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NCT00899847 · REGISTRY CONDITION SEARCH

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

Found through the registry condition index, not selected as a treatment recommendation. This discovery collection was restricted to studies with posted results.

Phase
PHASE2
Status at capture
COMPLETED
Registry last update
2017-10-20

To evaluate the toxicity and tolerability of this tandem autologous/allogeneic transplant approach for patients with advanced stage multiple myeloma.

Open the original ClinicalTrials.gov record → · Download preserved record

What did the study report?

Outcomes, safety and baseline populations are separate source sections. Quality-of-life measures appear under their original outcome titles.

flow

Participant flow

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baseline

Baseline characteristics

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outcome · POSTED

Incidence of Graft Versus Host Disease (GvHD)

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outcome · POSTED

Median Time to Engraftment After Auto-PBSC Transplant

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outcome · POSTED

Median Time to Engraftment After Allo-PBSC Transplant

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outcome · POSTED

Overall Response Rate (ORR)

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outcome · POSTED

Complete Response Rate (CRR)

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outcome · POSTED

Partial Response Rate (PRR)

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outcome · POSTED

Event-free Survival (EFS)

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outcome · POSTED

Overall Survival (OS)

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adverse events

Adverse events

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more info

Limitations, agreements, and source contact

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Who could take part
eligibility Criteria
PARTICIPANT INCLUSION CRITERIA * Stage II-III multiple myeloma or have progression after initial treatment of Stage I disease (Durie Salmon Staging). Patients with plasma cell leukemia are also included. * Multiple myeloma / plasma cell leukemia diagnosis confirmed by pathology reviewed at Stanford University Medical Center. * 18 to ≤ 75 years of age * Karnofsky Performance Status \> 70%. * Corrected Carbon monoxide diffusing capacity (Dlco) \> 60% * Left ventricle ejection fraction (LVEF) \> 50%. * Alanine aminotransferase (ALT) ≤ 2 x normal * Aspartate aminotransferase (AST) ≤ 2 x normal * Total bilirubin ≤ 2 mg/dL, unless hemolysis or Gilbert's disease. * Estimated creatinine clearance \> 50 mL/min. * Identified related or unrelated Human leukocyte antigen (HLA)-identical donor or donor with one antigen/allele mismatch in (HLA-A, B, C or DRB1). * Signed informed consent. DONOR INCLUSION CRITERIA * At least 17 years of age * HIV-seronegative * Must be capable of giving signed, informed consent * No contraindication to the administration of filgrastim * Willing to have a central venous catheter placed for apheresis if peripheral veins are inadequate PARTICIPANT EXCLUSION CRITERIA * Prior allogeneic hematopoietic cell transplantation * Uncontrolled active infection * Uncontrolled congestive heart failure or angina * HIV-positive * Pregnant or nursing DONOR EXCLUSION CRITERIA * Serious medical or psychological illness * Pregnant or lactating * Prior malignancies within the last 5 years except for non-melanoma skin cancers
healthy Volunteers
false
maximum Age
75 Years
minimum Age
18 Years
sex
ALL
std Ages
  1. ADULT
  2. OLDER_ADULT
Treatment arms and interventions
arm Groups
  1. description
    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.
    intervention Names
    1. Procedure: Autologous peripheral blood stem cells (auto-PBSC) transplantation
    2. Procedure: Allogeneic peripheral blood stem cells (allo-PBSC) transplantation
    3. Drug: Filgrastim
    4. Drug: Cyclophosphamide
    5. Drug: Melphalan
    6. Drug: Cyclosporine
    7. Radiation: Total lymphoid irradiation
    8. Biological: Rabbit anti-thymocyte globulin
    9. Drug: Mycophenolate Mofetil 250mg
    10. Drug: Solumedrol
    11. Drug: Diphenhydramine
    12. Drug: Acetaminophen
    label
    Autologous-Allogeneic Peripheral Blood Stem Cell Transplant
    type
    EXPERIMENTAL
interventions
  1. arm Group Labels
    1. Autologous-Allogeneic Peripheral Blood Stem Cell Transplant
    description
    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
    name
    Autologous peripheral blood stem cells (auto-PBSC) transplantation
    other Names
    1. auto-PBPC
    2. Autologous peripheral blood progenitor cells (auto-PBPC) transplantation
    type
    PROCEDURE
  2. arm Group Labels
    1. Autologous-Allogeneic Peripheral Blood Stem Cell Transplant
    description
    Allo-PBSC (target collection ≥ 5 x 10e6 CD34+ cells/kg) are intravenously (IV) infused as part of the combination stem cell therapy.
    name
    Allogeneic peripheral blood stem cells (allo-PBSC) transplantation
    other Names
    1. allo-PBSC
    2. Allogeneic peripheral blood progenitor cells (allo-PBPC) transplantation
    type
    PROCEDURE
  3. arm Group Labels
    1. Autologous-Allogeneic Peripheral Blood Stem Cell Transplant
