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NCT01251952 · REGISTRY CONDITION SEARCH

Dose Escalation Trial of Denileukin Diftitox (Ontak) Post Autologous Transplantation

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

Phase
PHASE1
Status at capture
TERMINATED
Registry last update
2017-06-20

The primary goal of this study is to determine the feasibility and safety of giving two doses of denileukin diftitox (DD) at days 0 and 21 post autologous stem cell transplantation in a dose escalation fashion. Secondary goals include evaluating the the effect of DD on the number and percentage of T-regs in the peripheral blood post transplant at each dose level, the effect of DD on T cell (CD4/CD8) reconstitution post transplant at each dose level and determining the time to engraftment: absolute neutrophil count (\>0.5 x 10\^9/L for 3 consecutive days), and platelet (\>20X 10\^9/L for 3 consecutive days). The hypothesis for the study is based on the ability of DD to deplete T-regs and subsequently enhance the immune reconstitution and reverse post transplant lymphopenia. This may indirectly enhance the efficacy of autologous transplantation and reduce disease relapse.

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

Assess Toxicities of Giving Two Doses of Ontak at Days 0 and 21 Post Autologous Stem Cell Transplantation in a Dose Escalation Fashion.

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outcome · NOT POSTED

To Evaluate the Effect of Ontak on the Number and Percentage of Regulatory T Cells in the Peripheral Blood Post Transplant at Each Dose Level.

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outcome · NOT POSTED

To Evaluate the Effect of Ontak on T Cell CD4/CD8 Reconstitution Post Transplant at Each Dose.

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outcome · NOT POSTED

To Evaluate the Effect of Ontak on Engraftment of Neutrophils and Platelets Post Transplant at Each Dose.

