Multiple MyelomaPhase 2NCT01458288
A Study to Evaluate the Safety, Pharmacokinetics, and Hematopoietic Stem Cell Mobilization of TG-0054 Alone or in Combination With G-CSF in Patients With Multiple Myeloma, Non-Hodgkin Lymphoma or Hodgkin Disease
A Phase 2 study testing TG-0054 in people with Multiple Myeloma and Non-hodgkin's Lymphoma, run by GPCR Therapeutics, Inc. at 1 site in United States.
Trial summary
This Phase II study is to Evaluate the Safety, Pharmacokinetics, and Hematopoietic Stem Cell Mobilization of TG-0054 alone or in combination with G-CSF in Patients with Multiple Myeloma, Non-Hodgkin Lymphoma or Hodgkin Disease. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Multiple Myeloma, Non-hodgkin's Lymphoma, Hodgkin's Disease
- What is being tested?
- TG-0054
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2012to Jul 2013
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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;
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- 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 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.
Who cannot join
- 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 x 106 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;
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- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Stony Brook University Hospital
Stony Brook, New York, 11794
About this study
This Phase II study is to Evaluate the Safety, Pharmacokinetics, and Hematopoietic Stem Cell Mobilization of TG-0054 alone or in combination with G-CSF in Patients with Multiple Myeloma, Non-Hodgkin Lymphoma or Hodgkin Disease.
- Conditions
- Multiple Myeloma, Non-hodgkin's Lymphoma, Hodgkin's Disease
- Being tested
- TG-0054
- 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-0054Drug
Also called burixafor
3.14 mg/kg TG-0054 administrated via 15-min IV infusion(allow a maximum of four leukapheresis sessions)
| Study group | Role | What they receive |
|---|---|---|
| TG-0054 (3.14 mg/kg) | Experimental | TG-0054 (3.14 mg/kg) Receives: Drug: TG-0054 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Patients Achieving the CD34+ Hematopoietic Stem Cell (HSC) Mobilization Target of ≧2.5×1000000 Cells/kg
Patients were all with multiple myeloma (MM), Non-Hodgkin lymphoma (NHL) or Hodgkin disease (HD).
Number of patients who mobilized the targeted total number of CD34+ cells within a maximum of 4 leukapheresis sessions in study arm 1 and arm 3. Patients in arm 1 followed administration of TG-0054 (3.14 mg/kg) alone and leukapheresis start from study day 1. Patients in arm 3 followed administration of TG-0054 (3.14 mg/kg) combined with granulocyte colony-stimulating factor (G-CSF) and leukapheresis start from study day 8.
Measured: 1 week
Secondary outcomes (2)
the Average Number of Leukapheresis Sessions
To determine the average number of leukapheresis sessions required to collect 2.5 x10^6 CD34+ cells/kg.
Measured: 1 week
Circulating CD34+ Cell Count in Peripheral Blood
Calculate the median total CD34+ cell counts across all leukapheresis sessions following TG 0054 administration alone and in combination with G-CSF mobilization in order to evaluate the pharmacodynamics (PD) of TG-0054 by determining circulating CD34+ cell counts in peripheral blood.
Measured: pre-dose(-2 to 0 h),2, 4 and 6 hr after dosing.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Oct 2011 (estimated)
- Study startOct 2012
- Primary completionJul 2013
- Study completionJul 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Multiple MyelomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- GPCR Therapeutics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Michael W. Schuster, M.D., Principal investigator, Stony Brook University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01458288
- Sponsor's protocol ID
- TG-0054-03
- Status last verified
- Apr 2021
- First submitted
- 13 Oct 2011
- Last updated
- 19 Apr 2021
- Results posted
- Yes, on ClinicalTrials.gov
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
Study at a glance
From the registry record, last updated by the sponsor on 19 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study to Evaluate the Safety, Pharmacokinetics, and Hematopoietic Stem Cell Mobilization of TG-0054 Alone or in Combination With G-CSF in Patients With Multiple Myeloma, Non-Hodgkin Lymphoma or Hodgkin Disease
- ClinicalTrials.gov ID
- NCT01458288
- Acronym / sponsor ID
- TG-0054-03
- Conditions
- Multiple Myeloma, Non-hodgkin's Lymphoma, Hodgkin's Disease
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- GPCR Therapeutics, Inc.Industry (pharma, biotech, devices)
- Study start
- Oct 2012
- Primary completion
- Jul 2013 (actual)
- Study completion
- Jul 2013 (actual)
- First posted
- 24 Oct 2011 (estimated)
- Results
- Posted 8 Jan 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This Phase II study is to Evaluate the Safety, Pharmacokinetics, and Hematopoietic Stem Cell Mobilization of TG-0054 alone or in combination with G-CSF in Patients with Multiple Myeloma, Non-Hodgkin Lymphoma or Hodgkin Disease.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| TG-0054 (3.14 mg/kg) | Experimental | Drug: TG-0054TG-0054 (3.14 mg/kg) |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (20 listed)
- 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;
Key exclusion criteria (17 listed)
- 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 x 106 CD34+ cells/kg within 4 leukapheresis sessions after receiving granulocyte colony-stimulating factor (G-CSF)];
- Patients who have undergone previous stem cell transplantation procedure;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TG-0054Also: burixafor3.14 mg/kg TG-0054 administrated via 15-min IV infusion(allow a maximum of four leukapheresis sessions) | Drug | TG-0054 (3.14 mg/kg) |
Primary outcome
Number of Patients Achieving the CD34+ Hematopoietic Stem Cell (HSC) Mobilization Target of ≧2.5×1000000 Cells/kg
Time frame: 1 week
Patients were all with multiple myeloma (MM), Non-Hodgkin lymphoma (NHL) or Hodgkin disease (HD). Number of patients who mobilized the targeted total number of CD34+ cells within a maximum of 4 leukapheresis sessions in study arm 1 and arm 3. Patients in arm 1 followed administration of TG-0054 (3.14 mg/kg) alone and leukapheresis start from study day 1. Patients in arm 3 followed administration of TG-0054 (3.14 mg/kg) combined with granulocyte colony-stimulating factor (G-CSF) and leukapheresis start from study day 8.
2 secondary outcomes
the Average Number of Leukapheresis Sessions
Time frame: 1 week
Circulating CD34+ Cell Count in Peripheral Blood
Time frame: pre-dose(-2 to 0 h),2, 4 and 6 hr after dosing.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Apr 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 40156952Pan 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michael W. Schuster, M.D. principal investigator
Stony Brook University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing TG-0054 in people with Multiple Myeloma and Non-hodgkin's Lymphoma, run by GPCR Therapeutics, Inc. at 1 site in United States.
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 20 inclusion and 17 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 19 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. 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 8 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 Achieving the CD34+ Hematopoietic Stem Cell (HSC) Mobilization Target of ≧2.5×1000000 Cells/kg (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 NCT01458288, 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 19 Apr 2021.