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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

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I agree to use the specified methods of contraception.

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My kidney disease related to MGRS was confirmed by a biopsy.

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I haven't been exposed to kidney-damaging substances recently.

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My bone marrow test shows abnormal plasma cells.

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I have a confirmed diagnosis of monoclonal gammopathy-related kidney condition, either by kidney biopsy or specific urine and blood tests.

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My blood test shows a single type of abnormal protein.

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I have been diagnosed with newly diagnosed multiple myeloma.

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I am 18 years old or older.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 2 years

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

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Bortezomib

2005

Completed Phase 2

~1090

Cyclophosphamide

1995

Completed Phase 3

~3770

Daratumumab

2014

Completed Phase 3

~1990

Dexamethasone

2007

Completed Phase 4

~2590

0 / 8Eligibility criteria met

Find a Location

Who is running the clinical trial?

Janssen PharmaceuticalsIndustry Sponsor

80 Previous Clinical Trials

205,018 Total Patients Enrolled

1 Trials studying Monoclonal Gammopathy

42 Patients Enrolled for Monoclonal Gammopathy

Memorial Sloan Kettering Cancer CenterLead Sponsor

1,936 Previous Clinical Trials

588,845 Total Patients Enrolled

Hani Hassoun, MDPrincipal InvestigatorMemorial Sloan Kettering Cancer Center

5 Previous Clinical Trials

131 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any volunteers currently being sought for this investigation?

"The analytics on clinicaltrials.gov inform us that this medical trial is not presently recruiting, but it was first posted on October 1st 2023 and last modified on October 9th of the same year. Fortunately, there are 825 other trials with open participation opportunities."

Answered by AI

Is this experiment being conducted in multiple sites across the state?

"This medical research is actively seeking participants from 7 distinct sites, including Middletown, Montvale and Commack. It would be advantageous to pick a location near you in order to minimize required travel if participating."

Answered by AI

What potential risks accompany the utilization of Arm A, which encompasses individuals with cast nephropathy?

"Our team at Power rated the safety of Arm A, which involves treating cast nephropathy, to be 2 due to its Phase 2 status, suggesting that while there is evidence for its safety, none exists regarding efficacy."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

A Study of CyBorD (Cyclophosphamide, Bortezomib, Dexamethasone) Plus Daratumumab in People With Monoclonal Gammopathy of Renal Significance (MGRS)

2023. "A Study of CyBorD (Cyclophosphamide, Bortezomib, Dexamethasone) Plus Daratumumab in People With Monoclonal Gammopathy of Renal Significance (MGRS)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06083922.