Plerixafor and Filgrastim Following Cyclophosphamide for Stem Cell Mobilization in Patients With Multiple Myeloma
NCT ID: NCT01074060
Last Updated: 2013-02-15
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
18 participants
INTERVENTIONAL
2010-04-30
2013-02-28
Brief Summary
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PURPOSE: To assess the safety, tolerability, and best dose of intravenous plerixafor following cyclophosphamide priming.
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Detailed Description
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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.
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Arm I
MOBILIZATION: Patients receive cyclophosphamide 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.
plerixafor
Given IV
filgrastim
Given SC
cyclophosphamide
Given IV
autologous hematopoietic stem cell transplantation
autologous hematopoietic stem cell transplantation
laboratory biomarker analysis
Correlative studies
Interventions
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plerixafor
Given IV
filgrastim
Given SC
cyclophosphamide
Given IV
autologous hematopoietic stem cell transplantation
autologous hematopoietic stem cell transplantation
laboratory biomarker analysis
Correlative studies
Other Intervention Names
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Eligibility Criteria
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Exclusion Criteria
* 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
18 Years
70 Years
ALL
No
Sponsors
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City of Hope Medical Center
OTHER
Responsible Party
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Principal Investigators
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Amrita Krishnan
Role: PRINCIPAL_INVESTIGATOR
City of Hope Medical Center
Locations
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City of Hope
Duarte, California, United States
Countries
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Other Identifiers
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NCI-2010-00160
Identifier Type: -
Identifier Source: secondary_id
08186
Identifier Type: -
Identifier Source: org_study_id
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