Study Details

Open

A Study of Investigational Medication for Relapsed or Refractory Multiple Myeloma

In this study, we want to compare different combinations of drugs for patients with multiple myeloma who have not responded to previous treatment. We want to learn if an investigational medication may be beneficial for the treatment of multiple myeloma.

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

At you first visit, we will review your medications and medical history. We will also take some measurements like your weight, heigh, blood pressure, and breathing rate. We will do imaging (bone x-ray, MRI, CT scan or PET/CT scan) and take a bone marrow aspirate and biopsy. At each visit, we will take your pulse, breathing rate, blood pressure, and oxygen levels. At the start of the treatment period, we will take a urine sample and take your temperature, then we will give you the study medication.

Incentives

You or your insurance provider will not have to pay for the investigational medication, the study treatment drug (daratumumab), and tests that are part of the study.

In-person visits:
At least one visit for screening, 10 visits during the first two cycles, two visits per cycle thereafter, one end of treatment visit, and one follow-up visit every 28 days (pre progressive disease) or every 16 weeks (post progressive disease)

Total length of participation:
This study will last for approximately 5 years. How long you participate will depend on how well your multiple myeloma responds to the treatment

Looking for Specific Volunteers

Able to participate:

You have multiple myeloma that has not responded to treatment or has come back after treatment.
You have been treated for multiple myeloma with at least one prior line of therapy including a proteasome inhibitor and lenolidomide (an immunomodulary drug).
You have not received Pomalidomide therapy.

Not eligible if:

You have myelodysplastic syndrome or active cancer other than multiple myeloma, with some exceptions.
You have certain cardiac conditions (congestive heart failure, heart attack, ventricular arrhythmia or unexplained fainting, or non-ischemic cardiomyopathy).
You have plasma cell leukemia, POEMS syndrome, or AL amyloidosis.
You are pregnant.

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

Samuel Rubinstein
Medicine-Hematology

Study Type

Clinical or Medical
Interventional

Study Topics

Blood Conditions
Cancer (Multiple Myeloma)

IRB Number

22-2031

ClinicalTrials.gov

NCT05455320