Non-myeloablative Allogeneic Transplantation for the Treatment of Multiple Myeloma

Sponsor
Wen-Kai Weng (Other)
Overall Status
Completed
CT.gov ID
NCT00185614
Collaborator
(none)
63
Enrollment
1
Location
1
Arm
116
Duration (Months)
0.5
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Mixed chimerism transplantation is an approach to allogeneic transplants that attempts to decrease regimen-related toxicity by using non-myeloablative preparatory regimens; establish mixed chimerism using low dose total body irradiation along with immunosuppression using cyclosporine and mycophenolate mofetil; suppress graft-vs-host and host-vs-graft reactions to allow a mixed chimeric state to be established, encourage tolerance and prevent graft-vs-host disease (GvHD) during the mixed chimerism period and use donor lymphocyte infusions to convert the patient to a full chimera while developing a graft-vs-tumor effect.

Condition or DiseaseIntervention/TreatmentPhase
  • Procedure: Autologous hematopoietic cell transplant (Auto-HCT)
  • Procedure: Allogeneic hematopoietic cell transplant (Allo-HCT)
  • Drug: Cyclophosphamide
  • Drug: Filgrastim
  • Drug: Melphalan
  • Radiation: Total body irradiation (TBI)
  • Procedure: Cyclosporine (CSP)
  • Drug: Mycophenolate Mofetil (MMF)
Phase 2

Detailed Description

Participants are mobilized with cyclophosphamide 4 g/m2 and filgrastim 10 µg/kg/day for peripheral blood progenitor cell (PBPC) collection by apheresis. Transplant conditioning is high-dose melphalan 200 mg/m2, followed by PBPC infusion as melphalan rescue [ie, autologous hematopoietic cells transplant (auto-HCT)]. Post-infusion support includes filgrastim 5 µg/kg/day, starting 6 days following melphalan. Participants with stable or responsive disease at 4 weeks eligible to continue on to the planned allogenic HCT (allo-HCT). For allo-HCT, a sibling donor that is fully matched for human leukocyte antigen (HLA-matched) is identified. Participants receive a single dose of total body irradiation (TBI) 200 centigray (cGy) as well as immunosuppression with cyclosporine (CSP) 6.25 mg/kg and mycophenolate mofetil (MMF) 15 mg/kg. The HLA-matched donor begins filgrastim injections 16 µg/kg/day on day -4 continuing to Day 0, with apheresis collections on Day -1 and Day 0, to a target of > 5 x 10e6 CD34 cells/kg. Allo-HCT is infused to participant on Day 0, with premedication hydrocortisone 100 mg IV and diphenhydramine 50 mg IV. CSP will be tapered beginning Day 56 with a goal of discontinuing CSP on Day 180, adjusted as needed.

Study Design

Study Type:
Interventional
Actual Enrollment :
63 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Non-myeloablative Allogeneic Transplantation for the Treatment of Multiple Myeloma
Study Start Date :
Aug 1, 2000
Actual Primary Completion Date :
Apr 1, 2009
Actual Study Completion Date :
Apr 1, 2010

Arms and Interventions

ArmIntervention/Treatment
Experimental: Auto- then Allo-HCT

Auto-HCT mobilization is cyclophosphamide 4 g/m2 + filgrastim 10 µg/kg/day for peripheral blood progenitor cell (PBPC) collection by apheresis. Transplant conditioning is high-dose melphalan 200 mg/m2, followed by PBPC infusion as melphalan rescue [ie, autologous hematopoietic cells transplant (Auto-HCT)]. Post-infusion support is filgrastim 5 µg/kg/day, starting 6 days after melphalan. Stable/responsive disease at 4 weeks continues to allogenic HCT (Allo-HCT) from sibling donor fully-matched for human leukocyte antigen (HLA). Allo-HCT conditioning is total body irradiation (TBI) 200 centigray (cGy) + cyclosporine (CSP) 6.25 mg/kg + mycophenolate mofetil (MMF) 15 mg/kg. Donor mobilization is filgrastim 16 µg/kg/day on day -4 to Day 0; apheresis collections on Day -1 & Day 0, to a target of > 5 x 10e6 CD34 cells/kg. Allo-HCT is infused to participant on Day 0, with premedication hydrocortisone 100 mg IV & diphenhydramine 50 mg IV. CSP tapering on Day 56 to Day 180, adjusted as needed.

Procedure: Autologous hematopoietic cell transplant (Auto-HCT)
The target cell dose is 2.6 x 10e6 CD34+ cells/kg

Procedure: Allogeneic hematopoietic cell transplant (Allo-HCT)
The target cell dose is 5 x 10e6 CD34 cells/kg

Drug: Cyclophosphamide
Cyclophosphamide administered intravenously (IV) at 4 mg /m² mobilize peripheral blood progenitor cells (PBPC) for autologous re-infusion
Other Names:
  • Cytoxan
  • Neosar
  • Drug: Filgrastim
    Filgrastim 10 µg/kg/day to mobilize peripheral blood progenitor cells (PBPC) for autologous re-infusion (Auto-HCT) Filgrastim 5 µg/kg/day starting 6 days after melphalan (Day 4 after Auto-HCT) Filgrastim 16 µg/kg/day to mobilize donor peripheral blood progenitor cells (PBPC) for allogeneic transplant (Allo-HCT)
    Other Names:
  • Neupogen
  • Granulocyte-colony stimulating factor (G-CSF)
  • Drug: Melphalan
    Melphalan 200 mg/m2 (high-dose) intravenously as conditioning for Auto-HCT
    Other Names:
  • Melphalan hydrochloride
  • Melphalan HCl
  • Radiation: Total body irradiation (TBI)
    200 centigray (cGy) total body irradiation delivered on Day 0

    Procedure: Cyclosporine (CSP)
    Cyclosporine administered twice-daily by mouth at a dose of 6.25 mg/kg from Day -3 through Day 56
    Other Names:
  • Cyclosporine A
  • Drug: Mycophenolate Mofetil (MMF)
    Mycophenolate mofetil will begin at 15 mg/kg twice-daily by mouth from Day 0 to Day 27
    Other Names:
  • CellCept
  • Outcome Measures

    Primary Outcome Measures

    1. Event-free Survival (EFS) [3 years]

      Event-free survival (EFS) as determined for all participants who received the initial Auto-HCT treatment. "Event" was defined as any of the following within 3 years of the participant's last infusion of Auto-HCT or Allo-HCT: relapse; death; or last follow-up if there is no data to document the participant remained alive at 3 years.

    Secondary Outcome Measures

    1. Relapse Rate [3 years]

      Relapse rate as determined for all participants who received the initial Auto-HCT treatment. Relapse was protocol-specified as progressive disease, indicated by an increase as compared to pre-Auto-HCT baseline, of serum or urine monoclonal protein >25%; bone marrow plasmacytosis >25%; or bone lesions on skeletal survey (any increase).

    2. Overall Survival (OS) [3 years]

      Overall Survival (OS) as determined for all participants who received the initial Auto-HCT treatment, as assessed from the date of the last transplant.

    3. Acute Graft-vs-Host-Disease (aGvHD) [6 months]

      Development of acute graft-vs-host-disease (aGvHD) within 6 months, for participants receiving Allo-HCT.

    4. Chronic Graft-vs-Host-Disease (cGvHD) [3 years]

      Development of chronic graft versus host disease (cGvHD) within 3 years, for participants receiving Allo-HCT. Reported as "Extensive cGvHD;" "cGvHD, Not Extensive;" or "No cGvHD," as determined by investigator judgement (no protocol-specified criteria).

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 70 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No

    PATIENT INCLUSION CRITERIA

    • Multiple myeloma, early Stage II-III or relapsed / progression after initial treatment of Stage I disease

    • Patient has HLA-identical sibling donor

    • Age ≤ 70 years

    • No prior therapy which would preclude the use of low-dose total body irradiation

    • Pathology review and diagnosis confirmation by Stanford University Medical Center

    • Karnofsky performance status (KPS) > 70%

    • DLCO ≥ 60% predicted

    • ALT and AST < 2 x upper limit of normal (ULN)

    • Total bilirubin < 2 mg/dL

    • Serum creatinine < 2.0, or 24-hour creatinine clearance ≥ 60 mL/min

    • HIV-negative

    • Signed informed consent document

    PATIENT EXCLUSION CRITERIA

    • Smoldering multiple myeloma; monoclonal gammopathy of unknown significance; or primary amyloidosis

