Multiple myeloma (MM) patients undergoing autologous hematopoietic stem cell transplantation. Multiple myeloma
Conditions
Interventions
Intervention 1: Intervention group: Pentoxifylline group: Patients who underwent autologous transplantation receive Pentoxifylline 800 mg/d, orally as 2 divided daily doses, respectively from day +15
Sponsors
Shahid Beheshti University of Medical Sciences
Eligibility
Sex/Gender
All
Age
21 Years to 70 Years
Inclusion criteria
Inclusion criteria: Patients with symptomatic MM Patients must be in complete response (CR) after primary therapy. MM patient must be a candidate for autologous hematopoietic stem cell transplantation (ASCT) as determined by treating physician. Age greater than or equal to 21 and less than or equal to 70 years old. HIV Negative and no active Hepatitis B or C.
Exclusion criteria
Exclusion criteria: Patients with CNS Myeloma at time of enrollment. Patients with cardiac, pulmonary, hepatic diseases. Active autoimmune disease including but not limited to: Rheumatoid arthritis, Inflammatory bowel disease, Celiac disease, Systemic lupus erythematosis, Scleroderma or Multiple sclerosis. Use of systemic immunosuppressive medications, including tacrolimus, mycophenolate mofetil, sirolimus or cyclosporine A. Psychiatric illness which may make compliance to the clinical protocol unmanageable or which may compromise the ability of the patient to give informed consent.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Regulatory T cell. Timepoint: Days +14 and +99 post-autologous transplantation. Method of measurement: Number of T regulatory cells (CD4, CD25, FOXP3) in peripheral blood mononuclear cells (PBMC) by using flow cytometry technique. | — |
Secondary
| Measure | Time frame |
|---|---|
| Number and phenotype of CD8+ T cells. Timepoint: Day 99+ post-autologous transplantation. Method of measurement: Number and phenotype of CD8 + T cells in peripheral blood mononuclear cells using flow cytometry technique (CD8, CD28, PD1).;IL-10, TGF-B, IFN-G. Timepoint: Day 99+ post-autologous transplantation. Method of measurement: Determining the serum levels of cytokines at day +99 post-autologous transplantation by using ELISA. | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactDavood Bashash
Shahid Beheshti University of Medical Sciences
Outcome results
None listed