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NCT04775550 · ClinicalTrials.gov registry record · Phase 2
DARA RVD For High Risk SMM
A Phase 2 study of Multiple Myeloma and High-risk Smoldering Multiple Myeloma, sponsored by Omar Nadeem, MD.
- Active
- Registry status
- Phase 2
- Development phase
- 61
- Enrollment target
- 6
- Study locations
NCT04775550: Active Phase 2 study of Multiple Myeloma and High-risk Smoldering Multiple Myeloma, sponsored by Omar Nadeem, MD.
NCT04775550 is a Phase 2 study of Multiple Myeloma and High-risk Smoldering Multiple Myeloma that is active but no longer recruiting, run by Omar Nadeem, MD. The registered enrollment target is 61 participants, below the 547-participant average among 438 other Multiple Myeloma trials with a reported enrollment target (89% lower). The trial reports 6 study locations across 2 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04775550, a Phase 2 study of Multiple Myeloma and High-risk Smoldering Multiple Myeloma, is active but no longer recruiting, sponsored by Omar Nadeem, MD.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 2
- Development phase
- 61 participants
- Enrollment target
- 6
- Study locations
Study Summary
The purpose of this research study is to learn whether the combination of daratumumab SC ( Darzalex Faspro), lenalidomide (Revlimid), bortezomib (Velcade) and dexamethasone works in treating smoldering multiple myeloma and preventing progression to active or symptomatic multiple myeloma. The names of the study drugs involved in this study are: * Daratumumab (also called Darzalex Faspro) * Bortezomib (also called Velcade) * Lenalidomide (also called Revlimid) * Dexamethasone
Primary Outcome
MRD negative disease (MRD-) is defined as zero residual sequence cells detected at a level of one million cells. At time of final analysis, the 2-year MRD- rate will be summarized as a proportion with a 90% exact binomial confidence interval
Conditions Studied
Interventions
- DRUG Dexamethasone
- DRUG Lenalidomide
- DRUG Daratumumab
- DRUG Bortezomib
Study Locations (6)
Massachusetts
- Brigham and Women's Hospital - Boston
- Dana-Farber Cancer Institute - Boston
- Dana-Farber Brigham Cancer Center - Foxborough - Foxborough
- Dana-Farber Cancer Institute - Merrimack Valley - Methuen
- Dana-Farber Brigham Cancer Center - South Weymouth
Connecticut
- Stamford Hospital - Stamford
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 61 participants |
| Start Date | 2021-03-08 |
| Est. Completion | 2030-12-08 |
| Phase | Phase 2 |
What the registry record for NCT04775550 still lists
NCT04775550 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 61 participants, a relatively small participant target, below the 547-participant average among 438 other Multiple Myeloma trials with a reported enrollment target (89% lower).
The record links to 2 conditions, with Multiple Myeloma appearing as the primary indexed condition, and to 4 interventions - of which Dexamethasone is the first listed.
NCT04775550 lists 6 locations in 2 states (Massachusetts, Connecticut).
Frequently Asked Questions
What is clinical trial NCT04775550 about?
NCT04775550 is a clinical study titled "DARA RVD For High Risk SMM". The purpose of this research study is to learn whether the combination of daratumumab SC ( Darzalex Faspro), lenalidomide (Revlimid), bortezomib (Velcade) and dexamethasone works in treating smoldering multiple myeloma and preventing progression to active or symptomatic multiple myeloma. The names ...
What is the current status of trial NCT04775550?
This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 61 participants. The study started on 2021-03-08. Estimated completion is 2030-12-08.
What conditions does trial NCT04775550 study?
This clinical trial studies the following conditions: Multiple Myeloma, High-risk Smoldering Multiple Myeloma.
What interventions are being tested in trial NCT04775550?
The interventions under investigation include: Dexamethasone (DRUG), Lenalidomide (DRUG), Daratumumab (DRUG), Bortezomib (DRUG).
Who is sponsoring clinical trial NCT04775550?
This trial is sponsored by Omar Nadeem, MD, which has 3 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04775550 being conducted?
This trial has 6 study locations across Connecticut, Massachusetts. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT04775550's enrollment target sits among peer trials
61 226th of 438 higher than 212 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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