Overview

This trial is active, not recruiting.

Condition multiple myeloma
Treatments amils, allogeneic myeloma vaccine
Phase phase 2
Sponsor Sidney Kimmel Comprehensive Cancer Center
Start date December 2009
End date December 2014
Trial size 32 participants
Trial identifier NCT01045460, J0997, NA_00029491

Summary

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
aMILs
amils
Activated marrow infiltrating lymphocytes
(Experimental)
aMILs + allogeneic myeloma vaccine
amils
Activated marrow infiltrating lymphocytes
allogeneic myeloma vaccine
Allogeneic granulocyte macrophage colony-stimulating factor (GM-CSF)-based myeloma cellular vaccine

Primary Outcomes

Measure
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

Secondary Outcomes

Measure
Evaluate Progression-free Survival and Overall Survival
time frame: Days 60, 180, and 360
Anti-tumor immune response
time frame: Days 60, 180, and 360
The effect of aMILs on osteoclastogenesis
time frame: Days 60, 180, and 360
Effect of aMILs on clonogenic myeloma precursors
time frame: Days 60, 180, and 360

Eligibility Criteria

Male or female participants from 18 years up to 70 years old.

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

Additional Information

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
Trial information was received from ClinicalTrials.gov and was last updated in April 2015.
Information provided to ClinicalTrials.gov by Sidney Kimmel Comprehensive Cancer Center.