Quadruplet Induction Followed by Teclistamab Consolidation and Doublet Maintenance in Patients With Primary Plasma Cell Leukemia: The QUANTUM Trial
National Cancer Institute (NCI)
Summary
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.
Description
PRIMARY OBJECTIVE: I. To determine if quadruplet induction therapy followed by autologous stem cell transplantation, consolidation with teclistamab, a BCMA-targeted, T-cell redirecting bispecific antibody, and doublet maintenance treatment will improve overall survival compared to those receiving standard of care consolidation therapy (i.e. daratumumab, carfilzomib, lenalidomide, and dexamethasone \[D-KRd\]). SECONDARY OBJECTIVES: I. To evaluate the progression free survival of quadruplet induction, autologous stem cell transplantation, consolidation, and doublet maintenance therapy. II. T…
Eligibility
- Age range
- 18–80 years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * 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 * Measurable disease at the time of initial diagnosis of at least one of the following as defined by IMWG criteria: * 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 * Age 18 - 80 years * Prior treatment: * ≤ 1 cycle of induction treatment based o…
Interventions
- ProcedureAutologous Hematopoietic Stem Cell Transplantation
Undergo autoHSCT
- ProcedureBiospecimen Collection
Undergo collection of blood samples
- ProcedureBone Marrow Aspiration
Undergo bone marrow aspiration
- ProcedureBone Marrow Biopsy
Undergo bone marrow biopsy
- DrugCarfilzomib
Given IV
- ProcedureComputed Tomography
Undergo PET/CT and/or CT
- DrugDaratumumab and Recombinant Human Hyaluronidase
Given SC
- DrugDexamethasone
Given PO
- OtherFludeoxyglucose F-18
Undergo FDG PET/CT
- DrugLenalidomide
Given PO
- ProcedureMagnetic Resonance Imaging
Undergo MRI
- DrugMelphalan
Given IV
- DrugPlerixafor
Given SC
- ProcedurePositron Emission Tomography
Undergo PET/CT
- BiologicalRecombinant Granulocyte Colony-Stimulating Factor
Given SC
- ProcedureStem Cell Isolation
Undergo stem cell collection
- DrugTeclistamab
Given SC
- ProcedureTransthoracic Echocardiography Test
Undergo TTE
Locations (2)
- Roswell Park Cancer InstituteBuffalo, New York
- Huntsman Cancer Institute/University of UtahSalt Lake City, Utah