Multiple Myeloma Clinical Trial
Official title:
A Phase II Trial of Nonmyeloablative Haploidentical Peripheral Blood Stem Cell Transplantation Followed By Maintenance Therapy With the Novel Oral Proteasome Inhibitor, MLN9708, in Patients With High-risk Hematologic Malignancies
Verified date | September 2021 |
Source | Northside Hospital, Inc. |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
In an attempt to reduce relapse risk and improve outcomes following haploidentical transplantation for patients with high risk hematologic malignancies, the investigators will implement several strategies to augment the well documented effect of NK cell alloreactivity seen in HLA-mismatched transplantation. These strategies include (1) choosing potential haploidentical donors for optimal NK-alloreactivity, (2) utilizing proteasome inhibition post-transplant with MLN9708 to both sensitize tumor cells to NK cytotoxicity and protect against graft-versus-host disease (GVHD), and (3) eliminating mycophenolate mofetil from the post-transplant immunosuppression regimen to improve NK cell reconstitution following haploidentical peripheral blood stem cell transplantation.
Status | Completed |
Enrollment | 29 |
Est. completion date | July 28, 2020 |
Est. primary completion date | July 28, 2020 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Availability of a 3/6 - 5/6 matched (HLA-A, B, DR) related donor - Donor must have negative HLA cross-match in the host vs. graft direction. - Donor must be willing to donate mobilized peripheral blood stem cells - Age = 18 years - Karnofsky status = 70% - One of the following high-risk malignancies: - Chronic Myelogenous Leukemia (chronic phase, resistant and/or intolerant to tyrosine kinase inhibitors (OR) accelerated phase (OR) blast crisis in 2nd chronic phase following induction chemotherapy) - Acute Myelogenous Leukemia (2nd or subsequent complete remission [CR] (OR) Primary induction chemotherapy failure, but subsequently entered into a CR(OR) 1st CR with poor risk cytogenetics or molecular markers; or arising from preceding hematological disease) - Myelodysplastic Syndrome (treatment-related, monosomy 7 or complex cytogenetics, IPSS score of 1.5 or greater, Chronic myelomonocytic leukemia [CMML]) - Acute lymphocytic leukemia/lymphoblastic lymphoma (2nd or subsequent CR (OR) Primary induction chemotherapy failure, but subsequently entered into a CR (OR) 1st CR with poor risk cytogenetics) - Chronic Lymphocytic Leukemia / Prolymphocytic Leukemia (Duration of remission <12 months after receiving chemotherapy with a nucleoside analog (OR) High risk features (i.e. 17p deletion), (OR) Second or subsequent relapse) - Hodgkin's or Non-Hodgkin's Lymphoma (including low-grade, mantle cell, and intermediate-grade/diffuse) (Previously treated disease that has either relapsed or failed to respond adequately to conventional-dose therapy or autologous transplantation (AND) Chemoresponsive to most recent salvage therapy - Multiple Myeloma (Presence of a poor risk cytogenetic abnormality [i.e. 17p, t(4;14)], Relapse post autologous transplant) Exclusion Criteria: - Poor cardiac function: left ventricular ejection fraction <40% - Poor pulmonary function: FEV1, FVC, or DLCO <50% predicted - Poor liver function: bilirubin >2.5 mg/dl (not due to hemolysis, Gilbert's or primary malignancy), AST/ALT > 3X ULN - Poor renal function: Creatinine >2.0 mg/dl or creatinine clearance (calculated creatinine clearance is permitted) < 40 mL/min - Ongoing or active systemic infection, active hepatitis B or C virus infection, or known human immunodeficiency virus (HIV) positive. - Women of childbearing potential who currently are pregnant or who are not practicing adequate contraception - Patients who have any debilitating medical or psychiatric illness which would preclude their giving informed consent or their receiving optimal treatment and follow-up. - Systemic treatment, within 14 days before the first dose of MLN9708, with strong strong inhibitors of CYP3A (clarithromycin, telithromycin, itraconazole, voriconazole, ketoconazole, nefazodone, posaconazole) or strong CYP3A inducers (rifampin, rifapentine, rifabutin, carbamazepine, phenytoin, phenobarbital), or use of Ginkgo biloba or St. John's wort. - Patient has >/= Grade 3 peripheral neuropathy, or Grade 2 with pain on clinical examination during the screening period. - Participation in other clinical trials, including those with other investigational agents not included in this trial, within 21days of the start of this trial and throughout the duration of this trial. - Infection requiring systemic antibiotic therapy or other serious infection within 14 days before study enrollment. - Evidence of current uncontrolled cardiovascular conditions, including uncontrolled hypertension, uncontrolled cardiac arrhythmias, symptomatic congestive heart failure, unstable angina, or myocardial infarction within the past 6 months. - Known allergy to any of the study medications, their analogues, or excipients in the various formulations of any agent. - Known GI disease or GI procedure that could interfere with the oral absorption or tolerance of MLN9708 including difficulty swallowing |
Country | Name | City | State |
---|---|---|---|
United States | Northside Hospital | Atlanta | Georgia |
Lead Sponsor | Collaborator |
---|---|
Northside Hospital, Inc. | Millennium Pharmaceuticals, Inc. |
United States,
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* Note: There are 39 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Number of Participants Experiencing Relapse or Progression | To estimate the incidence of relapse/progression at one-year post-transplant. | 1 year | |
Secondary | Neutrophil Engraftment | To obtain time to neutrophil engraftment post-transplant | 1 year | |
Secondary | Time to Platelet Recovery Post Transplant | To measure the time to platelet recovery post-transplant | 1 year | |
Secondary | Day 30 CD3 Donor Chimerism | To measure CD3 donor chimerism post-transplant | 30 days | |
Secondary | Day 30 CD33 Donor Chimerism | To measure CD33 donor chimerism at Day 30 | 30 days | |
Secondary | Graft Versus Host Disease | To measure days to onset of acute graft versus host disease | 100 days |
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