Study on Effective and Cost-Conscious Maintenance Dosing of Daratumumab for Multiple Myeloma

Inclusion Criteria

• Must provide written consent to participate.
• Men and women aged 18 to 70 with newly diagnosed multiple myeloma who have had a stem cell transplant and responded well to treatment.
• Must have received a specific type of initial treatment that includes certain drugs.
• Must be in good general health with a performance status score of 0 to 2.
• Must have specific blood counts and organ function levels within normal ranges.
• Women of childbearing potential must not be pregnant and must agree to use effective birth control during the study and for 3 months after.
• Men must agree to use condoms during the study and for 3 months after, even if they have had a vasectomy.
• Must agree not to donate blood, sperm, or eggs during the study and for a specified time after.

Exclusion Criteria

• Cannot have amyloidosis or plasma cell leukemia.
• Cannot be pregnant or breastfeeding.
• Cannot have received a live vaccine within 30 days before starting the study.
• Cannot be participating in another study of an investigational drug or device.
• Cannot have a diagnosis of immunodeficiency or be on high-dose steroid therapy.
• Cannot have another active cancer that required treatment in the past 3 years.
• Cannot have untreated or active cancer spread to the brain or spinal cord.
• Cannot have had a previous organ transplant.
• Cannot have severe allergies to Daratumumab or Lenalidomide.
• Cannot have significant heart disease or recent stroke.
• Cannot have uncontrolled illness or psychiatric conditions that would interfere with the study.
• Cannot have active autoimmune diseases or known immunodeficiency diseases.
• Cannot have gastrointestinal diseases that affect drug absorption.
• Must be willing to undergo preventive treatment for blood clots.