This phase I trial tests the effect of allogeneic Orca-Q stem cell transplant in treating patients with high-risk multiple myeloma that has come back after a period of improvement (relapsed) or that has not responded to previous treatment (refractory). An allogeneic (donor) transplant uses blood forming stem cells (graft) from a matched donor. When the healthy blood forming (stem) cells from a donor are infused into a patient, they may help the patient's bone marrow make more healthy cells and platelets and may help destroy any remaining cancer cells. Sometimes the transplanted cells from a donor can attack the body's normal cells (called graft-versus-host disease \[GVHD\]). Orca-Q includes some T cells (a type a white blood cell) that are thought to help prevent some of the known complications as well as help attack the cancer cells. However, Orca-Q removes a specific type of T cell called naive T lymphocytes. Naive T cells may contribute to GVHD and are not thought to be required for the success of the treatment. Removing these cells may help reduce the frequency or severity of GVHD. Giving chemotherapy, such as thiotepa, busulfan, and fludarabine, before a donor stem cell transplant helps kill cancer cells in the body and prepare the body to receive the transplant graft. Giving allogeneic Orca-Q may be safe, tolerable, and/or effective in treating patients with relapsed or refractory (R/R) high-risk multiple myeloma.
Ability to understand and sign informed consent
Age ≥ 18 years and ≤ 65 years
Patients should be in very good partial response (VGPR) (5% or less plasma cells in the marrow) or better response status at the time of stem cell transplant with no evidence of central nervous system (CNS) disease. Patients in complete response (CR) should have minimal residual disease (MRD) positivity
Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 1; or Karnofsky performance status (KPS) of ≥ 70%
Prior allogeneic hematopoietic cell transplantation (HCT)
Planned pharmaceutical in vivo or ex vivo T cell depletion, e.g., post-transplant cyclophosphamide (Cy), peri-transplant anti-thymocyte globulin (ATG), or alemtuzumab
A positive crossmatch test of any titer; or
The presence of anti-donor HLA antibody to any HLA locus
Single group
Allogeneic Defined Hematopoietic Stem Cells/Immune Cells
Biological/VaccineGiven Orca-Q prime IV
Allogeneic Defined Hematopoietic Stem Cells/Immune Cells
Biological/VaccineGiven Orca-Q supplement IV
Busulfan
DrugGiven IV
Filgrastim
Biological/VaccineGiven SC
Fludarabine
DrugGiven IV
Granulocyte Colony-Stimulating Factor
DrugGiven SC
Thiotepa
DrugGiven IV
Incidence of primary graft failure without grade II-IV acute graft-versus-host disease (GVHD)
Frequency and proportions will be obtained.
Overall survival
The Kaplan-Meier (KM) method will be used to estimate the median and percentiles for time-to-event endpoints with 95% confidence intervals (CIs).
Progression-free survival
The KM method will be used to estimate the median and percentiles for time-to-event endpoints with 95% CIs.
Time to relapse
Non-relapse mortality
Will be analyzed using the cumulative incidence function to account for the competing risk of disease relapse/progression.
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University of California, Davis
Lead sponsor
National Cancer Institute (NCI)
Collaborator
Orca Biosystems, Inc.
Collaborator
This trial is not recruiting at the moment. You can still explore other options:
