bb2121 for Multiple Myeloma

Phase-Based Progress Estimates
2
Effectiveness
3
Safety
Multiple Myelomabb2121 - Biological
Eligibility
18+
All Sexes
What conditions do you have?
Select

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

2 of 3
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

3 of 3
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: Biological
Arm 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.