Busulfan, Melphalan, Fludarabine and T-Cell Depleted Allogeneic Hematopoietic Stem Cell Transplantation Followed by Post Transplantation Donor Lymphocyte Infusions

Sponsor
Memorial Sloan Kettering Cancer Center (Other)
Overall Status
Completed
CT.gov ID
NCT01131169
Collaborator
Otsuka America Pharmaceutical (Industry), Ludwig Institute for Cancer Research (Other)
66
1
2
120.5
0.5

Study Details

Study Description

Brief Summary

The patients are being offered a stem cell transplant. Stem cells are very early blood cells. They have not yet matured to become red or white blood cells or platelets. They have already received the standard treatment of chemotherapy and an autologous stem cell transplant. An autologous stem cell transplant is when the patient receives their infusion of their own cells. Thi will give the patient a better chance of curing the disease, this protocol includes an infusion of stem cells from the blood (or the bone marrow) of another person. This is called an allogeneic stem cell transplant. The stem cells will begin to grow in the bone marrow and produce new blood cells.

Allogeneic stem cell transplants can cause a condition called graft-versus-host disease or GVHD. In GVHD, a kind of white blood cell from the donor (graft) begins to attack the body (host). That blood cell is called a T-cell. It is a cell that normally helps to protects against things like bacteria and viruses. In this case, the donor's T-cells see the body as foreign in the same way they would see bacteria as foreign. GVHD can be fatal. In order to lower the chance that the patient will get GVHD this protocol treatment will remove the T-cells from the donor's cells. This is called T-cell depletion. The T cells are removed by a system called "Clinimacs". This method is still being evaluated through clinical trials and not been approved by the Federal Drug Administration (FDA) at this time.

Before the transplant, the physician will treat the bone marrow to get rid of the cancer. The physician uses three chemotherapy drugs plus ATG. The chemotherapy drugs (Busulfan, Melphalan and Fludarabine) kills the cancer. ATG gets rid of any of the patients T cells that survive the chemotherapy. This ensures that the donor stem cells are not rejected. The patient will also receive additional white blood cells called lymphocytes from the donor. This is called a donor lymphocyte infusion or DLI. These additional infusions will help cause a graft-versus-myeloma effect and can help the donor stem cells grow.

Condition or Disease Intervention/Treatment Phase
  • Drug: busulfan, melphalan and fludarabine
  • Drug: busulfan, melphalan and fludarabine
Phase 2

Study Design

Study Type:
Interventional
Actual Enrollment :
66 participants
Allocation:
Non-Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Trial of Busulfan, Melphalan, Fludarabine and T-Cell Depleted Allogeneic Hematopoietic Stem Cell Transplantation Followed by Post Transplantation Donor Lymphocyte Infusions for Patients With Relapsed or High-Risk Multiple Myeloma
Actual Study Start Date :
May 1, 2010
Actual Primary Completion Date :
May 15, 2020
Actual Study Completion Date :
May 15, 2020

Arms and Interventions

Arm Intervention/Treatment
Experimental: relapsed multiple myeloma

This is a two arm phase II trial to assess the progression-free and overall survival as well as the safety and efficacy of allogeneic hematopoietic stem cell transplantation using a preparative regimen with busulfan, melphalan, fludarabine, and anti-thymocyte globulin (ATG), and a T cell depleted stem cell transplant from a histocompatible related or unrelated donor in patients with relapsed or high-risk multiple myeloma.

Drug: busulfan, melphalan and fludarabine
Patients will be cytoreduced with IV busulfan, melphalan and fludarabine. Busulfan will be administered at a dose of 0.8mg/Kg q6hrs for 10 doses on days -9, -8, -7. Doses for busulfan should be adjusted according to pharmacokinetic studies. Melphalan will be administered at a dose of 70 mg/m2/day for 2 days on days -7, -6. Fludarabine will be administered at a dose of 25 mg/m2/day for 5 days on days -6, -5, -4, -3, -2. Patients will also receive rabbit anti-thymocyte globulin (ATG) to prevent immune mediated graft rejection. The ATG will be administered at a dose of 2.5 mg/Kg/day IV on days -3 and -2. Doses for busulfan, melphalan and ATG should be adjusted if patient is > 125% ideal body weight and should be calculated on adjusted ideal body weight.
Other Names:
  • Doses of fludarabine should be reduced to 80% of dose for measured creatinine
  • clearance of 40-70ml/min. Day - 1 will be a day of rest before receiving the
  • T-cell depleted stem cell product on day 0. The preferred stem cell product
  • will be peripheral blood stem cells but if the donor is unable or unwilling to
  • donate peripheral blood stem cells, bone marrow will be used as the stem cell
  • source. Patients will receive post-transplant G-CSF starting on day +7.
  • Experimental: high-risk multiple myeloma

