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NCT00322387 · REGISTRY CONDITION SEARCH

Mobilization of Stem Cells With Plerixafor, Chemotherapy and G-CSF in Multiple Myeloma or Non-Hodgkin's Lymphoma Patients

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
2014-03-13

Patients with multiple myeloma (MM) and non-Hodgkin's lymphoma (NHL) will be mobilized with chemotherapy and G-CSF plus plerixafor (AMD3100). The purpose of this protocol is to determine if plerixafor given after chemotherapy and G-CSF mobilization regimen is safe, if it can increase the circulating levels of peripheral blood stem cells (PBSCs) by ≥ 2-fold before apheresis, and if transplantation with the apheresis product was successful, as measured by time to engraftment of polymorphonuclear leukocytes (PMNs) and platelets (PLTs).

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

Overall Participant Counts of Adverse Events (AEs) Up to Twelve Months Post Transplant

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outcome · POSTED

Fold (i.e., Relative) Increase in Peripheral Blood (PB) CD34+ Cells/µL

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outcome · POSTED

Number of Transplants in Which Participants Achieved Polymorphonuclear Leukocyte (PMN) Engraftment by Day 12 But No Later Than Day 21 Post Peripheral Blood Stem Cell (PBSC) Transplant

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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 Criteria (Abbreviated List): * MM in first partial response/complete response, first relapse, or second partial/complete response * NHL in first or second partial or complete remission * NHL patients who do not have bone marrow involvement and \< 10% for follicular involvement * MM patients who have stable disease with \< 40% bone marrow involvement * No more than three prior regimens of chemotherapy (thalidomide and Decadron are not considered chemotherapy) * Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 * White blood cell count (WBC) \>3.0 x 10\^9/L * Absolute neutrophil count \>1.5 x 10\^9/L * Platelet count \>100 x 10\^9/L Exclusion Criteria (Abbreviated List): * Brain metastases or carcinomatous meningitis * Hypercalcaemia \[\>1 mg/dl above the upper limit of normal (ULN)\] * Cardiovascular disease that includes proven or predisposition to ventricular arrhythmias * Acute Infection
healthy Volunteers
false
maximum Age
70 Years
minimum Age
18 Years
sex
ALL
std Ages
  1. ADULT
  2. OLDER_ADULT
Treatment arms and interventions
arm Groups
  1. description
    Participants received chemotherapy and G-CSF mobilization for 7 days according to standard procedures at the study center. When participants achieved a target CD34+ count of ≥20 cells/µL, apheresis began. G-CSF was given daily in the morning on the days of apheresis. After the first apheresis, plerixafor (240 µg/kg) was administered each evening (approximately 10pm) followed by apheresis 10 to 11 hours later for up to 4 consecutive days. Called 'Cohort A' in protocol, study report and publications.
    intervention Names
    1. Drug: G-CSF and plerixafor
    label
    Plerixafor PM
    type
    EXPERIMENTAL
  2. description
    Participants received chemotherapy and G-CSF mobilization for 7 days according to standard procedures at the study center. When participants achieved a target CD34+ count of ≥20 cells/µL, apheresis began. G-CSF was given daily in the morning on the days of apheresis. The morning of the second day after the first apheresis, plerixafor (240 µg/kg) was administered followed by apheresis 6 hours later. Plerixafor (240 µg/kg) was administered in the morning followed by apheresis 6 hours later for up to 4 consecutive days. Called 'Cohort B' in protocol, study report and publications.
    intervention Names
    1. Drug: G-CSF and plerixafor
    label
    Plerixafor AM
    type
    EXPERIMENTAL
  3. description
    Participants received chemotherapy and G-CSF mobilization for 7 days according to standard procedures at the study center. If participants had a CD34+ count of \>=10 cells/µL but \<20 cells/µL on 2 consecutive days, plerixafor (240 µg/kg) was given in the evening. G-CSF was administered and apheresis performed in the morning. Plerixafor (240 µg/kg) administered in the evening followed by G-CSF and apheresis 10 to 11 hours later was repeated for up to 4 consecutive days. Called 'Cohort C' in protocol, study report and publications.
    intervention Names
    1. Drug: G-CSF and plerixafor
    label
    Low CD34+ Count/ Plerixafor PM
    type
    EXPERIMENTAL
  4. description
