Tests daratumumab with chemotherapy in newly diagnosed multiple myeloma with kidney failure
Tests a daratumumab combination treatment in adults with new myeloma and kidney failure.
Plain-language title generated from the registry record
Registry title: Pilot Study Dara-CyBorD in Newly Diagnosed Multiple Myeloma Patients With Renal Failure
Key facts
- Where
- Augusta, United StatesSee the site
- Phase
- Early phase 1
AI summary: who the study is looking for
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults aged 18 to 80 with newly diagnosed multiple myeloma and kidney problems. All get daratumumab-hyaluronidase with cyclophosphamide, bortezomib and dexamethasone.
- Age
- 18 to 80 years
- Sex
- All sexes
- Disease stage
- Newly diagnosed multiple myeloma with kidney failure (eCrCl < 60 mL/min and/or needing dialysis). Performance status (ECOG) 2 or lower.
Main reasons for not taking part
- HIV, hepatitis B or hepatitis C
- Chronic obstructive pulmonary disease (COPD), or moderate to severe persistent or uncontrolled asthma
- Heart attack within 6 months or unstable heart disease
- Pregnant, breastfeeding or planning pregnancy
- Grade 3 or 4 nerve damage in hands or feet, other active cancer needing treatment, brain or spinal fluid involvement, plasma cell leukemia or AL amyloidosis
Read by machine on 9 November 2026.
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 80 years old?
Source: NCT06142396, who can take part
Where in United States
- Georgia Cancer Center (Augusta University)Augusta, United StatesTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Augusta University
- Trial code
- NCT06142396
- Record updated
- 12 March 2026
- Original description
The goal of this study is to assess the efficacy of induction treatment with daratumumab-hyaluronidase (dara SC) with cyclophosphamide, bortezomib, and dexamethasone (Dara-CyBorD) for four cycles in patients with newly diagnosed multiple myeloma who have new onset renal failure. This study will also investigate the difference responses in African American (AA) patients versus non-African American patients.Read full original descriptionShow less
Pilot Study of Daratumumab in Combination With Bortezomib, Cyclophosphamide, and Dexamethasone (Dara-CyBorD) in Newly Diagnosed Multiple Myeloma Patients With Renal Failure
The goal of this study is to assess the efficacy of induction treatment with daratumumab-hyaluronidase (dara SC) with cyclophosphamide, bortezomib, and dexamethasone (Dara-CyBorD) for four cycles in patients with newly diagnosed multiple myeloma who have new onset renal failure. This study will also investigate the difference responses in African American (AA) patients versus non-African American patients.
The primary questions this study aims to answer are:
1. To evaluate the very good partial response rate (VGPR) after 4 cycles of Dara-CyBord. 2. To evaluate the renal response rate (RRR) after 4 cycles of Dara-CyBord.
Inclusion: Patients must have had a confirmed new diagnosis of MM following revised IMWG criteria; Patients must have Zubrod/ECOG Performance Status ≤ 2; Patients must have renal insufficiency. Renal insufficiency is defined as eCrCl < 60 mL/min (using Cockcroft-Gault Equation for Cr Cl) and/or necessitating dialysis; must not have known allergies to any of the study drugs. Must have adequate organ function; International normalized ratio (INR) and prothrombin time (PT) ≤1.5 × ULN. Activated partial thromboplastin time (aPTT) ≤1.5 × ULN.
Exclusion: 1. Known seropositive for: human immunodeficiency virus (HIV), Hepatitis B, or Hepatitis C; Known Chronic obstructive pulmonary disease (COPD). 3. Known Moderate or severe persistent asthma within the past 2 years, or uncontrolled asthma of any classification; Known Clinically significant heart disease is defined as: myocardial infarction within 6 months before enrollment, or unstable or uncontrolled disease/condition related to or affection cardiac function; Women who are pregnant, breastfeeding, or planning to become pregnant while enrolled in this study; Patients with grade 3 or 4 peripheral neuropathy 7. Patients with other active malignancies that require concurrent treatment 8. Known CNS involvement or plasma cell leukemia, or AL amyloidosis 9. Participants with active infection requiring systemic therapy 10. Has known substance abuse disorders that would interfere with cooperation with the requirements of the study.