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Plerixafor in Treating Patients With Multiple Myeloma Previously Treated With Lenalidomide and Planning to Undergo Autologous Stem Cell Transplant

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00998049
Recruitment Status : Completed
First Posted : October 20, 2009
Results First Posted : July 30, 2012
Last Update Posted : May 14, 2015
Information provided by (Responsible Party):
Mayo Clinic

Brief Summary:
Rationale: Giving colony-stimulating factors, such as G-CSF and plerixafor helps stem cells move from the patient's bone marrow to the blood so they can be collected and stored. Purpose: This phase II trial is studying how well plerixafor works in patients with multiple myeloma previously treated with lenalidomide and planning to undergo autologous stem cell transplant.

Condition or disease Intervention/treatment Phase
Multiple Myeloma Refractory Multiple Myeloma Stage I Multiple Myeloma Stage II Multiple Myeloma Stage III Multiple Myeloma Drug: plerixafor Drug: filgrastim Phase 2

Detailed Description:
Primary Objective: I. To determine the proportion of patients reaching a stem cell yield of 3 million CD34 cells/kg by second day of apheresis with intravenously administered AMD3100 among patients receiving primary therapy for myeloma with lenalidomide. Secondary Objectives: I. Safety and tolerability of intravenously administered AMD3100. II. Rate of failure to mobilize. Outline: Patients receive plerixafor IV on days 5-8 and filgrastim subcutaneously on days 1-8 in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed at 30 days.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase II Trial of Intravenously Administered AMD3100 (Plerixafor) for Stem Cell Mobilization in Patients With Multiple Myeloma Undergoing Autologous Stem Cell Transplantation Following a Lenalidomide Based Initial Therapy
Study Start Date : December 2009
Actual Primary Completion Date : November 2011
Actual Study Completion Date : April 2015

Arm Intervention/treatment
Experimental: Plerixafor

Plerixafor 160mg/kg/dose by IV on days 5-8

Filgrastim (G-CSF) 10 mg/kg/dose subcutaneously on days 1-8.

Drug: plerixafor
Plerixafor 160mg/kg/dose by IV on days 5-8
Other Names:
  • AMD 3100
  • LM-3100
  • Mozobil

Drug: filgrastim
Filgrastim (G-CSF) 10 mg/kg/dose subcutaneously on days 1-8.
Other Names:
  • G-CSF
  • granulocyte colony-stimulating factor
  • Neupogen
  • r-metHuG-CSF
  • Recombinant Methionyl Human Granulocyte Colony Stimulating Factor

Primary Outcome Measures :
  1. Number of Patients Achieving 3 Million CD34 Cells/kg After 2 Days of Apheresis [ Time Frame: After 2 days of apheresis ]

    Number of CD34 cells/kg collected on days 1-2.

    Apheresis is the process when blood is taken out through a catheter in a vein in one arm, blood is sent through a machine that takes out the stem cells and the rest of the blood is then returned through a vein in your other arm.

Secondary Outcome Measures :
  1. CD34 Yield on Day 1 [ Time Frame: Day 1 ]
    Number of CD34 cells/kg collected on day 1.

  2. CD34 Yield Day 2 [ Time Frame: Day 2 ]
    Number of CD34 cells/kg collected on day 2

  3. Median Number of Days of Apheresis [ Time Frame: Duration of apheresis (up to 7 days) ]
  4. Time to Reach 6 Million CD34 Cells [ Time Frame: Duration of apheresis (up to 7 days) ]
    Number (median and 95% confidence interval) of days to reach 6 million CD34 cells/kg was estimated using the Kaplan Meier method. Participants were lower than 6 million CD34 cells/kg at time of last follow-up will be censored at that date.

  5. Rate of Failure to Mobilize [ Time Frame: Duration of apheresis (up to 7 days) ]
    The rate of failure to mobilize will be estimated by dividing the number of patients that fail to mobilize by the total number of evaluable patients. A patient is considered a failure if they never achieve 2.5 million CD34 cells/kg.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Inclusion - Absolute neutrophil count >= 1000/uL - Platelet >= 75000/uL - Hemoglobin >= 8.0 g/dL - Serum aspartate aminotransferase (AST)/serum glutamic oxaloacetic transaminase (SGOT), serum alanine aminotransferase (ALT)/serum glutamic pyruvic transaminase (SGPT) and total bilirubin < 2 x upper limit of normal (ULN) - Confirmed diagnosis of multiple myeloma, requiring therapy - Initial treatment for symptomatic myeloma using a lenalidomide based treatment regimen, started =< 12 months prior to registration - Received at least 2 cycles of treatment with the lenalidomide regimen - Last dose of lenalidomide > 2 weeks prior to registration - Eligible to undergo autologous transplantation - ECOG performance status (PS) 0 or 1 - Willingness to return for follow-up - Provide informed written consent - Adequate cardiopulmonary function: ejection fraction >= 45%, corrected pulmonary diffusion capacity of >= 50%, FEV1 >= 50%, FVC >= 50% - Negative serum or urine pregnancy test done =< 7 days prior to registration, for women of childbearing potential only Exclusion - A co-morbid condition which, in the view of the Investigators, renders the patient at high risk from treatment complications - Active malignancy with the exception of non melanoma skin cancer or in situ cervical or breast cancer - Other co-morbidity which would interfere with patient's ability to participate in the trial, e.g. uncontrolled infection, uncompensated heart or lung disease - Other concurrent chemotherapy, radiotherapy, or any ancillary therapy considered investigational - Use of cyclophosphamide as part of stem cell mobilization - Use of more than one regimen for treatment of symptomatic myeloma - Dialysis dependent renal failure - Pregnant women or women of reproductive ability who are unwilling to use effective contraception - Nursing women - Men who are unwilling to use a condom (even if they have undergone a prior vasectomy) while having intercourse with any woman, while taking the drug and for 4 weeks after stopping treatment - Acute infection, active HIV infection

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 identifier (NCT number): NCT00998049

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United States, Arizona
Mayo Clinic in Arizona
Scottsdale, Arizona, United States, 85259
United States, Minnesota
Mayo Clinic
Rochester, Minnesota, United States, 55905
Sponsors and Collaborators
Mayo Clinic
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Study Chair: Shaji Kumar, M.D. Mayo Clinic
Principal Investigator: Joseph R. Mikhael, M.D. Mayo Clinic

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Responsible Party: Mayo Clinic Identifier: NCT00998049     History of Changes
Other Study ID Numbers: MC0889
NCI-2009-01328 ( Registry Identifier: NCI-CTRP )
MC0889 ( Other Identifier: Mayo Clinic Cancer Center )
08-005644 ( Other Identifier: Mayo Clinic IRB )
First Posted: October 20, 2009    Key Record Dates
Results First Posted: July 30, 2012
Last Update Posted: May 14, 2015
Last Verified: April 2015
Additional relevant MeSH terms:
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Neoplasms, Plasma Cell
Multiple Myeloma
Neoplasms by Histologic Type
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Lymphoproliferative Disorders
Immunoproliferative Disorders
Immune System Diseases
Plerixafor octahydrochloride
Immunologic Factors
Physiological Effects of Drugs
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Growth Inhibitors
Antineoplastic Agents
Adjuvants, Immunologic
Anti-HIV Agents
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents