Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
Phase 2 Study With Minimal Residual Disease (MRD) Driven Adaptive Strategy in Treatment for Newly Diagnosed Multiple Myeloma (MM) With Upfront Daratumumab-based Therapy
NCT04140162 · View on ClinicalTrials.gov ↗
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.
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 |
Interested in This Trial?
Always speak with your doctor before enrolling in a clinical trial.
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04140162
The ClinicalTrials.gov registry entry for NCT04140162 describes a study currently listed as active not recruiting. It is categorized as Phase 2, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 57 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Michigan Rogel Cancer Center, which has 261 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT04140162 reports 4 study locations spanning 3 distinct geographic areas — top geographies include Michigan, New York, Texas. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT04140162?
The interventions under investigation include: Dexamethasone (DRUG), Lenalidomide (DRUG), Daratumumab (DRUG), Bortezomib (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT04140162?
This trial is sponsored by University of Michigan Rogel Cancer Center, which has 261 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
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
How Clinical Trials Work
Understand phases 1-4, trial design, randomization, and the informed consent process.
Patient Rights in Clinical Trials
Your rights as a participant: consent, withdrawal, privacy, and who to contact.
Finding the Right Clinical Trial
A practical guide to searching trials, understanding eligibility, and evaluating options.
All Guides
Browse our complete library of clinical trial educational resources.
Read our methodology — how this data is sourced, computed, and verified.