Phase 1/2 Study of Elranatamab (PF-06863135) Monotherapy in Participants With Relapsed/Refractory MM
Research type
Research Study
Full title
A PHASE 1/2, OPEN-LABEL, MULTICENTER STUDY TO EVALUATE A DOSING REGIMEN WITH TWO STEP-UP PRIMING DOSES AND LONGER DOSING INTERVALS OF ELRANATAMAB (PF-06863135) MONOTHERAPY IN PARTICIPANTS WITH RELAPSED/REFRACTORY MULTIPLE MYELOMA
IRAS ID
1003867
Contact name
Erik Rene Vandendries
Contact email
Sponsor organisation
Pfizer Inc.
Eudract number
2021-001371-16
Clinicaltrials.gov Identifier
Research summary
Multiple Myeloma (MM) is a cancer of plasma cells, a type of white blood cell that normally produces antibodies. Globally, there are approximately 160,000 new cases and 106,000 deaths per year attributed to MM. In the UK, there were an estimated 6,377 new cases of MM and 3,572 deaths attributed to MM in 2020.
The purpose of the study is to evaluate whether a novel therapy - single-agent PF-06863135 can provide clinical benefit in participants whose MM has relapsed after receiving the 3 main classes of standard treatments and whose MM no longer responds to these treatments. This is termed Relapsed Refractory Multiple Myeloma (RRMM) (i.e. multiple myeloma which may initially appear to have disappeared but then returns and/or does not respond to treatment). This study will test a new dosing regimen of PF-06863135 in RRMM patients in order to reduce the potential risk of Cytokine Release Syndrome or CRS (a potentially serious/life-threatening side effect resulting from immune system activation by PF-06863135 and similar drugs), learn about safety effects and to find the best dose and best dosing frequency for treating RRMM. Further, the study will evaluate the pharmacokinetics and pharmacodynamics (i.e. the distribution and effects of the drug in the body and on the cancer cells), and preliminary activity of PF-06863135 against myeloma.
This study will be conducted in 2 parts; patients will either be enrolled in Part 1 or Part 2:
• Part 1 aims to learn about the effects of PF-06863135 using 76mg, an equivalent dose already tested in another ongoing study (C1071001).
• Part 2 aims to test further the safety of PF-06863135, and to find the best dose and dosing frequency for treating RRMM. Higher doses (>76mg) will be used in this part.
Participants could remain in the study for at least 2 years.
The study is being conducted at about 30 different study sites in up to 4 countries. A maximum of approximately 76 participants will be enrolled and treated.REC name
Wales REC 2
REC reference
21/WA/0221
Date of REC Opinion
19 Aug 2021
REC opinion
Further Information Favourable Opinion