Testing the Investigational Medication Combination of Teclistamab and Pomalidomide Compared to the Usual Treatment (Carfilzomib, Pomalidomide, and Dexamethasone) for Patients With Multiple Myeloma Who Have Relapsed Shortly After Treatment

Summary

This phase Ib/II trial compares the effect of teclistamab and pomalidomide to standard treatment with carfilzomib, pomalidomide and dexamethasone in treating patients with multiple myeloma that has come back after a period of improvement (relapsed). Teclistamab is a bispecific antibody that can bind to two different antigens at the same time. Teclistamab binds to B-cell maturation antigen (BCMA), a protein found on some B-cells and myeloma cells, and CD3 on T-cells (a type of white blood cell) and may interfere with the ability of cancer cells to grow and spread. Pomalidomide is in a class of medications called immunomodulatory agents. It works by helping the immune system kill cancer cells and by helping the bone marrow to produce normal blood cells. Carfilzomib blocks the action of enzymes called proteasomes, which may help keep cancer cells from growing and may kill them. It is a type of proteasome inhibitor. 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. Giving teclistamab and pomalidomide may be safe, tolerable and improve response by lowering myeloma cells to undetectable levels when compared to standard treatment with carfilzomib, pomalidomide and dexamethasone in treating patients with relapsed multiple myeloma.

Conditions

• Recurrent Multiple Myeloma
• Refractory Multiple Myeloma

Interventions

PROCEDURE

Biospecimen Collection

Undergo urine and blood sample collection

PROCEDURE

Bone Marrow Aspiration

Undergo bone marrow biopsy and/or aspiration

PROCEDURE

Bone Marrow Biopsy

Undergo bone marrow biopsy and/or aspiration

DRUG

Carfilzomib

Given IV

PROCEDURE

Computed Tomography

Undergo FDG PET/CT

DRUG

Dexamethasone

Given PO or IV

PROCEDURE

FDG-Positron Emission Tomography

Undergo FDG PET/CT

OTHER

Fludeoxyglucose F-18

Given FDG

DRUG

Pomalidomide

Given PO

DRUG

Teclistamab

Given SC

Sponsors & Collaborators

• National Cancer Institute (NCI)

  lead NIH

Principal Investigators

• Murali Janakiram · ECOG-ACRIN Cancer Research Group

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2026-06-26

Primary Completion

2026-08-31

Completion

2026-08-31

FDA Drug

Yes