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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.

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

Autologous peripheral blood stem cells (auto-PBSC) transplantation

Allo-PBSC (target collection ≥ 5 x 10e6 CD34+ cells/kg) are intravenously (IV) infused as part of the combination stem cell therapy.

Allogeneic peripheral blood stem cells (allo-PBSC) 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.

Filgrastim

Cyclophosphamide is administered intravenously (IV) at 4 g/m2 on Day 1 of the auto-PBSC mobilization regimen.

Melphalan is administered after CSP at 200 mg/m2 intravenously (IV) on Day -2 before auto-PBSC infusion.

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 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.

Total lymphoid irradiation

ATG 1.5 mg/kg is administered intravenously (IV) on Day -11 to -7 before allo-PBSC infusion.

Rabbit anti-thymocyte globulin

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

Mycophenolate Mofetil 250mg

Solumedrol 1 mg/kg is administered intravenously (IV) on Day -11 to -7 as a premedication for ATG and allo-PBSC infusion

Solumedrol

Diphenhydramine 25 to 50 mg is administered as a premedication for the ATG; allo-PBSC; and DLI infusions.

Acetaminophen 650 mg is administered as a premedication for the ATG and allo-PBSC infusions.

Hydrocortisone 100 mg is administered intravenously (IV) is a premedication for the allo-PBSC and DLI infusions.

Wen-Kai Weng

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.

Phase 2 Study of Autologous Followed by Nonmyeloablative Allogeneic Transplantation Using TLI & ATG

A Phase 2 Study of Autologous Followed by Nonmyeloablative Allogeneic Transplantation Using Total Lymphoid Irradiation (TLI) and Antithymocyte Globulin (ATG) in Multiple Myeloma Patients

To evaluate the incidence acute GvHD of this tandem autologous/allogeneic transplant setting

Engraftment is assessed as:

* Neutrophil engraftment is \> 0.5 x 10⁹/L after cytopenia
* Platelet engraftment is \> 20 x 10⁹/L after cytopenia

Overall response rate (ORR) = Complete Response Rate (CRR) + Partial Response Rate (PRR)

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

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.

To evaluate the graft versus myeloma effect by monitoring rate of event-free survival (EFS)

To evaluate the graft versus myeloma effect by monitoring rate of overall survival (OS)

Stanford University

Assistant Professor of Medicine (Blood and Marrow Transplantation)

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.

Autologous-Allogeneic Hematopoietic Stem Cell Transplant

Age, Categorical

Age, Continuous

Sex: Female, Male

Ethnicity (NIH/OMB)

Race (NIH/OMB)

Wen-Kai Weng, MD; Associate Professor of Medicine

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.

Incidence of Graft Versus Host Disease (GvHD)

Neutrophil Engraftment

Platelet Engraftment

Median Time to Engraftment After Auto-PBSC Transplant

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.

Median Time to Engraftment After Allo-PBSC Transplant

Autologous-Allogeneic Peripheral Blood Stem Cell Transplant

Overall Response Rate (ORR)

Complete Response Rate (CRR)

Partial Response Rate (PRR)

Event-free Survival (EFS)

Overall Survival (OS)

Overall Study

Symptoms and General Pathology

Respiratory Tract (Lung and Bronchial) Diseases

Diseases and Abnormalities at or Before Birth

Wounds and Injuries

Infections

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Syndrome

Necrosis

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Respiratory Distress Syndrome, Newborn

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Lung Injury

Pneumonia

Bronchiolitis

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Bronchiolitis Obliterans

Communicable Diseases

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Organizing Pneumonia

Graft vs Host Disease

Respiratory Distress Syndrome, Infant

Acute Respiratory Distress Syndrome

Acute Graft Versus Host Disease

Bronchiolitis Obliterans Organizing Pneumonia

Homologous Wasting Disease

Etanercept

Anti-Inflammatory Agents, Non-Steroidal

etanercept

Kenneth Cooke, M.D.

The purpose of this study is to determine the effects of etanercept, and define the toxicity, when administered to patients with acute non-infectious lung injury (idiopathic pneumonia syndrome, IPS) and with subacute pulmonary dysfunction after allogeneic stem cell transplantation.

Over the last 2 decades, allogeneic bone marrow transplantation (BMT) has emerged as an important treatment option for a number of malignant and non-malignant disorders. Unfortunately, pulmonary dysfunction remains a frequent and severe complication of allogeneic BMT. One of the main chemicals felt to cause lung damage is Tumor Necrosis Factor (TNF). Etanercept is an experimental drug that attempts to block TNF lung damage. Patients will undergo blood tests, x-rays, and a bronchoscopy with broncho-alveolar lavage prior to treatment with etanercept to check for infection. If no infection is evident after 24 hours, the etanercept will be started and administered twice weekly for 4 weeks by subcutaneous injection. There will be weekly blood tests and bronchoscopy after the last drug dose.

Etanercept for Non-Infectious Lung Injury Following Bone Marrow Transplantation

Soluble Tumor Necrosis Factor Receptor: Enbrel (Etanercept) for the Treatment of Acute Pulmonary Dysfunction (Idiopathic Pneumonia Syndrome) Following Allogeneic Stem Cell Transplantation

FDA Office of Orphan Products Development

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Phase 2 Study of Autologous Followed by Nonmyeloablative Allogeneic Transplantation Using TLI & ATG	NCT00899847	Transplantation... Transplantation... Multiple Myelom... Blood and Marro...	Autologous peri... Allogeneic peri... Filgrastim Cyclophosphamid... Melphalan Cyclosporine Total lymphoid ... Rabbit anti-thy... Mycophenolate M... Solumedrol Diphenhydramine Acetaminophen Hydrocortisone	18 Years - 75 Years	Stanford University
Etanercept for Non-Infectious Lung Injury Following Bone Marrow Transplantation	NCT00029328	Respiratory Dis... Bronchiolitis O... Pneumonia	etanercept	12 Months -	FDA Office of Orphan Products Development

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