Study Summary
This trial is comparing the efficacy and safety of bb2121 versus standard regimens in subjects with relapsed and refractory multiple myeloma.
Eligible Conditions
- Multiple Myeloma
Treatment Effectiveness
Effectiveness Progress
This is further along than 85% of similar trials
Study Objectives
1 Primary · 18 Secondary · Reporting Duration: Minimum 5 years after bb2121 infusion
Year 5
Pharmacokinetics- AUC
Pharmacokinetics- AUC0-28days
Pharmacokinetics- Cmax
Pharmacokinetics- t-last
Pharmacokinetics- tmax
Year 5
Adverse Events (AEs)
Complete Response (CR) Rate
Duration of Response (DOR)
Event-free Survival (EFS)
Minimal Residual Disease (MRD)
Overall Response Rate (ORR)
Overall Survival (OS)
Progression-free Survival (PFS)
Progression-free survival after next line therapy (PFS2)
Subject-reported outcomes as measured by EuroQoL Group European Quality of Life-5 Dimensions health state classifier to 5 Levels (EQ-5D-5L) Health Questionnaire
Subject-reported outcomes as measured by European Organization for Research and Treatment of Cancer Quality-of-Life questionnaire (EORTC-QLQ-C30)
Subject-reported outcomes as measured by European Quality of Life Multiple Myeloma Module (EORTC-QLQ-MY20)
Time to Response (TTR)
Time to next antimyeloma treatment
Trial Safety
Safety Progress
This is further along than 85% of similar trials
Trial Design
2 Treatment Groups
Arm A - Administration of bb2121
1 of 2
Arm B- standard regimens as per Investigator's discretion
1 of 2
Experimental Treatment
381 Total Participants · 2 Treatment Groups
Primary Treatment: bb2121 · No Placebo Group · Phase 3
Arm A - Administration of bb2121
Biological
Experimental Group · 1 Intervention: bb2121 · Intervention Types: BiologicalArm B- standard regimens as per Investigator's discretionExperimental Group · 8 Interventions: Pomalidomide, Daratumumab, Dexamethasone, Bortezomib, Ixazomib, Carfilzomib, Elotuzumab, Lenalidomide · Intervention Types: Drug, Drug, Drug, Drug, Drug, Drug, Drug, Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Pomalidomide
FDA approved
Idecabtagene vicleucel
FDA approved
Daratumumab
FDA approved
Dexamethasone
FDA approved
Bortezomib
FDA approved
Ixazomib
FDA approved
Carfilzomib
FDA approved
Elotuzumab
FDA approved
Lenalidomide
FDA approved
Trial Logistics
Trial Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: minimum 5 years after bb2121 infusion
Who is running the clinical trial?
CelgeneLead Sponsor
625 Previous Clinical Trials
172,893 Total Patients Enrolled
139 Trials studying Multiple Myeloma
39,043 Patients Enrolled for Multiple Myeloma
Steven Novick, MDStudy DirectorCelgene
Bristol-Myers SquibbStudy DirectorBristol-Myers Squibb
1,406 Previous Clinical Trials
3,308,338 Total Patients Enrolled
62 Trials studying Multiple Myeloma
21,455 Patients Enrolled for Multiple Myeloma
Eligibility Criteria
Age 18+ · All Participants · 10 Total Inclusion Criteria
Mark “Yes” if the following statements are true for you:You must understand and voluntarily sign an ICF prior to any study-related assessments/procedures being conducted.
M-protein (serum protein electrophoresis [sPEP] or urine protein electrophoresis [uPEP]): sPEP ≥ 0.
You have received at least 2 but no greater than 4 prior MM regimens.
You have not achieved a response to at least 1 prior treatment regimen.
You have a performance status of 0 or 1.
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top
Conditions
Cancer Related
Treatments