A Phase 2, Multicenter Study to Determine the Efficacy and Safety of bb2121 in Subjects With Relapsed and Refractory Multiple Myeloma

Celgene48 sites in 8 countries149 target enrollmentDecember 13, 2017

ConditionsMultiple Myeloma

Interventionsbb2121

Drugsbb2121

Overview

Phase: Phase 2
Intervention: bb2121
Conditions: Multiple Myeloma
Sponsor: Celgene
Enrollment: 149
Locations: 48
Primary Endpoint: Overall Response Rate
Status: Completed
Last Updated: 11 months ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

This is an open label, single-arm, multicenter, Phase 2 study to evaluate the efficacy and safety of bb2121 in subjects with relapsed and refractory multiple myeloma. A leukapheresis procedure will be performed to manufacture bb2121 chimeric antigen receptor (CAR) modified T cells. Prior to bb2121 infusion subjects will receive lymphodepleting therapy with fludarabine and cyclophosphamide.

Detailed Description

Anti-myeloma bridging treatment is allowed for disease control while bb2121 is being manufactured.

Registry

clinicaltrials.gov

Start Date

December 13, 2017

End Date

December 20, 2023

Last Updated

11 months ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Celgene

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Eligibility is determined prior to leukapheresis. Subjects must satisfy the following criteria to be enrolled in the study:
•Subject is ≥ 18 years of age at the time of signing the informed consent form (ICF).
•Documented diagnosis of multiple myeloma
•Must have received at least 3 prior MM treatment regimens. Note: induction with or without hematopoietic stem cell transplant and with or without maintenance therapy is considered a single regimen.
•Must have undergone at least 2 consecutive cycles of treatment for each regimen, unless PD was the best response to the regimen.
•Must have received a proteasome inhibitor, an immunomodulatory agent and an anti-CD38 antibody.
•Must be refractory to the last treatment regimen.
•Eastern Cooperative Oncology Group (ECOG) performance status 0 or
•Subjects must have measurable disease, including at least one of the criteria below:
•Serum M-protein greater or equal to 1.0 g/dL

Exclusion Criteria

•The presence of any of the following will exclude a subject from enrollment:
•Subjects with known central nervous system involvement with myeloma.
•History or presence of clinically relevant central nervous system (CNS) pathology.
•Subjects with active or history of plasma cell leukemia.
•Subjects with solitary plasmacytomas or non-secretory myeloma without other evidence of measurable disease
•Inadequate organ function
•Ongoing treatment with chronic immunosuppressants
•Previous history of an allogeneic hematopoietic stem cell transplantation or treatment with any gene therapy-based therapeutic for cancer or investigational cellular therapy for cancer or BCMA targeted therapy
•Evidence of human immunodeficiency virus (HIV) infection.
•Seropositive for and with evidence of active viral infection with hepatitis B virus (HBV)

Arms & Interventions

Administration of bb2121

bb2121 autologous CAR T cells will be infused at a dose ranging from 15 - 450 x 10\^6 CAR+ T cells after receiving lymphodepleting chemotherapy.

Intervention: bb2121

Outcomes

Primary Outcomes

Overall Response Rate

Time Frame: From first dose to 24 Months

Number of participants who achieved partial response (PR) or better according to IMWG Uniform Response Criteria for Multiple Myeloma as assessed by an independent response committee (IRC).

Secondary Outcomes

Number of Participants With Safety Related Events(From screening to the end of follow up (approximately 5 years and 2 months))
Complete Response Rate(From first dose to 24 Months)
Cmax(From first dose to the end of follow up (Approximately 5 years))
Time to Response(From first dose to initial response (approximately on average 1.2 months, max of 8.8 months))
Duration of Response(From first dose to 24 months after first dose)
Progression Free Survival (PFS)(From first dose to 24 months after first dose)
Time to Progression (TTP)(From first dose to 24 months after first dose)
AUC 0-9M(at 9 months post first dose (Approximtately 9 Months))
Tmax(From first dose to the end of follow up (Approximately 5 years))
Number of Participants With Anti-CAR-Antibodies(From first dose to the end of follow up (Approximately 5 years))
Overall Survival(From screening to the end of follow up (approximately 5 years and 2 months))
Percentage of Participants Who Achieved >= VGPR and MRD Negative Status(From screening to the end of follow up (Approximately 5 years and 2 months))
Mean Change From Baseline on the EORTC QLQ-C30 - Fatigue.(At Day 1 and at specific time points up to month 24)
Mean Change From Baseline on the EORTC QLQ-C30 - Pain(At Day 1 and at specific time points up to month 24)
Mean Change From Baseline on the EORTC QLQ-C30 - Physical Functioning(At Day 1 and at specific time points up to month 24)
Mean Change From Baseline on the EORTC QLQ-C30 - Cognitive Functioning(At Day 1 and at specific time points up to month 24)
Mean Change From Baseline on the EORTC QLQ-C30 - Global Heath/QoL(At Day 1 and at specific time points up to month 24)
Mean Change From Baseline on the EORTC QLQ-MY20 - Disease Symptoms(At Day 1 and at specific time points up to month 24)
Mean Change From Baseline on the EORTC QLQ-MY20 - Side Effects(At Day 1 and at specific time points up to month 24)
Mean Change From Baseline on the EQ-5D-5L Index(At Day 1 and at specific time points up to month 24)