Multiple MyelomaPhase 2NCT02104427

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

A Phase 2 study testing TG-0054 combined with G-CSF in people with Multiple Myeloma and Non-Hodgkin Lymphoma, run by GPCR Therapeutics, Inc. at 2 sites in United States.

Completed

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

Official record

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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. Read more about this study

Who is it for?: Ages 18 to 75 years
Conditions the study is for: Multiple Myeloma, Non-Hodgkin Lymphoma, Hodgkin Disease
What is being tested?: TG-0054 combined with G-CSF
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 12 participants
Where: 2 sitesUnited States
Study dates: Feb 2015to Nov 2015
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*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:
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 2.0*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;

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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

2 sites in 1 country.

United States2 sites

Tennessee Oncology, PLLC
Nashville, Tennessee, 37203
Stony Brook University Hospital
Stony Brook, New York, 11794

Other trials in United States

About this study

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

Conditions: Multiple Myeloma, Non-Hodgkin Lymphoma, Hodgkin Disease
Being tested: TG-0054 combined with G-CSF
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 combined with G-CSFDrug

Study groups in NCT02104427
Study group	Role	What they receive
TG-0054 combined with G-CSF	Experimental	1. G-CSF: 10 μg/kg/day, administrated via SC injections from Day 1 to Day 8; 2. TG-0054: 3.14 mg/kg, administrated via 15-min IV infusion from Day 5 to Day 9 as needed to reach the target collection goal Receives: Drug: TG-0054 combined with G-CSF

What is being measured

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

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.
Measured: Day 5 to Day 8

Secondary outcomes (3)

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.
Measured: Day 5 to Day 8
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.
Measured: Day 5 to Day 9
the Pharmacodynamics (PD) Following Treatment With TG-0054 When Combined With G-CSF
determine circulating CD34+ cell counts in peripheral blood
Measured: Day 5 (1st leukapheresis session) to Day 6 (2nd leukapheresis session)

Timeline

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

Feb 2015Nov 2015

First posted4 Apr 2014 (estimated)
Study startFeb 2015
Primary completionNov 2015
Study completionNov 2015

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 (2)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)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02104427
Sponsor's protocol ID: TG-0054-04
Status last verified: Apr 2021
First submitted: 26 Mar 2014
Last updated: 19 Apr 2021
Results posted: Yes, on ClinicalTrials.gov

Publications

Sukhtankar DD, Cardarelli PM, Jalilizeinali B, Setia G, Kim G, Chang LW, Tsai CY, Caculitan NG, Schuster MW. Burixafor, a CXCR4 inhibitor with a differentiated kinetics profile: results of a phase 2 study for rapid cell mobilization in multiple myeloma and lymphoma patients undergoing transplant. Ann Hematol. 2026 Feb 4;105(3):86. doi: 10.1007/s00277-026-06858-9.
PubMed 41636886
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

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Multiple Myeloma trials

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 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
ClinicalTrials.gov ID: NCT02104427
Acronym / sponsor ID: TG-0054-04
Conditions: Multiple Myeloma, Non-Hodgkin Lymphoma, Hodgkin 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: Feb 2015
Primary completion: Nov 2015 (actual)
Study completion: Nov 2015 (actual)
First posted: 4 Apr 2014 (estimated)
Results: Posted 13 Dec 2017

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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 combined with G-CSF	Experimental	Drug: TG-0054 combined with G-CSF1. G-CSF: 10 μg/kg/day, administrated via SC injections from Day 1 to Day 8; 2. TG-0054: 3.14 mg/kg, administrated via 15-min IV infusion from Day 5 to Day 9 as needed to reach the target collection goal

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 2.0*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;

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-0054 combined with G-CSF	Drug	TG-0054 combined with G-CSF

Primary outcome

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
Time frame: Day 5 to Day 8
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.

3 secondary outcomes

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
Time frame: Day 5 to Day 8
Proportion of Patients Who Mobilized the Targeted Total Number of CD34+ Cells (≥6.0 x 10^6 Cells/kg) Within 5 Leukapheresis Sessions
Time frame: Day 5 to Day 9
the Pharmacodynamics (PD) Following Treatment With TG-0054 When Combined With G-CSF
Time frame: Day 5 (1st leukapheresis session) to Day 6 (2nd leukapheresis session)

Results and safety

Results posted to the registry on 13 Dec 2017, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
TG-0054 Combined With G-CSF	12	12

Primary outcome: 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

Time frame: Day 5 to Day 8. Number (95% Confidence Interval). Unit: Proportion of participants

Measure	Within 1 Leukapheresis Session n = 12	Within 2 Leukapheresis Sessions n = 12	Within 3 Leukapheresis Sessions n = 12	Within 4 Leukapheresis Sessions n = 12
Overall	0.50000 (0.2109 to 0.7891)	0.9167 (0.6152 to 0.9979)	0.9167 (0.6152 to 0.9979)	0.9167 (0.6152 to 0.9979)
Multiple Myeloma	0.6667 (0.2993 to 0.9251)	0.8889 (0.5175 to 0.9972)	0.8889 (0.5175 to 0.9972)	0.8889 (0.5175 to 0.9972)
Non-Hodgkin Lymphoma or Hodgkin Disease	0.0000 (0.0000 to 0.0000)	1.0000 (0.2924 to 1.0000)	1.0000 (0.2924 to 1.0000)	1.0000 (0.2924 to 1.0000)

Population analysed: There were total 9 MM patients and 3 NHL or HD patients . A MM patient was treated with Revlimid, Following 2 leukapheresis sessions, a cumulative total of 0.18 x 10\^6 cells/kg were collected. PI and Medical Monitor didn't feel that further leukapheresis sessions would achieve more cells, so the patient didn't have additional sessions.

3 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
10 µg/kg/Day G-CSF Alone	0 of 12 (0%)	2 of 12 (16.7%)	0 of 12
10 µg/kg/Day G-CSF + 3.14 mg/kg TG-0054	0 of 12 (0%)	6 of 12 (50%)	0 of 12
Overall	0 of 12 (0%)	7 of 12 (58.3%)	0 of 12

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 41636886Sukhtankar DD, Cardarelli PM, Jalilizeinali B, Setia G, Kim G, Chang LW, Tsai CY, Caculitan NG, Schuster MW. Burixafor, a CXCR4 inhibitor with a differentiated kinetics profile: results of a phase 2 study for rapid cell mobilization in multiple myeloma and lymphoma patients undergoing transplant. Ann Hematol. 2026 Feb 4;105(3):86. doi: 10.1007/s00277-026-06858-9.
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 M Schuster, MD principal investigator

Stony Brook University Hospital

2 sites 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 combined with G-CSF in people with Multiple Myeloma and Non-Hodgkin Lymphoma, run by GPCR Therapeutics, Inc. at 2 sites 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 2 sites 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 13 Dec 2017). 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?

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 (time frame: Day 5 to Day 8). 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 NCT02104427, which also lists 2 linked publications.

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.