Study Details

Open

A Phase 2/3 Study Evaluating the Efficacy and Safety of Etentamig and Daratumumab Compared to Daratumumab, Lenalidomide, and Dexamethasone in Subjects with Newly Diagnosed Multiple Myeloma Not Eligible for Transplant

The purpose of this study is to see if etentamig is safe and to identify the optimal etentamig dose when combined with daratumumab in participants with Newly Diagnosed Multiple Myeloma (NDMM) who are not eligible for transplant.

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

To determine if you are eligible to participate in the study, you will be asked to complete the screening procedures, which include informed consent, medical history, review of previous and current medications, height, weight, vital signs, physical exam, ECOG performance status, IMWG Myeloma Frailty Index Score, electrocardiogram, pregnancy test (for women who can have children), blood and urine tests, HIV testing, SARS-CoV-2 test, skeletal survey (X-ray, CT, PET-CT, or MRI), plasmacytoma evaluation, bone marrow biopsy and aspirate, and adverse event assessment. If you are eligible to participate in this study, you will undergo the study procedures described above, as well as health and medication questions, plasmacytoma biopsy collection (optional), study drug administration, and treatment and monitoring to reduce the risk of side effects. For post-treatment visits, you may be asked to return to the study site for tests or you may receive a phone call to provide information, such as new cancer therapies you have started.

Incentives

You will be reimbursed for travel expenses through the Greenphire program. Neither you nor your insurance company will have to pay for the study drug(s) or procedures that are done only for the study.

In-person visits:
This will depend on how long you receive study treatment.

Phone or online visits:
This will depend on how long you receive study treatment.

Total length of participation:
You will receive study treatment until your disease worsens, you no longer tolerate study treatment, or until you meet other criteria for discontinuation.

Looking for Specific Volunteers

Able to participate:

You have confirmed newly diagnosed multiple myeloma.
You are not eligible for stem cell transplant.
You have an ECOG performance status of less than or equal to one.
You have measurable disease according to certain laboratory tests.
You have adequate blood, kidney, and liver function according to certain laboratory tests.

Not eligible if:

You have been or are on therapy or stem cell transplant for multiple myeloma or any other blood disorder, except short course corticosteroids.
You have received anti-cancer therapy within 21 days or five half-lives of the anit-cancer therapy prior to the first dose of study treatment.
You have known active central nervous system involvement of mulitple myeloma.
You have a history of significant heart disease within six months of the first dose of study drug.
You have a known history of or active cancers within the past three years with some exceptions.

Contact the Team

Visit Location

Contact & Visit Location

Primary Contact

Lineberger Clinical Research
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

Eben Lichtman
LCCC - Clinical Trials

Study Type

Clinical or Medical
Interventional

Study Topics

Blood Conditions
Cancer (Multiple Myeloma)

IRB Number

25-2337

ClinicalTrials.gov

NCT07095452