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

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.

Conditions

• Plasma Cell Leukemia

Interventions

PROCEDURE

Autologous Hematopoietic Stem Cell Transplantation

Undergo autoHSCT

PROCEDURE

Biospecimen Collection

Undergo collection of blood samples

PROCEDURE

Bone Marrow Aspiration

Undergo bone marrow aspiration

PROCEDURE

Bone Marrow Biopsy

Undergo bone marrow biopsy

DRUG

Carfilzomib

Given IV

PROCEDURE

Computed Tomography

Undergo PET/CT and/or CT

DRUG

Daratumumab and Recombinant Human Hyaluronidase

Given SC

DRUG

Dexamethasone

Given PO

OTHER

Fludeoxyglucose F-18

Undergo FDG PET/CT

DRUG

Lenalidomide

Given PO

PROCEDURE

Magnetic Resonance Imaging

Undergo MRI

DRUG

Melphalan

Given IV

DRUG

Plerixafor

Given SC

PROCEDURE

Positron Emission Tomography

Undergo PET/CT

BIOLOGICAL

Recombinant Granulocyte Colony-Stimulating Factor

Given SC

PROCEDURE

Stem Cell Isolation

Undergo stem cell collection

DRUG

Teclistamab

Given SC

PROCEDURE

Transthoracic Echocardiography Test

Undergo TTE

Sponsors & Collaborators

• National Cancer Institute (NCI)

  lead NIH

Principal Investigators

• Douglas W Sborov · Alliance for Clinical Trials in Oncology

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

80 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2026-07-01

Primary Completion

2032-11-06

Completion

2032-11-06

FDA Drug

Yes