SIM0500 for Relapsed or Refractory Multiple Myeloma
This study is testing a new drug called SIM0500 for adults with multiple myeloma that has come back or isn't responding to other treatments (relapsed or refractory multiple myeloma). You might be able to join if you are at least 18 years old, have been diagnosed with relapsed or refractory multiple myeloma, and have tried all standard treatments. The main goal is to see how safe SIM0500 is and what dose is best. Researchers will also look at how well it works and how your body processes the drug. The study will continue until your disease gets worse, side effects are too strong, you decide to stop, or the study ends.
- Study design
- This is an open-label, multi-center Phase 1 study, meaning everyone knows what treatment is being given. It plans to enroll 130 participants.
- What's involved
- Participants will receive SIM0500 in 28-day cycles until their disease progresses, side effects are too severe, they withdraw, or the study ends.
- Compensation
- Not stated in the trial record.
- Follow-up
- Not specified.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
Study of SIM0500 Alone in Participants With Relapsed or Refractory Multiple Myeloma
At a glance
Conditions
Where it's being run
16 sites across 15 statesWho to contact
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What this trial measures
- Part 1: Number of Participants with Dose-limiting toxicity (DLT)From enrollment up to 35 days afterward
DLTs are defined as specific non-hematologic toxicity, or hematologic toxicity
- Parts 1 and 2: Number of Participants with Adverse Events (AEs) by SeverityFrom enrollment up to 24 months afterward
An adverse event is any untoward medical occurrence in a clinical study participant that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. Severity will be graded according to the NCI-CTCAE version 5.0. Severity scale ranges from grade 1 to Grade 5.