A Phase 1 interventional study of bb2121 and Fludarabine in Multiple Myeloma, sponsored by Celgene. Completed at 22 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-08-23.
Sponsored by Celgene · Phase 1, Interventional, and Treatment
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.
3,632 studies on the registry are indexed under Multiple Myeloma; 745 are open to participants now.
This study's enrollment of 13 is below the median of 41 across 2,907 interventional studies indexed under Multiple Myeloma.
Browse Multiple Myeloma studies →Celgene is the lead sponsor of 419 studies on the registry; 13 are open to participants now.
Of its 100 completed or terminated interventional studies of FDA-regulated products, 29 (29%) have results posted.
Counted across the registry records on this site, refreshed daily.
Subjects must satisfy all of the following criteria to be enrolled in the study:
Subject has measurable disease at initial diagnosis by
Subject has high-risk MM at the time of initial diagnosis of MM per R-ISS Stage III as defined by IMWG:
Subjects has received ≤ to 3 cycles of the following induction anti-myeloma therapy prior to enrollment:
Exclusion Criteria:
The presence of any of the following will exclude a subject from enrollment: The presence of any of the following will exclude a subject from enrollment:
At initial diagnosis, screening and prior to initiation of induction therapy for MM:
Subject has non-secretory MM
During Screening:
Subject has any of the following laboratory abnormalities:
Subject has cardiac conditions such as:
Subject has Pulmonary conditions such as:
* bb2121 autologous CAR T cells will be infused at a dose ranging from 150 - 800 x 10\^6 CAR+ T cells after receiving lymphodepleting chemotherapy with a planned starting dose of 450 x 10\^6 CAR+ T cells. * Lenalidomide maintenance therapy is recommended for all patients and should be initiated upon adequate bone marrow recovery or from 90-day post-bb2121 infusion, whichever is later
Biological: bb2121 · Drug: Fludarabine · Drug: Cyclophosphamide · Drug: Lenalidomide
CAR-T Cell Therapy
Also known as: ide-cel
Lymphodepleting Chemotherapy
Lymphodepleting Chemotherapy
Maintenance Therapy
Dose-limiting toxicity (DLT) rates
DLTs will be assessed during the DLT interval (ie, within 21 days immediately after bb2121 infusion). DLTs are defined as any bb2121 related Grade 3 to 5 toxicity.
Time frame: Up to completion of DLT period after last subject bb2121 infused
Adverse Events (AEs)
An AE is any noxious, unintended, or untoward medical occurrence that may appear or worsen in a subject during the course of a study. It may be a new intercurrent illness, a worsening concomitant illness, an injury, or any concomitant impairment of the subject's health, including laboratory test values, regardless of etiology. Any worsening (ie, any clinically significant adverse change in the frequency or intensity of a preexisting condition) should be considered an AE.
Time frame: Approximately 2 years after last subject bb2121 infused
Proportion of subjects who achieved Complete Response (CR) Rate
Is defined as proportion of subjects who achieved CR or better according to IMWG Uniform Response Criteria for Multiple Myeloma for multiple myeloma will be determined by an Investigator assessment.
Time frame: Approximately 2 years after last subject bb2121 infused
Overall Response Rate (ORR)
Is defined as proportion of subjects who achieved PR or better according to IMWG Uniform Response Criteria for Multiple Myeloma as determined by an Investigator assessment
Time frame: Approximately 2 years after last subject bb2121 infused
Duration of Response (DoR)
Is defined as time from first documentation of response (PR or better) to first documentation of progressive disease (PD) or death from any cause, whichever occurs first, for responders.
Time frame: Approximately 2 years after last subject bb2121 infused
Time to Complete Response (TCR)
Is defined as time from bb2121 infusion date to first documentation of CR for responders (Complete Response (CR) or better).
Time frame: Approximately 2 years after last subject bb2121 infused
Time to start maintenance
Is defined as time to start lenalidomide maintenance therapy post-bb2121 infusion
Time frame: Approximately 2 years after last subject bb2121 infused
Feasibility of initiating maintenance
Number of subjects starting the maintenance or on maintenance between D90 and D110
Time frame: Approximately 2 years after last subject bb2121 infused
Progression-free Survival (PFS)
Is defined as time from bb2121 infusion date to first documentation of PD, or death due to any cause, whichever occurs first.
Time frame: Approximately 2 years after last subject bb2121 infused
Overall Survival (OS)
Is defined as time from bb2121 infusion date to time of death due to any cause
Time frame: Approximately 2 years after last subject bb2121 infused
Pharmacokinetics - Cmax
Maximum transgene level
Time frame: Approximately 2 years after last subject bb2121 infused
Pharmacokinetics - Tmax
Time to peak transgene level
Time frame: Approximately 2 years after last subject bb2121 infused
Pharmacokinetics - AUC
Area under the curve of the transgene level
Time frame: Approximately 2 years after last subject bb2121 infused
Plan to share: Yes — Information relating to our policy on data sharing and the process for requesting data can be found at the following link: https://www.celgene.com/research-development/clinical-trials/clinical-trials-data-sharing/
Supporting information: Study protocol, Sap, Icf, Csr, Analytic code
This study is completed, as verified in Aug 2023. You cannot join it, but the record below documents what was studied.
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