In short
Clinical trials are investigating Alnuctamab in people with relapsed and/or refractory multiple myeloma. These studies are looking at safety, tolerability, and how well the treatment works, including comparisons with standard care. The target groups are adults whose disease has come back or no longer responds to treatment.
Key points
- Clinical trials of Alnuctamab are focused on relapsed and/or refractory multiple myeloma, which is myeloma that has come back or is not responding well to treatment. One study is a Phase 2 trial with a Phase 1b part, and it looks at Alnuctamab with mezigdomide and also compares the combination with Alnuctamab alone. Another study is a Phase 3 trial that compares Alnuctamab with standard care regimens. The main goals include safety, tolerability, finding the right dose schedule, overall response rate, and progression-free survival. The trial populations are adults with relapsed or refractory disease. One study was withdrawn, and the larger Phase 3 study was completed.
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.
The trial program included one Phase 2 study with an early Phase 1b part and one Phase 3 study.
Phase 2 study with mezigdomide
The Phase 2 trial tested Alnuctamab in combination with mezigdomide in participants with relapsed and/or refractory multiple myeloma.
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.
In the Phase 2a part, the trial also compared the combination with Alnuctamab alone to look for early signs of benefit.
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.
This study was designed to see whether Alnuctamab could help people live longer without their cancer getting worse than the standard treatment options.
The trial was completed and included 466 participants.
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.
It also measured the overall response rate in the Phase 2a part, which means how many participants had their cancer shrink or improve.
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.
Who the trials were for
The target population in both trials was participants with relapsed and/or refractory multiple myeloma.
This means the studies focused on adults whose myeloma had returned after treatment or was no longer responding well to treatment.
Study status and size
One study was withdrawn and had an enrollment of 67 participants.
The Phase 3 study was completed and enrolled 466 participants.