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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

Must not have

Female patients who are lactating or have a positive serum pregnancy test during the screening period

Disease-related central nervous system involvement

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 2 years

Awards & highlights

No Placebo-Only Group

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.

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.

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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am not pregnant or breastfeeding.

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My cancer has spread to my brain or spinal cord.

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I do not have any severe illnesses or active infections.

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I am not taking strong medication that affects liver enzymes while on this study.

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My condition is related to blood disorders but not caused by plasma cell issues.

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I have moderate to severe numbness, tingling, or pain in my hands or feet.

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I have severe COPD or asthma, with less than half the normal lung function in the past 2 years.

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I have been diagnosed with plasma cell leukemia, AL amyloidosis, or POEMS syndrome.

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I have not had chemotherapy in the last 14 days.

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My liver function is moderately to severely impaired.

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I have a serious heart condition.

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I cannot take blood thinners or medications that prevent blood clots.

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I have not had major surgery in the last 14 days.

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I have had severe or uncontrolled asthma in the last 2 years.

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Phase II (Cohort A) best renal response

Pilot study (Cohort B) best renal response

Run-in Phase- Dose-limiting toxicity (DLT) rates

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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 3

~1410

Cyclophosphamide

2010

Completed Phase 4