Clinical trial · Interventional
An Exploratory Safety Study to Investigate the Extent of Tumor Cell Mobilization (TCM) After Use of G-CSF Alone or G-CSF Plus Plerixafor in Multiple Myeloma (MM) Patients Who May be Poor Mobilizers of Stem Cells
A Pilot, Exploratory, Randomized, Phase 2 Safety Study Evaluating Tumor Cell (Plasma Cell) Mobilization and Apheresis Product Contamination in Plerixafor Plus Non-pegylated G-CSF Mobilized Patients and in Non-pegylated G-CSF Alone Mobilized Patients
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The primary objective of this study is to evaluate tumor cell mobilization (TCM) with non-pegylated G-CSF alone compared with non-pegylated G-CSF plus plerixafor in patients with multiple myeloma (MM) who are potentially poor mobilizers of hematopoietic stem cells (HSC). Second objectives are to evaluate survival and disease status of G-CSF alone compared with GCSF plus plerixafor, and the efficacy and safety of G-CSF plus plerixafor when used to mobilize stem cells for autologous transplantation.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Multiple Myeloma | Multiple Myeloma | CURATED_EXACT | 0.92 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Granulocyte-colony stimulating factor (G-CSF) | Drug | — | UNRESOLVED |
| Plerixafor | Drug | Plerixafor | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- G-CSF alone
- description
- Patients will receive G-CSF for 5 consecutive days
- interventionNames
- Drug: Granulocyte-colony stimulating factor (G-CSF)
- type
- EXPERIMENTAL
- label
- G-CSF plus plerixafor
- description
- Patients will receive G-CSF for 4 consecutive days, then receive plerixafor before the 5th dose of G-CSF
- interventionNames
- Drug: Plerixafor
- Drug: Granulocyte-colony stimulating factor (G-CSF)
Primary outcomes (6)
- measure
- The presence of myeloma tumor cells as measured by the percentage of myeloma tumor cells/CD34+ cells
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Patients with a diagnosis of MM in partial response or complete response, who are undergo an autologous hematopoietic stem cell transplantation and could be considered potentially poor mobilizers. Exclusion Criteria: * Does not have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1. * Has a history of any acute or chronic leukemia (including myelodysplastic syndrome). * Had prior allogeneic or autologous transplantation. * Less than 3 to 6 weeks since last anti-cancer therapy. * Chemotherapy for mobilization is not allowed. * Has bone marrow involvement \>10% assessed based on the most recent bone marrow aspirate or biopsy performed prior to first dose of G-CSF. * Was treated with G-CSF or other cytokine within 14 days prior to the first dose of G-CSF for mobilization. * Has previously received plerixafor. * Is known to be HIV positive. * Has active hepatitis B or hepatitis C. * Has an acute infection within 24 hours prior to dosing or antibiotic therapy within 7 days prior to the first dose of G-CSF. * Has hypercalcaemia as evidenced by \>1 mg/dL above upper limit of normal (ULN). * Previously received investigational therapy within 4 weeks of screening in this protocol or currently enrolled in another investigational protocol during the mobilization phase. * Has central nervous system involvement including brain metastases or leptomeningeal disease. * Has an electrocardiogram (ECG) or study result indicative of cardiac ischemia or a history of clinically significant rhythm disturbance(arrhythmias), or other conduction abnormality. * Has co-morbid condition(s), which may render the patient at high risk from treatment complications or impairs his/her ability to comply with the study treatment and protocol. * Has a white blood cell (WBC) count \<2.5 x 10\^9/L. * Has an absolute neutrophil count (ANC) \<1.5 x 10\^9/L. * Has a platelet count \<100 x 10\^9/L. * Has an estimated creatine clearance ≤50 mL/min. * Has aspartate aminotransferase/serum glutamic oxaloacetic transaminase (AST/SGOT), alanine aminotransferase/serum glutamic pyruvic transaminase (ALT/SGPT), and total bilirubin ≥2.5 x ULN. * Does not have adequate cardiac, and pulmonary function sufficient to undergo apheresis and transplantation. * Pregnant or breastfeeding women. * Does not agree to use a highly effective method of contraception while on study treatment and for at least 3 months following study treatment.
References
Publications (0)
Data not yet available