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NCT04140162 · ClinicalTrials.gov registry record · Phase 2
Phase 2 Study With Minimal Residual Disease (MRD) Driven Adaptive Strategy in Treatment for Newly Diagnosed Multiple Myeloma (MM) With Upfront Daratumumab-based Therapy
A Phase 2 study of Multiple Myeloma, sponsored by University of Michigan Rogel Cancer Center.
- Active
- Registry status
- Phase 2
- Development phase
- 57
- Enrollment target
- 4
- Study locations
NCT04140162: Active Phase 2 study of Multiple Myeloma, sponsored by University of Michigan Rogel Cancer Center.
NCT04140162 is a Phase 2 study of Multiple Myeloma that is active but no longer recruiting, run by University of Michigan Rogel Cancer Center. The registered enrollment target is 57 participants, below the 547-participant average among 438 other Multiple Myeloma trials with a reported enrollment target (90% lower). The trial reports 4 study locations across 3 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04140162, a Phase 2 study of Multiple Myeloma, is active but no longer recruiting, sponsored by University of Michigan Rogel Cancer Center.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 2
- Development phase
- 57 participants
- Enrollment target
- 4
- Study locations
Study Summary
This phase 2 trial will test whether the combination of DaraRd (daratumumab + lenalidomide + dexamethasone) as induction therapy, followed by DRVd (daratumumab + lenalidomide + bortezomib + dexamethasone) consolidation therapy, if needed, will result in more patients achieving minimal residual disease (MRD)-negative status, relative to the standard of care. Consolidation therapy will be administered only to those patients with MRD-positive status after induction therapy. This is a study based on adaptive design for decision making of treatment options. Duration of therapy (daratumumab cycles) will depend on individual approach, response, evidence of disease progression and tolerance.
Primary Outcome
Of participants who complete at least one cycle of induction therapy, proportion that achieve MRD-negativity after completion of induction + those who achieve MRD-negativity after completion of consolidation (if still MRD-positive after induction). MRD status determined by International Myeloma Working Group (IMWG) Response Criteria.
Conditions Studied
Interventions
- DRUG Dexamethasone
- DRUG Lenalidomide
- DRUG Daratumumab
- DRUG Bortezomib
Study Locations (4)
Michigan
- University of Michigan Rogel Cancer Center - Ann Arbor
- Barbara Ann Karmanos Cancer Institute - Detroit
New York
- University of Rochester - Rochester
Texas
- University of Texas Southwestern -- Simmons Comprehensive Cancer Center - Dallas
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 57 participants |
| Start Date | 2020-10-05 |
| Est. Completion | 2026-05-02 |
| Phase | Phase 2 |
What the registry record for NCT04140162 still lists
NCT04140162 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 57 participants, a relatively small participant target, below the 547-participant average among 438 other Multiple Myeloma trials with a reported enrollment target (90% lower).
The record links to 1 condition, with Multiple Myeloma appearing as the primary indexed condition, and to 4 interventions - of which Dexamethasone is the first listed.
NCT04140162 reports a single indexed study location in Michigan, New York, Texas.
Frequently Asked Questions
What is clinical trial NCT04140162 about?
NCT04140162 is a clinical study titled "Phase 2 Study With Minimal Residual Disease (MRD) Driven Adaptive Strategy in Treatment for Newly Diagnosed Multiple Myeloma (MM) With Upfront Daratumumab-based Therapy". This phase 2 trial will test whether the combination of DaraRd (daratumumab + lenalidomide + dexamethasone) as induction therapy, followed by DRVd (daratumumab + lenalidomide + bortezomib + dexamethasone) consolidation therapy, if needed, will result in more patients achieving minimal residual disea...
What is the current status of trial NCT04140162?
This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 57 participants. The study started on 2020-10-05. Estimated completion is 2026-05-02.
What conditions does trial NCT04140162 study?
This clinical trial studies the following conditions: Multiple Myeloma.
What interventions are being tested in trial NCT04140162?
The interventions under investigation include: Dexamethasone (DRUG), Lenalidomide (DRUG), Daratumumab (DRUG), Bortezomib (DRUG).
Who is sponsoring clinical trial NCT04140162?
This trial is sponsored by University of Michigan Rogel Cancer Center, which has 292 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04140162 being conducted?
This trial has 4 study locations across Michigan, New York, Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Multiple Myeloma
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT04140162's enrollment target sits among peer trials
57 235th of 438 higher than 201 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.
Source ClinicalTrials.gov registry export · 2026-08-08
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