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IRCT20230315057722N1 IRCT 2023-06-14 Shahid Beheshti University of Medical Sciences Effect of pentoxifylline in multiple myeloma (MM) patients undergoing autologous hematopoietic stem cell transplantation (ASCT) The efficacy of pentoxifylline in suppressing the regulatory T (Tregs) cells in multiple myeloma (MM) patients undergoing autologous hematopoietic stem cell transplantation (ASCT) compared to the control group and its impact on disease outcome 2023-05-15 anticipated 30 Complete https://irct.ir/trial/69164 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: 1. Random sequence generation: Patients were assigned in groups according to the random allocation rule. Based on the size of the research sample, we prepared 30 cards on which the PTXF and control groups were recorded and placed these cards in a lottery container. Then the cards are randomly removed from the container without replacement, and the created sequence is recorded. 2. Allocation concealment: The sequentially numbered, opaque, sealed envelope (SNOSE) method is used to perform randomization. Based on the sample size of the research, several envelopes were prepared with aluminum wrappers, and each of the random sequences created on a card was recorded and the cards were placed in the envelopes of the letter, respectively. To maintain a random sequence, the envelopes were numbered in the same way on the outer surface. Finally, the lids of the letter envelopes were glued and placed in a box, respectively. 3. Randomization execution: At the beginning of the registration of the participants, according to the order of entry of the eligible participants, one of the envelopes will be opened in order and the assigned group of that participant will be revealed. 2 Multiple myeloma (MM) patients undergoing autologous hematopoietic stem cell transplantation. 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 through day +98 post-transplant. Intervention 2: Control group: Multiple myeloma patients undergoing autologous transplantation who do not receive any intervention. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is There is no further information
public Davood Bashash
Shahid Beheshti University of Medical Sciences, School of Allied Medical Sciences, Darband St.
Tehran Iran (Islamic Republic of) 1971653313 +98 21 2271 8528-31 david_5980@yahoo.com Shahid Beheshti University of Medical Sciences scientific Samareh Younesian
Shahid Beheshti University of Medical Sciences, School of Allied Medical Sciences, Darband St.
Tehran Iran (Islamic Republic of) 1971653313 +98 21 2271 8528-31 samareyounesian@gmail.com Shahid Beheshti University of Medical Sciences Iran (Islamic Republic of) 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. 21 years 70 years Both 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. C90.0 Multiple myeloma Treatment - Drugs Other Intervention group: Pentoxifylline group: Patients who underwent autologous transplantation receive Pentoxifylline 800 mg/d, orally as 2 divided daily doses, respectively from day +15 through day +98 post-transplant Control group: Multiple myeloma patients undergoing autologous transplantation who do not receive any intervention 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. 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. - Approved 2023-03-05 Ethics committee of Shahid Beheshti University of Medical Sciences Shahid Beheshti University of Medical Sciences, School of Allied Medical Sciences, Darband St. Tehran Tehran Iran (Islamic Republic of)