Phase 2
Completed N=35
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
Source: ClinicalTrials.gov NCT01045460 ↗Enrolled (actual)
35
Serious AEs
0.0%
Results posted
Oct 2019
Primary outcomePrimary: Response Rates by Blade Criteria — 2; 5; 3; 2 Participants
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Response Rates by Blade Criteria |
2; 5; 3; 2; 1; 1 | — |
| SECONDARY Progression-free Survival |
15.5; 18.6 | — |
| SECONDARY Overall Survival |
7; 9 | — |
| SECONDARY Feasibility as Measured by Participant Withdrawal or Removal |
3; 3 | — |
| SECONDARY Safety as Measured by Grade 3-5 Adverse Events |
0; 1 | — |
| SECONDARY Anti-tumor Immune Response |
— | — |
| SECONDARY The Effect of aMILs on Osteoclastogenesis as Measured by Bone Turnover (RANKL/OPG Ratio) |
— | — |
| SECONDARY The Effect of aMILs on Osteoclastogenesis as Measured by Bone Turnover (Serum C Telopeptide Levels) |
— | — |
| SECONDARY The Effect of aMILs on Osteoclastogenesis as Measured by Bone Turnover (bAlkaline Phosphatase Levels) |
— | — |
| SECONDARY The Effect of aMILs on Osteoclastogenesis as Measured by Bone Turnover (Osteocalcin Levels) |
— | — |
| SECONDARY Effect of aMILs on Clonogenic Myeloma Precursors |
— | — |
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
Data sourced from ClinicalTrials.gov (NCT01045460). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.