    • Severe psychological or medical illness

    • Prior allogeneic hematopoietic cell transplantation

    • Pregnant or lactating

    ALLOGENEIC DONOR INCLUSION CRITERIA

    • Age ≥ 17

    • HIV-seronegative

    • Signed informed consent document

    ALLOGENEIC DONOR EXCLUSION CRITERIA

    • Serious medical or psychological illness

    • Pregnant or lactating

    • Prior malignancies within the last 5 years, except for non-melanoma skin cancers

    Contacts and Locations

    Locations

    SiteCityStateCountryPostal Code
    1Stanford University School of MedicineStanfordCaliforniaUnited States94305

    Sponsors and Collaborators

    • Wen-Kai Weng

    Investigators

    • Principal Investigator: Wen-Kai Weng, MD, Stanford University

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Wen-Kai Weng, Assistant Professor of Medicine, Stanford University
    ClinicalTrials.gov Identifier:
    NCT00185614
    Other Study ID Numbers:
    • IRB-13378
    • 75190
    • BMT109
    First Posted:
    Sep 16, 2005
    Last Update Posted:
    Jan 18, 2018
    Last Verified:
    Jan 1, 2018
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:

    Study Results

    Participant Flow

    Recruitment Details
    Pre-assignment Detail
    Arm/Group TitleAuto- Then Allo-HCT
    Arm/Group DescriptionAuto-HCT mobilization is cyclophosphamide 4 g/m2 + filgrastim 10 µg/kg/day for peripheral blood progenitor cell (PBPC) collection by apheresis. Transplant conditioning is high-dose melphalan 200 mg/m2, followed by PBPC infusion as melphalan rescue [ie, autologous hematopoietic cells transplant (Auto-HCT)]. Post-infusion support is filgrastim 5 µg/kg/day, starting 6 days after melphalan. Stable/responsive disease at 4 weeks continues to allogenic HCT (Allo-HCT) from sibling donor fully-matched for human leukocyte antigen (HLA). Allo-HCT conditioning is total body irradiation (TBI) 200 centigray (cGy) + cyclosporine (CSP) 6.25 mg/kg + mycophenolate mofetil (MMF) 15 mg/kg. Donor mobilization is filgrastim 16 µg/kg/day on day -4 to Day 0; apheresis collections on Day -1 & Day 0, to a target of > 5 x 10e6 CD34 cells/kg. Allo-HCT is infused to participant on Day 0, with premedication hydrocortisone 100 mg IV & diphenhydramine 50 mg IV. CSP tapering on Day 56 to Day 180, adjusted as needed.
    Period Title: Autologous HCT (Auto-HCT)
    STARTED63
    COMPLETED63
    NOT COMPLETED0
    Period Title: Autologous HCT (Auto-HCT)
    STARTED63
    COMPLETED59
    NOT COMPLETED4
    Period Title: Autologous HCT (Auto-HCT)
    STARTED59
    COMPLETED59
    NOT COMPLETED0

    Baseline Characteristics

    Arm/Group TitleAuto- Then Allo-HCT
    Arm/Group DescriptionAuto-HCT mobilization is cyclophosphamide 4 g/m2 + filgrastim 10 µg/kg/day for peripheral blood progenitor cell (PBPC) collection by apheresis. Transplant conditioning is high-dose melphalan 200 mg/m2, followed by PBPC infusion as melphalan rescue [ie, autologous hematopoietic cells transplant (Auto-HCT)]. Post-infusion support is filgrastim 5 µg/kg/day, starting 6 days after melphalan. Stable/responsive disease at 4 weeks continues to allogenic HCT (Allo-HCT) from sibling donor fully-matched for human leukocyte antigen (HLA). Allo-HCT conditioning is total body irradiation (TBI) 200 centigray (cGy) + cyclosporine (CSP) 6.25 mg/kg + mycophenolate mofetil (MMF) 15 mg/kg. Donor mobilization is filgrastim 16 µg/kg/day on day -4 to Day 0; apheresis collections on Day -1 & Day 0, to a target of > 5 x 10e6 CD34 cells/kg. Allo-HCT is infused to participant on Day 0, with premedication hydrocortisone 100 mg IV & diphenhydramine 50 mg IV. CSP tapering on Day 56 to Day 180, adjusted as needed.
    Overall Participants63
    Age (Count of Participants)
    <=18 years
    0
    0%
    Between 18 and 65 years
    60
    95.2%
    >=65 years
    3
    4.8%
    Sex: Female, Male (Count of Participants)
    Female
    20
    31.7%
    Male
    43
    68.3%
    Ethnicity (NIH/OMB) (Count of Participants)
    Hispanic or Latino
    5
    7.9%
    Not Hispanic or Latino
    43
    68.3%
    Unknown or Not Reported
    15
    23.8%
    Race (NIH/OMB) (Count of Participants)
    American Indian or Alaska Native
    0
    0%
    Asian
    7
    11.1%
    Native Hawaiian or Other Pacific Islander
    3
    4.8%
    Black or African American
    5
    7.9%
    White
    43
    68.3%
    More than one race
    0
    0%
    Unknown or Not Reported
    5
    7.9%

