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Adoptive Cellular Immunotherapy Following Autologous Peripheral Blood Stem Cell Transplantation for Multiple Myeloma

This study is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00439465
First Posted: February 23, 2007
Last Update Posted: May 24, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
The Leukemia and Lymphoma Society
Information provided by (Responsible Party):
Dartmouth-Hitchcock Medical Center
  Purpose

The purpose of this study is to determine whether the administration of highly effective "killer" cells (cytotoxic T cells), along with IL-2 and GM-CSF immediately following Autologous Peripheral Blood Stem Cell Transplantation (APBSCT) will enhance anti-tumor immune reconstitution and improve outcome of Multiple Myeloma patients.

The overall hypothesis of this proposal is that immediately following APBSCT the immune reconstitution is optimal to administer "killer" cells, combined with the administration of IL-2 and GM-CSF.


Condition Intervention Phase
Myeloma Transplant-eligible Patients Biological: Autologous ex-vivo expanded effector cells Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Adoptive Cellular Immunotherapy Following Autologous Peripheral Blood Stem Cell Transplantation for Multiple Myeloma

Resource links provided by NLM:


Further study details as provided by Dartmouth-Hitchcock Medical Center:

Primary Outcome Measures:
  • To establish the safety (toxicity), time to engraftment and clinical outcomes of myeloma patients treated with high dose melphalan, APBSCT& adoptive transfer of cytotoxic effector cells with IL-2 and GM-CSF. [ Time Frame: From initiation of treatment on protocol until Day 100 ]

Secondary Outcome Measures:
  • Identify CD8+ effector cell-versus-myeloma effects in vivo by determining recovery,function& mechanism of tumor cell killing of PB CD8+ cells prior to& after completing therapy. [ Time Frame: From initiation of treatment on protocol until Day 100 ]

Estimated Enrollment: 20
Study Start Date: January 2007
Estimated Study Completion Date: December 2018
Estimated Primary Completion Date: February 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Autologous ex-vivo expanded effector cells
Infusing IL-2 and GM-CSF post-HCST
Biological: Autologous ex-vivo expanded effector cells
This trial will test if the combination of infusing ex vivo expanded cytotoxic effector cells with IL-2 and GM-CSF post-transplant will accelerate immune reconstitution, resulting in an effector cell-versus-myeloma effect and, possibly, improved clinical outcomes.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

Multiple Myeloma:

  • Patients must meet criteria for diagnosis of Multiple Myeloma.
  • Patient must meet either criterion listed below:

    • Stage I, II, or III newly diagnosed multiple myeloma
    • Progressive or relapsed disease in PR or CR
    • Primary refractory disease.
    • Relapsed refractory disease.
    • Patients may have received a prior autologous transplant.
  • The patients must have recovered from all serious and life threatening effects of previous treatment at the time of study entry (unless this abnormality is believed to be due to the underlying myeloma).
  • The patient must have adequate bone marrow function, i.e. a total WBC of > 2,000/ul, a Hgb of > 7 gm/dl, and a platelet count of > 50,000/ul, unless this abnormality is believed to be due to the underlying myeloma.
  • The patient must have adequate liver function, i.e. bilirubin <2.0 mg/dl, SGOT, SGPT not greater than 2 times the upper normal limit (unless this abnormality is believed to be due to the underlying myeloma).
  • The patient must have adequate renal function, i.e. serum creatinine < 3.0 mg/dl, and/or creatinine clearance >50 ml/min. This eligibility criterion is excluded if renal insufficiency is believed to be secondary to myeloma.
  • Age >18 years and < 75 years old
  • The patient must have a Karnofsky status > 80%
  • Patients must have a life expectancy of at least 12 weeks
  • Left ventricular ejection fraction of > 45% by radionuclide scan or echocardiography
  • Pulmonary function tests: forced vital capacity, DLCO and FEV1 must be > 50% of predicted
  • No significant co-morbid medical or psychiatric illness which would significantly compromise the patient's clinical care and chances of survival.
  • Informed written consent must be obtained. Patients must be able to give informed consent as a prerequisite to this procedure. The Informed Consent form will become part of his/her permanent record and a copy will be given to the patient

Exclusion Criteria:

  • Medical, social, or psychological factors which would prevent the patient from receiving or cooperating with the full course of therapy.
  • Evidence on physical exam, LP, CT, or MRI scan of CNS involvement with malignancy
  • Any clinically significant cardiac disease (angina, myocardial infarction, congestive heart failure, ventricular arrhythmias requiring therapy) or clinically significant obstructive/restrictive pulmonary disease
  • Serology positive for HIV or HTLVI
  • Active hepatitis B or C
  • History of seizures
  • Concurrent or expected need for therapy with corticosteroids
  • Active connective tissue disease
  • Current "clinically significant" pleural effusion, pericardial effusion, or ascites
  • Positive pregnancy test or presence of lactation
  • Collection of fewer than 1 x 106 CD34+ cells/kg (peripheral blood stem cells). If the apheresis collection is inadequate based on this criteria, the patient will be removed from protocol and a marrow harvest may be performed
  • A history of a second malignancy (other then squamous cell/ basal cell carcinoma of the skin or cervical dysplasia) must be reviewed by the Principal Investigator, before inclusion or exclusion in the study. Based upon the PI's review, this patient may be eligible (i.e., distant past history of a malignancy)
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00439465


Locations
United States, New Hampshire
Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, United States, 03756
Sponsors and Collaborators
Dartmouth-Hitchcock Medical Center
The Leukemia and Lymphoma Society
Investigators
Principal Investigator: Kenneth Meehan, MD Dartmouth-Hitchcock Medical Center
  More Information

Responsible Party: Dartmouth-Hitchcock Medical Center
ClinicalTrials.gov Identifier: NCT00439465     History of Changes
Other Study ID Numbers: D0717
LLS-6061-06
First Submitted: February 21, 2007
First Posted: February 23, 2007
Last Update Posted: May 24, 2016
Last Verified: May 2016

Additional relevant MeSH terms:
Multiple Myeloma
Neoplasms, Plasma Cell
Neoplasms by Histologic Type
Neoplasms
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Paraproteinemias
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Lymphoproliferative Disorders
Immunoproliferative Disorders
Immune System Diseases