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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
Inclusion Criteria: All patients age \> =18 who have been diagnosed with Multiple Myeloma and are scheduled for autologous peripheral blood hematopoietic stem cell transplant (AHSCT) will be screened for eligibility. Patients must fulfill all of the following inclusion criteria to be eligible for this study: 1. Diagnosis of Multiple Myeloma 2. Age \>=18 and no more than 70 years. 3. Able to understand and sign a consent form. 4. Can collect peripheral blood stem cells with a CD34+ cell dose of at least 5.0 x 106/kg. The CD34 molecule is a Cluster of Differentiation molecule present on hematopoietic stem cells. 5. Conditioning regimen to be high dose Melphalan at a dose of 200mg/m2. 6. Karnofsky Performance Score (KPS) \>60 or ECOG (Eastern Cooperative Oncology Group) performance status \<=2 7. Kidney function:Creatinine \<2.0 mg/dl or creatinine clearance \>50 ml/min 8. Heart function: Ejection fraction \>45% 9. Liver function tests :Serum bilirubin, alanine aminotransferase (ALT), aspartate aminotransferase (AST) less than 3 X upper limit of normal 10. Lung function tests: Forced Vital Capacity (FVC), Forced Expiratory Volume in One Second (FEV1) or Diffusing Capacity of the Lung for Carbon Monoxide (DLCO) \>45% predicted Exclusion Criteria: 1. Age \<18 years or \> 70 years 2. Previous exposure to denileukin diftitox. 3. Patients with documented uncontrolled central nervous system (CNS) disease. 4. Previous AHSCT. 5. Significant organ dysfunction deemed to be inappropriate for autologous transplantation.
healthy Volunteers
false
maximum Age
70 Years
minimum Age
18 Years
sex
ALL
std Ages
  1. ADULT
  2. OLDER_ADULT
Treatment arms and interventions
arm Groups
  1. description
    Denileukin Diftitox (Ontak) administered Post Autologous Transplantation.
    intervention Names
    1. Drug: Denileukin Diftitox (Ontak)
    label
    Denileukin Diftitox (Ontak)
    type
    EXPERIMENTAL
interventions
  1. arm Group Labels
    1. Denileukin Diftitox (Ontak)
    description
    After receiving their stem cell transplant on Day 0, participants will receive study agent via a 30 minute infusion. Participants will also receive a 30 minute infusion of study agent on Day 21. Follow-up visits for clinical assessment, blood draws for routine clinical laboratory studies and for immuno-correlative studies will also take place on days 42, 90, 180 and 360.
    name
    Denileukin Diftitox (Ontak)
    other Names
    1. Ontak®
    type
    DRUG
Study design
allocation
NON_RANDOMIZED
intervention Model
SINGLE_GROUP
masking Info
masking
NONE
primary Purpose
TREATMENT
Enrollment
count
2
type
ACTUAL
Registered outcome plans (not posted results)
primary Outcomes
  1. description
    After drug infusion, participants will be closely monitored for at least 4 hours for side effects
    measure
    Assess Toxicities of Giving Two Doses of Ontak at Days 0 and 21 Post Autologous Stem Cell Transplantation in a Dose Escalation Fashion.
    time Frame
    Up to 21 days post transplant
secondary Outcomes
  1. measure
    To Evaluate the Effect of Ontak on the Number and Percentage of Regulatory T Cells in the Peripheral Blood Post Transplant at Each Dose Level.
    time Frame
    days 0 and 21 post autologous stem cell transplantation
  2. measure
    To Evaluate the Effect of Ontak on T Cell CD4/CD8 Reconstitution Post Transplant at Each Dose.
    time Frame
    days 0 and 21 post autologous stem cell transplantation
  3. description
    During hospitalization stay (approximately 2 weeks), participants will receive injections of G-CSF on a daily basis starting on Day 6 and ending when white blood cells have engrafted. Participants usually remain hospitalized until engraftment.
    measure
    To Evaluate the Effect of Ontak on Engraftment of Neutrophils and Platelets Post Transplant at Each Dose.
    time Frame
    days 0 and 21 post autologous stem cell transplantation
Full study description
brief Summary
The primary goal of this study is to determine the feasibility and safety of giving two doses of denileukin diftitox (DD) at days 0 and 21 post autologous stem cell transplantation in a dose escalation fashion. Secondary goals include evaluating the the effect of DD on the number and percentage of T-regs in the peripheral blood post transplant at each dose level, the effect of DD on T cell (CD4/CD8) reconstitution post transplant at each dose level and determining the time to engraftment: absolute neutrophil count (\>0.5 x 10\^9/L for 3 consecutive days), and platelet (\>20X 10\^9/L for 3 consecutive days). The hypothesis for the study is based on the ability of DD to deplete T-regs and subsequently enhance the immune reconstitution and reverse post transplant lymphopenia. This may indirectly enhance the efficacy of autologous transplantation and reduce disease relapse.
Source references
Source notices and limitations
    Discovery and provenance
    1. release id
      ctgov-registry-1336d216cbd1bbff780dac70
      edge id
      nct-edge-5b4451d24cdaacb3fe50
      requested nct id
      NCT01251952
      primary nct id
      NCT01251952
      source kind
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      source record id
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      source file sha256
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      payload sha256
      c12596a3c14f75f8a4bda3d8766c00a5f32f0ce4973301c06988da5940f2c7ed
      payload
      clinical indication matching status
      condition_index_match_asserted_by_registry_not_reviewed
      end exclusive
      true
      id
      nct-edge-5b4451d24cdaacb3fe50
      link basis
      returned_by_explicit_condition_and_posted_results_filter_query
      nct id
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      occurrences
      1. context exact
        NCT01251952
        end
        11
        exact text
        NCT01251952
        start
        0
      offset unit
      unicode_code_points
      query cond
      Plasma Cell Neoplasms
      query disease state id
      ds-plasma-cell-neoplasms
      source file
      /Users/arunverma/Documents/ChatGPT/Cancer Statistics Website/research-data/2026-09-10/clinicaltrials-condition/round-0000/raw/cond-plasma-cell-neoplasms-000.json
      source file sha256
      2314ce01316b2d7044d298c6d25eda12e99cc5f44273bc75efed6cd5e03a8c14
      source json pointer
      /studies/556/protocolSection/identificationModule/nctId
      source kind
      ctgov_condition_query
      source record id
      Source null
      source string basis
      parsed_JSON_string_unmodified
      source string sha256
      eafe5e287b0c4d5d7522aac8a99aafc26c5914a85fb11e82196adb9e6fc124c1

    Preserved source evidence · Not medical advice