Multiple Myeloma Clinical Trial
Official title:
Adoptive Immunotherapy in Patients With Relapsed Hematological Malignancy: Effect of Duration and Intensity of Early GVHD Prophylaxis on Long-Term Clinical Outcomes
Verified date | January 2023 |
Source | Virginia Commonwealth University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Determine the relapse-free, donor lymphocyte infusion (DLI)-free survival in patients receiving the investigational regimen.This is a randomized phase II clinical trial, comparing two different dosing schedules of mycophenolate mofetil for graft versus host disease (GVHD) prevention following allogeneic stem cell transplantation. Risk for relapse, GVHD and non-relapse mortality will be assessed. Adaptive randomization between two study arms will be performed based on T cell counts at day 60.
Status | Completed |
Enrollment | 31 |
Est. completion date | March 18, 2022 |
Est. primary completion date | March 18, 2022 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 74 Years |
Eligibility | Inclusion Criteria - Any of the following high risk or recurrent hematological malignancies: - Hodgkin lymphoma (HL) - Non-Hodgkin lymphoma (NHL) - Chronic lymphocytic leukemia (CLL) - Multiple myeloma (MM) - Acute myelogenous leukemia (AML) - Acute lymphocytic leukemia (ALL) - Chronic myelogenous leukemia (CML) - Myelodysplastic syndrome (MDS) *Note: Determination that the malignancy is high risk will be made by the investigator. - Investigator determination that the patient is an appropriate candidate for reduced intensity allogeneic SCT with the standard Massey Cancer Center-Virginia Commonwealth Health System Bone Marrow Transplant Massey Cancer Center Virginia Commonwealth University Health System Bone Marrow Transplant (MCC-VCUHS BMT) Program regimen employed in this trial - Patients with or without previous myeloablative autologous transplant - HLA-matched stem cell donor, either related (6/6 or 5/6 loci matched) or unrelated (8/8 or 7/8 loci matched) *Note: Unrelated donors must be matched at HLA-A, -B, -C, and -DRB1 loci. However, a single locus mismatch will be acceptable in the event a more closely matched donor is not available. - Age = 40 to < 75 years; patients 18 to 39 years of age will be eligible only if the investigator has determined that the patient has comorbidity(ies) precluding conventional allogeneic transplantation with full intensity myeloablative conditioning - Karnofsky Performance Status of 70-100% - Negative serology for HIV - Women who are not postmenopausal or have not undergone hysterectomy must have a documented negative serum pregnancy test per standard MCC-VCUHS BMT Program guidelines - Ability to understand and the willingness to sign a written informed consent document *Note: The consent form must be signed and dated prior to initiation of SCT preparative treatments. Exclusion Criteria - Previous therapeutic radiation therapy (RT) that exceeds critical structure tolerance doses as determined by a radiation oncologist - Uncontrolled viral, fungal, or bacterial infection - Active meningeal or central nervous system disease - Previous therapy with rabbit anti-thymocyte globulin (ATG); previous treatment with equine ATG is allowed if more than 3 months ago *Note: Previous myeloablative autologous transplant is permitted but not required. - Pregnancy or breastfeeding - Medical, psychological, or social condition that, in the opinion of the investigator, may increase the patient's risk or limit the patient's adherence with study requirements |
Country | Name | City | State |
---|---|---|---|
United States | Virginia Commonwealth University/Massey Cancer Center | Richmond | Virginia |
Lead Sponsor | Collaborator |
---|---|
Virginia Commonwealth University | Massey Cancer Center |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | The Number of Patients With Relapse-free/Donor Lymphocyte Infusion(DLI)-Free Survival Rates Between Patients Randomized to MMF-30 (Control Cohort) and MMF-15 (Investigational Cohort). | The primary outcome in this study is event-free survival, where the conditional events are the occurrence of relapse DLI. | Up to 2 years following stem cell transplant | |
Secondary | The Difference Between Patients Randomized to MMF-30 (Control Cohort) and MMF-15 (Investigational Cohort) Day 60 Donor-derived (dd) Cluster of Differentiation (CD)3 10E3per microL Counts. | Day 60 donor-derived (dd) cluster of differentiation (CD)3 counts measured by 10E3per microL. | 60 Days Following Stem Cell Transplant | |
Secondary | The Probability of Overall Survival (OS) Between Patients Randomized to MMF-30 (Control Cohort) and MMF-15 (Investigational Cohort) | Overall survival (days to event or survival: time-to-event; survival: categorical) | Randomization up to 2 years | |
Secondary | Differences Between Patients Randomized to MMF-30 (Control Cohort) and MMF-15 (Investigational Cohort) With Acute Graft Vs Host Disease (GVHD) | The number of patients diagnosed with acute acute GVHD between patients randomized to MMF-30 (control cohort) and MMF-15 (investigational cohort) | 60 Days following stem cell transplant | |
Secondary | Differences Between Patients Randomized to MMF-30 (Control Cohort) and MMF-15 (Investigational Cohort) Diagnosed With Chronic Graft vs Host Disease (GVHD) | The differences in the rates of chronic GVHD between patients randomized to MMF-30 (control cohort) and MMF-15 (investigational cohort) | 60 Days following stem cell transplant | |
Secondary | Differences Between Patients Randomized to MMF-30 (Control Cohort) and MMF-15 (Investigational Cohort) Diagnosed With Opportunistic Infections | The number of patients diagnosed with an opportunistic infections. | 60 Days following stem cell transplant | |
Secondary | Determine the Differences Between Patients Randomized to MMF-30 (Control Cohort) and MMF-15 (Investigational Cohort) With Diagnosis of Engraftment Loss. | Number of patients with engraftment loss. | 60 Days Following Stem Cell Transplant | |
Secondary | Differences Between Patients Randomized to MMF-30 (Control Cohort) and MMF-15 (Investigational Cohort)Diagnosed With Differences in the Rates of Engraftment Syndrome. | Number of patients diagnosed with engraftment syndrome. | 60 Days Following Stem Cell Transplant | |
Secondary | Differences in the Rates of Achieving Donor Chimerisms (the Percentage of DNA in the Sample Which Comes From the Donor) Between Patients Randomized to MMF-30 (Control Cohort) and MMF-15 (Investigational Cohort). | Number of patients that achieved donor chimerisms by day 100. | 100 Days following Stem Cell Transplant | |
Secondary | Differences in the Rates of T-cell Recovery Kinetics Following Stem Cell Transplantation (SCT) Between Patients Randomized to MMF-30 (Control Cohort) and MMF-15 (Investigational Cohort). | Number of T Cells 10E3 per microL per arm indicating rates of T-cell recovery by Day 100 following SCT. | 100 Days Following Stem Cell Transplantation |
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