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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2009-01328 | Registry Identifier | NCI-CTRP | |
| MC0889 | Other Identifier | Mayo Clinic Cancer Center | |
| 08-005644 | Other Identifier | Mayo Clinic IRB |
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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.
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Plerixafor | Experimental | Plerixafor 160mg/kg/dose by IV on days 5-8 Filgrastim (G-CSF) 10 mg/kg/dose subcutaneously on days 1-8. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| plerixafor | Drug | Plerixafor 160mg/kg/dose by IV on days 5-8 |
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| Measure | Description | Time Frame |
|---|---|---|
| Number of Patients Achieving 3 Million CD34 Cells/kg 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. | After 2 days of apheresis |
| Measure | Description | Time Frame |
|---|---|---|
| CD34 Yield on Day 1 | Number of CD34 cells/kg collected on day 1. | Day 1 |
| CD34 Yield Day 2 | Number of CD34 cells/kg collected on day 2 |
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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
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| Name | Affiliation | Role |
|---|---|---|
| Shaji Kumar, M.D. | Mayo Clinic | Study Chair |
| Joseph R. Mikhael, M.D. | Mayo Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mayo Clinic in Arizona | Scottsdale | Arizona | 85259 | United States | ||
| Mayo Clinic |
One participant was deemed ineligible and is excluded from all analyses per study design.
Forty (40) participants were recruited at Mayo Clinic (Rochester, Florida and Arizona) between December 2009 and October 2011.
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| ID | Title | Description |
|---|---|---|
| FG000 | Plerixafor | Plerixafor 160mg/kg/dose by IV on days 5-8 Filgrastim (G-CSF) 10 mg/kg/dose subcutaneously on days 1-8. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| filgrastim | Drug | Filgrastim (G-CSF) 10 mg/kg/dose subcutaneously on days 1-8. |
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| Day 2 |
| Median Number of Days of Apheresis | Duration of apheresis (up to 7 days) |
| Time to Reach 6 Million CD34 Cells | 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. | Duration of apheresis (up to 7 days) |
| Rate of Failure to Mobilize | 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. | Duration of apheresis (up to 7 days) |
| Rochester |
| Minnesota |
| 55905 |
| United States |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Plerixafor | Plerixafor 160mg/kg/dose by IV on days 5-8 Filgrastim (G-CSF) 10 mg/kg/dose subcutaneously on days 1-8. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median | Full Range | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Patients Achieving 3 Million CD34 Cells/kg 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. | Posted | Number | participants | After 2 days of apheresis |
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| Secondary | CD34 Yield on Day 1 | Number of CD34 cells/kg collected on day 1. | Posted | Median | Full Range | cells/kg | Day 1 |
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| Secondary | CD34 Yield Day 2 | Number of CD34 cells/kg collected on day 2 | Posted | Median | Full Range | cells/kg | Day 2 |
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| Secondary | Median Number of Days of Apheresis | Posted | Median | Full Range | days | Duration of apheresis (up to 7 days) |
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| Secondary | Time to Reach 6 Million CD34 Cells | 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. | Posted | Median | 95% Confidence Interval | days | Duration of apheresis (up to 7 days) |
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| Secondary | Rate of Failure to Mobilize | 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. | Posted | Number | 95% Confidence Interval | percentage of participants | Duration of apheresis (up to 7 days) |
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Plerixafor | Plerixafor 160mg/kg/dose by IV on days 5-8 Filgrastim (G-CSF) 10 mg/kg/dose subcutaneously on days 1-8. | 0 | 39 | 25 | 39 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anemia | Blood and lymphatic system disorders | MedDRA 12 | Systematic Assessment |
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| Abdominal pain | Gastrointestinal disorders | MedDRA 12 | Systematic Assessment |
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| Bloating | Gastrointestinal disorders | MedDRA 12 | Systematic Assessment |
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| Diarrhea | Gastrointestinal disorders | MedDRA 12 | Systematic Assessment |
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| Nausea | Gastrointestinal disorders | MedDRA 12 | Systematic Assessment |
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| Injection site reaction | General disorders | MedDRA 12 | Systematic Assessment |
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| Platelet count decreased | Investigations | MedDRA 12 | Systematic Assessment |
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| Dizziness | Nervous system disorders | MedDRA 12 | Systematic Assessment |
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| Headache | Nervous system disorders | MedDRA 12 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Shaji Kumar | Mayo Clinic | kumar.shaji@mayo.edu |
| ID | Term |
|---|---|
| D009101 | Multiple Myeloma |
| ID | Term |
|---|---|
| D054219 | Neoplasms, Plasma Cell |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D020141 | Hemostatic Disorders |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D010265 | Paraproteinemias |
| D001796 | Blood Protein Disorders |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D006474 | Hemorrhagic Disorders |
| D008232 | Lymphoproliferative Disorders |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
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| ID | Term |
|---|---|
| C088327 | plerixafor |
| D000069585 | Filgrastim |
| D016179 | Granulocyte Colony-Stimulating Factor |
| ID | Term |
|---|---|
| D003115 | Colony-Stimulating Factors |
| D006023 | Glycoproteins |
| D006001 | Glycoconjugates |
| D002241 | Carbohydrates |
| D016298 | Hematopoietic Cell Growth Factors |
| D016207 | Cytokines |
| D036341 | Intercellular Signaling Peptides and Proteins |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D011506 | Proteins |
| D001685 | Biological Factors |
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