    This is a two arm phase II trial to assess the progression-free and overall survival as well as the safety and efficacy of allogeneic hematopoietic stem cell transplantation using a preparative regimen with busulfan, melphalan, fludarabine, and anti-thymocyte globulin (ATG), and a T cell depleted stem cell transplant from a histocompatible related or unrelated donor in patients with relapsed or high-risk multiple myeloma.

    Drug: busulfan, melphalan and fludarabine
    Patients will be cytoreduced with IV busulfan, melphalan and fludarabine. Busulfan will be administered at a dose of 0.8mg/Kg q6hrs for 10 doses on days -9, -8, -7. Doses for busulfan should be adjusted according to pharmacokinetic studies. Melphalan will be administered at a dose of 70 mg/m2/day for 2 days on days -7, -6. Fludarabine will be administered at a dose of 25 mg/m2/day for 5 days on days -6, -5, -4, -3, -2. Patients will also receive rabbit anti-thymocyte globulin (ATG) to prevent immune mediated graft rejection. The ATG will be administered at a dose of 2.5 mg/Kg/day IV on days -3 and -2. Doses for busulfan, melphalan and ATG should be adjusted if patient is > 125% ideal body weight and should be calculated on adjusted ideal body weight.
    Other Names:
  • Doses of fludarabine should be reduced to 80% of dose for measured creatinine
  • clearance of 40-70ml/min. Day - 1 will be a day of rest before receiving the
  • T-cell depleted stem cell product on day 0. The preferred stem cell product
  • will be peripheral blood stem cells but if the donor is unable or unwilling
  • to donate peripheral blood stem cells, bone marrow will be used as the stem cell
  • source. Patients will receive post-transplant G-CSF starting on day +7.
  • Outcome Measures

    Primary Outcome Measures

    1. Proportion of Participants With Relapsed Multiple Myeloma With Progression-free (PFS) [2 years]

    Secondary Outcome Measures

    1. Proportion of Participants With Relapsed Multiple Myeloma Alive at 2 Years [2 years]

    2. Number of Participants Who Relapse That Are Restored to Remission (CR) [3 years]

      To compute the current multiple myeloma free survival curve in order to account for patients who relapse and are restored to remission through DLI.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    21 Years to 72 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • Patient must have multiple myeloma that has either relapsed or has high risk cytogenetics.

    • Patients with relapsed multiple myeloma following autologous stem cell transplantation must have achieved at least partial response following additional chemotherapy (cohort 1):

    • Patients are eligible if relapse occurs with complex/high-risk cytogenetics or occurs with normal cytogenetics but within 15 months following the autologous transplant.

    • Patients with high risk cytogenetics at diagnosis must have achieved at least very good partial response following autologous stem cell transplantation (cohort 2):

    • Patients must have complex karyotype, 1q25, del17p, t4;14 and/or t14;16 by FISH and/or del13 by karyotyping.

    DONOR: Patients must have a healthy HLA matched or mismatched related or unrelated donor who is willing to receive G-CSF injections and undergo apheresis for PBSC collection, or undergo a marrow harvesting procedure.

    1. HLA-matched related and unrelated donors Patients who have an HLA-matched related or unrelated donor are eligible for entry on this protocol. This will include a healthy donor who is genotypically matched at all A, B, C, DRB1 and DQB1 locus, loci, as tested by DNA analysis.

    2. HLA- mismatched related and unrelated donors Patients who do not have an HLA-matched donor but have a related or unrelated donor who have one antigen or one allele mismatch at the HLA A, B, C, DRB1 or DQB1 loci; or who have two mismatches, at HLA-DQB1 and at one other locus, will be eligible for entry on this protocol.

    The following inclusion criteria are also required:
    • Patients should be ≥ 21, < 73 years old.

    • Patients may be of either gender or any ethnic background.

