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CAR T-cell Therapy

bb2121 for Multiple Myeloma

Phase 1

Waitlist Available

Research Sponsored by Celgene

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up day 1 through month 60

Awards & highlights

Study Summary

This trial is testing a new cancer treatment on patients who have already tried other treatments that didn't work.

Eligible Conditions

Multiple Myeloma

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ day 1 through month 60

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~day 1 through month 60

This trial's timeline: 3 weeks for screening, Varies for treatment, and day 1 through month 60 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Incidence of adverse events (AEs) and abnormal laboratory test results, including dose limiting toxicities (DLTs)

Secondary outcome measures

Disease-specific response criteria including: overall response rate (ORR), complete response (CR), very good partial response (VGPR), and partial response (PR) according to the International Myeloma Working Group (IMWG) Uniform Response Criteria for MM.

Trial Design

1Treatment groups

Experimental Treatment

Group I: bb2121Experimental Treatment1 Intervention

bb2121 autologous CAR T cells will be infused at a dose ranging from 150 - 450 x 10^6 CAR+ T cells after receiving lymphodepleting chemotherapy

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Idecabtagene vicleucel

FDA approved

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

CelgeneLead Sponsor

636 Previous Clinical Trials

128,888 Total Patients Enrolled

142 Trials studying Multiple Myeloma

40,796 Patients Enrolled for Multiple Myeloma

bluebird bioIndustry Sponsor

20 Previous Clinical Trials

1,976 Total Patients Enrolled

1 Trials studying Multiple Myeloma

72 Patients Enrolled for Multiple Myeloma

Kristen Hege, MDStudy DirectorCelgene Corporation

3 Previous Clinical Trials

206 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Has bb2121 been tested through any prior medical experiments?

"Presently, 8 clinical trials are actively investigating bb2121, with one of them in the third phase. While numerous studies on this medication have been conducted at Houston's hospitals and clinics, it can be studied at over two hundred different medical locations across America."

Answered by AI

Has bb2121 received regulatory authorization from the FDA?

"Due to the limited efficacy and safety data available, our Power team assigned bb2121 a rating of 1 on their scale."

Answered by AI

What is the total capacity of participants for this research project?

"Currently, this medical study is not recruiting participants. It was first posted on December 22nd 2015 and last updated on December 2nd 2020. If you are wanting to take part in a different trial, there are 807 clinical trials for multiple myeloma that are actively seeking patients as well as 8 studies looking for individuals taking bb2121."

Answered by AI

Is this test protocol the innovatory of its type?

"At present, 8 trials for bb2121 are taking place across 54 cities in 13 nations. The first instance of this medication being tested was back in 2015 and involved 67 individuals. Sponsored by Celgene, the Phase 1 drug approval stage completed successfully; however, there have been no additional tests since then."

Answered by AI

Are there any current openings to participate in this trial?

"This trial has concluded its recruitment phase. It was posted on December 22nd, 2015 and the final update occured on December 2nd 2020. However, there are still 807 clinical trials accepting participants with multiple myeloma and 8 studies recruiting patients for bb2121 treatment."

Answered by AI

What specific medical issues is bb2121 usually utilized to treat?

"bb2121 has been developed to treat refractory multiple myeloma and other complex medical conditions, such as a history of proteasome inhibitor treatment, anti-cd38 monoclonal antibody therapy, or the presence of ≥4 prior lines of medication."

Answered by AI

How many medical facilities are actively engaged in this clinical trial?

"Currently, 9 medical sites are running this clinical trial; Bethesda, Stanford and Nashville being the primary locations. To reduce travel commitments for potential participants, it is recommended to select a local site if available."

Answered by AI

Recent research and studies

New England Journal of MedicineJournal

Anti-bcma CAR T-cell Therapy Bb2121 in Relapsed or Refractory Multiple Myeloma

Raje, Noopur, Jesus Berdeja, Yi Lin, David Siegel, Sundar Jagannath, Deepu Madduri, Michaela Liedtke, et al.. 2019. “Anti-bcma CAR T-cell Therapy Bb2121 in Relapsed or Refractory Multiple Myeloma”. New England Journal of Medicine. Massachusetts Medical Society. doi:10.1056/nejmoa1817226.

clinicaltrials.govStudy

Study of bb2121 in Multiple Myeloma

2015. "Study of bb2121 in Multiple Myeloma". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02658929.