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NCT04933539 · ClinicalTrials.gov registry record · Phase 2
Subcutaneous Daratumumab, Once Weekly Carfilzomib, and Dexamethasone (DKd) in Patients With High-Risk Smoldering Multiple Myeloma
A Phase 2 study of Multiple Myeloma, sponsored by National Cancer Institute (NCI).
- Active
- Registry status
- Phase 2
- Development phase
- 14
- Enrollment target
- 1
- Study location
NCT04933539: Active Phase 2 study of Multiple Myeloma, sponsored by National Cancer Institute (NCI).
NCT04933539 is a Phase 2 study of Multiple Myeloma that is active but no longer recruiting, run by National Cancer Institute (NCI). The registered enrollment target is 14 participants, below the 547-participant average among 438 other Multiple Myeloma trials with a reported enrollment target (97% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04933539, a Phase 2 study of Multiple Myeloma, is active but no longer recruiting, sponsored by National Cancer Institute (NCI).
- ACTIVE NOT RECRUITING
- Registry status
- Phase 2
- Development phase
- 14 participants
- Enrollment target
- 1
- Study location
Study Summary
Background: Multiple myeloma (MM) is a tumor in which malignant plasma cells accumulate in the bone marrow. It can cause organ damage and is not curable. Researchers want to see if a combination drug treatment can help. Objective: To try to prevent or slow down developing MM and its associated organ damage by treating it while still in the smoldering phase with a mix of drugs known as DKd. Eligibility: People ages 18 and older with smoldering MM that is at high risk of converting to symptomatic MM. Design: Participants will be screened with: Medical history Physical exam Blood and urine tests Bone survey (x-rays of their bones) Spinal magnetic resonance imaging Bone marrow biopsy (a needle is used to remove bone marrow from their hipbone) Electrocardiogram (to check heart function) Lung function tests Treatment will be given in 28-day cycles. Participants will get daratumumab by injection under the skin. They will get carfilzomib intravenously (IV) through a tube inserted in a vein. They will get dexamethasone as oral tablets or as an IV. They will get all 3 drugs for 8 or 12 cycles. Then they will get daratumumab alone for up to 24 cycles. They may have stem cells collected. Participants will have frequent study visits. At these visits, they will repeat some screening tests. They will complete questionnaires. They will have imaging scans. For these scans, they may receive an oral or IV contrast. Participants will have a follow-up visit 30 days after treatment ends. Then they will have visits every 3-12 months. They will be followed on this study for life. ...
Primary Outcome
To assess the remission rate of DKd in participants with high-risk (HR) SMM by determining the minimal residual disease (MRD) negative complete response (CR) by flow cytometry (10-5 sensitivity) rate after 12 cycles of therapy
Conditions Studied
Interventions
- DRUG Dexamethasone
- BIOLOGICAL Daratumumab
- DRUG Carfilzomib
Study Locations (1)
Maryland
- National Institutes of Health Clinical Center - Bethesda
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 14 participants |
| Start Date | 2022-10-31 |
| Est. Completion | 2032-10-31 |
| Phase | Phase 2 |
What the registry record for NCT04933539 still lists
NCT04933539 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 14 participants, a relatively small participant target, below the 547-participant average among 438 other Multiple Myeloma trials with a reported enrollment target (97% lower).
The record links to 1 condition, with Multiple Myeloma appearing as the primary indexed condition, and to 3 interventions - of which Dexamethasone is the first listed.
NCT04933539 reports a single indexed study location in Maryland.
Frequently Asked Questions
What is clinical trial NCT04933539 about?
NCT04933539 is a clinical study titled "Subcutaneous Daratumumab, Once Weekly Carfilzomib, and Dexamethasone (DKd) in Patients With High-Risk Smoldering Multiple Myeloma". Background: Multiple myeloma (MM) is a tumor in which malignant plasma cells accumulate in the bone marrow. It can cause organ damage and is not curable. Researchers want to see if a combination drug treatment can help. Objective: To try to prevent or slow down developing MM and its associated or...
What is the current status of trial NCT04933539?
This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 14 participants. The study started on 2022-10-31. Estimated completion is 2032-10-31.
What conditions does trial NCT04933539 study?
This clinical trial studies the following conditions: Multiple Myeloma.
What interventions are being tested in trial NCT04933539?
The interventions under investigation include: Dexamethasone (DRUG), Daratumumab (BIOLOGICAL), Carfilzomib (DRUG).
Who is sponsoring clinical trial NCT04933539?
This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04933539 being conducted?
This trial has 1 study location across Maryland. 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 NCT04933539's enrollment target sits among peer trials
14 411th of 438 higher than 25 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.
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