    description
    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.
    name
    Filgrastim
    other Names
    1. Neupogen
    2. Granulocyte colony-stimulating factor (G-CSF)
    3. r-metHuG-CSF
    type
    DRUG
  4. arm Group Labels
    1. Autologous-Allogeneic Peripheral Blood Stem Cell Transplant
    description
    Cyclophosphamide is administered intravenously (IV) at 4 g/m2 on Day 1 of the auto-PBSC mobilization regimen.
    name
    Cyclophosphamide
    other Names
    1. Ciclofosfamida
    2. Ciclofosfamide
    3. Claphene
    4. CP monohydrate (CPM)
    5. CSP
    type
    DRUG
  5. arm Group Labels
    1. Autologous-Allogeneic Peripheral Blood Stem Cell Transplant
    description
    Melphalan is administered after CSP at 200 mg/m2 intravenously (IV) on Day -2 before auto-PBSC infusion.
    name
    Melphalan
    other Names
    1. L-Sarcolysin
    2. L-phenylalanine mustard (L-PAM)
    3. L-Sarcolysin phenylalanine mustard
    4. L-sarcolysine
    type
    DRUG
  6. arm Group Labels
    1. Autologous-Allogeneic Peripheral Blood Stem Cell Transplant
    description
    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.
    name
    Cyclosporine
    other Names
    1. Cyclosporin
    2. Cyclosporin A
    3. Ciclosporin
    4. CSP
    type
    DRUG
  7. arm Group Labels
    1. Autologous-Allogeneic Peripheral Blood Stem Cell Transplant
    description
    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.
    name
    Total lymphoid irradiation
    other Names
    1. TLI
    type
    RADIATION
  8. arm Group Labels
    1. Autologous-Allogeneic Peripheral Blood Stem Cell Transplant
    description
    ATG 1.5 mg/kg is administered intravenously (IV) on Day -11 to -7 before allo-PBSC infusion.
    name
    Rabbit anti-thymocyte globulin
    other Names
    1. Thymoglobulin
    2. ATG
    type
    BIOLOGICAL
  9. arm Group Labels
    1. Autologous-Allogeneic Peripheral Blood Stem Cell Transplant
    description
    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
    name
    Mycophenolate Mofetil 250mg
    other Names
    1. CellCept
    2. MMF
    type
    DRUG
  10. arm Group Labels
    1. Autologous-Allogeneic Peripheral Blood Stem Cell Transplant
    description
    Solumedrol 1 mg/kg is administered intravenously (IV) on Day -11 to -7 as a premedication for ATG and allo-PBSC infusion
    name
    Solumedrol
    other Names
    1. Solumedin
    2. Soludecadron
    type
    DRUG
  11. arm Group Labels
    1. Autologous-Allogeneic Peripheral Blood Stem Cell Transplant
    description
    Diphenhydramine 25 to 50 mg is administered as a premedication for the ATG; allo-PBSC; and DLI infusions.
    name
    Diphenhydramine
    other Names
    1. Benadryl
    type
    DRUG
  12. arm Group Labels
    1. Autologous-Allogeneic Peripheral Blood Stem Cell Transplant
    description
    Acetaminophen 650 mg is administered as a premedication for the ATG and allo-PBSC infusions.
    name
    Acetaminophen
    other Names
    1. Tylenol
    type
    DRUG
Study design
allocation
NA
intervention Model
SINGLE_GROUP
masking Info
masking
NONE
primary Purpose
TREATMENT
Enrollment
count
9
type
ACTUAL
Registered outcome plans (not posted results)
primary Outcomes
  1. description
    To evaluate the incidence acute GvHD of this tandem autologous/allogeneic transplant setting
    measure
    Incidence of Graft Versus Host Disease (GvHD)
    time Frame
    2 years after the last participant is enrolled.
secondary Outcomes
  1. description
    Engraftment is assessed as: * Neutrophil engraftment is \> 0.5 x 10⁹/L after cytopenia * Platelet engraftment is \> 20 x 10⁹/L after cytopenia
    measure
    Median Time to Engraftment After Auto-PBSC Transplant
    time Frame
    1 month
  2. description
    Engraftment is assessed as: * Neutrophil engraftment is \> 0.5 x 10⁹/L after cytopenia * Platelet engraftment is \> 20 x 10⁹/L after cytopenia
    measure
    Median Time to Engraftment After Allo-PBSC Transplant
    time Frame
    1 month
  3. description
    Overall response rate (ORR) = Complete Response Rate (CRR) + Partial Response Rate (PRR)
    measure
    Overall Response Rate (ORR)
    time Frame
    1 year
  4. description
    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
    measure
    Complete Response Rate (CRR)
    time Frame
    1 year
  5. description
    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.
    measure
    Partial Response Rate (PRR)
    time Frame
    1 year
  6. description
    To evaluate the graft versus myeloma effect by monitoring rate of event-free survival (EFS)
    measure
    Event-free Survival (EFS)
    time Frame
    2 years after the last participant is enrolled
  7. description
    To evaluate the graft versus myeloma effect by monitoring rate of overall survival (OS)
    measure
    Overall Survival (OS)
    time Frame
    2 years after the last participant is enrolled
Full study description
brief Summary
To evaluate the toxicity and tolerability of this tandem autologous/allogeneic transplant approach for patients with advanced stage multiple myeloma.
detailed Description
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.
Source references
Source notices and limitations
    Discovery and provenance
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    Preserved source evidence · Not medical advice