    Outcome Measures

    1. Primary Outcome
    TitleEvent-free Survival (EFS)
    DescriptionEvent-free survival (EFS) as determined for all participants who received the initial Auto-HCT treatment. "Event" was defined as any of the following within 3 years of the participant's last infusion of Auto-HCT or Allo-HCT: relapse; death; or last follow-up if there is no data to document the participant remained alive at 3 years.
    Time Frame3 years

    Outcome Measure Data

    Analysis Population Description
    The outcome data are reported as the number of participants who do not experience an EFS event within 3 years from the date of the last transplant, for the "Auto-HCT only" population, the "Auto-HCT then Allo-HCT" population, and the overall study population (ie, "Auto-HCT only" plus +"Auto-HCT then Allo-HCT").
    Arm/Group TitleAuto- Then Allo-HCT
    Arm/Group DescriptionAuto-HCT mobilization is cyclophosphamide 4 g/m2 + filgrastim 10 µg/kg/day for peripheral blood progenitor cell (PBPC) collection by apheresis. Transplant conditioning is high-dose melphalan 200 mg/m2, followed by PBPC infusion as melphalan rescue [ie, autologous hematopoietic cells transplant (Auto-HCT)]. Post-infusion support is filgrastim 5 µg/kg/day, starting 6 days after melphalan. Stable/responsive disease at 4 weeks continues to allogenic HCT (Allo-HCT) from sibling donor fully-matched for human leukocyte antigen (HLA). Allo-HCT conditioning is total body irradiation (TBI) 200 centigray (cGy) + cyclosporine (CSP) 6.25 mg/kg + mycophenolate mofetil (MMF) 15 mg/kg. Donor mobilization is filgrastim 16 µg/kg/day on day -4 to Day 0; apheresis collections on Day -1 & Day 0, to a target of > 5 x 10e6 CD34 cells/kg. Allo-HCT is infused to participant on Day 0, with premedication hydrocortisone 100 mg IV & diphenhydramine 50 mg IV. CSP tapering on Day 56 to Day 180, adjusted as needed.
    Measure Participants63
    Auto-HCT only
    0
    0%
    Auto-HCT then Allo-HCT
    24
    38.1%
    All Participants
    24
    38.1%
    2. Secondary Outcome
    TitleRelapse Rate
    DescriptionRelapse rate as determined for all participants who received the initial Auto-HCT treatment. Relapse was protocol-specified as progressive disease, indicated by an increase as compared to pre-Auto-HCT baseline, of serum or urine monoclonal protein >25%; bone marrow plasmacytosis >25%; or bone lesions on skeletal survey (any increase).
    Time Frame3 years

    Outcome Measure Data

    Analysis Population Description
    The outcome data are reported as the number of participants who relapse per criteria within 3 years.
    Arm/Group TitleAuto- Then Allo-HCT
    Arm/Group DescriptionAuto-HCT mobilization is cyclophosphamide 4 g/m2 + filgrastim 10 µg/kg/day for peripheral blood progenitor cell (PBPC) collection by apheresis. Transplant conditioning is high-dose melphalan 200 mg/m2, followed by PBPC infusion as melphalan rescue [ie, autologous hematopoietic cells transplant (Auto-HCT)]. Post-infusion support is filgrastim 5 µg/kg/day, starting 6 days after melphalan. Stable/responsive disease at 4 weeks continues to allogenic HCT (Allo-HCT) from sibling donor fully-matched for human leukocyte antigen (HLA). Allo-HCT conditioning is total body irradiation (TBI) 200 centigray (cGy) + cyclosporine (CSP) 6.25 mg/kg + mycophenolate mofetil (MMF) 15 mg/kg. Donor mobilization is filgrastim 16 µg/kg/day on day -4 to Day 0; apheresis collections on Day -1 & Day 0, to a target of > 5 x 10e6 CD34 cells/kg. Allo-HCT is infused to participant on Day 0, with premedication hydrocortisone 100 mg IV & diphenhydramine 50 mg IV. CSP tapering on Day 56 to Day 180, adjusted as needed.
    Measure Participants63
    Auto-HCT only
    2
    3.2%
    Auto-HCT then Allo-HCT
    29
    46%
    All Participants
    31
    49.2%
    3. Secondary Outcome
    TitleOverall Survival (OS)
    DescriptionOverall Survival (OS) as determined for all participants who received the initial Auto-HCT treatment, as assessed from the date of the last transplant.
    Time Frame3 years

