← Back to Search

Proteasome Inhibitor

CyBorD + Daratumumab for Kidney Disease Related to Multiple Myeloma

Phase 2
Recruiting
Led By Hani Hassoun, MD
Research Sponsored by Memorial Sloan Kettering Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Male patients must agree to specific contraception methods
Histologically confirmed diagnosis of MGRS-associated renal disease by kidney biopsy
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 years
Awards & highlights

Study Summary

This trial will determine if a combination of CyBorD and daratumumab is safe and effective for kidney disease related to multiple myeloma.

Who is the study for?
This trial is for adults with a specific kidney disease linked to abnormal protein production (MGRS) and related conditions. Participants must have certain levels of kidney function, no recent exposure to nephrotoxic substances, and be able to follow the study plan. Pregnant or breastfeeding women, those with other serious health issues like HIV or severe lung disease, or who've had certain treatments recently can't join.Check my eligibility
What is being tested?
Researchers are testing if combining cyclophosphamide, bortezomib, dexamethasone (CyBorD), and daratumumab is safe and effective for treating MGRS-associated kidney disease. The study will assess this combination's impact on patients' condition by monitoring their response to treatment.See study design
What are the potential side effects?
Possible side effects include low blood counts leading to increased infection risk; nausea; hair loss; nerve damage causing numbness or pain; allergic reactions during infusion; liver problems; fatigue; and an increased risk of developing new cancers.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I agree to use the specified methods of contraception.
Select...
My kidney disease related to MGRS was confirmed by a biopsy.
Select...
I haven't been exposed to kidney-damaging substances recently.
Select...
My bone marrow test shows abnormal plasma cells.
Select...
I have a confirmed diagnosis of monoclonal gammopathy-related kidney condition, either by kidney biopsy or specific urine and blood tests.
Select...
My blood test shows a single type of abnormal protein.
Select...
I have been diagnosed with newly diagnosed multiple myeloma.
Select...
I am 18 years old or older.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Phase II (Cohort A) best renal response
Pilot study (Cohort B) best renal response
Run-in Phase- Dose-limiting toxicity (DLT) rates

Trial Design

2Treatment groups
Experimental Treatment
Group I: Arm B will include all other MGRS associated diseases with the exclusion of AL amyloidosisExperimental Treatment4 Interventions
Planned 8 cycles of CyBorD-Dara SC, treatment will be left to the discretion of the treating physician. It is recommended that patients eligible for ASCT undergo ASCT after 8 cycles of induction and that patient ineligible for ASCT, continue maintenance Bortezomib/Dexamethasone administered every other week with daratumumab SC administered every 4 weeks, for a period of 2 years from start of treatment.
Group II: Arm A will include patients with cast nephropathyExperimental Treatment4 Interventions
Planned 8 cycles of CyBorD-Dara SC, treatment will be left to the discretion of the treating physician. It is recommended that patients eligible for ASCT undergo ASCT after 8 cycles of induction and that patient ineligible for ASCT, continue maintenance Bortezomib/Dexamethasone administered every other week with daratumumab SC administered every 4 weeks, for a period of 2 years from start of treatment.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Bortezomib
2005
Completed Phase 2
~1060
Daratumumab
2014
Completed Phase 3
~1960
Cyclophosphamide
1995
Completed Phase 3
~3770
Dexamethasone
2007
Completed Phase 4
~2590

Find a Location

Who is running the clinical trial?

Memorial Sloan Kettering Cancer CenterLead Sponsor
1,940 Previous Clinical Trials
588,839 Total Patients Enrolled
Janssen PharmaceuticalsIndustry Sponsor
81 Previous Clinical Trials
205,110 Total Patients Enrolled
1 Trials studying Monoclonal Gammopathy
42 Patients Enrolled for Monoclonal Gammopathy
Hani Hassoun, MDPrincipal InvestigatorMemorial Sloan Kettering Cancer Center
5 Previous Clinical Trials
131 Total Patients Enrolled
~35 spots leftby Oct 2026
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top