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NCT07085728 · ClinicalTrials.gov registry record · Phase 2
Testing the Investigational Agent Combination of Daratumumab, Bortezomib, and Dexamethasone Compared to the Usual Treatment of Cyclophosphamide, Bortezomib, and Dexamethasone in Newly Diagnosed Multiple Myeloma Patients With Kidney Failure
A Phase 2 study, sponsored by Eastern Cooperative Oncology Group.
- Active
- Registry status
- Phase 2
- Development phase
- 74
- Enrollment target
NCT07085728: Active Phase 2 study, sponsored by Eastern Cooperative Oncology Group.
NCT07085728 is a Phase 2 study that is active but no longer recruiting, run by Eastern Cooperative Oncology Group. The registered enrollment target is 74 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (44% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT07085728, a Phase 2 study, is active but no longer recruiting, sponsored by Eastern Cooperative Oncology Group.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 2
- Development phase
- 74 participants
- Enrollment target
Study Summary
This study is being done to answer the following question: Can the addition of daratumumab-hyaluronidase to the usual treatment of bortezomib and dexamethasone improve kidney function in patients who are newly diagnosed with multiple myeloma and have kidney failure? This study is being done because the investigators want to find out if this approach is better or worse than the usual approach for the participant's newly diagnosed multiple myeloma. The usual approach is defined as care most people get for multiple myeloma. If the participant decides to take part in this study, they will either get the study medications daratumumab-hyaluronidase, bortezomib, and dexamethasone for four months (4 cycles), or the typical medications used to treat your cancer (cyclophosphamide, bortezomib, and dexamethasone) for 4 months (4 cycles). After the participant finishes their study treatment, their doctor will continue to follow their condition for 10 years to watch them for side effects and monitor their disease status. Their doctor will follow up with them every 3 months for years 1 and 2 and then every 6 months for years 3 through 10.
Primary Outcome
Renal response rate (RRR) is the proportion of patients achieving complete or partial renal response based on International Myeloma Working Group (IMWG) renal response criteria (Dimopoulos 2023) over 4 cycles of treatment.
Interventions
- DRUG Cyclophosphamide
- DRUG Dexamethasone
- DRUG Bortezomib (VELCADE)
- DRUG Daratumumab-hyaluronidase
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 74 participants |
| Start Date | 2025-08-11 |
| Est. Completion | 2027-02-01 |
| Phase | Phase 2 |
What the registry record for NCT07085728 still lists
NCT07085728 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 74 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (44% lower).
The record links to 0 conditions, and to 4 interventions - of which Cyclophosphamide is the first listed.
NCT07085728 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT07085728 about?
NCT07085728 is a clinical study titled "Testing the Investigational Agent Combination of Daratumumab, Bortezomib, and Dexamethasone Compared to the Usual Treatment of Cyclophosphamide, Bortezomib, and Dexamethasone in Newly Diagnosed Multiple Myeloma Patients With Kidney Failure". This study is being done to answer the following question: Can the addition of daratumumab-hyaluronidase to the usual treatment of bortezomib and dexamethasone improve kidney function in patients who are newly diagnosed with multiple myeloma and have kidney failure? This study is being done because...
What is the current status of trial NCT07085728?
This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 74 participants. The study started on 2025-08-11. Estimated completion is 2027-02-01.
What interventions are being tested in trial NCT07085728?
The interventions under investigation include: Cyclophosphamide (DRUG), Dexamethasone (DRUG), Bortezomib (VELCADE) (DRUG), Daratumumab-hyaluronidase (DRUG).
Who is sponsoring clinical trial NCT07085728?
This trial is sponsored by Eastern Cooperative Oncology Group, which has 141 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT07085728's enrollment target sits among peer trials
74 920th of 2000 higher than 1,077 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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.
Source ClinicalTrials.gov registry export · 2026-08-08
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