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NCT05767359 · ClinicalTrials.gov registry record · Phase 2
CAR- PRISM (PRecision Intervention Smoldering Myeloma)
A Phase 2 study of Multiple Myeloma and Smoldering Multiple Myeloma, sponsored by Dana-Farber Cancer Institute.
- Active
- Registry status
- Phase 2
- Development phase
- 20
- Enrollment target
- 1
- Study location
NCT05767359: Active Phase 2 study of Multiple Myeloma and Smoldering Multiple Myeloma, sponsored by Dana-Farber Cancer Institute.
NCT05767359 is a Phase 2 study of Multiple Myeloma and Smoldering Multiple Myeloma that is active but no longer recruiting, run by Dana-Farber Cancer Institute. The registered enrollment target is 20 participants, below the 547-participant average among 438 other Multiple Myeloma trials with a reported enrollment target (96% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05767359, a Phase 2 study of Multiple Myeloma and Smoldering Multiple Myeloma, is active but no longer recruiting, sponsored by Dana-Farber Cancer Institute.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 2
- Development phase
- 20 participants
- Enrollment target
- 1
- Study location
Study Summary
The goal of this research study is to test if ciltacabtagene autoleucel (cilta-cel) is safe and effective in treating participants with high-risk, smoldering myeloma. The names of the treatment interventions used in this study are: * Cilta-cel (or chimeric antigen receptor T cells) * Cyclophosphamide (a lymphodepleting chemotherapy) * Fludarabine (a lymphodepleting chemotherapy)
Primary Outcome
Incidence of Dose Limiting Toxicities (DLTs) during the first 28 days after anti-BCMA CAR-T cell administration. Dose-Limiting Toxicities (DLTs) will be defined as follows: * Grade 4 non-hematologic toxicity of any duration including Grade 4 CRS and ICANS * Grade 3 CRS that does not improve to a grade 2 or less in 72 hours following adequate therapy. * Grade 3 neurological toxicity of any duration * Grade 3 toxicity of any duration involving vital organs (cardiac, pulmonary). Exceptions can be
Conditions Studied
Interventions
- DRUG Cyclophosphamide
- DRUG Fludarabine Phosphate
- DRUG Ciltacabtagene Autoleucel
Study Locations (1)
Massachusetts
- Dana Farber Cancer Institute - Boston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 20 participants |
| Start Date | 2023-04-19 |
| Est. Completion | 2040-01-15 |
| Phase | Phase 2 |
What the registry record for NCT05767359 still lists
NCT05767359 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 20 participants, a relatively small participant target, below the 547-participant average among 438 other Multiple Myeloma trials with a reported enrollment target (96% lower).
The record links to 2 conditions, with Multiple Myeloma appearing as the primary indexed condition, and to 3 interventions - of which Cyclophosphamide is the first listed.
NCT05767359 reports a single indexed study location in Massachusetts.
Frequently Asked Questions
What is clinical trial NCT05767359 about?
NCT05767359 is a clinical study titled "CAR- PRISM (PRecision Intervention Smoldering Myeloma)". The goal of this research study is to test if ciltacabtagene autoleucel (cilta-cel) is safe and effective in treating participants with high-risk, smoldering myeloma. The names of the treatment interventions used in this study are: * Cilta-cel (or chimeric antigen receptor T cells) * Cyclophospham...
What is the current status of trial NCT05767359?
This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 20 participants. The study started on 2023-04-19. Estimated completion is 2040-01-15.
What conditions does trial NCT05767359 study?
This clinical trial studies the following conditions: Multiple Myeloma, Smoldering Multiple Myeloma.
What interventions are being tested in trial NCT05767359?
The interventions under investigation include: Cyclophosphamide (DRUG), Fludarabine Phosphate (DRUG), Ciltacabtagene Autoleucel (DRUG).
Who is sponsoring clinical trial NCT05767359?
This trial is sponsored by Dana-Farber Cancer Institute, which has 781 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05767359 being conducted?
This trial has 1 study location across Massachusetts. 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 NCT05767359's enrollment target sits among peer trials
20 381st of 438 higher than 47 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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