R5458-ONC-2158 (Multiple Myeloma)

Purpose of this Study

We are doing this study to find the most effective, safe dose of an experimental drug called linvoseltamab (the study drug) in people with newly diagnosed multiple myeloma.

Who Can Participate?

Eligibility

Adults ages 18+ who:
  • Are diagnosed with multiple myeloma
  • Have not received any therapy for treating multiple myeloma, with the exception of radiation
  • Have adequate bone marrow reserves
  • Have no evidence of central nervous system involvement
For more information, contact the study team at jennifer.tichon@duke.edu.

Age Range

18-110

Sex/Genders

Male (cisgender)
Female (cisgender)
Non-binary or gender fluid
Transgender male
Transgender female
Looking for Healthy Participants
No

What is Involved?

Description

This study consists of 2 phases. If you choose to join this study, your study doctor will tell you the phase of the study in which you will participate.
  • Phase 1: If you take part in Phase 1, you will get one of several different doses of the study drug. This part of the study is to establish what the regimen (first doses and maximum dose) should be for this drug.
  • Phase 2: If you take part in Phase 2, you will get a dose of the study drug that is determined to be the most effective based on Part 1.
The study drug is given as an intravenous (IV) infusion into a vein. If you are transplant eligible, you may proceed to a transplant after 16 weeks of taking the study drug (or sooner at your doctor's discretion, but you will need to receive the study drug for at least 8 weeks before having a transplant). If your transplant is successful, you will continue to get the study drug for an additional 12 weeks after you recover. If you are not transplant eligible, your dosing schedule will change after 16 weeks of taking the study drug to every other week.

Locations

Duke University Hospital

Visit Timing

Weekdays

Compensation

No

Spanish Materials Available

No

Study Details

Full Title

PHASE 1/2 STUDY OF LINVOSELTAMAB (ANTI-BCMA X ANTI-CD3 BISPECIFIC ANTIBODY) IN PREVIOUSLY UNTREATED PATIENTS WITH SYMPTOMATIC MULTIPLE MYELOMA

Principal Investigator

Yubin
Kang

Protocol Number

PRO00117037

NCT ID

NCT05828511

Phase

I/II

Enrollment Status

Pending Open to Enrollment
ClinicalTrials.gov