusion

  5. Terminal Elimination Rate Constant (λz) of TG-0054 in 12 Consented Patients With MM, NHL or HD.

    Plasma concentrations of TG-0054 were determinate by validated LC-MS/MS method.

    Measured: 36 hrs after infusion

  6. 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.

    Plasma concentrations of TG-0054 were determinate by validated LC-MS/MS method.

    Measured: 36 hrs after infusion

  7. 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.

    Plasma concentrations of TG-0054 were determinate by validated LC-MS/MS method.

    Measured: 36 hrs after infusion

  8. Clearance (CL) of TG-0054 in 12 Consented Patients With MM, NHL or HD.

    Plasma concentrations of TG-0054 were determinate by validated LC-MS/MS method.

    Measured: 36 hrs after infusion

  9. Volume of Distribution at the Terminal State (Vz) of TG-0054 in 12 Consented Patients With MM, NHL or HD.

    Plasma concentrations of TG-0054 were determinate by validated LC-MS/MS method.

    Measured: 36 hrs after infusion

  10. Volume of Distribution at Steady State (Vss) of TG-0054 in 12 Consented Patients With MM, NHL or HD.

    Plasma concentrations of TG-0054 were determinate by validated LC-MS/MS method.

    Measured: 36 hrs after infusion

  11. Circulating CD34+ Cell Counts in Peripheral Blood.

    Measured: Baseline, 3 hours and 6 hours after infusion

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Nov 2009 (estimated)
  2. Study startFeb 2010
  3. Primary completionOct 2011
  4. Study completionOct 2011

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
19 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01018979
Sponsor's protocol ID
TG-0054-02
Status last verified
Apr 2021
First submitted
24 Nov 2009
Last updated
11 May 2021
Data monitoring committee
Yes

Publications

  • Pan KS, Wang Z, Pfeil C, Bergkamp ND, Mobach S, Roth S, Rizk A, Lohse MJ, Annibale P, Siderius M, Zimmermann M, Smit MJ, Bosma R. Pharmacological characterization of a clinical candidate, TG-0054, a small molecule inverse agonist targeting CXCR4. Mol Pharmacol. 2025 Apr;107(4):100015. doi: 10.1016/j.molpha.2025.100015. Epub 2025 Jan 31.

    PubMed 40156952

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing TG-0054 (2.24 mg/kg) and TG-0054 (3.14 mg/kg) in people with Multiple Myeloma and Non-Hodgkin Lymphoma, run by GPCR Therapeutics, Inc. at 6 sites in Taiwan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 21 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 11 May 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 6 sites in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 15 Jan 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01018979, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 May 2021.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in