Clinical trial · Interventional
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
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Multiple Myeloma | Multiple Myeloma | CURATED_EXACT | 0.92 |
Interventions
Interventions (7)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Activated marrow infiltrating lymphocytes | Biological | — | UNRESOLVED |
| Allogeneic Myeloma Vaccine | Biological | — | UNRESOLVED |
| Autologous stem cell transplant | Biological | — | UNRESOLVED |
| Cyclophosphamide | Drug | Cyclophosphamide | ALIAS |
| Filgrastim | Biological | Filgrastim | ALIAS |
| Leukapheresis | Procedure | — | UNRESOLVED |
| Melphalan | Drug | Melphalan | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- ASCT + MILs
- description
- Cyclophosphamide and filgrastim will be given to mobilize peripheral blood stem cells. Leukapheresis will be performed to collect peripheral blood from which activated marrow infiltrating lymphocytes will be produced. A melphalan conditioning regimen will be used prior to autologous stem cell transplant, and the MILs product will be administered on Days 3 and 4.
- interventionNames
- Biological: Activated marrow infiltrating lymphocytes
- Drug: Cyclophosphamide
- Biological: Filgrastim
- Procedure: Leukapheresis
- Drug: Melphalan
- Biological: Autologous stem cell transplant
- type
- EXPERIMENTAL
- label
- ASCT + MILs + vaccine
- description
- Cyclophosphamide and filgrastim will be given to mobilize peripheral blood stem cells. Leukapheresis will be performed to collect peripheral blood from which activated marrow infiltrating lymphocytes will be produced. A melphalan conditioning regimen will be used prior to autologous stem cell transplant, and the MILs product will be administered on Days 3 and 4. The allogeneic myeloma vaccine will be administered on Days 21, 60, 180, and 300.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 70 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available