Study on Daratumumab, Carfilzomib, Lenalidomide, and Low Dose Dexamethasone for Newly Diagnosed Multiple Myeloma

Inclusion Criteria

• Newly diagnosed with multiple myeloma and need treatment.
• Previous treatments for certain symptoms or aggressive myeloma with specific drugs are allowed if they were limited.
• Both patients who are candidates for a transplant and those who are not can join.
• Must have symptomatic multiple myeloma as defined by medical guidelines.
• Have a certain level of cancer cells in the bone marrow or a specific type of tumor.
• Have measurable disease based on specific protein levels in blood or urine.
• Must provide a bone marrow sample for study purposes.
• Must be 18 years or older.
• Must be in good general health with a performance status of 0 or 1.
• Must have adequate liver function and specific blood cell counts.
• Must have good kidney function.
• Women of childbearing potential must have negative pregnancy tests and agree to use two forms of birth control or abstain from sex during the study and for a period after.
• Men must agree to use condoms during sex and for a period after the study.
• Must agree to participate in a safety program for one of the study drugs.
• Must provide written informed consent to participate.

Exclusion Criteria

• Frail patients who are not candidates for a transplant.
• Have a type of myeloma that does not produce measurable proteins.
• Have certain other medical conditions like POEMS syndrome, amyloidosis, or plasma cell leukemia.
• Have had recent extensive radiation or immunotherapy.
• Have participated in another study recently.
• Have progressive disease as defined by medical guidelines.
• Cannot tolerate any of the study drugs.
• Have significant nerve damage or severe diarrhea.
• Have cancer involving the central nervous system.
• Are pregnant or breastfeeding.
• Have had major surgery recently.
• Have had recent heart problems or severe heart conditions.
• Have had a blood clot in the lungs.
• Have severe asthma or chronic lung disease.
• Have a prolonged QT interval on an ECG.
• Have uncontrolled high blood pressure or diabetes.
• Have a serious infection requiring treatment recently.
• Have active viral infections like HIV, hepatitis B, or hepatitis C.
• Have had another type of cancer recently, except for certain skin or prostate cancers.
• Have any other significant medical condition that might interfere with the study.