Phase 2 N=49 Treatment

Mobilization of Stem Cells With AMD3100 (Plerixafor) and G-CSF in Non-Hodgkin's Lymphoma and Multiple Myeloma Patients

Lymphoma, Non-Hodgkin · Multiple Myeloma

Bottom Line

View on ClinicalTrials.gov: NCT00322491 ↗

Enrolled (actual)

Serious AEs

2.0%

Results posted

Nov 2010

Primary outcome: Primary: Number of Participants in Overall Safety Summary of Treatment Emergent Adverse Events (TEAE) — 23; 26; 49; 8 participants

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: G-CSF Plus Plerixafor (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Genzyme, a Sanofi Company
Primary completion: Jun 2006

Outcome Measures

Outcome	Result	p-value
PRIMARY Number of Participants in Overall Safety Summary of Treatment Emergent Adverse Events (TEAE)	23; 26; 49; 8; 9; 17	—
SECONDARY Number of Participants Achieving a Two-Fold (Relative) Increase in Peripheral Blood (PB) CD34+ Cells/µL Following the First Dose of Plerixafor	20; 17; 37; 3; 9; 12	—
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	19; 20; 39; 3; 7; 10	—

Summary

This study evaluates the safety and efficacy of plerixafor given in addition to granulocyte-colony stimulating factor (G-CSF) for collection of peripheral blood stem cells (PBSCs) for autologous transplantation in patients with non-Hodgkin's lymphoma (NHL) and multiple myeloma (MM). Efficacy outcomes include evaluation of fold increase in circulating CD34+ cells from just before the first plerixafor injection to 10-11 hours post plerixafor (just before apheresis) and assessment of successful polymorphonuclear leukocyte (PMN) engraftment after transplantation. Data from this protocol will assist in the determination of the dosing schedule for future studies.

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
Forced expiratory volume of the lung in the first second (FEV1) >60% of predicted or diffusing capacity of the lung for carbon monoxide (DLCO) >45% of predicted
Negative for human immunodeficiency virus (HIV) type 1
Women of child bearing potential 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
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 175% 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.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00322491). 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.