Lymphoma, Multiple Myeloma
Conditions
Keywords
Myeloma, Multiple Myeloma or Lymphoma Patients undergoing, mobilization for the purpose of autologous stem cell collection
Brief summary
Poor mobilization of hematopoietic progenitors needed to support autologous transplantation is a serious clinical problem. We are investigating the role of plerixafor administered in an at risk population to augment successful stem cell collection. OBJECTIVES To determine if plerixafor when administered on the day prior to planned autologous collection on first mobilization attempt in those with a peripheral blood CD34 ≤ 10X106/L will: * increase the number of patients successfully collected in one day * increase the number of patients successfully mobilized on first collection attempt * is cost neutral within a Canadian setting
Interventions
DRUGPlerixafor
Plerixafor will be administered at 23:00 of Day -1 to experimental subjects at a dose of 240 mcg/kg subcutaneously, and possibly repeated the following day
OTHERObservation: Nonintervention
Nonintervention group, no drug will be given, observation only
Sponsors
CancerCare Manitoba
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Participants must be 18 years of age or older 2. Patients must be able to provide written consent 3. Participants must have a diagnosis of lymphoma or multiple myeloma and be undergoing autologous stem cell mobilization for the purposes of ASCT 4. Females of child bearing age will be asked to use an approved form of contraception
Exclusion criteria
1. Patients who are pregnant or breastfeeding 2. Patients whose creatinine ≥ 250 μM 3. Serum AST, ALT or total bilirubin \>5X upper limit of normal 4. Acute infection
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To increase the proportion of Poor Mobilizers who after receiving plerixafor are successfully collected in one day. The anticipated proportion increase is from 30%-60%. | within 1-2 days after commencing therapy |
Secondary
| Measure | Time frame |
|---|---|
| To increase the proportion of Poor Mobilizers who after receiving plerixafor are successfully collected on first mobilization attempt rather than requiring a second mobilization. | After therapy |
| To describe the kinetics of platelet and neutrophil recovery post ASCT in those treated and not treated with plerixafor | After therapy |
| To examine the immune recovery at day 100 post ASCT in those treated and not treated with plerixafor | After therapy |
| To undertake a pharmacoeconomic evaluation to examine the impact of plerixafor on resource utilization in a population at risk for poor mobilization | After therapy |
Countries
Canada
Outcome results
None listed