Thread by @HadidiSamer

To understand how problematic some of smoldering myeloma trials are, look at the primary endpoint of a single arm study that is currently recruiting👇#mmsm
🛑using IMWG response criteria for multiple myeloma in smoldering myeloma is an inaccurate assumption 🧵

➡️What is a response definition per 1ry endpoint?
All of:
1️⃣Disappearance of original monoclonal protein from blood and urine
2️⃣<5% plasma cells in bone marrow
3️⃣No increase in size or number of lytic bone lesions
4️⃣Disappearance of soft tissue plasmacytomas

Number 3️⃣+4️⃣ are criteria that automatically assign patients into multiple myeloma and should not be present in smoldering myeloma to start with = inaccurate

Number 1️⃣+2️⃣ are criteria that are assumed to be important in smoldering myeloma with no supportive evidence=assumption

So we are actually just using myeloma response criteria in smoldering myeloma inaccurately and assuming this will matter for asymptomatic pts

Now how those patients qualify to be enrolled: “high risk” , a recent example of risk score discordance @rajshekharucms

👇

https://twitter.com/rajshekharucms/status/1646223487231737856

All other issues aside(single arm, short f/u,etc),we cannot even know if what we define as 1ry endpoint is accurate or means anything

Not sure how this is helpful for pts or field

Before implementing ttt for asymptomatic pts,can we pause and think what are we doing

End 🧵