Trial of Activated Marrow Infiltrating Lymphocytes Alone or in Conjunction With an Allogeneic Granulocyte Macrophage Colony-stimulating Factor (GM-CSF)-Based Myeloma Cellular Vaccine in the Autologous Transplant Setting in Multiple Myeloma (aMILs)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Sidney Kimmel Comprehensive Cancer Center
ClinicalTrials.gov Identifier:
NCT01045460
First received: December 14, 2009
Last updated: September 20, 2013
Last verified: September 2013
  Purpose

Patient Population: Patients with active myeloma (Stage II/III) that have completed induction therapy and are eligible for an autologous stem cell transplant.

Number of Patients: Will treat a total of 32 evaluable patients in a 1:1 randomization of aMILs vs aMILs plus vaccine. An evaluable patient is defined as one which has received the activated MILs and is at least 6 months post-transplant.

Study Objectives:

Disease response as determined by the Blade' criteria will be the primary endpoint of the trial at one year.

Additional study endpoints include progression free survival, parameters of T cell reconstitution, anti-tumor immune responses as well as the effect on osteoclastogenesis and clonogenic myeloma precursor cells.


Condition Intervention Phase
Multiple Myeloma
Biological: aMILs
Biological: Allogeneic Myeloma Vaccine
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Randomized Trial of Activated Marrow Infiltrating Lymphocytes Alone or in Conjunction With an Allogeneic GM-CSF-based Myeloma Cellular Vaccine in the Autologous Transplant Setting in Multiple Myeloma

Resource links provided by NLM:


Further study details as provided by Sidney Kimmel Comprehensive Cancer Center:

Primary Outcome Measures:
  • Evaluate clinical efficacy of activated marrow infiltrating lymphocytes (aMILs) administered alone or in combination with allogeneic myeloma cell vaccine combined with GM-CSF producing bystander cell in patients undergoing an ASCT for multiple myeloma. [ Time Frame: Days 60, 180, and 360 ] [ Designated as safety issue: No ]

    2.1.1 Evaluate Response Rates utilizing the Blade' criteria

    • Complete Response (CR) rate
    • Near Complete Response (nCR) rate
    • Very Good Partial Response (VGPR) rate
    • Partial Response (PR) rate
    • Minimal Response (MR) rate
    • Overall response rate (CR, VGPR, PR)


Secondary Outcome Measures:
  • Evaluate Progression-free Survival and Overall Survival [ Time Frame: Days 60, 180, and 360 ] [ Designated as safety issue: Yes ]
    Patients will be monitored for progression/relapse on Days 60, 180, and 360, and as clinically indicated. Following one year follow-up, patients will be followed annually for the next four years.

  • Anti-tumor immune response [ Time Frame: Days 60, 180, and 360 ] [ Designated as safety issue: No ]
    • Evaluate tumor specific responses in blood and bone marrow
    • Examine T cell responses to DC-pulsed myeloma cell lines
    • Examine induction of novel antibody responses

  • The effect of aMILs on osteoclastogenesis [ Time Frame: Days 60, 180, and 360 ] [ Designated as safety issue: No ]

    Parameters of bone turnover that will include:

    • RANKL/OPG ratio
    • Serum C Telopeptide levels
    • bAlkaline phosphatase and osteocalcin

  • Effect of aMILs on clonogenic myeloma precursors [ Time Frame: Days 60, 180, and 360 ] [ Designated as safety issue: No ]
    • Examine side population of CD19 enriched PBLs throughout study.


Estimated Enrollment: 32
Study Start Date: December 2009
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
aMILs
Biological: aMILs
Activated marrow infiltrating lymphocytes
Experimental: 2
aMILs + allogeneic myeloma vaccine
Biological: aMILs
Activated marrow infiltrating lymphocytes
Biological: Allogeneic Myeloma Vaccine
Allogeneic granulocyte macrophage colony-stimulating factor (GM-CSF)-based myeloma cellular vaccine

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Durie-Salmon Stage II or III multiple myeloma
  • Newly diagnosed either prior to receiving treatment or having completed induction therapy
  • Relapsed myeloma not previously transplanted within the past 5 years
  • Measurable serum and/or urine M-protein from prior to induction therapy documented and available. A positive serum free lite assay is acceptable
  • Age greater than 18 years old
  • ECOG performance status of 0 - 2
  • Meet all institutional requirements for autologous stem cell transplantation
  • The patient must be able to comprehend and have signed the informed consent

Exclusion Criteria:

  • Diagnosis of any of the following plasma cell disorders: POEMS syndrome (plasma cell dyscrasia with polyneuropathy, organomegaly, endocrinopathy, monoclonal protein [M-protein] and skin changes) Non-secretory myeloma (no measurable protein on Serum Free Lite Assay)
  • Plasma cell leukemia
  • Amyloidosis
  • Use of corticosteroids (glucocorticoids) within 21 days of pre-transplant vaccine or bone marrow collection
  • Use of any myeloma-specific therapy other than lenalidomide within 21 days of pre-transplant vaccine
  • In a complete remission at the time of bone marrow collection
  • Infection requiring treatment with antibiotics, antifungal, or antiviral agents within seven days of vaccination or bone marrow collection
  • Participation in any clinical trial, within four weeks prior to vaccination or bone marrow collection on this trial, which involved an investigational drug or device
  • History of malignancy other than multiple myeloma within five years of vaccination or bone marrow collection, except adequately treated basal or squamous cell skin cancer
  • Active autoimmune disease (e.g., rheumatoid arthritis, multiple sclerosis, systemic lupus erythematosis) requiring systemic treatment. Hypothyroidism without evidence of Grave's Disease or Hashimoto's thyroiditis is permitted
  • Evidence of spinal cord compression at time of transplant
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01045460

Locations
United States, Maryland
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Baltimore, Maryland, United States, 21231
Sponsors and Collaborators
Sidney Kimmel Comprehensive Cancer Center
  More Information

No publications provided

Responsible Party: Sidney Kimmel Comprehensive Cancer Center
ClinicalTrials.gov Identifier: NCT01045460     History of Changes
Other Study ID Numbers: J0997, NA_00029491
Study First Received: December 14, 2009
Last Updated: September 20, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Sidney Kimmel Comprehensive Cancer Center:
Patients with active myeloma (Stage II/III) that have completed induction therapy and are eligible for an autologous stem cell transplant

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

ClinicalTrials.gov processed this record on October 30, 2014