Pilot Study Dara-CyBorD in Newly Diagnosed Multiple Myeloma Patients With Renal Failure

Part of paid clinical trials in Augusta, Georgia.

Sponsor
Augusta University
Study ID
NCT06142396
Phase
EARLY_PHASE1
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 80 Years
Healthy Volunteers
Not accepted

Interventions

Study Details

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.

Key Dates

Start date
Nov 1, 2024
Status verified
Mar 2026
Primary completion
Nov 1, 2027
Completion
Nov 1, 2027

Study Design

Enrollment
30 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

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.

Primary Outcome Measure

VGPR [ Time Frame: 4 months ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Georgia Cancer Center-Augusta UniversityAugustaGeorgia30912
Amany RA Keruakous, MD
[email protected]
7067212505
James T Sonnenberg, BS
[email protected]
9106192597
Amany RA Keruakous, MD (PRINCIPAL_INVESTIGATOR)
Amber B. Clemmons, PharmD (SUB_INVESTIGATOR)

Find similar trials in Augusta, GA

By condition
Multiple myeloma
By specialty
OncologyBlood cancer
By research site
Georgia Cancer Center-Augusta University· Augusta, GA

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