Recruiting
Early Phase 1

Dara-CyBorD

Sponsor:

Augusta University

Code:

NCT06142396

Conditions

Multiple Myeloma

Renal Failure

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Daratumumab-hyaluronidase in Combination with Bortezomib, Cyclophosphamide, and Dexamethasone

Study Details

Brief summary:

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.

Conditions

Multiple Myeloma

Renal Failure

Study ID

NCT06142396

Start date

Nov 1, 2024

Status verified date

Mar, 2026

Completion date

Nov 1, 2027

Anticipated

Primary completion date

Nov 1, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Inclusion Criteria:

1. Patients must have had a confirmed new diagnosis of MM following revised IMWG criteria.
2. Patients must have Zubrod/ECOG Performance Status ≤ 2.
3. 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
4. must not have known allergies to any of the study drugs. Must have adequate organ function.
5. International normalized ratio (INR) and prothrombin time (PT) ≤1.5 × ULN. Activated partial thromboplastin time (aPTT) ≤1.5 × ULN.

Exclusion Criteria:

  • 1\. Known seropositive for: human immunodeficiency virus (HIV), Hepatitis B, or Hepatitis C.

2\. Known Chronic obstructive pulmonary disease (COPD). 3. Known Moderate or severe persistent asthma within the past 2 years, or uncontrolled asthma of any classification.

4\. 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.

5\. Women who are pregnant, breastfeeding, or planning to become pregnant while enrolled in this study.

6\. 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.

Study Design

Enrollment

30 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Dara-CyBorD

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.

Interventions

Daratumumab-hyaluronidase in Combination with Bortezomib, Cyclophosphamide, and Dexamethasone

This intervention is Daratumumab-hyaluronidase in combination with the chemotherapy regimen "CyBord" (cyclophosphamide, bortezomib, and dexamethasone) and then with lenalidomide maintenance in patients with newly diagnosed multiple myeloma who have new onset renal failure.

Primary outcome measure

  • VGPR [ Time Frame: 4 months ]
  • Renal Response Rate (RRR) [ Time Frame: 4 months ]

Central Contacts and Locations

Central contacts

Locations

Georgia Cancer Center-Augusta University

Recruiting

Augusta, Georgia, United States, 30912

Contacts

Principal Investigator:

Amany RA Keruakous, MD

More Information

Sponsor

Augusta University

Last update posted

Mar 12, 2026

Last verified

Mar, 2026

Keywords

  • Daratumumab
  • Bortezomib
  • Cyclophosphamide
  • Dexamethasone

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Augusta University on 2026-03-12.