Study on Daratumumab for Patients with Newly Diagnosed Multiple Myeloma

Inclusion Criteria

• Newly diagnosed with multiple myeloma, confirmed by specific medical tests.
• Have measurable disease based on recent tests, such as certain levels of proteins in the blood or urine.
• Show signs of organ damage or specific myeloma-related events, like high calcium levels, anemia, or bone damage.
• Have good kidney function.
• Be 18 years or older.
• Be in good overall health, with a performance status score between 0 and 2.
• Have adequate blood cell counts and liver function.
• Be able to take certain blood-thinning medications.
• Be registered in the eREMS® program and comply with its requirements.
• Women of childbearing potential must have negative pregnancy tests and agree to use effective birth control methods. Men must agree to use condoms during sexual contact.

Exclusion Criteria

• Have received more than one cycle of prior treatment for multiple myeloma.
• Have certain other medical conditions, like plasma cell leukemia, POEMS syndrome, or amyloidosis.
• Have severe lung disease or uncontrolled high blood pressure or diabetes.
• Have active hepatitis B or C infection, or HIV.
• Have significant heart disease or recent heart attack.
• Be pregnant or breastfeeding.
• Have severe nerve damage or other medical conditions that would interfere with the study.
• Have had major surgery recently.