    • Patients must have a Karnofsky (adult) or Performance Status ≥ 70%

    • Patients must have adequate organ function measured by:

    Cardiac: asymptomatic or if symptomatic then LVEF at rest must be ≥ 50% and must improve with exercise. Hepatic: < 3x ULN ALT and ≤ 1.5 total serum bilirubin, unless there is congenital benign hyperbilirubinemia.

    Renal: serum creatinine <1.2 mg/dl or if serum creatinine is outside the normal range, then CrCl > 40 ml/min (measured or calculated/estimated) with dose adjustment of Fludarabine for <70ml/min.

    Pulmonary: asymptomatic or if symptomatic, DLCO > 50% of predicted (corrected for hemoglobin)

    • Each patient must be willing to participate as a research subject and must sign an informed consent form.
    Exclusion Criteria:
    • Patients achieving < Partial Response following preceding chemotherapy (cohort 1) or < Very Good Partial Response following autologous stem cell transplantation (cohort 2).

    • Patients with Plasma Cell Leukemia.

    • Female patients who are pregnant or breast-feeding

    • Active viral, bacterial or fungal infection

    • Patient seropositive for HIV-I/II; HTLV -I/II

    • Patients who have undergone prior allogeneic hematopoietic stem cell transplantation.

    • Patients who have had a previous malignancy that is not in remission.

    • Patients with known hypersensitivity to mouse proteins (murine antibodies in ISOLEX) if receiving SBA-E- bone marrow, or chicken egg products.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Memorial Sloan Kettering Cancer Center New York New York United States 10065

    Sponsors and Collaborators

    • Memorial Sloan Kettering Cancer Center
    • Otsuka America Pharmaceutical
    • Ludwig Institute for Cancer Research

    Investigators

    • Principal Investigator: Sergio Giralt, MD, Memorial Sloan Kettering Cancer Center

    Study Documents (Full-Text)

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    Memorial Sloan Kettering Cancer Center
    ClinicalTrials.gov Identifier:
    NCT01131169
    Other Study ID Numbers:
    • 10-051
    First Posted:
    May 26, 2010
    Last Update Posted:
    Dec 2, 2021
    Last Verified:
    Jun 1, 2019

    Study Results

    Participant Flow

    Recruitment Details
    Pre-assignment Detail
    Arm/Group Title Relapsed Multiple Myeloma High-risk Multiple Myeloma
    Arm/Group Description This is a two arm phase II trial to assess the progression-free and overall survival as well as the safety and efficacy of allogeneic hematopoietic stem cell transplantation using a preparative regimen with busulfan, melphalan, fludarabine, and anti-thymocyte globulin (ATG), and a T cell depleted stem cell transplant from a histocompatible related or unrelated donor in patients with relapsed or high-risk multiple myeloma This is a two arm phase II trial to assess the progression-free and overall survival as well as the safety and efficacy of allogeneic hematopoietic stem cell transplantation using a preparative regimen with busulfan, melphalan, fludarabine, and anti-thymocyte globulin (ATG), and a T cell depleted stem cell transplant from a histocompatible related or unrelated donor in patients with relapsed or high-risk multiple myeloma.
    Period Title: Overall Study
    STARTED 47 19
    COMPLETED 47 19
    NOT COMPLETED 0 0

