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

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ClinicalTrials.gov Identifier: NCT01074060
Recruitment Status : Completed
First Posted : February 24, 2010
Last Update Posted : February 15, 2013
Sponsor:
Information provided by (Responsible Party):
City of Hope Medical Center

Study Description
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Brief Summary:

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.


Condition or disease Intervention/treatment Phase
Refractory Multiple Myeloma Stage I Multiple Myeloma Stage II Multiple Myeloma Stage III Multiple Myeloma Drug: plerixafor Biological: filgrastim Drug: cyclophosphamide Procedure: autologous hematopoietic stem cell transplantation Other: laboratory biomarker analysis Phase 1

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 18 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase I/Pilot Study of Intravenous PLERIXAFOR Following Cyclophosphamide Mobilization in Patients With Multiple Myeloma
Study Start Date : April 2010
Actual Primary Completion Date : February 2013
Actual Study Completion Date : February 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Multiple Myeloma

Arms and Interventions
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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.

 Drug: plerixafor
Given IV
Other Names:
  • AMD 3100
  • LM-3100
  • Mozobil

Biological: filgrastim
Given SC
Other Names:
  • G-CSF
  • granulocyte colony-stimulating factor
  • Neupogen
  • r-metHuG-CSF
  • Recombinant Methionyl Human Granulocyte Colony Stimulating Factor

Drug: cyclophosphamide
Given IV
Other Names:
  • CPM
  • CTX
  • Cytoxan
  • Endoxan
  • Endoxana
  • Enduxan

Procedure: autologous hematopoietic stem cell transplantation
autologous hematopoietic stem cell transplantation

Other: laboratory biomarker analysis
Correlative studies


Outcome Measures
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Primary Outcome Measures :
  1. 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 ]
  2. 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.


Secondary Outcome Measures :
  1. 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 ]
  2. Percentage of plasma cells [ Time Frame: 5 days post apheresis ]
  3. Completion of 100 days post-transplant [ Time Frame: 100 days post-transplant ]
  4. Overall and disease-free survival [ Time Frame: 6months and one year post transplant ]
  5. Time to engraftment [ Time Frame: 6 months post transplant ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01074060


Locations
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United States, California
City of Hope
Duarte, California, United States, 91010
Sponsors and Collaborators
City of Hope Medical Center
Investigators
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Principal Investigator: Amrita Krishnan City of Hope Medical Center
More Information
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Responsible Party: City of Hope Medical Center
ClinicalTrials.gov Identifier: NCT01074060    
Other Study ID Numbers: 08186
NCI-2010-00160
First Posted: February 24, 2010    Key Record Dates
Last Update Posted: February 15, 2013
Last Verified: February 2013
Additional relevant MeSH terms:
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Multiple Myeloma
Neoplasms, Plasma Cell
Neoplasms by Histologic Type
Neoplasms
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Paraproteinemias
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Lymphoproliferative Disorders
Immunoproliferative Disorders
Immune System Diseases
Plerixafor octahydrochloride
 Cyclophosphamide
Lenograstim
Sargramostim
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Myeloablative Agonists
Adjuvants, Immunologic
Anti-HIV Agents
Anti-Retroviral Agents