Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| SU-04142009-2259 | Other Identifier | Stanford University | |
| BMT201 | Other Identifier | OnCore Number |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Autologous-Allogeneic Peripheral Blood Stem Cell Transplant | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Autologous peripheral blood stem cells (auto-PBSC) transplantation | Procedure | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of Graft Versus Host Disease (GvHD) | To evaluate the incidence acute GvHD of this tandem autologous/allogeneic transplant setting | 2 years after the last participant is enrolled. |
| Measure | Description | Time Frame |
|---|---|---|
| Median Time to Engraftment After Auto-PBSC Transplant | Engraftment is assessed as:
| 1 month |
| Median Time to Engraftment After Allo-PBSC Transplant |
Not provided
PARTICIPANT INCLUSION CRITERIA
DONOR INCLUSION CRITERIA
PARTICIPANT EXCLUSION CRITERIA
DONOR EXCLUSION CRITERIA
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Wen-Kai Weng | Stanford University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Stanford University School of Medicine | Stanford | California | 94305 | United States |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Autologous-Allogeneic Hematopoietic Stem Cell Transplant | 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. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
|
| Allogeneic peripheral blood stem cells (allo-PBSC) transplantation | Procedure | Allo-PBSC (target collection ≥ 5 x 10e6 CD34+ cells/kg) are intravenously (IV) infused as part of the combination stem cell therapy. |
|
|
| Filgrastim | Drug | 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. |
|
|
| Cyclophosphamide | Drug | Cyclophosphamide is administered intravenously (IV) at 4 g/m2 on Day 1 of the auto-PBSC mobilization regimen. |
|
|
| Melphalan | Drug | Melphalan is administered after CSP at 200 mg/m2 intravenously (IV) on Day -2 before auto-PBSC infusion. |
|
|
| Cyclosporine | Drug | 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. |
|
|
| Total lymphoid irradiation | Radiation | 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. |
|
|
| Rabbit anti-thymocyte globulin | Biological | ATG 1.5 mg/kg is administered intravenously (IV) on Day -11 to -7 before allo-PBSC infusion. |
|
|
| Mycophenolate Mofetil 250mg | Drug | 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 |
|
|
| Solumedrol | Drug | Solumedrol 1 mg/kg is administered intravenously (IV) on Day -11 to -7 as a premedication for ATG and allo-PBSC infusion |
|
|
| Diphenhydramine | Drug | Diphenhydramine 25 to 50 mg is administered as a premedication for the ATG; allo-PBSC; and DLI infusions. |
|
|
| Acetaminophen | Drug | Acetaminophen 650 mg is administered as a premedication for the ATG and allo-PBSC infusions. |
|
|
| Hydrocortisone | Drug | Hydrocortisone 100 mg is administered intravenously (IV) is a premedication for the allo-PBSC and DLI infusions. |
|
Engraftment is assessed as:
|
| 1 month |
| Overall Response Rate (ORR) | Overall response rate (ORR) = Complete Response Rate (CRR) + Partial Response Rate (PRR) | 1 year |
| Complete Response Rate (CRR) | Complete response rate (CRR) was assessed as all of:
| 1 year |
| Partial Response Rate (PRR) | Partial response rate (PRR) was assessed as
| 1 year |
| Event-free Survival (EFS) | To evaluate the graft versus myeloma effect by monitoring rate of event-free survival (EFS) | 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) | 2 years after the last participant is enrolled |
| COMPLETED |
|
| NOT COMPLETED |
|
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Autologous-Allogeneic Hematopoietic Stem Cell Transplant | A high-dose sequential chemotherapy approach with cyclophosphamide and etoposide followed by granulocyte colony stimulating factor (G-CSF) for collection of peripheral blood progenitor cells as well as for cytoreduction. Total Lymphoid irradiation and anti-thymocyte globulin (TLI/ATG).The preparatory regimens use BCNU and melphalan. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
| ||||||||||||||||||||
| Age, Continuous | Median | Full Range | years |
| |||||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Incidence of Graft Versus Host Disease (GvHD) | To evaluate the incidence acute GvHD of this tandem autologous/allogeneic transplant setting | Due to the significance of the allo-PBSC transplant as a component to the treatment plan, participants who did not receive allo-PBSC are not included. | Posted | Count of Participants | Participants | 2 years after the last participant is enrolled. |
|
|
| ||||||||||||||||||||||||||
| Secondary | Median Time to Engraftment After Auto-PBSC Transplant | Engraftment is assessed as:
| Includes all study participants | Posted | Median | Full Range | Days | 1 month |
|
| ||||||||||||||||||||||||||
| Secondary | Median Time to Engraftment After Allo-PBSC Transplant | Engraftment is assessed as:
| Due to the less intensive conditioning before allo-PBSC, only 2 participants experienced cytopenia, and thus only 2 participants could be evaluated for engraftment after allo-PBSC. | Posted | Median | Full Range | Days | 1 month |
|
| ||||||||||||||||||||||||||
