Study Details

Open

Smoldering Multiple Myeloma Study

In this study, we want to learn how well a combination of medications (lenalidomide and dexamethasone) work with or without another medication (daratumumab) in patients with high-risk smoldering 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

This study will include thyroid testing, Hepatitis B and C testing, HIV testing (for patients who are HIV positive), blood tests, bone marrow biopsies and aspirates, PET/CT scans, questionnaires, pregnancy testing (for women who can have children) and study drug administration.

In-person visits:
Four visits during cycles 1 and 2, two visits during cycles 3 through 6, one visit during cycles 7 through 24, one visit at study discontinuation or progression, one visit 28 days after discontinuation of treatment, one follow-up visit every three months if patient is < two years from study entry, one follow-up visit every six months if patient is 2-5 years from study entry, and one follow-up visit every year if patient is 6-15 years from that date of randomization.

Total length of participation:
15 years

Looking for Specific Volunteers

Able to participate:

You have been diagnosed with asymptomatic high-risk smoldering multiple myeloma within the past 12 months.
You have "measurable disease," meaning your smoldering myeloma can be tracked through measurements of myeloma protein in the blood or urine.
You do not have chronic obstructive pulmonary disease (COPD).
You have adequate liver, kidney, and bone marrow function.

Not eligible if:

You have more than one focal marrow lesion.
You are using erythropoietin.
You have an active, uncontrolled infection.
You have New York Heart Association classification III or IV heart failure.
If you are a female patient, you are pregnant or breastfeeding.

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

Sascha Tuchman
LCCC - Clinical Trials

Study Type

Clinical or Medical
Interventional

Study Topics

Blood Conditions
Cancer (Multiple Myeloma)

IRB Number

19-1679

ClinicalTrials.gov

NCT03937635