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.
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. To evaluate the safety of quadruplet induction, autologous stem cell transplantation, consolidation, and doublet maintenance therapy. III. To evaluate response rates per International Myeloma Working Group (IMWG) criteria (overall response rate, partial response, very good partial response, complete response, stringent complete response). EXPLORATORY OBJECTIVE: I. To evaluate minimal residual disease negativity by next generation sequencing (10\^-5 and 10\^-6) after induction, autologous stem cell transplant, consolidation, and after 1 and 2 years of maintenance treatment. OUTLINE: INDUCTION THERAPY (CYCLES 1-4): Patients receive daratumumab and recombinant human hyaluronidase (daratumumab and hyaluronidase-fihj) subcutaneously (SC) on days 1, 8, 15, and 22 of cycles 1 and 2 and days 1 and 15 of cycles 3 and 4, carfilzomib intravenously (IV) on days 1, 8, and 15 of each cycle, lenalidomide orally (PO) once daily (QD) on days 1-21 of each cycle, and dexamethasone PO on days 1, 8, and 15 of each cycle. Cycles repeat every 28 days in for up to 4 cycles in the absence of disease progression or unacceptable toxicity. AUTOLOGOUS STEM CELL TRANSPLANT: Within 60 days of completing induction therapy, patients undergo stem cell mobilization using recombinant granulocyte colony-stimulating factor SC and plerixafor SC followed by stem cell collection according to standard of care. Patients then receive melphalan IV followed by autologous hematopoietic stem cell transplant (autoHSCT). CONSOLIDATION THERAPY (CYCLES 5-12): Patients are randomized to 1 of 2 arms for consolidation therapy, to start within 120 days of autoHSCT. ARM 1: Patients receive daratumumab and hyaluronidase-fihj SC on days 1 and 15 of cycles 5-6 and on day 1 of cycles 7-12, carfilzomib IV on days 1, 8, and 15 of each cycle, lenalidomide on days 1-21 of each cycle, and dexamethasone PO on days 1, 8, and 15 of each cycle. Cycles repeat every 28 days for up to 8 cycles in the absence of disease progression or unacceptable toxicity. ARM 2: Patients receive teclistamab SC on days 1, 3, 7, and 15 of cycle 5, once weekly thereafter for cycles 5-6, every 2 weeks in cycles 7-10, and every 4 weeks in cycles 11-12. Cycles repeat every 28 days for up to 8 cycles in the absence of disease progression or unacceptable toxicity. MAINTENANCE THERAPY (CYCLES 13-36): Within 60 days of completing consolidation therapy, patients receive carfilzomib IV on days 1 and 15 of each cycle and lenalidomide PO QD on days 1-21 of each cycle. Cycles repeat every 28 days for up to 24 cycles in the absence of disease progression or unacceptable toxicity. Patients also undergo transthoracic echocardiography (TTE) at screening and then as clinically indicated and undergo bone marrow biopsy and aspiration, collection of blood samples, and fludeoxyglucose F-18 (FDG) positron emission tomography (PET)/computed tomography (CT), magnetic resonance imaging (MRI), and/or CT throughout the trial. After completion of study treatment, patients are followed up every 3 or 6 months for up to 5 years from registration.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
74
Undergo autoHSCT
Undergo collection of blood samples
Undergo bone marrow aspiration
Undergo bone marrow biopsy
Given IV
Undergo PET/CT and/or CT
Given SC
Given PO
Undergo FDG PET/CT
Given PO
Undergo MRI
Given IV
Given SC
Undergo PET/CT
Given SC
Undergo stem cell collection
Given SC
Undergo TTE
Memorial Sloan Kettering Monmouth
Middletown, New Jersey, United States
RECRUITINGMemorial Sloan Kettering Bergen
Montvale, New Jersey, United States
RECRUITINGRoswell Park Cancer Institute
Buffalo, New York, United States
RECRUITINGMemorial Sloan Kettering Commack
Commack, New York, United States
RECRUITINGMemorial Sloan Kettering Westchester
Harrison, New York, United States
RECRUITINGMemorial Sloan Kettering Cancer Center
New York, New York, United States
RECRUITINGHuntsman Cancer Institute/University of Utah
Salt Lake City, Utah, United States
RECRUITINGOverall survival (OS)
The time to event outcome of overall survival will be evaluated and compared using a log-rank test to compare differences between arms. OS distributions will be evaluated graphically using the methods of Kaplan and Meier, along with estimation of the 3-year OS rates with corresponding 95% confidence intervals and other time points of interest. In a secondary manner, Cox regression models will also be used to evaluate differences in OS between treatment arms when adjusting for factors of interest as well as stratifying on the stratification factors including prior treatment status and t(11;14) status.
Time frame: From randomization to the time of death due to any cause, assessed up to 5 years
Incidence of adverse events
Adverse events (AEs) will be summarized per the National Cancer Institute Common Terminology Criteria for Adverse Events version 5, and where toxicities will be defined as adverse events that are deemed to be at least possibly treatment-related (i.e., attribution of "possibly", "probably", or "definite"). Note that some AEs will be defined using other criteria where specified. The maximum grade for each type of treatment-related AE will be recorded for each patient, and the frequency of each will be summarized across all patients for the induction phase, and by treatment arm for the consolidation and maintenance phases of treatment. Frequency tables and graphical evaluations of AEs and treatment-related AEs will be summarized and evaluated to assess if there are any patterns or differences in the rates or types of AEs including, but not limited to, AEs of special interest including cytokine release syndrome, neurotoxicity, and second primary malignancies.
Time frame: Up to 5 years
Progression free survival (PFS)
Will use Kaplan-Meier analyses and Cox regression models to evaluate this endpoint and how the PFS distributions differ between the treatment arms.
Time frame: From randomization to the time of progression and/or death due to any cause, assessed up to 5 years
Overall response rate
Overall response rate will be summarized for each of the treatment arms and defined as the number of patients who achieve at least a partial response to therapy divided by the total number of patients treated on that arm. Will summarize the incidence and depth of objective response both post-induction as well as post-consolidation. Response rates will be calculated along with 95% binomial confidence intervals for each of the t(11;14) subjects and treatment arms.
Time frame: Up to 5 years
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