bb2121 for Multiple Myeloma

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
Multiple Myelomabb2121 - Biological
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

This trial is testing a new cancer treatment involving CAR T cells. Lymphodepleting therapy will be used prior to infusion of the CAR T cells.

Eligible Conditions
  • Multiple Myeloma

Treatment Effectiveness

Study Objectives

1 Primary · 15 Secondary · Reporting Duration: Minimum of 24 months post-bb2121 infusion

Month 24
Subject-reported outcomes as measured by EuroQoL Group EQ-5D-5L Health Questionnaire
Month 24
Adverse Events (AEs)
Complete Response (CR) Rate
Duration of Response
Immunogenicity
Neoplasm, Residual
Overall Response Rate (ORR)
Overall Survival (OS)
Pharmacokinetics - AUC
Pharmacokinetics - Cmax
Pharmacokinetics - Tmax
Progression-free Survival (PFS)
Subject-reported outcomes as measured by EORTC-QLQ-MY20
Subject-reported outcomes as measured by European Organization for Research and Treatment of Cancer Quality-of-Life questionnaire (EORTC-QLQ-C30)
Time to Progression (TTP)
Time to Response

Trial Safety

Safety Progress

2 of 3
This is further along than 68% of similar trials

Trial Design

1 Treatment Group

Administration of bb2121
1 of 1

Experimental Treatment

149 Total Participants · 1 Treatment Group

Primary Treatment: bb2121 · No Placebo Group · Phase 2

Administration of bb2121
Biological
Experimental Group · 1 Intervention: bb2121 · Intervention Types: Biological
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Idecabtagene vicleucel
FDA approved

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: minimum of 24 months post-bb2121 infusion

Who is running the clinical trial?

CelgeneLead Sponsor
625 Previous Clinical Trials
173,021 Total Patients Enrolled
139 Trials studying Multiple Myeloma
39,171 Patients Enrolled for Multiple Myeloma
Kristen HegeStudy DirectorCelgene
1 Previous Clinical Trials
50 Total Patients Enrolled
1 Trials studying Multiple Myeloma
50 Patients Enrolled for Multiple Myeloma
Bristol-Myers SquibbStudy DirectorBristol-Myers Squibb
1,407 Previous Clinical Trials
3,309,018 Total Patients Enrolled
62 Trials studying Multiple Myeloma
21,584 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:
The subject is old enough to make an informed decision when they sign the form.
is rare Rarely, a person is diagnosed with multiple myeloma.
Must have received at least 3 prior treatments with different chemotherapy drugs.
Must have undergone at least 2 consecutive cycles of treatment for each regimen, unless the patient's cancer was in remission or the best response to the regimen.
The individual must have received a proteasome inhibitor, an immunomodulatory agent, and an anti-CD38 antibody.
Must not have responded to the last treatment regimen.
A person's urine has M-protein levels that are greater than or equal to 200 milligrams per 24 hours.
A person with an ECOG performance status of 0 or 1 is able to carry out all usual activities and has no symptoms.
A serum protein level greater than or equal to 1.0 g/dL is suggestive of monoclonal gammopathy.
A serum free light chain assay is considered positive if the involved FLC level is greater or equal to 10 mg/dL (100 mg/L) and the serum FLC ratio is abnormal.
References