    Outcome Measure Data

    Analysis Population Description
    The outcome data are reported as the number of participants who could be documented as remaining alive through 3 years from the date of the last transplant, for the "Auto-HCT only" population, the "Auto-HCT then Allo-HCT" population, and the overall study population (ie, "Auto-HCT only" plus +"Auto-HCT then Allo-HCT").
    Arm/Group TitleAuto- Then Allo-HCT
    Arm/Group DescriptionAuto-HCT mobilization is cyclophosphamide 4 g/m2 + filgrastim 10 µg/kg/day for peripheral blood progenitor cell (PBPC) collection by apheresis. Transplant conditioning is high-dose melphalan 200 mg/m2, followed by PBPC infusion as melphalan rescue [ie, autologous hematopoietic cells transplant (Auto-HCT)]. Post-infusion support is filgrastim 5 µg/kg/day, starting 6 days after melphalan. Stable/responsive disease at 4 weeks continues to allogenic HCT (Allo-HCT) from sibling donor fully-matched for human leukocyte antigen (HLA). Allo-HCT conditioning is total body irradiation (TBI) 200 centigray (cGy) + cyclosporine (CSP) 6.25 mg/kg + mycophenolate mofetil (MMF) 15 mg/kg. Donor mobilization is filgrastim 16 µg/kg/day on day -4 to Day 0; apheresis collections on Day -1 & Day 0, to a target of > 5 x 10e6 CD34 cells/kg. Allo-HCT is infused to participant on Day 0, with premedication hydrocortisone 100 mg IV & diphenhydramine 50 mg IV. CSP tapering on Day 56 to Day 180, adjusted as needed.
    Measure Participants63
    Auto-HCT only
    1
    1.6%
    Auto-HCT then Allo-HCT
    41
    65.1%
    All Participants
    42
    66.7%
    4. Secondary Outcome
    TitleAcute Graft-vs-Host-Disease (aGvHD)
    DescriptionDevelopment of acute graft-vs-host-disease (aGvHD) within 6 months, for participants receiving Allo-HCT.
    Time Frame6 months

    Outcome Measure Data

    Analysis Population Description
    Graft versus host disease (aGvHD) only occurs in participants receiving Allo-HCT, as determined by investigator judgement (no protocol-specified criteria).
    Arm/Group TitleAuto- Then Allo-HCT
    Arm/Group DescriptionAuto-HCT mobilization is cyclophosphamide 4 g/m2 + filgrastim 10 µg/kg/day for peripheral blood progenitor cell (PBPC) collection by apheresis. Transplant conditioning is high-dose melphalan 200 mg/m2, followed by PBPC infusion as melphalan rescue [ie, autologous hematopoietic cells transplant (Auto-HCT)]. Post-infusion support is filgrastim 5 µg/kg/day, starting 6 days after melphalan. Stable/responsive disease at 4 weeks continues to allogenic HCT (Allo-HCT) from sibling donor fully-matched for human leukocyte antigen (HLA). Allo-HCT conditioning is total body irradiation (TBI) 200 centigray (cGy) + cyclosporine (CSP) 6.25 mg/kg + mycophenolate mofetil (MMF) 15 mg/kg. Donor mobilization is filgrastim 16 µg/kg/day on day -4 to Day 0; apheresis collections on Day -1 & Day 0, to a target of > 5 x 10e6 CD34 cells/kg. Allo-HCT is infused to participant on Day 0, with premedication hydrocortisone 100 mg IV & diphenhydramine 50 mg IV. CSP tapering on Day 56 to Day 180, adjusted as needed.
    Measure Participants59
    Count of Participants [Participants]
    7
    11.1%
    5. Secondary Outcome
    TitleChronic Graft-vs-Host-Disease (cGvHD)
    DescriptionDevelopment of chronic graft versus host disease (cGvHD) within 3 years, for participants receiving Allo-HCT. Reported as "Extensive cGvHD;" "cGvHD, Not Extensive;" or "No cGvHD," as determined by investigator judgement (no protocol-specified criteria).
    Time Frame3 years