    Baseline Characteristics

    Arm/Group Title Relapsed Multiple Myeloma High-risk Multiple Myeloma Total
    Arm/Group Description This is a two arm phase II trial to assess the progression-free and overall survival as well as the safety and efficacy of allogeneic hematopoietic stem cell transplantation using a preparative regimen with busulfan, melphalan, fludarabine, and anti-thymocyte globulin (ATG), and a T cell depleted stem cell transplant from a histocompatible related or unrelated donor in patients with relapsed or high-risk multiple myeloma This is a two arm phase II trial to assess the progression-free and overall survival as well as the safety and efficacy of allogeneic hematopoietic stem cell transplantation using a preparative regimen with busulfan, melphalan, fludarabine, and anti-thymocyte globulin (ATG), and a T cell depleted stem cell transplant from a histocompatible related or unrelated donor in patients with relapsed or high-risk multiple myeloma. Total of all reporting groups
    Overall Participants 47 19 66
    Age (years) [Mean (Full Range) ]
    Mean (Full Range) [years]
    55.3
    49.5
    54
    Sex: Female, Male (Count of Participants)
    Female
    12
    25.5%
    5
    26.3%
    17
    25.8%
    Male
    35
    74.5%
    14
    73.7%
    49
    74.2%
    Ethnicity (NIH/OMB) (Count of Participants)
    Hispanic or Latino
    5
    10.6%
    2
    10.5%
    7
    10.6%
    Not Hispanic or Latino
    42
    89.4%
    17
    89.5%
    59
    89.4%
    Unknown or Not Reported
    0
    0%
    0
    0%
    0
    0%
    Race (NIH/OMB) (Count of Participants)
    American Indian or Alaska Native
    0
    0%
    0
    0%
    0
    0%
    Asian
    4
    8.5%
    0
    0%
    4
    6.1%
    Native Hawaiian or Other Pacific Islander
    0
    0%
    0
    0%
    0
    0%
    Black or African American
    8
    17%
    2
    10.5%
    10
    15.2%
    White
    34
    72.3%
    17
    89.5%
    51
    77.3%
    More than one race
    0
    0%
    0
    0%
    0
    0%
    Unknown or Not Reported
    1
    2.1%
    0
    0%
    1
    1.5%
    Region of Enrollment (participants) [Number]
    United States
    46
    97.9%
    19
    100%
    65
    98.5%
    Turkey
    1
    2.1%
    0
    0%
    1
    1.5%

    Outcome Measures

    1. Primary Outcome
    Title Proportion of Participants With Relapsed Multiple Myeloma With Progression-free (PFS)
    Description
    Time Frame 2 years

    Outcome Measure Data

    Analysis Population Description
    This objective only applies to Arm I: Participants with Relapsed Multiple Myeloma
    Arm/Group Title Relapsed Multiple Myeloma High-risk Multiple Myeloma
    Arm/Group Description This is a two arm phase II trial to assess the progression-free and overall survival as well as the safety and efficacy of allogeneic hematopoietic stem cell transplantation using a preparative regimen with busulfan, melphalan, fludarabine, and anti-thymocyte globulin (ATG), and a T cell depleted stem cell transplant from a histocompatible related or unrelated donor in patients with relapsed or high-risk multiple myeloma This is a two arm phase II trial to assess the progression-free and overall survival as well as the safety and efficacy of allogeneic hematopoietic stem cell transplantation using a preparative regimen with busulfan, melphalan, fludarabine, and anti-thymocyte globulin (ATG), and a T cell depleted stem cell transplant from a histocompatible related or unrelated donor in patients with relapsed or high-risk multiple myeloma.
    Measure Participants 47 0
    Number (95% Confidence Interval) [Proportion of participants PFS]
    0.31
    0.7%
    2. Secondary Outcome
    Title Proportion of Participants With Relapsed Multiple Myeloma Alive at 2 Years
    Description
    Time Frame 2 years

    Outcome Measure Data

    Analysis Population Description
    This objective is only for participants with relapsed multiple myeloma.
    Arm/Group Title Relapsed Multiple Myeloma High-risk Multiple Myeloma
    Arm/Group Description This is a two arm phase II trial to assess the progression-free and overall survival as well as the safety and efficacy of allogeneic hematopoietic stem cell transplantation using a preparative regimen with busulfan, melphalan, fludarabine, and anti-thymocyte globulin (ATG), and a T cell depleted stem cell transplant from a histocompatible related or unrelated donor in patients with relapsed or high-risk multiple myeloma This is a two arm phase II trial to assess the progression-free and overall survival as well as the safety and efficacy of allogeneic hematopoietic stem cell transplantation using a preparative regimen with busulfan, melphalan, fludarabine, and anti-thymocyte globulin (ATG), and a T cell depleted stem cell transplant from a histocompatible related or unrelated donor in patients with relapsed or high-risk multiple myeloma
    Measure Participants 44 0
    Number (95% Confidence Interval) [Proportion of pts alive at 2 years]
    0.54
    3. Secondary Outcome
    Title Number of Participants Who Relapse That Are Restored to Remission (CR)
    Description To compute the current multiple myeloma free survival curve in order to account for patients who relapse and are restored to remission through DLI.
    Time Frame 3 years

