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RECRUITING
NCT05972135
PHASE2

Outpatient Administration of Teclistamab or Talquetamab for Multiple Myeloma

Sponsor: SCRI Development Innovations, LLC

View on ClinicalTrials.gov

Summary

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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

100

Start Date

2023-10-23

Completion Date

2027-10

Last Updated

2026-02-23

Healthy Volunteers

No

Interventions

DRUG

Teclistamab

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.

DRUG

Talquetamab

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

DRUG

Tocilizumab

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.

DRUG

Oral 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