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
Multiple myeloma (MM) is a rare and largely incurable cancer of the plasma cells (a type of immune cell that produces antibodies). The major features of MM include infections, bleeding, anaemia, raised calcium levels in the blood (hypercalcaemia), bone pain/fractures as well as kidney damage and increased blood thickness (hyperviscosity).
During the last 10 years the introduction of immunomodulators (treatments that modify the immune response), proteasome inhibitors (treatments that block the cellular pathways that break down proteins) and monoclonal antibodies (antibodies made by identically cloning immune cells) have resulted in improved treatment outcomes in both newly diagnosed and recurrred MM disease. Despite this, virtually all patients will eventually progress and require additional treatment options.
This is a Phase 3 open-label study comparing the effectiveness and safety of bb2121 versus standard treatment options in patients with RRMM.
Approximately 381 patients (16 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
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)
Participants will need to have a number of different tests to determine if the study drug works and what side effects there might be, including: physical examinations, blood and urine tests, radiological scans and vital sign checks.
Study patients must be aged over 18 with RRMM and have received 2 to 4 prior myeloma treatments including DARA, an immunomodulator drug and the PI 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/0821
Date of REC Opinion
31 May 2019
REC opinion
Unfavourable Opinion