Stem Cell Transplant + Bortezomib for Blood Cancer
Trial Summary
What is the purpose of this trial?
Now haplo stem cell transplant using bone marrow or peripheral blood is becoming more feasible with better regimens to prevent graft versus host disease (GVHD) like post transplant cyclophosphamide , tacrolimus, mycophenolate . Recently Bortezomib has also been shown to inhibit dendritic cells maturation and function and possesses a number of other favorable immunomodulatory effect that can prevent GVHD and help enhance immune reconstitution. this study is to assess the engraftment rate in patients with hematologic malignancies who need allogeneic stem cell transplant but do not have a suitable matched related or unrelated stem cell donor and will get T-cell replete HLA-Haploidentical allogeneic peripheral stem cell transplantation using post transplant Cyclophosphamide and bortezomib
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.
What data supports the effectiveness of the drug Bortezomib (Velcade) for blood cancer?
Bortezomib (Velcade) has shown effectiveness in treating multiple myeloma and mantle cell lymphoma, improving progression-free survival in patients unsuitable for stem-cell transplantation. It has also demonstrated positive responses in clinical trials for relapsed and refractory multiple myeloma, indicating its potential benefit in blood cancers.12345
Is the combination of stem cell transplant and bortezomib safe for treating blood cancer?
Bortezomib (also known as Velcade) has been studied for safety in treating multiple myeloma and mantle cell lymphoma, often in combination with other drugs. Common side effects include blood-related issues like low platelet counts (thrombocytopenia) and low white blood cell counts (neutropenia), as well as nerve damage (neuropathy). Regular monitoring for these side effects is important.34567
How is the drug Bortezomib unique in treating blood cancer?
Bortezomib is unique because it is a proteasome inhibitor that disrupts the breakdown of proteins in cancer cells, enhancing their sensitivity to other treatments and potentially overcoming drug resistance. It is administered intravenously in a specific schedule, which differs from many other treatments for blood cancer.12345
Eligibility Criteria
This trial is for adults aged 18-65 with blood cancers who lack a fully matched donor but have a related half-matched (haploidentical) donor. They should be fit for stem cell transplant, have good organ function, and provide consent. Those with uncontrolled infections, suitable donors, HIV/hepatitis B/C, liver cirrhosis, brain involvement by cancer or pregnant women can't join.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Conditioning Regimen
Participants undergo a conditioning regimen with Fludarabine, Melphalan, and Total Body Irradiation
Transplantation
Participants receive HLA-Haploidentical Peripheral Blood Stem Cell Transplantation with post-transplant Cyclophosphamide and Bortezomib
Follow-up
Participants are monitored for engraftment rate and safety post-transplant
Treatment Details
Interventions
- Bortezomib
Bortezomib is already approved in European Union, United States, Canada, Japan for the following indications:
- Multiple myeloma
- Mantle cell lymphoma
- Multiple myeloma
- Mantle cell lymphoma
- Multiple myeloma
- Mantle cell lymphoma
- Multiple myeloma
- Mantle cell lymphoma
Find a Clinic Near You
Who Is Running the Clinical Trial?
Henry Ford Health System
Lead Sponsor