A Phase 2 interventional study of Autologous peripheral blood stem cells (auto-PBSC) transplantation and Allogeneic peripheral blood stem cells (allo-PBSC) transplantation in Transplantation, Homologous, Transplantation, Autologous and Multiple Myeloma, sponsored by Stanford University. Completed at 1 site in United States. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2017-10-20.
Sponsored by Stanford University · Phase 2, Interventional, and Treatment
To evaluate the toxicity and tolerability of this tandem autologous/allogeneic transplant approach for patients with advanced stage multiple myeloma.
Development of cell-based immunotherapy from allogeneic hematopoietic cell transplantation (HCT) is dependent upon stable T-cell engraftment and the success of this therapeutic approach is likely to be greatest when directed against a minimal rather than gross tumor burden. To this end, tandem transplants with high dose therapy and autologous hematopoietic cell transplantation (AHCT) for tumor cytoreduction followed by non-myeloablative allotransplant have been conducted. In myeloma, this tandem approach results in greater efficacy compared to conventional AHCT.
3,712 studies on the registry are indexed under Multiple Myeloma; 752 are open to participants now.
This study's enrollment of 9 is below the median of 41 across 2,965 interventional studies indexed under Multiple Myeloma.
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PARTICIPANT INCLUSION CRITERIA
DONOR INCLUSION CRITERIA
PARTICIPANT EXCLUSION CRITERIA
DONOR EXCLUSION CRITERIA
Study treatment is a high-dose sequential chemotherapy approach to hematopoietic stem cell (HSC) transplant that uses an autologous peripheral blood stem cell (auto-PBSC) transplant followed by allogeneic peripheral blood stem cell (allo-PBSC) transplant to evaluate improved graft vs host disease (GvHD) control. Participant auto-PBSC are mobilized with cyclophosphamide (also to provide cytoreduction) and filgrastim, followed by melphalan as an auto-PBSC conditioning agent, then auto-PBSC infusion. For the allo-PBSC transplant, donors are mobilized with filgrastim, and participants receive a regimen of total lymphoid irradiation and anti-thymocyte globulin (TLI/ATG), followed by infusion of donor allo-PBSC. Solumedrol, diphenhydramine, acetaminophen, and hydrocortisone are administered as premedications, and rabbit anti-thymocyte globulin (ATG) plus mycophenolate mofetil (MMF) are administered for post-allo-PBSC immunosuppression.
Procedure: Autologous peripheral blood stem cells (auto-PBSC) transplantation · Procedure: Allogeneic peripheral blood stem cells (allo-PBSC) transplantation · Drug: Filgrastim · Drug: Cyclophosphamide · Drug: Melphalan · Drug: Cyclosporine · Radiation: Total lymphoid irradiation · Biological: Rabbit anti-thymocyte globulin · Drug: Mycophenolate Mofetil 250mg · Drug: Solumedrol · Drug: Diphenhydramine · Drug: Acetaminophen · Drug: Hydrocortisone
Auto-PBSC ≥ 2 to 3 x 10e6 CD34+ cells/kg are intravenously (IV) infused as part of the combination stem cell therapy. and allogeneic stem cells are administered intravenous (IV) infusion to reestablish hematopoietic function in patients whose bone marrow or immune system is damaged or defective
Also known as: auto-PBPC, Autologous peripheral blood progenitor cells (auto-PBPC) transplantation
Allo-PBSC (target collection ≥ 5 x 10e6 CD34+ cells/kg) are intravenously (IV) infused as part of the combination stem cell therapy.
Also known as: allo-PBSC, Allogeneic peripheral blood progenitor cells (allo-PBPC) transplantation
Filgrastim is administered subcutaneously (SC) at 10 µg/kg/day for auto-PBSC mobilization starting day 2 of mobilization until the last day of apheresis. Filgrastim is administered SC at 5 µg/kg/day from Day 6 after auto-PBSC infusion to hematologic recovery. Filgrastim is administered SC at 16 µg/kg/day for donor allo-PBSC mobilization at from Day - 4 to Day 0, prior to allo-PBSC collection.
Also known as: Neupogen, Granulocyte colony-stimulating factor (G-CSF), r-metHuG-CSF
Cyclophosphamide is administered intravenously (IV) at 4 g/m2 on Day 1 of the auto-PBSC mobilization regimen.
