This trial is active, not recruiting.

Conditions multiple myeloma, refractory multiple myeloma, stage i multiple myeloma, stage ii multiple myeloma, stage iii multiple myeloma
Treatments plerixafor, filgrastim
Phase phase 2
Sponsor Mayo Clinic
Start date December 2009
End date November 2011
Trial size 40 participants
Trial identifier NCT00998049, 08-005644, MC0889, NCI-2009-01328


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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Plerixafor 160mg/kg/dose by IV on days 5-8 Filgrastim (G-CSF) 10 mg/kg/dose subcutaneously on days 1-8.
plerixafor AMD 3100
Plerixafor 160mg/kg/dose by IV on days 5-8
filgrastim G-CSF
Filgrastim (G-CSF) 10 mg/kg/dose subcutaneously on days 1-8.

Primary Outcomes

Number of Patients Achieving 3 Million CD34 Cells/kg After 2 Days of Apheresis
time frame: After 2 days of apheresis

Secondary Outcomes

CD34 Yield on Day 1
time frame: Day 1
CD34 Yield Day 2
time frame: Day 2
Median Number of Days of Apheresis
time frame: Duration of apheresis (up to 7 days)
Time to Reach 6 Million CD34 Cells
time frame: Duration of apheresis (up to 7 days)
Rate of Failure to Mobilize
time frame: Duration of apheresis (up to 7 days)

Eligibility Criteria

Male or female participants at least 18 years old.

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

Additional Information

Official 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
Principal investigator Joseph R. Mikhael, M.D.
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.
Trial information was received from ClinicalTrials.gov and was last updated in March 2015.
Information provided to ClinicalTrials.gov by Mayo Clinic.