Teclistamab in Relapsed or Refractory Multiple Myeloma
Research type
Research Study
Full title
A Phase 1/2b, First-in-Human, Open-Label, Dose Escalation Study of Teclistamab, a Humanised BCMA x CD3 Bispecific Antibody, in Subjects with Relapsed or Refractory Multiple Myeloma.
IRAS ID
283482
Contact name
David Wright
Contact email
Sponsor organisation
Janssen-Cilag International N.V
Eudract number
2016-002122-36
Clinicaltrials.gov Identifier
Duration of Study in the UK
2 years, 7 months, 26 days
Research summary
This is a Phase 2 Open-Label study to determine if the study drug is effective, safe and tolerable in a larger group of patients with relapsed or refractory multiple myeloma.
A global study composed of three parts. The UK will be involved in Part 3 only. Parts 1 & 2 were designed to define a safe and tolerable dose and to determine the potential effectiveness of the study drug for Part 3.
A total of 230 participants are to be enrolled, all participants will receive the study drug, teclistimab. Teclistamab is an antibody. Antibodies are proteins that attach to specific targets on cells or tissues to help the body fight cancer, infections and other diseases.
Although there are treatments available for multiple myeloma, the disease is still incurable. This study is in patients where their disease is worsening or not responding to the current treatments (relapsed and refractory). The increasing number of patients with relapsed and refractory disease requires new therapies to address this unmet medical need.
Potential participants will go through a screening phase of up to 28 days to determine their suitability for the study, with various health tests, including review of medical history, vital signs, electrocardiogram, blood samples, bone marrow samples, and imaging (X-Ray/CT).
If eligible and the patient wants to participate then they will move into the treatment phase of the study. Each treatment cycle lasts 28 days and there are 4 doses of study drug at each cycle. Various health tests, including vital signs, review of side effects, blood samples, imaging (X-Ray/CT) depending on the study visit schedule.
On completion of treatment participants go into a follow-up period, where long-term data on anti-cancer drugs and patient wellbeing. In total the participant will be on study for a maximum of two and a half years.
REC name
South Central - Hampshire B Research Ethics Committee
REC reference
20/SC/0343
Date of REC Opinion
13 Nov 2020
REC opinion
Further Information Favourable Opinion