Phase 3 Study of BB2121 Vs Standard Triplet Regimens in MM (KarMMa-3)
Research type
Research Study
Full title
A phase 3, multicentre, randomized, open-label study to compare the efficacy and safety of BB2121 versus standard triplet regimens in subjects with relapsed and refractory multiple myeloma (RRMM) (KarMMa-3)
IRAS ID
254152
Contact name
Reuben Benjamin
Contact email
Sponsor organisation
Celgene Corporation
Eudract number
2018-001023-38
Clinicaltrials.gov Identifier
N/A, N/A
Duration of Study in the UK
6 years, 5 months, 0 days
Research summary
This is a Phase 3 open-label study comparing the effectiveness and safety of bb2121 versus standard treatment options in patients with relapsed and refractory Multiple Myeloma.
There have been improved outcomes in newly diagnosed and relapsed MM patients, however mostly all MM patients will progress/relapse and need additional treatment.
bb2121 is a new type of therapy known as a CAR (Chimeric antigen receptor) T cell therapy. T cells are white blood cells which form part of the immune system. bb2121 therapy involves modifying a patient's own T cells so that they can recognise and destroy multiple myeloma cells.
To create the bb2121 drug product, some of the T cells will be collected from the patient's blood in a procedure called leukapheresis. A new gene will be inserted into the patient's T cells using a genetically modified virus. bb2121 will then be given back to patients intravenously.
Approximately 381 patients (14 in the UK) across 12 countries will be randomised between Arm A or Arm B:
• 254 patients will be randomised to receive Treatment Arm A: bb2121
• 127 patients will be randomised to receive Treatment Arm B: standard courses of treatment dependent on the patient’s most recent anti-myeloma treatment
The standard treatment options are:
- Daratumumab (DARA) in combination with pomalidomide (POM) and low-dose dexamethasone (dex) (DPd)OR
- DARA in combination with bortezomib (BTZ) and low-dose dex (DVd)
OR
- Ixazomib (IXA) in combination with lenalidomide (LEN) and low-dose dex (IRd)
Study procedures will include: physical examinations, blood and urine tests, radiological scans and vital sign checks.
Study patients must be aged over 18 with Relapsed/Refractory MM and have received 2 to 4 prior treatments including DARA, an immunomodulator drug and a PI. The patient must have documented disease progression during or within 60 days after the last therapy.
REC name
London - West London & GTAC Research Ethics Committee
REC reference
19/LO/1455
Date of REC Opinion
5 Dec 2019
REC opinion
Further Information Favourable Opinion