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Study of Lenalidomide/Ixazomib/Dexamethasone/Daratumumab in Transplant-Ineligible Patients With Newly Diagnosed MM
NCT04009109 · View on ClinicalTrials.gov ↗
Study Summary
A randomized Phase II clinical trial will be conducted to assess the impact on progression free survival (PFS) with the addition of ixazomib and daratumumab to lenalidomide as a maintenance treatment following induction with lenalidomide, ixazomib, dexamethasone, and daratumumab. Patients will be randomized to either: Arm A: 12 cycles of lenalidomide, ixazomib, daratumumab, and dexamethasone followed by lenalidomide until disease progression or unacceptable toxicity or a maximum of 2 years of maintenance therapy. Arm B: 12 cycles of lenalidomide, ixazomib, daratumumab and dexamethasone, followed by lenalidomide, ixazomib, and daratumumab until disease progression or unacceptable toxicity or a maximum of 2 years maintenance therapy.
Conditions Studied
Interventions
- DRUG Dexamethasone
- DRUG Lenalidomide
- DRUG Daratumumab Injection
- DRUG Ixazomib
Study Locations (7)
Massachusetts
- Massachusetts General Hospital — Boston
- Dana Farber Cancer Institute — Boston
Maine
- Northern Light Eastern Maine Medical Center — Bangor
Nebraska
- University of Nebraska Medical Center — Omaha
New York
- SUNY Upstate Medical Center — Syracuse
North Carolina
- University of North Carolina — Chapel Hill
South Carolina
- Gibbs Cancer Center & Research Institute/Spartanburg Regional Healthcare — Spartanburg
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 79 participants |
| Start Date | 2020-10-21 |
| Est. Completion | 2027-06 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04009109
The ClinicalTrials.gov registry entry for NCT04009109 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 79 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Alliance Foundation Trials, which has 71 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 Myeloma, Multiple 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: NCT04009109 reports 7 study locations spanning 6 distinct geographic areas — top geographies include Massachusetts, Maine, Nebraska. 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 NCT04009109 about?
NCT04009109 is a clinical study titled "Study of Lenalidomide/Ixazomib/Dexamethasone/Daratumumab in Transplant-Ineligible Patients With Newly Diagnosed MM". A randomized Phase II clinical trial will be conducted to assess the impact on progression free survival (PFS) with the addition of ixazomib and daratumumab to lenalidomide as a maintenance treatment following induction with lenalidomide, ixazomib, dexamethasone, and daratumumab. Patients will be r...
What is the current status of trial NCT04009109?
This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 79 participants. The study started on 2020-10-21. Estimated completion is 2027-06.
What conditions does trial NCT04009109 study?
This clinical trial studies the following conditions: Myeloma, Multiple. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT04009109?
The interventions under investigation include: Dexamethasone (DRUG), Lenalidomide (DRUG), Daratumumab Injection (DRUG), Ixazomib (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT04009109?
This trial is sponsored by Alliance Foundation Trials, which has 71 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT04009109 being conducted?
This trial has 7 study locations across Maine, Massachusetts, Nebraska, New York, North Carolina. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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