Study Details

Open

Linvolseltamab Plus Other Cancer Treatments for Relapsed/Refractory Multiple Myeloma

The study is researching an investigational drug called REGN5458 in combination with other drugs for the treatment of cancer. The study drug has previously been only studied by itself (without other cancer treatments) in participants who had multiple myeloma that returned and needed to be treated again. This study is the first time REGN5458 will be combined with other cancer therapies. The goal is to understand if REGN5458 can be given safely with other cancer treatments, and if so, what dose should be used for each combination.

Age & Gender

18 years ~ 99 years
Male, Female, Gender Inclusive

Visit Availability

Standard business hours (M-F, 8-5)
Visits can be combined with regular clinical appointments

Location

North Carolina (Statewide)

What will be asked of you

This study aims to treat your cancer and closely resembles routine care that would be received regardless of participating on a research study. To take part in the study, you will meet with a member of the study team regularly in addition to your oncology care team. The study involves questions about your health and life, physical examinations, pregnancy tests (for female participants who can have children), vital signs, whole body scan (PET, CT, or MRI), heart imaging (echocardiogram or MUGA scan), electrocardiogram, bone marrow biopsy and bone marrow aspirates, blood draws, urine samples, and study drug(s) treatment.

Incentives

study medication, hotel reimbursement, mileage reimbursement, hospital parking and meals stipend

In-person visits:
Up to 30 or more depending on how long you remain on treatment.

Phone or online visits:
Up to 16 for survival follow-up.

Total length of participation:
About 5 years

Looking for Specific Volunteers

Able to participate:

You have relapsed/refractory multiple myeloma with progressive disease.
You have good bone marrow and liver function.
You have a life expectancy of at least 6 months.

Not eligible if:

You have known multiple myeloma brain lesions or meningeal involvement.
You have received treatment with any systemic anti-myeloma therapy within 21 days prior to first administration of study drug regimen.
You have had an allogenic stem cell transplant within 12 weeks of study drug regimen.
You've received continuous systemic corticosteroid treatment with > 10 mg per day of prednisone or anti-inflammatory equivalent within 72 hours of start of study regimen.
You have another malignancy that is progressing or required treatment in the last three years.

Contact the Team

Visit Location

Contact & Visit Location

Primary Contact

Lineberger Clinical Trials Office
cancerclinicaltrials@med.unc.edu
(919) 966-4432

Primary Visit Location

NC Cancer Hospital (Basnight)
UNC Hospitals / UNC Medical Center
101 Manning Dr, Chapel Hill, NC 27514, USA

Secondary Visit Location

UNC Hospitals Hillsborough Campus
460 Waterstone Dr, Hillsborough, NC 27278, USA

Additional Study Information

Principal Investigator

Samuel Rubinstein
LCCC - Clinical Trials

Study Type

Clinical or Medical
Interventional

Study Topics

Blood Conditions
Cancer (Phase 1 Trials (all cancers), Multiple Myeloma)

IRB Number

23-0787

ClinicalTrials.gov

NCT05137054