Effect of pentoxifylline in multiple myeloma (MM) patients undergoing autologous hematopoietic stem cell transplantation (ASCT)

Phase 2

Recruiting

• Conditions: Multiple myeloma (MM) patients undergoing autologous hematopoietic stem cell transplantation.; Multiple myeloma; C90.0

• Registration Number: IRCT20230315057722N1
• Lead Sponsor: Shahid Beheshti University of Medical Sciences

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 26 June 2023

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 30

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

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.

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
umber 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.