RecruitingPhase 2NCT05972135

Outpatient Administration of Teclistamab or Talquetamab for Multiple Myeloma


Sponsor

SCRI Development Innovations, LLC

Enrollment

100 participants

Start Date

Oct 23, 2023

Study Type

INTERVENTIONAL

Conditions

Summary

This is a phase II study to evaluate the outpatient administration of Teclistamab or Talquetamab in Multiple Myeloma patients


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is looking at whether bispecific antibody therapies — teclistamab and talquetamab — for multiple myeloma (a blood cancer) can be given safely as an outpatient (without requiring a hospital stay for monitoring). These drugs are highly effective but carry a risk of a serious reaction called cytokine release syndrome. The study also tests the addition of tocilizumab and dexamethasone to help prevent or manage these reactions and enable outpatient dosing. **You may be eligible if...** - You are 18 years or older with a confirmed diagnosis of multiple myeloma - You have received 2 or more prior myeloma treatments including specific drug classes (a proteasome inhibitor, an immunomodulatory drug, and a CD38 antibody) — for most study arms - Some arms allow patients with 1 or more prior therapies - You have measurable disease based on blood, urine, or bone marrow tests - Your performance status and organ function meet the required minimums - HIV-positive patients may be eligible if their infection is well-controlled **You may NOT be eligible if...** - You have had fewer prior treatments than required for the specific treatment arm - Your myeloma is not measurable by the study's criteria - You have active serious infections or autoimmune conditions - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

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

DRUGTeclistamab

Teclistamab will be administered subcutaneously at step-up doses on Day 1, Day 4 and Day 8, one week after first treatment dose and weekly thereafter. In participants who have a partial response (PR) or better after 6 months of therapy, dosing frequency may be reduced to every 2 weeks.

DRUGTalquetamab

Talquetamab will be administered subcutaneously at step-up doses on Day 1, Day 4, Day 8 and Day 15, one week after first treatment dose and every 2 weeks thereafter. In participants who have a very good partial response (VGPR) or better after Cycle 4, dosing frequency may be reduced to every 4 weeks

DRUGTocilizumab

Tocilizumab will be administered as a pretreatment medication in advance of administration of the first step-up dose of teclistamab or talquetamab on Cycle 1 Day 1.

DRUGOral Dexamethasone

Oral dexamethasone will be administered as a pretreatment medication every 12 hours in 3 doses (PM/AM/PM) following each step-up dose and the first full dose of teclistamab in Cycle 1. A total of 9 doses of oral dexamethasone will be administered.


Locations(17)

Arizona Oncology Associates

Tucson, Arizona, United States

Colorado Blood Cancer Institute

Denver, Colorado, United States

Rocky Mountain Cancer Center

Denver, Colorado, United States

Medical Oncology Hematology Consultants

Newark, Delaware, United States

Florida Cancer Specialists

Lake Mary, Florida, United States

Maryland Oncology Hematology

Columbia, Maryland, United States

Minnesota Oncology Hematology

Minneapolis, Minnesota, United States

Virginia Oncology Associates

Elizabeth City, North Carolina, United States

Oncology Hematology Care

Cincinnati, Ohio, United States

Oncology Associates of Oregon

Eugene, Oregon, United States

TriStar Bone Marrow Transplant

Nashville, Tennessee, United States

Vanderbilt- Ingram Cancer Center

Nashville, Tennessee, United States

Texas Oncology

Austin, Texas, United States

Texas Oncology - San Antonio

San Antonio, Texas, United States

Texas Oncology - Northeast Texas

Tyler, Texas, United States

Virginia Cancer Specialists

Fairfax, Virginia, United States

Blue Ridge Cancer Center

Roanoke, Virginia, United States

View Full Details on ClinicalTrials.gov

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NCT05972135


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