* M20-917: Lemzoparlimab as Monotherapy & Combination therapy in R/R MM
Research type
Research Study
Full title
A Phase 1b, Dose Escalation and Expansion Study of Lemzoparlimab (TJ011133) with or without Dexamethasone and in Combination with Anti-Myeloma Regimens for the Treatment of Patients with Relapsed/Refractory Multiple Myeloma
IRAS ID
300003
Contact name
Matthew Streetly
Contact email
Sponsor organisation
AbbVie Ltd.
Eudract number
2021-001067-24
Clinicaltrials.gov Identifier
Duration of Study in the UK
3 years, 2 months, 20 days
Research summary
Multiple myeloma (MM) accounts for more than 10% of all blood cancers and 1% of all cancers. The purpose of this study is to assess how safe lemzoparlimab (TJ011133) is and how lemzoparlimab (TJ011133) moves through the body of adult participants with MM when given with or without dexamethasone, and in combination with other anti-myeloma regimens. Adverse events and change in disease activity will be assessed.
Lemzoparlimab (TJ01133) is an investigational drug being developed for the treatment of relapsed/refractory (R/R) MM. Study doctors put the participants in groups called treatment arms. Two different dose levels of lemzoparlimab (TJ011133) will be explored. Each treatment arm receives a different treatment combination depending on stage of the study and eligibility. This study will include a dose escalation phase to determine the best dose of lemzoparlimab (TJ011133), followed by a dose expansion phase to confirm the dose. Approximately 163 adult participants with R/R MM will be enrolled in the study in approximately 60 sites worldwide.
In the Dose Escalation arms, participants will receive intravenous (IV) lemzoparlimab (TJ011133) with or without dexamethasone (oral/IV) in combination with pomalidomide (oral) or carfilzomib (IV) or subcutaneous (SC) daratumumab in 28-day cycles. In the Dose Expansion arms, participants will receive lemzoparlimab (TJ011133) (IV) alone or with dexamethasone (oral/IV) in combination with pomalidomide (oral) or carfilzomib (IV) or daratumumab (SC) in 28-day cycles.
REC name
East Midlands - Nottingham 2 Research Ethics Committee
REC reference
22/EM/0194
Date of REC Opinion
9 Nov 2021
REC opinion
Further Information Favourable Opinion