Phase I is the first step in testing a new myeloma treatment in humans. The main goal is to determine a safe and tolerable dose, starting with a low dose and gradually increasing it to find the maximum tolerated dose.
Endpoints in this phase focus on safety, including side effects, adverse events, and understanding how the drug is processed by the body (pharmacokinetics and pharmacodynamics).
Early signs of effectiveness may be noted but are not the primary focus. Success in Phase I provides a foundation for testing the treatment’s effectiveness in later phases.
