Multiple myeloma
Conditions
Interventions
This is a double-blind randomized clinical trial in which research participants will be divided into two groups (control and intervention). For double blinding, patients in the control group will be a
if CD34+ count <10, the patient will be included in one of the 2 groups according to the randomization list. The control group, made up of 35 patients, will remain on the dose of G-CSF 10µg/kg/day
In the intervention group, composed of 35 patients, the dose will be doubled to 20µg/kg/day. The preparation and administration of G-CSF in D4 will be the responsibility of 2 nurses, properly trained
D23.529.374.410.240.350
Sponsors
Universidade Federal de Juiz de Fora UFJF
Hospital Universitário da Universidade Federal de Juiz de Fora da Empresa Brasileira de Serviços Hospitalares (HU-UFJF/Ebserh)
Eligibility
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: Patients diagnosed with multiple myeloma; patients who will undergo autologous hematopoietic stem cell transplantation; CD34+ count < 10 cells on the fourth day of mobilization; be 18 years old or older; be male or famale; be carrying out mobilization only with G-CSF; be carrying out the first mobilization
Exclusion criteria
Exclusion criteria: Patients undergoing chemomobilization; patients undergoing mobilization with G-CSF and plerixafor
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| It is expected to increase the percentage of patients capable of achieving sufficient cellularity for leukoapheresis, which will be measured by blood test, from the fourth day, reaching 68% of participants | — |
Secondary
| Measure | Time frame |
|---|---|
| It is expected to increase the percentage of patients who can achieve a CD34+ count greater than or equal to 10 x 10³/mL, which will be verified by blood test, on the fifth day of mobilization with G-CSF after doubling the dose on the fourth day;It is expected that doubling G-CSF on the fourth day will increase the CD34+ count on the fifth day, which will be measured through blood test;It is expected that patients who reached a CD34+ count greater than or equal to 10 using the doubled dose will have a better leukoapheresis performance compared to those who maintained the usual dose, which can be verified during the leukoapheresis itself;It is expected that certain patients with pre-HSCT clinical and epidemiological factors will have their mobilization performance impaired, which will be verified by blood tests;It is expected that the serum levels of complements C3 and C5, which will be verified through blood tests, during mobilization will influence the performance of the procedure, which can be verified through leukoapheresis;It is expected to find differences in the response to the doubled dose, which can be measured through blood tests, according to the data collected for analysis, being able to verify a population group that will benefit more from this new dosage;It is expected to be able to map the side effects related to increasing the dose in patients, which can be verified through laboratory tests and participant reports;It is expected to reach a minimum count of 2 x 106 CD34+ cells/kg in the collected product | — |
Countries
Brazil
Contacts
Public ContactCamila Mariana Silva Vieira
Hospital Universitário da Universidade Federal de Juiz de Fora
Outcome results
None listed