Clinical trial · Interventional
Plerixafor and Filgrastim Following Cyclophosphamide for Stem Cell Mobilization in Patients With Multiple Myeloma
A Phase I/Pilot Study of Intravenous PLERIXAFOR Following Cyclophosphamide Mobilization in Patients With Multiple Myeloma
NCT01074060CI-TRIAL-00009483completedPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- 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)
RATIONALE: There are different methods of stem cell mobilization, such as using colony-stimulating factors alone or following chemotherapy priming. More recently, the combination of plerixafor and colony-stimulating factors has been shown to enhance stem cell mobilization. This study will assess whether the combination of plerixafor and Granulocyte Colony-Stimulating Factor (G-CSF) is effective following chemotherapy mobilization with cyclophosphamide. PURPOSE: To assess the safety, tolerability, and best dose of intravenous plerixafor following cyclophosphamide priming.
Conditions
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Refractory Multiple Myeloma | Multiple Myeloma | CURATED_BROADER | 0.78 |
| Stage III Multiple Myeloma | Multiple Myeloma | CURATED_BROADER | 0.78 |
| Stage II Multiple Myeloma | Multiple Myeloma | CURATED_BROADER | 0.78 |
| Stage I Multiple Myeloma | Multiple Myeloma | CURATED_BROADER | 0.78 |
Interventions
Interventions (5)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| autologous hematopoietic stem cell transplantation | Procedure | — | UNRESOLVED |
| cyclophosphamide | Drug | Cyclophosphamide | ALIAS |
| filgrastim | Biological | Filgrastim | ALIAS |
| laboratory biomarker analysis | Other | — | UNRESOLVED |
| plerixafor | Drug | Plerixafor | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Arm I
- description
- MOBILIZATION: Patients receive cyclophosphamide IV. Patients also receive filgrastim subcutaneously (SC) daily beginning approximately 24 hours later. TREATMENT/APHERESIS: Beginning 10 days after cyclophosphamide, patients receive plerixafor IV over 30 minutes followed by filgrastim SC on each day of apheresis.
- interventionNames
- Drug: plerixafor
- Biological: filgrastim
- Drug: cyclophosphamide
- Procedure: autologous hematopoietic stem cell transplantation
- Other: laboratory biomarker analysis
Primary outcomes (2)
- measure
- To assess the MTD ( maximum tolerated dose) of IV plerixafor when given post cyclophosphamide and GCSF for stem cell priming.Dose limiting toxicity will be defined as any grade 3 or 4 nonhematologic toxicity.
- timeFrame
- 12 to 18 months
- measure
- Tolerability and safety of PLERIXAFOR
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 70 Years
Show eligibility criteria text
Criteria * Inclusion and exclusion criteria must be re-evaluated prior to dosing with PLERIXAFOR; if the patient does not meet any of these criteria (excluding the hepatic and hematologic criteria) the patient is not eligible to continue unless Genzyme grants a waiver Inclusion * Eligible to undergo autologous transplantation * Diagnosed with multiple myeloma (MM) * ECOG (Eastern Cooperative Oncology Group) performance status of 0 or 1 * The patient has recovered from all acute toxic effects of prior chemotherapy * White Blood Count (WBC) \> 2.5 x 10\^9/L * Absolute neutrophil count \>1.5 x 10\^9/L * Platelet count \> 100 x 10\^9/L * Serum creatinine \<= 2.5 mg/dl * Creatinine clearance \>= 50 ml/min (measured or calculated) * Serum glutamic oxaloacetic transaminase (SGOT) \< 2 x ULN (Upper Limit of Normal) * Serum glutamic pyruvic transaminase (SGPT) \< 2 x ULN * Total bilirubin \< 2 x ULN * Left ventricle ejection fraction \> 45% \[by normal ECHO (Echocardiogram) or MUGA (MUltiple Gated Acquisition) scan\] * FEV1 (forced expiratory volume in 1 second) \> 60% of predicted or DLCO (Carbon Monoxide Diffusing Capacity )\> 55% of predicted * No active infection of hepatitis B or C * Negative for HIV * Signed informed consent (may be obtained anytime prior to admission for cytoxan) * Women of child bearing potential agree to use an approved form of contraception Exclusion * A co-morbid condition which, in the view of the investigators, renders the patient at high risk from treatment complications * A residual acute medical condition resulting from prior chemotherapy * Brain metastases or carcinomatous meningitis * Acute infection * Fever (temp \> 38 degrees C/100.4 degrees F) * Positive pregnancy test in female patients * Lactating females * Patients of child-bearing potential unwilling to implement adequate birth control * Prior treatment with Plerixafor * Prior stem cell transplant, either autologous or allogeneic * Prior cyclophosphamide priming * Heart rate \< 50 at screening * Abnormal ECG (electrocardiogram) with a clinically significant rhythm disturbance or conduction abnormality that in the opinion of the investigator warrants exclusion of the subject from the trial * Patients with congestive heart failure at screening * History of atrial fibrillation * Patients who are currently on medication to control cardiac arrhythmias
References
Publications (0)
Data not yet available
No reference posted for this study.