Plerixafor and Filgrastim Following Cyclophosphamide for Stem Cell Mobilization in Patients With Multiple Myeloma

February 13, 2013 updated by: City of Hope Medical Center

A Phase I/Pilot Study of Intravenous PLERIXAFOR Following Cyclophosphamide Mobilization in Patients With Multiple Myeloma

RATIONALE: There are different methods of stem cell mobilization, such as using colony-stimulating factors alone or following chemotherapy priming. More recently, the combination of plerixafor and colony-stimulating factors has been shown to enhance stem cell mobilization. This study will assess whether the combination of plerixafor and Granulocyte Colony-Stimulating Factor (G-CSF) is effective following chemotherapy mobilization with cyclophosphamide.

PURPOSE: To assess the safety, tolerability, and best dose of intravenous plerixafor following cyclophosphamide priming.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Actual)

18

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Duarte, California, United States, 91010
        • City of Hope

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
Other: laboratory biomarker analysis
Correlative studies
Drug: cyclophosphamide
Given IV
Other Names:
  • Cytoxan
  • Endoxan
  • CPM
  • CTX
  • Endoxana
  • Enduxan
Biological: filgrastim
Given SC
Other Names:
  • G-CSF
  • r-metHuG-CSF
  • Neupogen
  • Recombinant Methionyl Human Granulocyte Colony Stimulating Factor
  • granulocyte colony-stimulating factor
Drug: plerixafor
Given IV
Other Names:
  • Mozobil
  • AMD 3100
  • LM-3100
Procedure: autologous hematopoietic stem cell transplantation
autologous hematopoietic stem cell transplantation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Time Frame: 12 to 18 months
12 to 18 months
Tolerability and safety of PLERIXAFOR
Time Frame: 6 months post transplant
Will be summarized in terms of type, severity (by National Cancer Institute Common Terminology Criteria for Adverse Events [NCI CTCAE] v4.0), date of onset, duration, reversibility, and attribution.
6 months post transplant

Secondary Outcome Measures

Outcome Measure
Time Frame
Frequency of collecting 5 x 10^6 or more CD34+ cells/kg in 2 or less apheresis days
Time Frame: 5 days post apheresis completion
5 days post apheresis completion
Percentage of plasma cells
Time Frame: 5 days post apheresis
5 days post apheresis
Completion of 100 days post-transplant
Time Frame: 100 days post-transplant
100 days post-transplant
Overall and disease-free survival
Time Frame: 6months and one year post transplant
6months and one year post transplant
Time to engraftment
Time Frame: 6 months post transplant
6 months post transplant

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

City of Hope Medical Center

Investigators

  • Principal Investigator: Amrita Krishnan, City of Hope Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2010

Primary Completion (Actual)

February 1, 2013

Study Completion (Actual)

February 1, 2013

Study Registration Dates

First Submitted

February 19, 2010

First Submitted That Met QC Criteria

February 22, 2010

First Posted (Estimate)

February 24, 2010

Study Record Updates

Last Update Posted (Estimate)

February 15, 2013

Last Update Submitted That Met QC Criteria

February 13, 2013

Last Verified

February 1, 2013

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 08186
  • NCI-2010-00160

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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