    This investigational cohort evaluated the effect of administering plerixafor before white blood cell recovery. Participants received mobilizing chemotherapy, followed by 5 consecutive days of G-CSF (10 µg/kg). Starting on the sixth day, participants received G-CSF (10 µg/kg) plus plerixafor (240 µg/kg) daily for up to 3 consecutive days. If CD34+ counts reached \>= 20 cells/µL 6 hours after any of the 3 plerixafor doses, apheresis began. If not, G-CSF administration continued until the participant qualified for one of the other treatment arms. Called 'Investigational Cohort' in protocol, study report and publications.
    intervention Names
    1. Drug: G-CSF and plerixafor
    label
    Plerixafor After Chemo
    type
    EXPERIMENTAL
interventions
  1. arm Group Labels
    1. Low CD34+ Count/ Plerixafor PM
    2. Plerixafor AM
    3. Plerixafor After Chemo
    4. Plerixafor PM
    description
    G-CSF and plerixafor were administered as described in the treatment arms.
    name
    G-CSF and plerixafor
    other Names
    1. Mozobil
    2. AMD3100
    type
    DRUG
Study design
allocation
NON_RANDOMIZED
intervention Model
PARALLEL
masking Info
masking
NONE
primary Purpose
TREATMENT
Enrollment
count
40
type
ACTUAL
Registered outcome plans (not posted results)
primary Outcomes
  1. description
    Safety assessment was based on the incidence of adverse event reports. Participant count of AEs (Adverse Events) by severity and by relationship to study drug. AEs were reported regardless of relationship to study treatment. The investigator graded each AE using the World Health Organization (WHO) Adverse Event Grading Scale and provided assessments of seriousness and relatedness to study treatment.
    measure
    Overall Participant Counts of Adverse Events (AEs) Up to Twelve Months Post Transplant
    time Frame
    13 months
secondary Outcomes
  1. description
    The fold increase was measured by fluorescence activated cell sorting (FACS) analysis and was expressed as a ratio. Fold increase = (pre-apheresis PB CD34+ cells/µL)/(pre-plerixafor dosing PB CD34+ cells/µL).
    measure
    Fold (i.e., Relative) Increase in Peripheral Blood (PB) CD34+ Cells/µL
    time Frame
    Days 4-5 (first dose of plerixafor to apheresis)
  2. description
    Participants were monitored for polymorphonuclear leukocyte (PMN) engraftment as per the local standard of care. The target for engraftment was 12 days after PBSC transplant and no transplant taking longer than 21 days for engraftment.
    measure
    Number of Transplants in Which Participants Achieved Polymorphonuclear Leukocyte (PMN) Engraftment by Day 12 But No Later Than Day 21 Post Peripheral Blood Stem Cell (PBSC) Transplant
    time Frame
    2 months
Full study description
brief Summary
Patients with multiple myeloma (MM) and non-Hodgkin's lymphoma (NHL) will be mobilized with chemotherapy and G-CSF plus plerixafor (AMD3100). The purpose of this protocol is to determine if plerixafor given after chemotherapy and G-CSF mobilization regimen is safe, if it can increase the circulating levels of peripheral blood stem cells (PBSCs) by ≥ 2-fold before apheresis, and if transplantation with the apheresis product was successful, as measured by time to engraftment of polymorphonuclear leukocytes (PMNs) and platelets (PLTs).
detailed Description
An open label, multi-center, phase 2 study was conducted in patients with MM or NHL who were to be treated with peripheral blood stem cells (PBSC) autologous transplantation. The only change to the standard of care was the addition of plerixafor to a mobilization regimen of chemotherapy and G-CSF. Patients were first given a mobilizing regimen of chemotherapy as per local practice guidelines and G-CSF (at customary doses) and apheresis was performed. After the first apheresis, plerixafor was given at 10PM, 10-11 hours before the second apheresis the next day or in the morning of the second day, 6 hours before the second apheresis. The change in the patient's peripheral CD34+ cell count between the plerixafor dose and the start of apheresis was measured. The apheresis yields on Day 1 and Day 2 were compared. This study was previously posted by AnorMED, Inc. In November 2006, AnorMED, Inc. was acquired by Genzyme Corporation. Genzyme Corporation is the sponsor of the trial.
Source references
references
  1. citation
    Dugan MJ, Maziarz RT, Bensinger WI, Nademanee A, Liesveld J, Badel K, Dehner C, Gibney C, Bridger G, Calandra G. Safety and preliminary efficacy of plerixafor (Mozobil) in combination with chemotherapy and G-CSF: an open-label, multicenter, exploratory trial in patients with multiple myeloma and non-Hodgkin's lymphoma undergoing stem cell mobilization. Bone Marrow Transplant. 2010 Jan;45(1):39-47. doi: 10.1038/bmt.2009.119. Epub 2009 Jun 1.
    pmid
    19483760
    type
    RESULT
Source notices and limitations
    Discovery and provenance
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        exact text
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    Preserved source evidence · Not medical advice