A Study to Evaluate the Safety of bb2121 in Subjects With High Risk, Newly Diagnosed Multiple Myeloma (NDMM)
Public ClinicalTrials.gov record NCT04196491. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Phase 1, Open-label, Multicenter Study to Evaluate the Safety of bb2121 in Subjects With High Risk, Newly Diagnosed Multiple Myeloma (KarMMa-4)
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT04196491
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 1
- Enrollment
- 13 participants
Conditions and interventions
Conditions
Interventions
- bb2121 Biological
- Fludarabine Drug
- Cyclophosphamide Drug
- Lenalidomide Drug
Biological · Drug
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- May 26, 2020
- Primary completion
- Jun 6, 2023
- Completion
- Jun 6, 2023
- Last update posted
- Aug 22, 2023
2020 – 2023
United States locations
- U.S. sites
- 22
- U.S. states
- 15
- U.S. cities
- 18
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Local Institution - 119 | Phoenix | Arizona | 85054 | — |
| Local Institution - 110 | Los Angeles | California | 90095 | — |
| Local Institution - 116 | San Francisco | California | 94143 | — |
| Local Institution - 106 | Denver | Colorado | 80218 | — |
| Local Institution - 101 | Jacksonville | Florida | 32224 | — |
| Local Institution - 113 | Tampa | Florida | 33612 | — |
| Local Institution - 108 | Atlanta | Georgia | 30322 | — |
| Local Institution - 123 | Atlanta | Georgia | 30342 | — |
| Local Institution - 115 | Boston | Massachusetts | 02114 | — |
| Local Institution - 122 | Boston | Massachusetts | 02215 | — |
| Local Institution - 117 | Hackensack | New Jersey | 07601 | — |
| Local Institution - 121 | New York | New York | 10016 | — |
| Local Institution - 109 | New York | New York | 10029 | — |
| Local Institution - 124 | New York | New York | 10065 | — |
| Local Institution - 120 | Charlotte | North Carolina | 28207 | — |
| Local Institution - 112 | Portland | Oregon | 97239 | — |
| Local Institution - 118 | Philadelphia | Pennsylvania | 19104 | — |
| Local Institution - 103 | Nashville | Tennessee | 37203 | — |
| Local Institution - 102 | Dallas | Texas | 75390 | — |
| Local Institution - 114 | Houston | Texas | 77030 | — |
| Local Institution - 104 | Seattle | Washington | 98109-1024 | — |
| Local Institution - 107 | Milwaukee | Wisconsin | 53226-3522 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT04196491, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Aug 22, 2023 · Synced Sep 5, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT04196491 live on ClinicalTrials.gov.