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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00998049
Other study ID # MC0889
Secondary ID NCI-2009-01328MC
Status Completed
Phase Phase 2
First received October 19, 2009
Last updated April 24, 2015
Start date December 2009
Est. completion date April 2015

Study information

Verified date April 2015
Source Mayo Clinic
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 40
Est. completion date April 2015
Est. primary completion date November 2011
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment


Intervention

Drug:
plerixafor
Plerixafor 160mg/kg/dose by IV on days 5-8
filgrastim
Filgrastim (G-CSF) 10 mg/kg/dose subcutaneously on days 1-8.

Locations

Country Name City State
United States Mayo Clinic Rochester Minnesota
United States Mayo Clinic in Arizona Scottsdale Arizona

Sponsors (1)

Lead Sponsor Collaborator
Mayo Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
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.
After 2 days of apheresis No
Secondary CD34 Yield on Day 1 Number of CD34 cells/kg collected on day 1. Day 1 No
Secondary CD34 Yield Day 2 Number of CD34 cells/kg collected on day 2 Day 2 No
Secondary Median Number of Days of Apheresis Duration of apheresis (up to 7 days) No
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. Duration of apheresis (up to 7 days) No
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. Duration of apheresis (up to 7 days) No
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