Study Details

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A Phase II Study of CyBorD Plus Daratumumab for Patients with MGRS

The purpose of this study is to find out whether a combination of drugs is a safe treatment for MGRS-associated kidney disease including cast nephropathy associated with multiple myeloma. The combination of drugs in this study is cyclophosphamide, bortezomib, dexamethasone (CyBorD) with daratumumab SC. In addition, we will find out whether the study drug combination is an effective treatment for these conditions.

Age & Gender

18 years ~ 99 years
Male, Female, Gender Inclusive

Visit Availability

Visits can be combined with regular clinical appointments

Location

North Carolina (Statewide)

What will be asked of you

This study will involve physical exams, routine blood tests, research blood tests, routine urine tests, research urine tests, pregnancy test (if applicable), electrocardiogram, pulmonary function test, skeletal survey or PET/CT or MRI total body, autologous stem cell transplant, bone marrow aspiration and biopsy, kidney biopsy (Cohort B), Dexamethasone administration, Bortezomib administration, Daratumumab SC administration, and Cyclophosphamide administration.

Incentives

You will not have to pay for daratumumab SC or for collection and use of blood and urine for research tests.

In-person visits:
Up to 40

Total length of participation:
approximately 33 months

Looking for Specific Volunteers

Able to participate:

You have an ECOG performance status of 0, 1, or 2.
You have no evidence of unequivocal recent nephrotoxic exposure.
You have no evidence of obstructive nephropathy.
You have adequate hematologic lab values per protocol.
You have adequate hepatic function lab values per protocol.

Not eligible if:

You have MGRS associated with diseases other than plasma cell dyscrasia.
You have plasma cell leukemia, AL amyloidosis, or POEMS syndrome.
You have received treatment with prior drugs aimed at the plasma cell dyscrasia.
You have had major surgery in the past 14 days.
You have disease-related central nervous system involvement.

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

Cancer (Multiple Myeloma)
Kidneys and Liver

IRB Number

24-0057

ClinicalTrials.gov

NCT06083922