    Outcome Measure Data

    Analysis Population Description
    Graft versus host disease (aGvHD) only occurs in participants receiving Allo-HCT.
    Arm/Group TitleAuto- Then Allo-HCT
    Arm/Group DescriptionAuto-HCT mobilization is cyclophosphamide 4 g/m2 + filgrastim 10 µg/kg/day for peripheral blood progenitor cell (PBPC) collection by apheresis. Transplant conditioning is high-dose melphalan 200 mg/m2, followed by PBPC infusion as melphalan rescue [ie, autologous hematopoietic cells transplant (Auto-HCT)]. Post-infusion support is filgrastim 5 µg/kg/day, starting 6 days after melphalan. Stable/responsive disease at 4 weeks continues to allogenic HCT (Allo-HCT) from sibling donor fully-matched for human leukocyte antigen (HLA). Allo-HCT conditioning is total body irradiation (TBI) 200 centigray (cGy) + cyclosporine (CSP) 6.25 mg/kg + mycophenolate mofetil (MMF) 15 mg/kg. Donor mobilization is filgrastim 16 µg/kg/day on day -4 to Day 0; apheresis collections on Day -1 & Day 0, to a target of > 5 x 10e6 CD34 cells/kg. Allo-HCT is infused to participant on Day 0, with premedication hydrocortisone 100 mg IV & diphenhydramine 50 mg IV. CSP tapering on Day 56 to Day 180, adjusted as needed.
    Measure Participants59
    Extensive cGvHD
    30
    47.6%
    cGvHD, not Extensive
    8
    12.7%
    No cGvHD
    21
    33.3%

