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NCT04009109 · ClinicalTrials.gov registry record · Phase 2
Study of Lenalidomide/Ixazomib/Dexamethasone/Daratumumab in Transplant-Ineligible Patients With Newly Diagnosed MM
A Phase 2 study of Myeloma Multiple, sponsored by Alliance Foundation Trials.
- Active
- Registry status
- Phase 2
- Development phase
- 79
- Enrollment target
- 7
- Study locations
NCT04009109: Active Phase 2 study of Myeloma Multiple, sponsored by Alliance Foundation Trials.
NCT04009109 is a Phase 2 study of Myeloma Multiple that is active but no longer recruiting, run by Alliance Foundation Trials. The registered enrollment target is 79 participants, roughly in line with the 75-participant average among 7 other Myeloma Multiple trials with a reported enrollment target. The trial reports 7 study locations across 6 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04009109, a Phase 2 study of Myeloma Multiple, is active but no longer recruiting, sponsored by Alliance Foundation Trials.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 2
- Development phase
- 79 participants
- Enrollment target
- 7
- Study locations
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.
Primary Outcome
Time interval between registration and progression or death.
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 |
What the registry record for NCT04009109 still lists
NCT04009109 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 79 participants, a relatively small participant target, roughly in line with the 75-participant average among 7 other Myeloma Multiple trials with a reported enrollment target.
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.
NCT04009109 lists 7 locations in 6 states (Massachusetts, Maine, Nebraska).
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.
What interventions are being tested in trial NCT04009109?
The interventions under investigation include: Dexamethasone (DRUG), Lenalidomide (DRUG), Daratumumab Injection (DRUG), Ixazomib (DRUG).
Who is sponsoring clinical trial NCT04009109?
This trial is sponsored by Alliance Foundation Trials, which has 20 total clinical trials registered on ClinicalTrials.gov.
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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