Also known as: Ciclofosfamida, Ciclofosfamide, Claphene, CP monohydrate (CPM), CSP
Melphalan is administered after CSP at 200 mg/m2 intravenously (IV) on Day -2 before auto-PBSC infusion.
Also known as: L-Sarcolysin, L-phenylalanine mustard (L-PAM), L-Sarcolysin phenylalanine mustard, L-sarcolysine
Cyclosporine is administered by mouth (PO) for allo-PBSC graft vs host disease (GvHD) prophylaxis at 5 mg/kg from Day -3 through Bay +56. Tacrolimus may substituted.
Also known as: Cyclosporin, Cyclosporin A, Ciclosporin, CSP
Total lymphoid irradiation is administered at 80 centigrey (cGy) on Day -11 to -7; and Day -4 to -2 before alllo-PBSC infusion. TLI is also administered at 80 centigrey (cGy) x 2 on Day -1 before alllo-PBSC infusion.
Also known as: TLI
ATG 1.5 mg/kg is administered intravenously (IV) on Day -11 to -7 before allo-PBSC infusion.
Also known as: Thymoglobulin, ATG
MMF is administered at 15 mg/kg 3x/day by mouth (PO) after allo-PBSC through Day 40, followed by 10% dose reduction weekly (dose taper) through day 96, and adjusted if there is evidence of MMF-related GI toxicity or excessive myelosuppression
Also known as: CellCept, MMF
Solumedrol 1 mg/kg is administered intravenously (IV) on Day -11 to -7 as a premedication for ATG and allo-PBSC infusion
Also known as: Solumedin, Soludecadron
Diphenhydramine 25 to 50 mg is administered as a premedication for the ATG; allo-PBSC; and DLI infusions.
Also known as: Benadryl
Acetaminophen 650 mg is administered as a premedication for the ATG and allo-PBSC infusions.
Also known as: Tylenol
Hydrocortisone 100 mg is administered intravenously (IV) is a premedication for the allo-PBSC and DLI infusions.
Incidence of Graft Versus Host Disease (GvHD)
To evaluate the incidence acute GvHD of this tandem autologous/allogeneic transplant setting
Time frame: 2 years after the last participant is enrolled.
Median Time to Engraftment After Auto-PBSC Transplant
Engraftment is assessed as: * Neutrophil engraftment is \> 0.5 x 10⁹/L after cytopenia * Platelet engraftment is \> 20 x 10⁹/L after cytopenia
Time frame: 1 month
Median Time to Engraftment After Allo-PBSC Transplant
Engraftment is assessed as: * Neutrophil engraftment is \> 0.5 x 10⁹/L after cytopenia * Platelet engraftment is \> 20 x 10⁹/L after cytopenia
Time frame: 1 month
Overall Response Rate (ORR)
Overall response rate (ORR) = Complete Response Rate (CRR) + Partial Response Rate (PRR)
Time frame: 1 year
Complete Response Rate (CRR)
Complete response rate (CRR) was assessed as all of: * Negative immunoflixation on the serum and urine * Disappearance of any soft tissue plasmacytomas * \< 5% plasma cells in bone marrow
Time frame: 1 year
Partial Response Rate (PRR)
Partial response rate (PRR) was assessed as * \> 50% reduction in serum M-protein plus urine M-protein reduction by 90% or \< 200 mg/24 hr * If serum M-protein is not measurable, then \> 50% reduction in the involved serum free light chain * If involved serum free light chain is not measurable, then \> 50% reduction in the bone marrow plasma cell percentage + \> 50% reduction in the size of any soft tissue plasmacytoma.
