Treatment With AMD3100 (Plerixafor) in Non-Hodgkin's Lymphoma and Multiple Myeloma Patients

Genzyme

Status and phase: Completed; Phase 2

Conditions: Multiple Myeloma; Lymphoma, Non-Hodgkin

Treatments: Drug: G-CSF Plus Plerixafor

Study type: Interventional

Funder types: Industry

Identifiers

NCT00322842

AMD3100-EU21

Details and patient eligibility

About

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.

Full description

Participants with non-Hodgkin's lymphoma and multiple myeloma who have undergone prior cyto-reductive chemotherapy and are to be autologously transplanted will be treated with a combination of plerixafor and granulocyte colony-stimulating factor (G-CSF) mobilization regimen on the day prior to apheresis. The only change to standard of European care is the addition of plerixafor to a G-CSF mobilizing regimen. Participants will undergo mobilization with G-CSF (10 µg/kg each day) and on each day prior to apheresis will receive plerixafor (240 µg/kg). Participants will undergo apheresis for up to 5 consecutive days in order to collect the target number of (≥ 5*10^6) CD34+ stem cells/kg. Participants will be transplanted with cells obtained from the G-CSF and plerixafor mobilization regimen. The number of CD34+ cells mobilized in the peripheral blood from the time of the plerixafor dose to just prior to apheresis and those harvested in the apheresis product will be measured. The number of apheresis sessions required to obtain ≥ 5*10^6 CD34+ cells/kg will also be measured. Success of the transplantation(s) will be evaluated by the time to engraftment of poly-morphonuclear leukocytes (PMN) and platelets (PLT). Participants will be followed for durability of their transplant for 12 months following transplantation.

This study was previously posted by AnorMED, Inc. In November 2006, AnorMED, Inc. was acquired by Genzyme Corporation. Genzyme Corporation is the sponsor of the trial.

Enrollment: 35 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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 <=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
• 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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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35 participants in 2 patient groups

Non-Hodgkin's Lymphoma (NHL)

Experimental group

Description:

Participants with NHL were mobilized with granulocyte colony-stimulating factor (G-CSF) 10 µg/kg/day for 4 days. Plerixafor 240 µg/kg was given the evening of day 4 and G-CSF given the next morning followed by apheresis. Evening doses of plerixafor and morning doses of G-CSF followed by apheresis continued for up to a maximum of 5 aphereses or until ≥ 5\*10\^6 CD34+ cells/kg were collected.

Treatment:

Drug: G-CSF Plus Plerixafor

Multiple Myeloma (MM)

Experimental group

Description:

Participants with MM were mobilized with granulocyte colony-stimulating factor (G-CSF) 10 µg/kg/day for 4 days. Plerixafor 240 µg/kg was given the evening of day 4 and G-CSF given the next morning followed by apheresis. Evening doses of plerixafor and morning doses of G-CSF followed by apheresis continued for up to a maximum of 5 aphereses or until ≥ 5\*10\^6 CD34+ cells/kg were collected.

Treatment:

Drug: G-CSF Plus Plerixafor