About this trial
This phase II trial compares standard consolidation with daratumumab, carfilzomib, lenalidomide, and dexamethasone to consolidation with teclistamab following standard induction therapy and autologous hematopoietic stem cell transplant for improving overall survival of patients with plasma cell leukemia. Consolidation therapy is treatment given after initial therapy to kill any cancer cells that may remain in the body. Daratumumab is in a class of medications called monoclonal antibodies. It binds to a protein called CD38, which is found on some types of immune cells and cancer cells, including myeloma cells. Daratumumab may block CD38 and help the immune system kill cancer cells. Carfilzomib inhibits protein complexes called proteasomes, which inhibits cancer cell growth and leads to cancer cell death. Lenalidomide may help kill cancer cells and prevents the growth of blood vessels that cancer cells need to survive. Dexamethasone is in a class of medications called corticosteroids. It is used to reduce inflammation and lower the body's immune response to help lessen the side effects of chemotherapy drugs. Teclistamab is a monoclonal antibody that may interfere with the ability of cancer cells to grow and spread. A monoclonal antibody is a type of protein that can bind to certain targets in the body, such as molecules that cause the body to make an immune response (antigens). Giving teclistamab as consolidation therapy after induction and autologous hematopoietic stem cell transplant may improve survival outcomes in patients with plasma cell leukemia, compared to standard consolidation with daratumumab, carfilzomib, lenalidomide, and dexamethasone.
Eligibility criteria
Qualifiers
Documented diagnosis of primary plasma cell leukemia according to IMWG criteria defined as 5% or greater circulating plasma cells at the time of initial diagnosis
Serum monoclonal protein ≥ 0.5 g/dL or
Urine monoclonal protein ≥ 200 mg/24 hours (h) or
Serum free light chain (FLC) assay: Serum free light chain ≥ 100 mg/L and abnormal serum free light chain ratio
Disqualifiers
None
Trial design
Treatments tested in this trial
- Autologous Hematopoietic Stem Cell Transplantation
- Biospecimen Collection
- Bone Marrow Aspiration
- Bone Marrow Biopsy
- Carfilzomib
- Computed Tomography
- Daratumumab and Recombinant Human Hyaluronidase
- Dexamethasone
- Fludeoxyglucose F-18
- Lenalidomide
- Magnetic Resonance Imaging
- Melphalan
- Plerixafor
- Positron Emission Tomography
- Recombinant Granulocyte Colony-Stimulating Factor
- Stem Cell Isolation
- Teclistamab
- Transthoracic Echocardiography Test