RecruitingPhase 2NCT07085728

Testing the Investigational Agent Combination of Daratumumab, Bortezomib, and Dexamethasone Compared to the Usual Treatment of Cyclophosphamide, Bortezomib, and Dexamethasone in Newly Diagnosed Multiple Myeloma Patients With Kidney Failure

A Randomized Phase II Trial Comparing Daratumumab-Bortezomib-Dexamethasone Versus Cyclophosphamide-Bortezomib-Dexamethasone in Newly Diagnosed Multiple Myeloma With Light Chain Cast Nephropathy (LCCN)


Sponsor

Eastern Cooperative Oncology Group

Enrollment

74 participants

Start Date

Mar 5, 2026

Study Type

INTERVENTIONAL

Conditions

Summary

This study is being done to answer the following question: Can the addition of daratumumab-hyaluronidase to the usual treatment of bortezomib and dexamethasone improve kidney function in patients who are newly diagnosed with multiple myeloma and have kidney failure? This study is being done because the investigators want to find out if this approach is better or worse than the usual approach for the participant's newly diagnosed multiple myeloma. The usual approach is defined as care most people get for multiple myeloma. If the participant decides to take part in this study, they will either get the study medications daratumumab-hyaluronidase, bortezomib, and dexamethasone for four months (4 cycles), or the typical medications used to treat your cancer (cyclophosphamide, bortezomib, and dexamethasone) for 4 months (4 cycles). After the participant finishes their study treatment, their doctor will continue to follow their condition for 10 years to watch them for side effects and monitor their disease status. Their doctor will follow up with them every 3 months for years 1 and 2 and then every 6 months for years 3 through 10.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called Bortezomib (VELCADE), a drug called Cyclophosphamide, and others for people with myeloma, multiple. The study is currently recruiting participants at 1 location.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGCyclophosphamide

Arm A

DRUGBortezomib (VELCADE)

Arm A, Arm B

DRUGDexamethasone

Arm A, Arm B

DRUGDaratumumab-hyaluronidase

Arm B


Locations(1)

Alaska Oncology and Hematology LLC

Anchorage, Alaska, United States

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NCT07085728


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