Phase 2
N=25
Activated White Blood Cells With ASCT for Newly Diagnosed Multiple Myeloma
Multiple Myeloma and Plasma Cell Neoplasm
Bottom Line
View on ClinicalTrials.gov: NCT00566098 ↗Enrolled (actual)
25
Serious AEs
4.6%
Results posted
Dec 2018
Primary outcome: Primary: Hematopoietic Engraftment — 17.9 days
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- MILs (Biological); Melphalan (Drug); PCV13 (Biological)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
- Primary completion
- Jun 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Hematopoietic Engraftment |
17.9 | — |
| PRIMARY Disease Response |
7; 6; 6; 3 | — |
| PRIMARY Feasibility of MILs Generation as Assessed by Percentage of Participants With Successful MIL Generation |
100 | — |
| SECONDARY T-cell Reconstitution as Determined by Absolute Lymphocyte Count (ALC) |
756; 1768; 1700; 1430; 1660 | — |
| SECONDARY Survival |
112.1; 12.3 | — |
| SECONDARY Pneumococcal-specific Vaccine Responses |
21.5; 14.4; 23.4; 20.1 | — |
| SECONDARY Anti-tumor Immune Responses |
1.58; 14.1; 18.1; 12.7 | — |
Summary
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.
Eligibility Criteria
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
- Radiotherapy
Data sourced from ClinicalTrials.gov (NCT00566098). 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.