Clinical trial NCT01045460: 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
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Multiple Myeloma
Keywords: multiple myeloma
Lead sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Sponsor class: OTHER
First posted: 2010-01-11
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


Eligibility 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

Primary outcomes:
measure: Response Rates by Blade Criteria
timeFrame: Up to 1 year
Secondary outcomes:
measure: Progression-free Survival
timeFrame: Up to 5 years
measure: Overall Survival
timeFrame: Up to 5 years
measure: Feasibility as Measured by Participant Withdrawal or Removal
timeFrame: Up to 1 year
measure: Safety as Measured by Grade 3-5 Adverse Events
timeFrame: Up to 1 year
measure: Anti-tumor Immune Response
timeFrame: Days 60, 180, and 360
measure: The Effect of aMILs on Osteoclastogenesis as Measured by Bone Turnover (RANKL/OPG Ratio)
timeFrame: Days 60, 180, and 360
measure: The Effect of aMILs on Osteoclastogenesis as Measured by Bone Turnover (Serum C Telopeptide Levels)
timeFrame: Days 60, 180, 360
measure: The Effect of aMILs on Osteoclastogenesis as Measured by Bone Turnover (bAlkaline Phosphatase Levels)
timeFrame: Days 60, 180, 360
measure: The Effect of aMILs on Osteoclastogenesis as Measured by Bone Turnover (Osteocalcin Levels)
timeFrame: Days 60, 180, 360
measure: Effect of aMILs on Clonogenic Myeloma Precursors
timeFrame: Days 60, 180, and 360
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
state: Maryland
Study officials:
affiliation: Johns Hopkins University
name: Ivan Borrello, MD
role: PRINCIPAL_INVESTIGATOR
References: