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
The efficacy of pentoxifylline in suppressing the regulatory T (Tregs) cells in multiple myeloma patients undergoing autologous hematopoietic stem cell transplantation (ASCT) and its impact on disease outcome
Design
This study is a Phase II clinical trial with the control group that will be randomized by the sequentially numbered, opaque, sealed envelope (SNOSE) method. The participants have been randomly divided into two groups of 15 people, pentoxifylline and control.
Settings and conduct
Eligible patients will be selected from those referred to the BMT department of Taleghani Hospital for ASCT.
Participants/Inclusion and exclusion criteria
Inclusion Criteria:
Patients with symptomatic MM
Patients must be in complete response after primary therapy.
MM patient must be a candidate for ASCT
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.
Intervention groups
Group 1: 15 patients with multiple myeloma undergoing ASCT who receive only routine treatment.
Group 2: 15 patients with multiple myeloma undergoing ASCT who receive routine treatment and pentoxifylline.
Main outcome variables
T regulatory cells (Tregs) and T CD8+
IL-10, TGF-B and IFN-G
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20230315057722N1
Registration date:2023-06-14, 1402/03/24
Registration timing:registered_while_recruiting
Last update:2023-06-14, 1402/03/24
Update count:0
Registration date
2023-06-14, 1402/03/24
Registrant information
Name
Samareh Younesian
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 11 5432 1402
Email address
samaryounesian@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-05-15, 1402/02/25
Expected recruitment end date
2024-11-16, 1403/08/26
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
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
Public title
Effect of pentoxifylline in multiple myeloma (MM) patients undergoing autologous hematopoietic stem cell transplantation (ASCT)
Purpose
Treatment
Inclusion/Exclusion 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:
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.
Age
From 21 years old to 70 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
30
More than 1 sample in each individual
Number of samples in each individual:
2
Peripheral blood samples will be taken from the participants (PTXF and control groups) on day +14 and day +99.
Randomization (investigator's opinion)
Randomized
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.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Shahid Beheshti University of Medical Sciences
Street address
Shahid Beheshti University of Medical Sciences, School of Allied Medical Sciences, Darband St.
Number of T regulatory cells (CD4, CD25, FOXP3) in peripheral blood mononuclear cells (PBMC) by using flow cytometry technique
Secondary outcomes
1
Description
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)
2
Description
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
Intervention groups
1
Description
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
Category
Treatment - Drugs
2
Description
Control group: Multiple myeloma patients undergoing autologous transplantation who do not receive any intervention