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Daratumumab-based Regimen for Multiple Myeloma with Kidney Failure

Phase < 1

Waitlist Available

Led By Amany RA Keruakous, MD

Research Sponsored by Augusta University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Patients must have renal insufficiency defined as eCrCl < 60 mL/min and/or necessitating dialysis

Patients must have Zubrod/ECOG Performance Status ≤ 2

Must not have

Clinically significant heart disease within 6 months before enrollment, or unstable or uncontrolled disease/condition related to or affecting cardiac function

Patients with grade 3 or 4 peripheral neuropathy

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 2 years

Awards & highlights

No Placebo-Only Group

Summary

This trial will assess the efficacy of a new treatment for multiple myeloma and investigate if there is a difference in responses among African American and non-African American patients.

Who is the study for?

This trial is for newly diagnosed multiple myeloma patients with new onset renal failure, without allergies to study drugs, good performance status (able to carry out daily activities), and adequate organ function. It's not for those with substance abuse issues, certain infections (HIV, Hepatitis B/C), severe lung or heart conditions, pregnant/breastfeeding women, CNS involvement diseases like plasma cell leukemia or amyloidosis.

What is being tested?

The study tests a combination of daratumumab-hyaluronidase with bortezomib, cyclophosphamide, and dexamethasone in patients over four cycles. It aims to assess the treatment's effectiveness on kidney function and cancer response rate especially comparing African American patients versus others.

What are the potential side effects?

Possible side effects include reactions at the injection site due to daratumumab-hyaluronidase; nerve damage from bortezomib; increased risk of infections from lowered blood counts; mouth sores and hair loss from cyclophosphamide; weight gain and mood changes from dexamethasone.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My kidney function is low or I need dialysis.

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I can take care of myself and am up and about more than half of the day.

Exclusion Criteria

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

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I haven't had serious heart issues or unstable heart conditions in the last 6 months.

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I have severe nerve damage in my hands or feet.

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I have brain involvement, plasma cell leukemia, or AL amyloidosis.

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I have been diagnosed with COPD.

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

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I am not pregnant, breastfeeding, nor planning to become pregnant during the study.

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I am currently being treated for an infection.

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

Renal Response Rate (RRR)

VGPR

Secondary study objectives

Dialysis independence

Duration of response (DOR)

Overall response rate (ORR)

+3 more

Awards & Highlights

No Placebo-Only Group

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

Trial Design

1Treatment groups

Experimental Treatment

Group I: Dara-CyBorDExperimental Treatment1 Intervention

Induction treatment with daratumumab-hyaluronidase (dara SC) in combination with cyclophosphamide, bortezomib, and dexamethasone (Dara-CyBorD) for four cycles of 28 days, followed by restaging with repeat PET-CT, bone marrow evaluation, and myeloma serological testing.

0 / 9Eligibility criteria met