    Adverse Events

    Time Frame3 years
    Adverse Event Reporting Description
    Arm/Group TitleAll Participants Receviing at Least Auto-HCT
    Arm/Group DescriptionAuto-HCT mobilization is cyclophosphamide 4 g/m2 + filgrastim 10 µg/kg/day for peripheral blood progenitor cell (PBPC) collection by apheresis. Transplant conditioning is high-dose melphalan 200 mg/m2, followed by PBPC infusion as melphalan rescue [ie, autologous hematopoietic cells transplant (Auto-HCT)]. Post-infusion support is filgrastim 5 µg/kg/day, starting 6 days after melphalan. Stable/responsive disease at 4 weeks continues to allogenic HCT (Allo-HCT) from sibling donor fully-matched for human leukocyte antigen (HLA). Allo-HCT conditioning is total body irradiation (TBI) 200 centigray (cGy) + cyclosporine (CSP) 6.25 mg/kg + mycophenolate mofetil (MMF) 15 mg/kg. Donor mobilization is filgrastim 16 µg/kg/day on day -4 to Day 0; apheresis collections on Day -1 & Day 0, to a target of > 5 x 10e6 CD34 cells/kg. Allo-HCT is infused to participant on Day 0, with premedication hydrocortisone 100 mg IV & diphenhydramine 50 mg IV. CSP tapering on Day 56 to Day 180, adjusted as needed.
    All Cause Mortality
    All Participants Receviing at Least Auto-HCT
    Affected / at Risk (%)# Events
    Total21/63 (33.3%)
    Serious Adverse Events
    All Participants Receviing at Least Auto-HCT
    Affected / at Risk (%)# Events
    Total63/63 (100%)
    Blood and lymphatic system disorders
    Coagulase-negative staphylococci3/63 (4.8%) 3
    Fungemia1/63 (1.6%) 1
    Gram-negative bacillary bacteremia6/63 (9.5%) 6
    Hyponatremia1/63 (1.6%) 1
    Platelet count decrease3/63 (4.8%) 4
    Pseudomonas bacteremia1/63 (1.6%) 1
    Cardiac disorders
    Heart Failure1/63 (1.6%) 1
    Cardiopulmonary Failure2/63 (3.2%) 2
    Supraventricular tachycardia1/63 (1.6%) 1
    Superior Vena Cava Syndrome1/63 (1.6%) 1
    Gastrointestinal disorders
    Diarrhea2/63 (3.2%) 2
    Erosive esophagitis1/63 (1.6%) 1
    Mucositis8/63 (12.7%) 8
    Nausea4/63 (6.3%) 4
    Immune system disorders
    Cytomegalovirus2/63 (3.2%) 2
    Infections and infestations
    Bacteremia2/63 (3.2%) 2
    Febrile Neutropenia31/63 (49.2%) 31
    Fever3/63 (4.8%) 3
    Klebsiella bacteremia1/63 (1.6%) 1
    Pneumonia2/63 (3.2%) 2
    Viral Pneumonitis1/63 (1.6%) 1
    Musculoskeletal and connective tissue disorders
    Myopathy1/63 (1.6%) 1
    Rhabdomyositis1/63 (1.6%) 1
    Right Parietal Encephalocele1/63 (1.6%) 1
    Nervous system disorders
    Herpetic stomatitis1/63 (1.6%) 1
    Psychiatric disorders
    Aseptic Encephalitis1/63 (1.6%) 1
    Renal and urinary disorders
    Acute Kidney Injury1/63 (1.6%) 1
    Renal Failure1/63 (1.6%) 1
    Respiratory, thoracic and mediastinal disorders
    Lung Aspergillosis1/63 (1.6%) 1
    Pulmonary Failure3/63 (4.8%) 3
    Lung Aspergillosis1/63 (1.6%) 2
    Respiratory syncytial virus pneumonitis5/63 (7.9%) 5
    Skin and subcutaneous tissue disorders
    Disseminated varicella zoster4/63 (6.3%) 4
    Other (Not Including Serious) Adverse Events
    All Participants Receviing at Least Auto-HCT
    Affected / at Risk (%)# Events
    Total63/63 (100%)
    Blood and lymphatic system disorders
    Coagulase-negative staphylococci1/63 (1.6%) 1
    Neutropenia16/63 (25.4%) 17
    Platelet count decrease14/63 (22.2%) 15
    Transaminitis1/63 (1.6%) 1
    Thrombotic Thrombocytopenic Purpura2/63 (3.2%) 2
    Gastrointestinal disorders
    Colitis1/63 (1.6%) 1
    Diarrhea1/63 (1.6%) 1
    Gastritis1/63 (1.6%) 1
    Mucositis6/63 (9.5%) 6
    Nausea7/63 (11.1%) 7
    Steroid Myopathy1/63 (1.6%) 1
    General disorders
    Dehyration1/63 (1.6%) 1
    Immune system disorders
    Cytomegalovirus5/63 (7.9%) 6
    Infections and infestations
    Bacteremia1/63 (1.6%) 1
    Clostridium Difficile Colitis2/63 (3.2%) 2
    Febrile neutropenia5/63 (7.9%) 5
    Fever2/63 (3.2%) 2
    Parainfluenza pneumonitis1/63 (1.6%) 1
    Viral Pneumonitis1/63 (1.6%) 1
    Nervous system disorders
    Herpes Zoster1/63 (1.6%) 1
    Renal and urinary disorders
    Acute Kidney Injury1/63 (1.6%) 1
    Ascites1/63 (1.6%) 1
    Renal Failure15/63 (23.8%) 16
    Respiratory, thoracic and mediastinal disorders
    Viral bronchitis1/63 (1.6%) 1
    Skin and subcutaneous tissue disorders
    Cellulitis1/63 (1.6%) 1
    Disseminated varicella zoster2/63 (3.2%) 2
    Maculo-papular rash6/63 (9.5%) 6
    Seborrheic dermatitis1/63 (1.6%) 1

    Limitations/Caveats

    [Not Specified]

    More Information

    Certain Agreements

    Principal Investigators are NOT employed by the organization sponsoring the study.

    There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

    Results Point of Contact

    Name/TitleWen-Kai Weng, MD; Associate Professor of Medicine
    OrganizationStanford University School of Medicine
    Phone650-723-7689
    Emailwkweng@stanford.edu
    Responsible Party:
    Wen-Kai Weng, Assistant Professor of Medicine, Stanford University
    ClinicalTrials.gov Identifier:
    NCT00185614
    Other Study ID Numbers:
    • IRB-13378
    • 75190
    • BMT109
    First Posted:
    Sep 16, 2005
    Last Update Posted:
    Jan 18, 2018
    Last Verified:
    Jan 1, 2018