    Outcome Measure Data

    Analysis Population Description
    This group consists of participants with residual disease either because they did not reach CR from salvage and transplant conditioning or because they were given this dose at the time of progression
    Arm/Group Title Relapsed Multiple Myeloma
    Arm/Group Description This is a two arm phase II trial to assess the progression-free and overall survival as well as the safety and efficacy of allogeneic hematopoietic stem cell transplantation using a preparative regimen with busulfan, melphalan, fludarabine, and anti-thymocyte globulin (ATG), and a T cell depleted stem cell transplant from a histocompatible related or unrelated donor in patients with relapsed or high-risk multiple myeloma
    Measure Participants 18
    Restored to CR, did not develop GVHD
    4
    8.5%
    Were not restored to CR, did not develop GVHD
    14
    29.8%

    Adverse Events

    Time Frame Through study completion, an average of 3 years
    Adverse Event Reporting Description
    Arm/Group Title Relapsed Multiple Myeloma High-risk Multiple Myeloma
    Arm/Group Description This is a two arm phase II trial to assess the progression-free and overall survival as well as the safety and efficacy of allogeneic hematopoietic stem cell transplantation using a preparative regimen with busulfan, melphalan, fludarabine, and anti-thymocyte globulin (ATG), and a T cell depleted stem cell transplant from a histocompatible related or unrelated donor in patients with relapsed or high-risk multiple myeloma This is a two arm phase II trial to assess the progression-free and overall survival as well as the safety and efficacy of allogeneic hematopoietic stem cell transplantation using a preparative regimen with busulfan, melphalan, fludarabine, and anti-thymocyte globulin (ATG), and a T cell depleted stem cell transplant from a histocompatible related or unrelated donor in patients with relapsed or high-risk multiple myeloma.
    All Cause Mortality
    Relapsed Multiple Myeloma High-risk Multiple Myeloma
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 17/47 (36.2%) 9/19 (47.4%)
    Serious Adverse Events
    Relapsed Multiple Myeloma High-risk Multiple Myeloma
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 29/47 (61.7%) 11/19 (57.9%)
    Blood and lymphatic system disorders
    Anemia 2/47 (4.3%) 2/19 (10.5%)
    Febrile neutropenia 2/47 (4.3%) 0/19 (0%)
    Cardiac disorders
    Cardiac disorders - Other, specify 1/47 (2.1%) 0/19 (0%)
    Ventricular tachycardia 1/47 (2.1%) 0/19 (0%)
    Eye disorders
    Uveitis 1/47 (2.1%) 0/19 (0%)
    Gastrointestinal disorders
    Abdominal pain 2/47 (4.3%) 1/19 (5.3%)
    Diarrhea 3/47 (6.4%) 4/19 (21.1%)
    Nausea 6/47 (12.8%) 3/19 (15.8%)
    Vomiting 3/47 (6.4%) 1/19 (5.3%)
    General disorders
    Death NOS 9/47 (19.1%) 2/19 (10.5%)
    Death not assoc w CTCAE term-Disease prog NOS 1/47 (2.1%) 0/19 (0%)
    Fatigue 1/47 (2.1%) 0/19 (0%)
    Fever 4/47 (8.5%) 0/19 (0%)
    Gen disorders & admin site conditions Other, spec 1/47 (2.1%) 0/19 (0%)
    Non-cardiac chest pain 1/47 (2.1%) 0/19 (0%)
    Infections and infestations
    Catheter related infection 2/47 (4.3%) 0/19 (0%)
    Inf norm ANC/gr1/2 neut-Pneumonia(lung) 1/47 (2.1%) 2/19 (10.5%)
    Infection, other 1/47 (2.1%) 1/19 (5.3%)
    Infections and infestations - Other, specify 17/47 (36.2%) 4/19 (21.1%)
    Lung infection 7/47 (14.9%) 0/19 (0%)
