Actively Recruiting
A Study of CyBorD (Cyclophosphamide, Bortezomib, Dexamethasone) Plus Daratumumab in People With Monoclonal Gammopathy of Renal Significance (MGRS)
Led by Memorial Sloan Kettering Cancer Center · Updated on 2026-04-16
20
Participants Needed
11
Research Sites
154 weeks
Total Duration
On this page
Sponsors
M
Memorial Sloan Kettering Cancer Center
Lead Sponsor
J
Janssen Pharmaceuticals
Collaborating Sponsor
AI-Summary
What this Trial Is About
The purpose of this study is to find out whether cyclophosphamide, bortezomib, dexamethasone (CyBorD) with daratumumab SC is a safe treatment combination for MGRS-associated kidney disease including cast nephropathy associated with multiple myeloma. In addition, the researchers will find out whether the study drug combination is an effective treatment for these conditions.
CONDITIONS
Official Title
A Study of CyBorD (Cyclophosphamide, Bortezomib, Dexamethasone) Plus Daratumumab in People With Monoclonal Gammopathy of Renal Significance (MGRS)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older at registration
- Confirmed diagnosis of newly diagnosed multiple myeloma (NDMM) with measurable disease OR confirmed diagnosis of MGRS-associated renal disease by kidney biopsy
- Estimated glomerular filtration rate (eGFR) less than 40 ml/min/1.73m2 or 24-hour urine protein over 1 gram
- Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2 within 14 days before registration
- Adequate blood counts: neutrophils at least 1.0 x 10^9/L, platelets at least 100 x 10^9/L for run-in and 75 x 10^9/L for phase II
- Hemoglobin at least 7.5 g/dL without recent red blood cell transfusion
- Adequate liver function within 14 days before registration with AST, ALT, or alkaline phosphatase no more than 3 times the upper limit of normal
- Total bilirubin no more than 1.5 times upper limit of normal unless history of Gilbert's syndrome
- Female participants must be postmenopausal, surgically sterile, or agree to effective contraception or abstinence during and 90 days after treatment
- Male participants must agree to use barrier contraception or abstinence during and 90 days after treatment
- Willingness and ability to comply with visits, treatments, and study procedures
- No recent nephrotoxic drug exposure or obstructive nephropathy by ultrasound
You will not qualify if you...
- Monoclonal gammopathy related to diseases other than plasma cell dyscrasia (e.g., CLL, B-cell neoplasm, Waldenstrom's macroglobulinemia)
- Plasma cell leukemia, AL amyloidosis, or POEMS syndrome
- Prior treatment targeting plasma cell disorders or investigational agents
- Lactating females or positive pregnancy test during screening
- Major surgery within 14 days before registration
- Focal radiation therapy within 14 days before registration except palliative radiotherapy
- Central nervous system involvement by disease
- Uncontrolled serious illness or active infection
- Significant heart disease including recent myocardial infarction or uncontrolled arrhythmia
- Serious medical or psychiatric illness interfering with treatment
- Allergies to study medications or their components
- Concurrent malignancies except certain treated cancers
- Grade 2 or higher peripheral neuropathy
- Chemotherapy within 14 days of registration
- Recent exposure to investigational drugs or devices
- Chronic obstructive pulmonary disease with severely reduced lung function or moderate/severe persistent asthma
- Contraindications to anticoagulation or antiplatelet agents
- Use of strong CYP3A4 or CYP1A2 inducers or inhibitors during study
- Hepatic Child-Pugh score B or C
- HIV positive or seropositive for hepatitis B or C without sustained virologic response
- Recent vaccination with live attenuated vaccines
- Plasmapheresis within 28 days before randomization
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 11 locations
1
Tufts Medical Center (Data Collection Only)
Boston, Massachusetts, United States, 02111
Active, Not Recruiting
2
Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities)
Basking Ridge, New Jersey, United States, 07920
Actively Recruiting
3
Memorial Sloan Kettering Monmouth (Limited Protocol Activities)
Middletown, New Jersey, United States, 07748
Actively Recruiting
4
Memorial Sloan Kettering Bergen (Limited Protocol Activities)
Montvale, New Jersey, United States, 07645
Actively Recruiting
5
Memorial Sloan Kettering Cancer Center Suffolk - Commack (Limited Protocol Activities)
Commack, New York, United States, 11725
Actively Recruiting
6
Memorial Sloan Kettering Westchester (Limited Protocol Activities)
Harrison, New York, United States, 10604
Actively Recruiting
7
Weill Cornell Medical Center (Data Collection Only)
New York, New York, United States, 10021
Not Yet Recruiting
8
Mount Sinai Hospital (Data Collection Only)
New York, New York, United States, 10029
Completed
9
Memorial Sloan Kettering Cancer Center (All Protocol Activities)
New York, New York, United States, 10065
Actively Recruiting
10
Memorial Sloan Kettering Nassau (Limited Protocol Activities)
Uniondale, New York, United States, 11553
Actively Recruiting
11
University of North Carolina (Data Collection Only)
Chapel Hill, North Carolina, United States, 27514
Actively Recruiting
Research Team
H
Hani Hassoun, MD
CONTACT
C
Carlyn R Tan, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
2
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