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NCT06142396 · ClinicalTrials.gov registry record · Early Phase 1
Pilot Study Dara-CyBorD in Newly Diagnosed Multiple Myeloma Patients With Renal Failure
A Early Phase 1 study of Multiple Myeloma and Renal Failure, sponsored by Augusta University.
- Recruiting
- Registry status
- Early Phase 1
- Development phase
- 30
- Enrollment target
- 1
- Study location
NCT06142396: Recruiting Early Phase 1 study of Multiple Myeloma and Renal Failure, sponsored by Augusta University.
NCT06142396 is a Early Phase 1 study of Multiple Myeloma and Renal Failure that is actively recruiting participants, run by Augusta University. The registered enrollment target is 30 participants, below the 547-participant average among 438 other Multiple Myeloma trials with a reported enrollment target (95% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06142396, a Early Phase 1 study of Multiple Myeloma and Renal Failure, is actively recruiting participants, sponsored by Augusta University.
- RECRUITING
- Registry status
- Early Phase 1
- Development phase
- 30 participants
- Enrollment target
- 1
- Study location
Study 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.
Primary Outcome
Very good partial response rate (VGPR) or better after 4 cycles of Dara-CyBorD
Conditions Studied
Interventions
- COMBINATION_PRODUCT Daratumumab-hyaluronidase in Combination with Bortezomib, Cyclophosphamide, and Dexamethasone
Study Locations (1)
Georgia
- Georgia Cancer Center-Augusta University - Augusta
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 30 participants |
| Start Date | 2024-11-01 |
| Est. Completion | 2027-11-01 |
| Phase | Early Phase 1 |
What NCT06142396 shows while recruiting
NCT06142396 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 30 participants, a relatively small participant target, below the 547-participant average among 438 other Multiple Myeloma trials with a reported enrollment target (95% lower).
The record links to 2 conditions, with Multiple Myeloma appearing as the primary indexed condition, and to 1 intervention - of which Daratumumab-hyaluronidase in Combination with Bortezomib, Cyclophosphamide, and Dexamethasone is the first listed.
NCT06142396 reports a single indexed study location in Georgia.
Frequently Asked Questions
What is clinical trial NCT06142396 about?
NCT06142396 is a clinical study titled "Pilot Study 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...
What is the current status of trial NCT06142396?
This trial is currently recruiting. It is a Early Phase 1 study. The enrollment target is 30 participants. The study started on 2024-11-01. Estimated completion is 2027-11-01.
What conditions does trial NCT06142396 study?
This clinical trial studies the following conditions: Multiple Myeloma, Renal Failure.
What interventions are being tested in trial NCT06142396?
The interventions under investigation include: Daratumumab-hyaluronidase in Combination with Bortezomib, Cyclophosphamide, and Dexamethasone (COMBINATION_PRODUCT).
Who is sponsoring clinical trial NCT06142396?
This trial is sponsored by Augusta University, which has 106 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06142396 being conducted?
This trial has 1 study location across Georgia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT06142396's enrollment target sits among peer trials
30 338th of 438 higher than 80 of 438 other Multiple Myeloma trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Multiple Myeloma trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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