Multiple Myeloma, Non-Hodgkin's Lymphoma
Conditions
Keywords
autologous transplantation, peripheral stem cell mobilization
Brief summary
This protocol will investigate the effectiveness of plerixafor in the up-front setting in avoiding a second round of mobilization and whether this translates into a clinical and economic benefit.
Detailed description
Peripheral blood stem cells are now considered the standard source of stem cells for autologous stem cell transplants. Unfortunately, there is still a 20-30% chance that inadequate numbers of stem cells will be collected, resulting in prolonged recovery of cell counts after transplantation and increased transfusion dependence. There is also a significant economic burden associated with remobilization and a risk that delays in collecting sufficient numbers of stem cells can result in an increased chance of disease recurrence prior to transplantation.
Interventions
DRUGPlerixafor
240 mcg/kg/day based on ideal body weight will be given for the following conditions: 1. Pre-apheresis peripheral blood CD34+ count \<20 cells/μL on day 5. 2. Estimated CD34+ cell collection is \< 25% of target cell dose after 1 day of apheresis. 3. Estimated CD34+ cell collection is \< 50% of target cell dose after 2 days of apheresis.
DRUGFilgrastim
All patients will receive filgrastim starting 4 days prior to apheresis (D1-4 mobilization). The dose and schedule of filgrastim will based upon the risk category of the patient: * Standard risk: 5 μg/kg SQ BID. * High risk: 10 μg/kg SQ BID.
Sponsors
University of Florida
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients with multiple myeloma or non-Hodgkin's lymphoma with a planned autologous transplant and who are eligible for peripheral stem cell mobilization. * Karnofsky Performance Status ≥ 70. * Age ≥ 18 * Less than 30% involvement of marrow with disease.
Exclusion criteria
* \> 30% marrow involvement with disease * Age \< 18. * Pregnant women.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Rate of successful collection with early introduction of plerixafor in patients predicted to be poor mobilizers | Day 2 of apheresis | The primary endpoint of the study will be the rate of successful collection with early introduction of plerixafor in patients predicted to be poor mobilizers based on peripheral blood CD34+ cell counts or CD34+ cell collection efficiency after 2 consecutive days of apheresis. Success will be defined as the ability to avoid a second mobilization attempt. Results will be compared to matched historical controls. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Economic impact | Day 2 of mobilization and Day +100 after transplantation | The economic impact of plerixafor use will be divided into two phases, mobilization and transplantation. The comparator arm for the mobilization phase would be matched historical controls. The comparator arm for the transplant phase will be patients who did not require plerixafor for mobilization during the study period. |
| Kinetics of CD34+ mobilization with early introduction of plerixafor | On Day 1 and Day 2 of apheresis | The kinetics of CD34+ cell counts during mobilization in this setting is unknown. We will attempt to determine mobilization kinetics by following peripheral blood CD34+ counts daily starting from first day of plerixafor administration until completion of apheresis. Kinetics will be analyzed according to the following parameters: * Peripheral CD34 cell counts on each day of apheresis. * Total CD34 cells collected on each day of apheresis * Multiple myeloma vs. NHL. |
| Graft composition | On Day 1 and Day 2 of apheresis | Graft composition will be analyzed on each day of successful apheresis. Cell populations to be quantitated include total CD3+ lymphocytes, CD4+ lymphocytes, CD8+ lymphocytes. |
Countries
United States
Outcome results
None listed