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NCT04196491 · ClinicalTrials.gov registry record · Phase 1
A Study to Evaluate the Safety of bb2121 in Subjects With High Risk, Newly Diagnosed Multiple Myeloma (NDMM)
A Phase 1 study, sponsored by Celgene.
- Completed
- Registry status
- Phase 1
- Development phase
- 13
- Enrollment target
NCT04196491 is a Phase 1 study that has completed, run by Celgene. The registered enrollment target is 13 participants.
The verdict
NCT04196491, a Phase 1 study, has completed, sponsored by Celgene.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 13 participants
- Enrollment target
Study Summary
This is a multicenter, open-label, phase 1, single arm study intended to determine the optimal target dose and safety of bb2121 in subjects with HR (R-ISS Stage III per IMWG criteria) NDMM. Subjects should have received 3 Cycles of standard induction therapy prior to undergoing leukapheresis procedure to collect autologous mononuclear cells for manufacture of the drug product (bb2121). Following manufacture of the drug product, subjects will receive fourth cycle of induction therapy followed by lymphodepleting therapy with fludarabine and cyclophosphamide prior to bb2121 infusion. Maintenance therapy is recommended for all subjects who have received bb2121 infusion and should be initiated upon adequate bone marrow recovery or from 90-day post-bb2121 infusion, whichever is later.
Interventions
- DRUG Cyclophosphamide
- DRUG Fludarabine
- DRUG Lenalidomide
- BIOLOGICAL bb2121
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 13 participants |
| Start Date | 2020-05-27 |
| Est. Completion | 2023-06-07 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04196491
The ClinicalTrials.gov registry entry for NCT04196491 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 13 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Celgene, which has 308 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 4 interventions - of which Cyclophosphamide is the first listed.
NCT04196491 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT04196491 about?
NCT04196491 is a clinical study titled "A Study to Evaluate the Safety of bb2121 in Subjects With High Risk, Newly Diagnosed Multiple Myeloma (NDMM)". This is a multicenter, open-label, phase 1, single arm study intended to determine the optimal target dose and safety of bb2121 in subjects with HR (R-ISS Stage III per IMWG criteria) NDMM. Subjects should have received 3 Cycles of standard induction therapy prior to undergoing leukapheresis procedu...
What is the current status of trial NCT04196491?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 13 participants. The study started on 2020-05-27. Estimated completion is 2023-06-07.
What interventions are being tested in trial NCT04196491?
The interventions under investigation include: Cyclophosphamide (DRUG), Fludarabine (DRUG), Lenalidomide (DRUG), bb2121 (BIOLOGICAL).
Who is sponsoring clinical trial NCT04196491?
This trial is sponsored by Celgene, which has 308 total clinical trials registered on ClinicalTrials.gov.
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