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NCT00998049 · REGISTRY CONDITION SEARCH

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

Found through the registry condition index, not selected as a treatment recommendation. This discovery collection was restricted to studies with posted results.

Phase
PHASE2
Status at capture
COMPLETED
Registry last update
2015-05-14

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.

Open the original ClinicalTrials.gov record → · Download preserved record

What did the study report?

Outcomes, safety and baseline populations are separate source sections. Quality-of-life measures appear under their original outcome titles.

flow

Participant flow

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baseline

Baseline characteristics

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outcome · POSTED

Number of Patients Achieving 3 Million CD34 Cells/kg After 2 Days of Apheresis

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outcome · POSTED

CD34 Yield on Day 1

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outcome · POSTED

CD34 Yield Day 2

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outcome · POSTED

Median Number of Days of Apheresis

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outcome · POSTED

Time to Reach 6 Million CD34 Cells

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outcome · POSTED

Rate of Failure to Mobilize

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adverse events

Adverse events

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more info

Limitations, agreements, and source contact

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Who could take part
eligibility Criteria
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
healthy Volunteers
false
minimum Age
18 Years
sex
ALL
std Ages
  1. ADULT
  2. OLDER_ADULT
Treatment arms and interventions
arm Groups
  1. description
    Plerixafor 160mg/kg/dose by IV on days 5-8 Filgrastim (G-CSF) 10 mg/kg/dose subcutaneously on days 1-8.
    intervention Names
    1. Drug: plerixafor
    2. Drug: filgrastim
    label
    Plerixafor
    type
    EXPERIMENTAL
interventions
  1. arm Group Labels
    1. Plerixafor
    description
    Plerixafor 160mg/kg/dose by IV on days 5-8
    name
    plerixafor
    other Names
    1. AMD 3100
    2. LM-3100
    3. Mozobil
    type
    DRUG
  2. arm Group Labels
    1. Plerixafor
    description
    Filgrastim (G-CSF) 10 mg/kg/dose subcutaneously on days 1-8.
    name
    filgrastim
    other Names
    1. G-CSF
    2. granulocyte colony-stimulating factor
    3. Neupogen
    4. r-metHuG-CSF
    5. Recombinant Methionyl Human Granulocyte Colony Stimulating Factor
    type
    DRUG
Study design
allocation
NA
intervention Model
SINGLE_GROUP
masking Info
masking
NONE
primary Purpose
TREATMENT
Enrollment
count
40
type
ACTUAL
Registered outcome plans (not posted results)
primary Outcomes
  1. description
    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.
    measure
    Number of Patients Achieving 3 Million CD34 Cells/kg After 2 Days of Apheresis
    time Frame
    After 2 days of apheresis
secondary Outcomes
  1. description
    Number of CD34 cells/kg collected on day 1.
    measure
    CD34 Yield on Day 1
    time Frame
    Day 1
  2. description
    Number of CD34 cells/kg collected on day 2
    measure
    CD34 Yield Day 2
    time Frame
    Day 2
  3. measure
    Median Number of Days of Apheresis
    time Frame
    Duration of apheresis (up to 7 days)
  4. description
    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.
    measure
    Time to Reach 6 Million CD34 Cells
    time Frame
    Duration of apheresis (up to 7 days)
  5. description
    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.
    measure
    Rate of Failure to Mobilize
    time Frame
    Duration of apheresis (up to 7 days)
Full study description
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.
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.
Source references
Source notices and limitations
    Discovery and provenance
    1. release id
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      edge id
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      payload
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      id
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      nct id
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      occurrences
      1. context exact
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        exact text
        NCT00998049
        start
        0
      offset unit
      unicode_code_points
      query cond
      Plasma Cell Neoplasms
      query disease state id
      ds-plasma-cell-neoplasms
      source file
      /Users/arunverma/Documents/ChatGPT/Cancer Statistics Website/research-data/2026-09-10/clinicaltrials-condition/round-0000/raw/cond-plasma-cell-neoplasms-000.json
      source file sha256
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      source json pointer
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      source kind
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      source record id
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      source string basis
      parsed_JSON_string_unmodified
      source string sha256
      537dd95a429f02a327c8ae1d56d92fcaaee85d5cf4bc5642665db5952dd75b4b

    Preserved source evidence · Not medical advice