    Sepsis 4/47 (8.5%) 0/19 (0%)
    Sinusitis 1/47 (2.1%) 1/19 (5.3%)
    Upper respiratory infection 1/47 (2.1%) 0/19 (0%)
    Investigations
    Alanine aminotransferase increased 0/47 (0%) 1/19 (5.3%)
    Alkaline phosphatase increased 0/47 (0%) 1/19 (5.3%)
    Aspartate aminotransferase increased 0/47 (0%) 1/19 (5.3%)
    Blood bilirubin increased 0/47 (0%) 1/19 (5.3%)
    Creatinine increased 0/47 (0%) 1/19 (5.3%)
    Platelet count decreased 0/47 (0%) 2/19 (10.5%)
    Metabolism and nutrition disorders
    Dehydration 2/47 (4.3%) 0/19 (0%)
    Musculoskeletal and connective tissue disorders
    Back pain 1/47 (2.1%) 0/19 (0%)
    Generalized muscle weakness 1/47 (2.1%) 0/19 (0%)
    Neck pain 1/47 (2.1%) 0/19 (0%)
    Pain in extremity 1/47 (2.1%) 0/19 (0%)
    Nervous system disorders
    Dizziness 0/47 (0%) 1/19 (5.3%)
    Lethargy 1/47 (2.1%) 0/19 (0%)
    Nervous system disorders - Other, specify 1/47 (2.1%) 0/19 (0%)
    Neurology - Other (specify) 1/47 (2.1%) 0/19 (0%)
    Vasovagal reaction 1/47 (2.1%) 0/19 (0%)
    Psychiatric disorders
    Confusion 1/47 (2.1%) 0/19 (0%)
    Renal and urinary disorders
    Acute kidney injury 1/47 (2.1%) 0/19 (0%)
    Hematuria 1/47 (2.1%) 1/19 (5.3%)
    Urinary tract pain 1/47 (2.1%) 1/19 (5.3%)
    Urinary urgency 1/47 (2.1%) 0/19 (0%)
    Respiratory, thoracic and mediastinal disorders
    Dyspnea 3/47 (6.4%) 1/19 (5.3%)
    Hypoxia 3/47 (6.4%) 0/19 (0%)
    Pneumonitis 1/47 (2.1%) 0/19 (0%)
    Resp, thoracic & mediastinal disorder Other, spec 0/47 (0%) 1/19 (5.3%)
    Sore throat 1/47 (2.1%) 0/19 (0%)
    Skin and subcutaneous tissue disorders
    Rash maculo-papular 2/47 (4.3%) 1/19 (5.3%)
    Vascular disorders
    Hypotension 2/47 (4.3%) 0/19 (0%)
    Thromboembolic event 2/47 (4.3%) 0/19 (0%)
    Other (Not Including Serious) Adverse Events
    Relapsed Multiple Myeloma High-risk Multiple Myeloma
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 47/47 (100%) 19/19 (100%)
    Gastrointestinal disorders
    Mucositis oral 5/47 (10.6%) 6/19 (31.6%)
    General disorders
    Pain 3/47 (6.4%) 0/19 (0%)
    Fatigue 4/47 (8.5%) 3/19 (15.8%)
    Investigations
    Weight loss 5/47 (10.6%) 5/19 (26.3%)
    Activated partial thromboplastin time prolonged 7/47 (14.9%) 3/19 (15.8%)
    Alanine aminotransferase increased 33/47 (70.2%) 12/19 (63.2%)
    Alkaline phosphatase increased 22/47 (46.8%) 7/19 (36.8%)
    Aspartate aminotransferase increased 30/47 (63.8%) 10/19 (52.6%)
    Metabolism and nutrition disorders
    Hypomagnesemia 3/47 (6.4%) 0/19 (0%)
    Hypoglycemia 5/47 (10.6%) 3/19 (15.8%)
    Hypertriglyceridemia 5/47 (10.6%) 0/19 (0%)
    Hypermagnesemia 6/47 (12.8%) 4/19 (21.1%)
    Anorexia 6/47 (12.8%) 6/19 (31.6%)
    Renal and urinary disorders
    Renal and urinary disorders - Other, specify 3/47 (6.4%) 0/19 (0%)
    Vascular disorders
    Hypotension 3/47 (6.4%) 0/19 (0%)

    Limitations/Caveats

    [Not Specified]

    More Information

    Certain Agreements

    All Principal Investigators ARE 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/Title Sergio Giralt, MD
    Organization Memorial Sloan Kettering Cancer Center
    Phone 646-608-3731
    Email GiraltS@mskcc.org
    Responsible Party:
    Memorial Sloan Kettering Cancer Center
    ClinicalTrials.gov Identifier:
    NCT01131169
    Other Study ID Numbers:
    • 10-051
    First Posted:
    May 26, 2010
    Last Update Posted:
    Dec 2, 2021
    Last Verified:
    Jun 1, 2019