Phase 2
Completed N=35
Treatment With AMD3100 (Plerixafor) in Non-Hodgkin's Lymphoma and Multiple Myeloma Patients
Lymphoma, Non-Hodgkin · Multiple Myeloma
Source: ClinicalTrials.gov NCT00322842 ↗
Enrolled (actual)
35
Serious AEs
5.7%
Results posted
Nov 2010
Primary outcomePrimary: Number of Participants in Overall Safety Summary of Treatment Emergent Adverse Events (TEAE) — 4; 20; 24; 2 participants
Summary
This study evaluates the safety of plerixafor and other outcomes that are purely exploratory in nature. One other pre-specified outcome is to evaluate an interval of 10-11 hours between dosing with plerixafor and the beginning of apheresis to determine if there will be at least a 2-fold increase in circulating CD34+ cells. Data from this protocol will assist in the determination of the dosing schedule for future studies.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants in Overall Safety Summary of Treatment Emergent Adverse Events (TEAE) |
4; 20; 24; 2; 16; 18 | — |
| SECONDARY Fold (i.e., Relative) Increase in Peripheral Blood (PB) CD34+ Cells/µL After First Dose of Plerixafor |
2.6; 2.6; 2.6 | — |
| SECONDARY Number of Transplants in Which Participants Achieved Polymorphonuclear Leukocyte (PMN) Engraftment by Day 12 But No Later Than Day 21 Post Peripheral Blood Stem Cell (PBSC) Transplant |
0; 8; 8; 2; 25; 27 | — |
| SECONDARY Increase in Peripheral Blood (PB) CD34+ Cells From Steady-state Hematopoiesis to Pre-leukapheresis in G-CSF+Plerixafor Treated Participants Compared to Historical Controls Treated With G-CSF Alone or Chemotherapy and G-CSF |
— | — |
Eligibility Criteria
Inclusion Criteria
- Diagnosis of non-Hodgkin's lymphoma (NHL) or multiple myoloma (MM) eligible for autologous transplantation
- No more than 3 prior regimens of chemotherapy
- More than 4 weeks since last cycle of chemotherapy. Patient recovered from all acute toxic effects of prior chemotherapy.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- White blood cell (WBC) count >3.0*10^9/L
- Absolute polymorphonuclear cells (PMN) count >1.5*10^9/L
- Platelet (PLT) count >100*10^9/L
- Serum creatinine 45% by normal echocardiogram or multiple-gated acquisition (MUGA) scan
- Negative for human immunodeficiency virus (HIV)
- Women of child bearing potential who agreed to use an approved form of contraception.
Exclusion Criteria
- Patients who have failed previous collections
- Brain metastases or carcinomatous meningitis
- History of ventricular arrhythmias
- History of paresthesias
- A co-morbid condition which, in the view of the investigator, renders the patient at high risk for treatment complications
- A residual acute medical condition resulting from prior chemotherapy
- Acute infection
- Fever (temp >38°C/100.4°F)
- Patients whose actual body weight exceeds 150% of their ideal body weight
- Patients who previously received experimental therapy within 4 weeks of enrolling in this study or who are currently enrolled in another experimental study during the mobilization period
- Positive pregnancy test in female patients
- Lactating females
- Patients of child-bearing potential unwilling to implement adequate birth control.
- Patients who have deterioration of their clinical status or laboratory parameters between the time of enrolment and transplant (such that they no longer meet entry criteria) may be removed from study at the discretion of the treating physician, principal investigator, or sponsor.
Data sourced from ClinicalTrials.gov (NCT00322842). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.