RecruitingPhase 2NCT07605416

Testing an Experimental Approach to Treat Patients With Plasma Cell Leukemia, The QUANTUM Trial

Quadruplet Induction Followed by Teclistamab Consolidation and Doublet Maintenance in Patients With Primary Plasma Cell Leukemia: The QUANTUM Trial


Sponsor

National Cancer Institute (NCI)

Enrollment

74 participants

Start Date

Apr 20, 2027

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 YearsMax Age: 80 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a procedure called Autologous Hematopoietic Stem Cell Transplantation, a procedure called Biospecimen Collection, and others for people with plasma cell leukemia. The study is currently recruiting participants at 1 location. People eligible for this study include aged 18 Years to 80 Years.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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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 Institute

Buffalo, New York, United States

Huntsman Cancer Institute/University of Utah

Salt Lake City, Utah, United States

View Full Details on ClinicalTrials.gov

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NCT07605416


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