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

Completed · Phase 2

Conditions studied: Lymphoma, Non-Hodgkin, Multiple Myeloma

In brief

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.

Key facts

Study ID: NCT00322491
Run by: Genzyme, a Sanofi Company
People needed: 49
Starts: 2004-03-01
Expected to finish: 2006-06-01
Last updated by the study team: 2014-03-13

Who can join

Age: 18 and older, up to 70. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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 <=2.2 mg/dL
Serum glutamic oxaloacetic transaminase (SGOT), serum glutamic pyruvic transaminase (SGPT) and total bilirubin <2 x upper limit of normal (ULN)
Left ventricle ejection fraction >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.

You may not qualify if…

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.

Where it is running

University of Arkansas for Medical Sciences — Little Rock, Arkansas, United States
UCLA School of Medicine — Loa Angeles, California, United States
Loyola University Medical Center — Maywood, Illinois, United States
University of Iowa — Iowa City, Iowa, United States
University of Minnesota — Minneapolis, Minnesota, United States
Mayo Clinic — Rochester, Minnesota, United States
Roswell Park Cancer Institute — Buffalo, New York, United States
Thomas Jefferson University — Philadelphia, Pennsylvania, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.