Table of contents
- Clinical trials overview
- Phase 2 study with mezigdomide
- Phase 3 study versus standard care
- What the trials measured
- Who the trials were for
- Study status and size
Clinical trials overview
These studies investigated Alnuctamab in people with relapsed and/or refractory multiple myeloma, which means the cancer came back or did not respond well to treatment.[1][2]
The trial program included one Phase 2 study with an early Phase 1b part and one Phase 3 study.[1][2]
Phase 2 study with mezigdomide
The Phase 2 trial tested Alnuctamab in combination with mezigdomide in participants with relapsed and/or refractory multiple myeloma.[1]
The study title also describes a Phase 1b part, which was used to find the recommended Phase 2 dose and dosing schedule for mezigdomide when given with Alnuctamab.[1]
In the Phase 2a part, the trial also compared the combination with Alnuctamab alone to look for early signs of benefit.[1]
Phase 3 study versus standard care
The Phase 3 trial compared Alnuctamab with standard of care regimens, meaning the usual treatments used in practice for this disease.[2]
This study was designed to see whether Alnuctamab could help people live longer without their cancer getting worse than the standard treatment options.[2]
The trial was completed and included 466 participants.[2]
What the trials measured
The Phase 2 study looked at safety and tolerability by tracking the type, frequency, seriousness, and severity of all adverse events.[1]
It also measured the overall response rate in the Phase 2a part, which means how many participants had their cancer shrink or improve.[1]
The Phase 3 study used progression-free survival as its main outcome, which is the time from treatment start until the cancer gets worse or the person dies from any cause.[2]
Who the trials were for
The target population in both trials was participants with relapsed and/or refractory multiple myeloma.[1][2]
This means the studies focused on adults whose myeloma had returned after treatment or was no longer responding well to treatment.[1][2]
Study status and size
One study was withdrawn and had an enrollment of 67 participants.[1]
The Phase 3 study was completed and enrolled 466 participants.[2]