| Secondary | Overall Response Rate (ORR) | Overall response rate (ORR) = Complete Response Rate (CRR) + Partial Response Rate (PRR) | Includes all study participants | Posted | Count of Participants | Participants | 1 year |
|
| |||||||||||||||||||||||||||
| Secondary | Complete Response Rate (CRR) | Complete response rate (CRR) was assessed as all of:
| Includes all study participants | Posted | Count of Participants | Participants | 1 year |
|
| |||||||||||||||||||||||||||
| Secondary | Partial Response Rate (PRR) | Partial response rate (PRR) was assessed as
| Includes all study participants | Posted | Count of Participants | Participants | 1 year |
| ||||||||||||||||||||||||||||
| Secondary | Event-free Survival (EFS) | To evaluate the graft versus myeloma effect by monitoring rate of event-free survival (EFS) | Includes all study participants | Posted | Number | 95% Confidence Interval | percentage of participants | 2 years after the last participant is enrolled |
|
| ||||||||||||||||||||||||||
| Secondary | Overall Survival (OS) | To evaluate the graft versus myeloma effect by monitoring rate of overall survival (OS) | Includes all study participants | Posted | Number | 95% Confidence Interval | percentage of participants | 2 years after the last participant is enrolled |
|
|
2 years
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Autologous-Allogeneic Hematopoietic Stem Cell Transplant | A high-dose sequential chemotherapy approach with cyclophosphamide and etoposide followed by granulocyte colony stimulating factor (G-CSF) for collection of peripheral blood progenitor cells as well as for cytoreduction. Total Lymphoid irradiation and anti-thymocyte globulin (TLI/ATG).The preparatory regimens use BCNU and melphalan. | 2 | 9 | 0 | 9 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pulmonary Embolism | Vascular disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Deep Vein Thrombosis | Vascular disorders | CTCAE (4.0) | Non-systematic Assessment |
|
Not provided
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Wen-Kai Weng, MD; Associate Professor of Medicine | Stanford University School of Med | 650-723-7689 | wkweng@stanford.edu |
| ID | Term |
|---|---|
| D009101 | Multiple Myeloma |
| ID | Term |
|---|---|
| D054219 | Neoplasms, Plasma Cell |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D020141 | Hemostatic Disorders |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D010265 | Paraproteinemias |
| D001796 | Blood Protein Disorders |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D006474 | Hemorrhagic Disorders |
| D008232 | Lymphoproliferative Disorders |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D014180 | Transplantation |
| D000069585 | Filgrastim |
| D016179 | Granulocyte Colony-Stimulating Factor |
| D003520 | Cyclophosphamide |
| D008558 | Melphalan |
| D016572 | Cyclosporine |
| D000961 | Antilymphocyte Serum |
| C512542 | thymoglobulin |
| D009173 | Mycophenolic Acid |
| D008776 | Methylprednisolone Hemisuccinate |
| D002123 | Calcium Dobesilate |
| D004155 | Diphenhydramine |
| D000082 | Acetaminophen |
| D006854 | Hydrocortisone |
| ID | Term |
|---|---|
| D013514 | Surgical Procedures, Operative |
| D003115 | Colony-Stimulating Factors |
| D006023 | Glycoproteins |
| D006001 | Glycoconjugates |
| D002241 | Carbohydrates |
| D016298 | Hematopoietic Cell Growth Factors |
| D016207 | Cytokines |
| D036341 | Intercellular Signaling Peptides and Proteins |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D011506 | Proteins |
| D001685 | Biological Factors |
| D010752 | Phosphoramide Mustards |
| D009588 | Nitrogen Mustard Compounds |
| D009150 | Mustard Compounds |
| D006846 | Hydrocarbons, Halogenated |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D063088 | Phosphoramides |
| D009943 | Organophosphorus Compounds |
| D010649 | Phenylalanine |
| D024322 | Amino Acids, Aromatic |
| D000598 | Amino Acids, Cyclic |
| D000596 | Amino Acids |
| D003524 | Cyclosporins |
| D010456 | Peptides, Cyclic |
| D047028 | Macrocyclic Compounds |
| D011083 | Polycyclic Compounds |
| D007106 | Immune Sera |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
| D001688 | Biological Products |
| D045424 | Complex Mixtures |
| D002208 | Caproates |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D005227 | Fatty Acids |
| D008055 | Lipids |
| D008775 | Methylprednisolone |
| D011239 | Prednisolone |
| D011246 | Pregnadienetriols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D001557 | Benzenesulfonates |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D001190 | Arylsulfonates |
| D017739 | Arylsulfonic Acids |
| D013451 | Sulfonic Acids |
| D013456 | Sulfur Acids |
| D013457 | Sulfur Compounds |
| D005021 | Ethylamines |
| D000588 | Amines |
| D001559 | Benzhydryl Compounds |
| D000083 | Acetanilides |
| D000813 | Anilides |
| D000577 | Amides |
| D000814 | Aniline Compounds |
| D011282 | Pregnenediones |
| D011283 | Pregnenes |
| D015062 | 11-Hydroxycorticosteroids |
| D006889 | Hydroxycorticosteroids |
| D000305 | Adrenal Cortex Hormones |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D015065 | 17-Hydroxycorticosteroids |
Not provided
Not provided
| Unknown or Not Reported |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
|
|
| Counts |
|---|
| Participants |
|
|
|
|
|
| Units | Counts |
|---|---|
| Participants |
|
|
|
|