Clinical trial · Interventional
Activated White Blood Cells With ASCT for Newly Diagnosed Multiple Myeloma
Adoptive Immunotherapy Utilizing Activated Marrow Infiltrating Lymphocytes 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)
RATIONALE: Activating white blood cells in the laboratory may help them kill more cancer cells when they are put back in the body. This may be an effective treatment for patients undergoing a stem cell transplant for multiple myeloma. PURPOSE: This phase I/II trial is studying the side effects of activated white blood cells and to see how well they work in treating patients who are undergoing a stem cell transplant for newly diagnosed stage II or stage III multiple myeloma.
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 and Plasma Cell Neoplasm | — | UNRESOLVED | — |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Melphalan | Drug | Melphalan | ALIAS |
| MILs | Biological | — | UNRESOLVED |
| PCV13 | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- ASCT+MILs
- description
- Autologous stem cell transplant with a conditioning regimen of melphalan 100 mg/m\^2 on each of Days -2 and -1. Infusion of activated marrow infiltrating lymphocytes (MILs) on Day 3. PCV13 vaccine will be given before and/or after Day 0 depending on when participants are enrolled.
- interventionNames
- Biological: MILs
- Drug: Melphalan
- Biological: PCV13
Primary outcomes (3)
- measure
- Hematopoietic Engraftment
- timeFrame
- Up to 1 year
- description
- Days to absolute neutrophil count \> 500 cells per microliter.
- measure
- Disease Response
- timeFrame
- Up to 2 years
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS:
* Diagnosis of multiple myeloma
* Newly diagnosed disease
* Durie-Salmon stage II or III disease
* Measurable disease, defined by any of the following:
* Measurable serum and/or urine M-protein levels documented and available prior to induction therapy
* Positive serum free light chain assay
* Must have completed a minimum of 3 courses of myeloma specific therapy
* Candidate for autologous stem cell transplantation
* Patients who have achieved a complete remission at the time of bone marrow harvest for marrow infiltrating lymphocytes (MILs) expansion are not eligible
* No evidence of spinal cord compression
* Diagnosis of the following cancers are not allowed:
* POEMS syndrome (plasma cell dyscrasia with polyneuropathy, organomegaly, endocrinopathy, monoclonal protein and skin changes)
* Non-secretory myeloma (no measurable protein on serum free light chain assay)
* Plasma cell leukemia
* No amyloidosis
PATIENT CHARACTERISTICS:
* ECOG performance status 0-2
* Life expectancy ≥ 6 months
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception during and up to day 180
* Corrected serum calcium \< 11 mg/dL and no evidence of symptomatic hypercalcemia
* Total bilirubin ≤ 2.0 times upper limit of normal (ULN)
* ALT ≤ 2.0 times ULN
* Serum creatinine \< 2.0 mg/dL
* No history of other malignancy within the past 5 years, except adequately treated basal cell or squamous cell skin cancer
* No history of autoimmune disease (e.g., rheumatoid arthritis, multiple sclerosis, systemic lupus erythematosus) requiring systemic treatment
* Hypothyroidism without evidence of Graves' disease or Hashimoto thyroiditis is allowed
* No infection requiring treatment with antibiotics, antifungal, or antiviral agents within the past 7 days
* No HIV infection
* No major organ system dysfunction including, but not limited to, the following:
* New York Heart Association class III or IV congestive heart failure
* Pulmonary disease requiring the use of inhaled steroids or bronchodilators
* Renal, hepatic, gastrointestinal, neurologic, or psychiatric dysfunction that would impair ability to participate in the study
PRIOR CONCURRENT THERAPY:
* See Disease Characteristics
* No prior hematopoietic stem cell transplantation
* At least 3 weeks since prior corticosteroids (i.e., glucocorticoids)
* At least 3 weeks since prior myeloma-specific therapy
* At least 4 weeks since participation in any clinical trial that involved an investigational drug or device
* No concurrent therapy with any of the following:
* Corticosteroids (e.g., hydrocortisone, prednisone, prednisolone, dexamethasone \[Decadron\])
* Inhaled steroids used for treatment of allergic rhinitis or pulmonary disease allowed
* Thalidomide
* Interferon
* Growth factors, interleukins, or other cytokines (except filgrastim \[G-CSF\] as outlined in the protocol, or erythropoietin)
* Cytotoxic chemotherapy agents (except cyclophosphamide for stem cell mobilization and high-dose melphalan)
* Immunosuppressive drugs
* Experimental therapies
* RadiotherapyReferences
Publications (1)
- RESULTNoonan KA, Huff CA, Davis J, Lemas MV, Fiorino S, Bitzan J, Ferguson A, Emerling A, Luznik L, Matsui W, Powell J, Fuchs E, Rosner GL, Epstein C, Rudraraju L, Ambinder RF, Jones RJ, Pardoll D, Borrello I. Adoptive transfer of activated marrow-infiltrating lymphocytes induces measurable antitumor immunity in the bone marrow in multiple myeloma. Sci Transl Med. 2015 May 20;7(288):288ra78. doi: 10.1126/scitranslmed.aaa7014. PMID 25995224