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NCT03338972 · ClinicalTrials.gov registry record · Phase 1
Immunotherapy With BCMA CAR-T Cells in Treating Patients With BCMA Positive Relapsed or Refractory Multiple Myeloma
A Phase 1 study of Refractory Plasma Cell Myeloma and Recurrent Plasma Cell Myeloma, sponsored by Fred Hutchinson Cancer Center.
- Completed
- Registry status
- Phase 1
- Development phase
- 28
- Enrollment target
- 1
- Study location
NCT03338972: Completed Phase 1 study of Refractory Plasma Cell Myeloma and Recurrent Plasma Cell Myeloma, sponsored by Fred Hutchinson Cancer Center.
NCT03338972 is a Phase 1 study of Refractory Plasma Cell Myeloma and Recurrent Plasma Cell Myeloma that has completed, run by Fred Hutchinson Cancer Center. The registered enrollment target is 28 participants, below the 46-participant average among 25 other Refractory Plasma Cell Myeloma trials with a reported enrollment target (39% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03338972, a Phase 1 study of Refractory Plasma Cell Myeloma and Recurrent Plasma Cell Myeloma, has completed, sponsored by Fred Hutchinson Cancer Center.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 28 participants
- Enrollment target
- 1
- Study location
Study Summary
This phase I trial studies the side effects and best dose of BCMA CAR-T cells in treating patients with BCMA positive multiple myeloma that has come back or does not respond to treatment. T cells are a type of white blood cell and a major component of the immune system. T-cells that have been genetically modified in the laboratory express BCMA and may kill cancer cells with the protein BCMA on their surface. Giving chemotherapy before BCMA CAR-T cells may reduce the amount of disease and to cause a low lymphocyte (white blood cell) count in the blood, which may help the infused BCMA CAR-T cells survive and expand.
Primary Outcome
Observed DLT rates will be summarized based on the DLT-Evaluable analysis set. Outcome will be reported as count of participants in each arm who experienced a DLT. No patients received more than one CAR T cell infusion, so DLT assessment period was only 28 days after first and only CAR T infusion for all patients.
Conditions Studied
Interventions
- DRUG Cyclophosphamide
- DRUG Fludarabine
- PROCEDURE Leukapheresis
- BIOLOGICAL Autologous Anti-BCMA-CAR-expressing CD4+/CD8+ T-lymphocytes FCARH143
Study Locations (1)
Washington
- Fred Hutch/University of Washington Cancer Consortium - Seattle
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 28 participants |
| Start Date | 2017-11-29 |
| Est. Completion | 2022-03-22 |
| Phase | Phase 1 |
What the finished NCT03338972 record still lists
NCT03338972 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 28 participants, a relatively small participant target, below the 46-participant average among 25 other Refractory Plasma Cell Myeloma trials with a reported enrollment target (39% lower).
The record links to 2 conditions, with Refractory Plasma Cell Myeloma appearing as the primary indexed condition, and to 4 interventions - of which Cyclophosphamide is the first listed.
NCT03338972 reports a single indexed study location in Washington.
Frequently Asked Questions
What is clinical trial NCT03338972 about?
NCT03338972 is a clinical study titled "Immunotherapy With BCMA CAR-T Cells in Treating Patients With BCMA Positive Relapsed or Refractory Multiple Myeloma". This phase I trial studies the side effects and best dose of BCMA CAR-T cells in treating patients with BCMA positive multiple myeloma that has come back or does not respond to treatment. T cells are a type of white blood cell and a major component of the immune system. T-cells that have been geneti...
What is the current status of trial NCT03338972?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 28 participants. The study started on 2017-11-29. Estimated completion is 2022-03-22.
What conditions does trial NCT03338972 study?
This clinical trial studies the following conditions: Refractory Plasma Cell Myeloma, Recurrent Plasma Cell Myeloma.
What interventions are being tested in trial NCT03338972?
The interventions under investigation include: Cyclophosphamide (DRUG), Fludarabine (DRUG), Leukapheresis (PROCEDURE), Autologous Anti-BCMA-CAR-expressing CD4+/CD8+ T-lymphocytes FCARH143 (BIOLOGICAL).
Who is sponsoring clinical trial NCT03338972?
This trial is sponsored by Fred Hutchinson Cancer Center, which has 483 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03338972 being conducted?
This trial has 1 study location across Washington. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Refractory Plasma Cell 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 NCT03338972's enrollment target sits among peer trials
28 15th of 25 higher than 11 of 25 other Refractory Plasma Cell Myeloma trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Refractory Plasma Cell 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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