Time frame: 1 year
Event-free Survival (EFS)
To evaluate the graft versus myeloma effect by monitoring rate of event-free survival (EFS)
Time frame: 2 years after the last participant is enrolled
Overall Survival (OS)
To evaluate the graft versus myeloma effect by monitoring rate of overall survival (OS)
Time frame: 2 years after the last participant is enrolled
| Milestone | Autologous-Allogeneic Hematopoietic Stem Cell Transplant |
|---|---|
| Started | 9 |
| Completed | 7 |
| Not completed | 2 |
| Withdrew: Lack of suitable allogeneic donor | 2 |
To evaluate the incidence acute GvHD of this tandem autologous/allogeneic transplant setting
| Participants | Autologous-Allogeneic Hematopoietic Stem Cell Transplant |
|---|---|
| Incidence of Graft Versus Host Disease (GvHD) | 1 |
Engraftment is assessed as: * Neutrophil engraftment is \> 0.5 x 10⁹/L after cytopenia * Platelet engraftment is \> 20 x 10⁹/L after cytopenia
| Days | Autologous-Allogeneic Hematopoietic Stem Cell Transplant |
|---|---|
| Neutrophil Engraftment | 11 (10 to 12) |
| Platelet Engraftment | 15 (10 to 20) |
Engraftment is assessed as: * Neutrophil engraftment is \> 0.5 x 10⁹/L after cytopenia * Platelet engraftment is \> 20 x 10⁹/L after cytopenia
| Days | Autologous-Allogeneic Hematopoietic Stem Cell Transplant |
|---|---|
| Neutrophil Engraftment | 24 (24 to 24) |
| Platelet Engraftment | 10 (10 to 10) |
Overall response rate (ORR) = Complete Response Rate (CRR) + Partial Response Rate (PRR)
| Participants | Autologous-Allogeneic Peripheral Blood Stem Cell Transplant |
|---|---|
| Overall Response Rate (ORR) | 7 |
Complete response rate (CRR) was assessed as all of: * Negative immunoflixation on the serum and urine * Disappearance of any soft tissue plasmacytomas * \< 5% plasma cells in bone marrow
| Participants | Autologous-Allogeneic Hematopoietic Stem Cell Transplant |
|---|---|
| Complete Response Rate (CRR) | 3 |
Partial response rate (PRR) was assessed as * \> 50% reduction in serum M-protein plus urine M-protein reduction by 90% or \< 200 mg/24 hr * If serum M-protein is not measurable, then \> 50% reduction in the involved serum free light chain * If involved serum free light chain is not measurable, then \> 50% reduction in the bone marrow plasma cell percentage + \> 50% reduction in the size of any soft tissue plasmacytoma.
| Participants | Autologous-Allogeneic Peripheral Blood Stem Cell Transplant |
|---|---|
| Partial Response Rate (PRR) | 4 |
To evaluate the graft versus myeloma effect by monitoring rate of event-free survival (EFS)
| percentage of participants | Autologous-Allogeneic Hematopoietic Stem Cell Transplant |
|---|---|
| Event-free Survival (EFS) | 44 (14 to 71) |
To evaluate the graft versus myeloma effect by monitoring rate of overall survival (OS)
| percentage of participants | Autologous-Allogeneic Hematopoietic Stem Cell Transplant |
|---|---|
| Overall Survival (OS) | 67 (28 to 87) |
Collected over 2 years. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Autologous-Allogeneic Hematopoietic Stem Cell Transplant | — | 2/9 (22.2%) | 0/9 (0%) |
| Event | Autologous-Allogeneic Hematopoietic Stem Cell Transplant |
|---|---|
| Pulmonary EmbolismVascular disorders | 1/9 |
| Deep Vein ThrombosisVascular disorders | 1/9 |
| Age, Categorical(Participants) | Autologous-Allogeneic Hematopoietic Stem Cell Transplant |
|---|---|
| <=18 years | 0 |
| Between 18 and 65 years | 9 |
| >=65 years | 0 |
| Age, Continuous(years) | Autologous-Allogeneic Hematopoietic Stem Cell Transplant |
|---|---|
| Median | 54 (33 to 59) |
| Sex: Female, Male(Participants) | Autologous-Allogeneic Hematopoietic Stem Cell Transplant |
|---|---|
| Female | 2 |
| Male | 7 |
| Ethnicity (NIH/OMB)(Participants) | Autologous-Allogeneic Hematopoietic Stem Cell Transplant |
|---|---|
| Hispanic or Latino | 1 |
| Not Hispanic or Latino | 8 |
| Unknown or Not Reported | 0 |
| Race (NIH/OMB)(Participants) | Autologous-Allogeneic Hematopoietic Stem Cell Transplant |
|---|---|
| American Indian or Alaska Native | 0 |
| Asian | 0 |
| Native Hawaiian or Other Pacific Islander | 0 |
| Black or African American | 0 |
| White | 9 |
| More than one race | 0 |
| Unknown or Not Reported | 0 |
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Studies of the drug tested here: Thymoglobulin