Clinical trial · Interventional
AMD3100 (Plerixafor) in Multiple Myeloma (MM) or Non-Hodgkin's Lymphoma (NHL) Patients Predicted to be Unable to Mobilize With G-CSF Alone
Effect of AMD3100 (240µg/kg) on the Apheresis Yield of CD34+ Cells When Given To Multiple Myeloma or Non-Hodgkin's Lymphoma Patients Predicted to be Unable to Mobilize ≥2 x 10^6 CD34+ Cells in Three Apheresis Days When Given G-CSF Alone
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Enrollment terminated in 2005 to focus on Phase 3 study enrollment.
Summary
Brief summary (as posted)
This Phase 2 study was designed to assess the safety and hematological activity of AMD3100 (plerixafor) in patients with non-Hodgkin's lymphoma (NHL) or multiple myeloma (MM) who were predicted to be unable to mobilize ≥2\*10\^6 CD34+ cells/kg within 3 apheresis days. Patients with NHL and MM were eligible to enter the study if they had undergone cyto-reductive chemotherapy, were to undergo autologous transplantation, and met the inclusion/exclusion criteria. The purpose of this protocol was to determine whether plerixafor in combination with Granulocyte Colony Stimulating Factor (G-CSF) can increase the circulating levels of peripheral blood stem cells (PBSCs) in patients whose peripheral CD34+ counts remain low after treatment with G-CSF alone, whether it was safe, and whether transplantation with the apheresis product was successful, as measured by time to engraftment of polymorphonuclear leukocytes (PMNs) and platelets (PLTs).
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Lymphoma, Non-Hodgkin's | Non-Hodgkin Lymphoma | ALIAS | 0.90 |
| Multiple Myeloma | Multiple Myeloma | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| G-CSF plus plerixafor | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- All Patients
- description
- Patients who were predicted to be unable to mobilize a minimum number of cells (≥2\*10\^6 CD34+ cells/kg) in 3 apheresis days when given granulocyte colony-stimulating factor (G-CSF) alone and who were eligible for autologous peripheral blood stem cell transplantation.
- interventionNames
- Drug: G-CSF plus plerixafor
Primary outcomes (1)
- measure
- Number of Patients Who Achieved ≥2*10^6 CD34+ Cells/kg Following Treatment With Plerixafor 240 µg/kg and G-CSF for up to 3 Consecutive Days
- timeFrame
- approximately days 6-9
- description
- The number of patients with a circulating CD34+ count \>= 5 and \< 20 cells/ml after 5 days of mobilization with G-CSF alone who achieved cumulative apheresis yields of ≥2\*10\^6 CD34+ cells/kg within 3 days of apheresis after receiving G-CSF plus plerixafor. Outcome was based on laboratory results from a central lab.
Secondary outcomes (5)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria (Abbreviated List): * Diagnosis of non-Hodgkin's lymphoma (NHL) or multiple myeloma (MM) * Eligible for autologous transplantation * \<=3 prior regimens of chemotherapy (Rituxan is not considered chemotherapy for the purpose of this study) * \>4 weeks since last cycle of chemotherapy (Rituxan is not considered chemotherapy for the purpose of this study) * Total dose of melphalan ≦200 mg * Eastern Co-operative Oncology Group (ECOG) performance status of 0 or 1 * White blood cell (WBC) count \>3.0\*10\^9/L prior to first dose of G-CSF * Absolute polymorphonuclear leukocyte (PMN) count \>1.5\*10\^9/L prior to first dose of G-CSF * Platelet (PLT) count \>100\*10\^9/L prior to first dose of granulocyte colony-stimulating factor (G-CSF) * Serum creatinine ≥2.2 mg/dL * SGOT, SGPT and total bilirubin \<2 times upper limit of normal (ULN) * Negative for HIV * CD34+ cell count between 5 and 19 CD34+ cells/ml after 5 days of mobilization with G-CSF alone Exclusion Criteria (Abbreviated List): * A co-morbid condition which, in the view of the investigator, renders the patient at high risk from treatment complications * Failed previous stem cell collection or collection attempts * A residual acute medical condition resulting from prior chemotherapy * Active brain metastases or carcinomatous meningitis * Active infection requiring antibiotic treatment * Received prior radio-immunotherapy with Zevalin or Bexxar * Received bone-seeking radionuclides (e.g., holmium) * Received thalidomide, dexamethasone, and/or Velcade within 7 days prior to the first dose of G-CSF * History of ventricular arrhythmias, including electrocardiogram (ECG)-documented premature ventricular contractions (PVCs), during the last 3 years * Patients who previously received experimental therapy within 4 weeks of enrolling in this protocol or who are currently enrolled in another experimental protocol during the mobilization phase * Had an apheresis yield \>1.3\*10\^6 CD34+ cells/kg on Day 5 (Applicable only to patients who, after 5 days of G-CSF mobilization, have peripheral blood (PB) CD34+ count of 8-19 cells/µl inclusive).
References
Publications (0)
Data not yet available