NCT06083922 · Memorial Sloan Kettering Cancer Center
A Study of CyBorD (Cyclophosphamide, Bortezomib, Dexamethasone) Plus Daratumumab in People With Monoclonal Gammopathy of Renal Significance (MGRS)
What this study 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.
View original scientific description
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.
Interventions
DRUG
Cyclophosphamide
Days 1, 8 and 15, Cycles 1-8
DRUG
Bortezomib
Days 1,8,15, Cycles 1-8, Days 1,15 Cycles 9+
DRUG
Dexamethasone
Days 1,2,8, 9,15,16, 22, 23, Cycles 1-8
DRUG
Daratumumab
Days 1,8,15,22, Cycles 1-2, Days 1,15 Cycles 3-6, Day 1 Cycles 7+
Primary outcome measures
Run-in Phase- Dose-limiting toxicity (DLT) rates
Time frame: 2 years
Any participant in the run-in-phase who received at least ≥ 75% of the planned doses of the combination regimen in cycle one will be evaluated for DLTs using NCI-CTCAE.
Phase II (Cohort A) best renal response
Time frame: 2 years
For patients with a decreased eGFR \<50mL/min/1.73 m2 with or without significant proteinuria (UTP\>0.5 gm/24h) at presentation, Assessment of renal response will be based on both the IMWG criteria for patient with decreased eGFR and the amyloid criteria for patients with proteinuria.
Pilot study (Cohort B) best renal response
Time frame: 2 years
For patients with a decreased eGFR \<50mL/min/1.73 m2 with or without significant proteinuria (UTP\>0.5 gm/24h) at presentation, renal response will be assessed using IMWG renal response criteria
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- Subjects must have a confirmed diagnosis of NDMM as per standard IMWG criteria
- Subjects must have measurable disease, defined as meeting at least 1 of the following criteria ≤ 14 days prior to registration:
- A monoclonal Immunoglobulin (M-protein) concentration on serum protein electrophoresis (SPEP) of ≥ 0.5 g/dL.
- Measurable urinary light chain secretion by quantitative analysis using urine protein electrophoresis (UPEP) of ≥ 200 mg/24 hours.
- Involved serum free light chain (FLC) level ≥ 10 mg/dL, provided the serum FLC ratio is abnormal.
- eGFR must be \<40 ml/min/1.73m2
- Subjects must have histologically confirmed diagnosis of monoclonal gammopathy associated CN by kidney biopsy OR If a kidney biopsy is not available, a percentage of urine albumin excretion (%UAE) \< 25 % AND FLC \> 50 mg/dL Inclusion criteria for other MGRS associated renal diseases
- Histologically confirmed diagno
Where
- Boston, Massachusetts
- Basking Ridge, New Jersey
- Middletown, New Jersey
- Montvale, New Jersey
- Commack, New York
- Harrison, New York
- New York, New York
- Uniondale, New York
- Chapel Hill, North Carolina
Collaborators
Janssen Pharmaceuticals
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jul 6, 2026 · Source of record for eligibility and locations