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Completed

NCT Number: NCT00998049

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

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

plerixafor

Drug

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

Other names: AMD 3100, LM-3100, Mozobil

Filgrastim

Drug

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 outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Registry information

Official study 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

Important dates

Study start
2009
Primary completion
2011
Study completion
2015
First posted
Oct 20, 2009
Registry last updated
May 14, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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