Lymphoma, Myeloma
Conditions
Brief summary
Generic plerixafor use at reduced-dose for mobilization on HSCT transplant
Detailed description
The objective of this study is to demonstrate that the use of a low dose of the generic form of a drug called plerixafor is effective in increasing the amount of hematopoietic cells (stem cells) in your blood, which will then be collected for your transplant. Plerixafor is a very effective medicine that is already used for this purpose, however its high cost limits its use in all patients.
Interventions
DRUGCelrixafor
Use a reduced-dose of generic plerixafor
Sponsors
Hospital Universitario Dr. Jose E. Gonzalez
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
SINGLE (Subject)
Masking description
The patient receive a subcutaenous application (placbe vs generic plerixafor)
Intervention model description
Parallel study comparing placebo vs generic plerixafor
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients with lymphoma or multiple myeloma who are candidates for autoHSCT * Patients \> 18 years old who signed our informed consent * Normal CBC count (Hb \> 10, WBC 4.0-11.00, plt \> 100,000)
Exclusion criteria
* Patients with HIV, Hepatitis C, Hepatitis B diagnosis * Pregnant women
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Post-RD plerixafor increase in CD34+/μL pre-count, final CD34+ cell yield and harvest | 1 year | The objective of this study is to demonstrate that the use of a low dose of the generic form of plerixafor is effective in increasing the amount of hematopoietic cells (stem cells). |
Countries
Mexico
Outcome results
None listed