Multiple Myeloma, Refractory Multiple Myeloma, Stage III Multiple Myeloma, Stage II Multiple Myeloma, Stage I Multiple Myeloma
Conditions
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.
Interventions
DRUGplerixafor
Plerixafor 160mg/kg/dose by IV on days 5-8
DRUGfilgrastim
Filgrastim (G-CSF) 10 mg/kg/dose subcutaneously on days 1-8.
Sponsors
Mayo Clinic
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Patients Achieving 3 Million CD34 Cells/kg After 2 Days of Apheresis | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| CD34 Yield on Day 1 | Day 1 | Number of CD34 cells/kg collected on day 1. |
| CD34 Yield Day 2 | Day 2 | Number of CD34 cells/kg collected on day 2 |
| Median Number of Days of Apheresis | Duration of apheresis (up to 7 days) | — |
| Time to Reach 6 Million CD34 Cells | Duration of apheresis (up to 7 days) | 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. |
| Rate of Failure to Mobilize | Duration of apheresis (up to 7 days) | 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. |
Countries
United States
Participant flow
Recruitment details
Forty (40) participants were recruited at Mayo Clinic (Rochester, Florida and Arizona) between December 2009 and October 2011.
Pre-assignment details
One participant was deemed ineligible and is excluded from all analyses per study design.
Participants by arm
| Arm | Count |
|---|---|
| Plerixafor Plerixafor 160mg/kg/dose by IV on days 5-8
Filgrastim (G-CSF) 10 mg/kg/dose subcutaneously on days 1-8. | 39 |
| Total | 39 |
Baseline characteristics
| Characteristic | Plerixafor |
|---|---|
| Age, Continuous | 60 years |
| Region of Enrollment United States | 39 participants |
| Sex: Female, Male Female | 14 Participants |
| Sex: Female, Male Male | 25 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 25 / 39 |
| serious Total, serious adverse events | 0 / 39 |
Outcome results
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.
Time frame: After 2 days of apheresis
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Plerixafor | Number of Patients Achieving 3 Million CD34 Cells/kg After 2 Days of Apheresis | 38 participants |
Secondary
CD34 Yield Day 2
Number of CD34 cells/kg collected on day 2
Time frame: Day 2
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Plerixafor | CD34 Yield Day 2 | 3550000 cells/kg |
Secondary
CD34 Yield on Day 1
Number of CD34 cells/kg collected on day 1.
Time frame: Day 1
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Plerixafor | CD34 Yield on Day 1 | 3870000 cells/kg |
Secondary
Median Number of Days of Apheresis
Time frame: Duration of apheresis (up to 7 days)
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Plerixafor | Median Number of Days of Apheresis | 4 days |
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.
Time frame: Duration of apheresis (up to 7 days)
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Plerixafor | Rate of Failure to Mobilize | 3 percentage of participants |
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.
Time frame: Duration of apheresis (up to 7 days)
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Plerixafor | Time to Reach 6 Million CD34 Cells | 5 days |