A Phase I/Pilot Study of Intravenous PLERIXAFOR Following Cyclophosphamide Mobilization in Patients With Multiple Myeloma
18 Years
70 Years
Both
Refractory Multiple Myeloma, Stage I Multiple Myeloma, Stage II Multiple Myeloma, Stage III Multiple Myeloma
Trial Information
A Phase I/Pilot Study of Intravenous PLERIXAFOR Following Cyclophosphamide Mobilization in Patients With Multiple Myeloma
PRIMARY OBJECTIVES:
I. To assess the safety and tolerability of intravenous(IV) PLERIXAFOR when given in
combination with cyclophosphamide and G-CSF as a mobilization regimen in patients with
Multiple Myeloma.
SECONDARY OBJECTIVES:
I. To determine if intravenous PLERIXAFOR, given with a cyclophosphamide and G-CSF
mobilizing regimen, will allow collection of greater than or equal to 5 x 10^6 CD34+
cells/kg in 2 or less apheresis days.
II. To review the timing of intravenous plerixafor administration prior to apheresis and
describe our experience.
OUTLINE:
MOBILIZATION: Patients receive cyclophosphamide intravenously (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.
Following the collection of an adequate number of stem cells, patients undergo high-dose
chemotherapy and autologous stem cell rescue. Patients are followed post-autologous stem
cell transplant for engraftment.
After completion of study treatment, patients are followed periodically.
Inclusion Criteria
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
Type of Study:
Interventional
Study Design:
Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome 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.
Outcome Time Frame:
12 to 18 months
Safety Issue:
Yes
Principal Investigator
Amrita Krishnan
Investigator Role:
Principal Investigator
Investigator Affiliation:
Beckman Research Institute
Authority:
United States: Institutional Review Board
Study ID:
08186
NCT ID:
NCT01074060
Start Date:
April 2010
Completion Date:
February 2013
Related Keywords:
- Refractory Multiple Myeloma
- Stage I Multiple Myeloma
- Stage II Multiple Myeloma
- Stage III Multiple Myeloma
- Multiple Myeloma
- Neoplasms, Plasma Cell
Name | Location |
|---|---|
| City of Hope | Duarte, California 91010 |
