NCT06142396

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. 1.To evaluate the very good partial response rate (VGPR) after 4 cycles of Dara-CyBord.
  2. 2.To evaluate the renal response rate (RRR) after 4 cycles of Dara-CyBord.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at P75+ for early_phase_1 multiple-myeloma

Timeline
17mo left

Started Nov 2024

Typical duration for early_phase_1 multiple-myeloma

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress54%
Nov 2024Nov 2027

First Submitted

Initial submission to the registry

November 16, 2023

Completed
5 days until next milestone

First Posted

Study publicly available on registry

November 21, 2023

Completed
12 months until next milestone

Study Start

First participant enrolled

November 1, 2024

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2027

Last Updated

March 12, 2026

Status Verified

March 1, 2026

Enrollment Period

3 years

First QC Date

November 16, 2023

Last Update Submit

March 11, 2026

Conditions

Multiple MyelomaRenal Failure

Keywords

DaratumumabBortezomibCyclophosphamideDexamethasone

Outcome Measures

Primary Outcomes (2)

  • VGPR

    Very good partial response rate (VGPR) or better after 4 cycles of Dara-CyBorD

    4 months

  • Renal Response Rate (RRR)

    Renal response rate (RRR, defined as \> 30% improvement in creatinine clearance - CrCl from baseline at the point of study entry) after 4 cycles of Dara-CyBorD

    4 months

Secondary Outcomes (6)

  • Overall response rate (ORR)

    4 months

  • VGPR, CR, & MRD

    4 months

  • Duration of response (DOR)

    2 years

  • Time to renal response

    2 years

  • Dialysis independence

    4 months

  • +1 more secondary outcomes

Study Arms (1)

Dara-CyBorD

EXPERIMENTAL

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.

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

Interventions

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

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.

Also known as: DaraCyBord
Dara-CyBorD

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • \. 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Georgia Cancer Center-Augusta University

Augusta, Georgia, 30912, United States

RECRUITING

MeSH Terms

Conditions

Multiple MyelomaRenal Insufficiency

Interventions

BortezomibCyclophosphamideDexamethasone

Condition Hierarchy (Ancestors)

Neoplasms, Plasma CellNeoplasms by Histologic TypeNeoplasmsHemostatic DisordersVascular DiseasesCardiovascular DiseasesParaproteinemiasBlood Protein DisordersHematologic DiseasesHemic and Lymphatic DiseasesHemorrhagic DisordersLymphoproliferative DisordersImmunoproliferative DisordersImmune System DiseasesKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital Diseases

Intervention Hierarchy (Ancestors)

Boronic AcidsAcids, NoncarboxylicAcidsInorganic ChemicalsBoron CompoundsOrganic ChemicalsPyrazinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsPhosphoramide MustardsNitrogen Mustard CompoundsMustard CompoundsHydrocarbons, HalogenatedHydrocarbonsPhosphoramidesOrganophosphorus CompoundsPregnadienetriolsPregnadienesPregnanesSteroidsFused-Ring CompoundsPolycyclic CompoundsSteroids, Fluorinated

Study Officials

  • Amany RA Keruakous, MD

    Augusta University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Amany RA Keruakous, MD

CONTACT

706-721-2505AKERUAKOUS@augusta.edu

James T Sonnenberg, BS

CONTACT

9106192597jsonnenberg@augusta.edu

Study Design

Study Type
interventional
Phase
early phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: Pilot study for combination medication treatment.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 16, 2023

First Posted

November 21, 2023

Study Start

November 1, 2024

Primary Completion (Estimated)

November 1, 2027

Study Completion (Estimated)

November 1, 2027

Last Updated

March 12, 2026

Record last verified: 2026-03

Locations

US(1)