A Phase 2 Study of Elranatamab (PF-06863135) Monotherapy in Participants With MM Who Are Refractory to at Least One PI, One IMiD and One Anti-CD38 mAb
Research type
Research Study
Full title
An Open-Label, Multicenter, Non-Randomized Phase 2 Study of Pf 06863135 Monotherapy in Participants with Multiple Myeloma Who Are Refractory To At Least One Proteasome Inhibitor, One Immunomodulatory Drug and One Anti-Cd38 Antibody
IRAS ID
292543
Contact name
Geoffrey Chan
Contact email
Sponsor organisation
Pfizer Inc.
Eudract number
2020-004533-21
Clinicaltrials.gov Identifier
Duration of Study in the UK
2 years, 0 months, 25 days
Research summary
Multiple Myeloma (MM) is a cancer that affects
plasma cells, a type of white blood cell that
helps protect the body by releasing proteins
called antibodies that fight infections. Around
the world, MM causes around 160,000 new
cases and 106,000 deaths per year. In patients
with MM, affected plasma cells, known as
myeloma, are shown to have more molecules
called B-cell maturation antigen (BCMA) than
normal plasma cells. Despite recent advances in
treatment, there is still no cure and almost all
patients, even those who initially respond to
treatment, are expected to have MM return.
PF-06863135 is a new investigational drug
being developed to treat MM that binds to a
protein called CD3 on T-cells (a type of
immune cell) and BCMA on myeloma cells,
which causes the T-cells to kill the myeloma
cells.
The purpose of the study is to learn more about
whether PF-06863135 can provide benefit to
participants with MM who are resistant at least
one proteasome-inhibitor, one
immunomodulatory drug and one anti-CD38
monoclonal antibody, which are all other
specific therapies to treat MM.
Because it is unknown how previous treatment
with BCMA-directed therapy (targeting BCMA on myeloma cells to treat MM) will affect how
PF-06863135 works, this study will enrol one
group with participants who have not
previously received a BCMA-directed therapy
(Cohort A) and one group with participants who
have received previous treatment with BCMAdirected
therapy (Cohort B).
The study is being done at about 60 different
study sites in up to 10 countries. A maximum of
around 150 participants will be enrolled and
treated, including a total of around 90
participants in Cohort A and around 60
participants in Cohort B.
At the start of study participation, participants
receive PF-06863135 once every week.
Participants could remain in the study for at least
2 years.REC name
South West - Central Bristol Research Ethics Committee
REC reference
21/SW/0020
Date of REC Opinion
6 May 2021
REC opinion
Further Information Favourable Opinion