Phase 2_bb2121_RR and HR Multiple Myeloma Study
Research type
Research Study
Full title
A Phase 2, Multi-Cohort, Open-Label, Multicenter Study to determine the efficacy and safety of bb2121 in subjects with Relapsed and Refractory Multiple Myeloma and in subjects with High-Risk Multiple Myeloma having progressed within one year of initial treatment. (KarMMa-2)
IRAS ID
250907
Contact name
Reuben Benjamin
Contact email
Sponsor organisation
Celgene Corporation
Eudract number
2018-000264-28
Clinicaltrials.gov Identifier
016664, IND Number
Duration of Study in the UK
5 years, 9 months, 0 days
Research summary
Phase 2, open-label study investigating whether bb2121 is safe and effective when treating symptoms related to relapsed (recurred illness) and refractory (RR)(unresponsive to treatment) multiple myeloma (MM) and symptoms related to high-risk (HR) MM that has progressed within one year of initial treatment. MM is a rare and largely incurable plasma cell neoplasm that accounts for 10% to 15% of all haematological malignancies (cancer that begins in cells of blood-forming tissue) with a global occurrence of approximately 120,000 cases per year. In Europe in 2012 there were an estimated 38,900 new cases and 24,300 deaths. There has been improved outcomes in newly diagnosed and relapsed MM patients, however mostly all MM patients will progress/relapse and need additional treatment.
bb2121 contains T cells filtered from individual patient’s blood. Each patient’s T cells are separated from their collected immune cells and a new gene is inserted using a genetically modified virus. bb2121 T cells product is given back to each patient through an intravenous line.
The study is open to adults 18 years of age or older; Cohort 1 is patients who have relapsed or refractory RRMM with at least 3 prior anti-myeloma regimens; Cohort 2 is patients with high-risk HR MM with 1 prior regimen having progressed within one year of initial treatment.
Approximately 122 globally enroled patients; 73 in Cohort 1, 49 in Cohort 2. Patients will be followed for a minimum of 24 months post-bb2121 infusion or until their multiple myeloma progresses, for up to a maximum of 5 years. When patients either prematurely discontinue from, or complete the study, monitoring will continue under a separate long-term follow-up protocol for up to 15 years after the last bb2121 infusion.
Procedures in this study include, Leukapheresis (separation of white blood cells from a sample of blood), ECG (recording of hearts electrical activity), ECHO/MUGA (2D or 3D image of the heart) chemotherapy, bone marrow aspiration/biopsy (bone marrow taken with a needle), x-ray, CT scan and MRI scan.REC name
North East - York Research Ethics Committee
REC reference
18/NE/0363
Date of REC Opinion
14 Dec 2018
REC opinion
Favourable Opinion