Study on Carfilzomib, Lenalidomide, Dexamethasone, and Daratumumab for Patients with Relapsed or Refractory Myeloma Undergoing Stem Cell Transplant

Inclusion Criteria

• Able and willing to provide written consent.
• Aged between 18 and 75 years.
• Confirmed diagnosis of multiple myeloma.
• Myeloma that has returned or not responded after 1 to 3 previous treatments.
• Eligible if received 1 cycle of therapy after recent relapse.
• Allowed treatments include corticosteroids, bisphosphonates, and prior radiotherapy.
• Must have enough stored stem cells for transplant.
• Planning to undergo a stem cell transplant as part of standard care.
• Meet specific health criteria, including:
  • Performance status above 70.
  • Heart function above 40%.
  • Kidney function above 40 cc/min.
  • Liver function within normal limits.
• Measurable disease based on specific medical tests.
• Hemoglobin and platelet counts above certain levels.
• Women must agree to pregnancy testing and use contraception.
• Men must agree to use contraception.
• Must be registered in the Revlimid REMS program and comply with its requirements.

Exclusion Criteria

• Plasma cell leukemia.
• POEMS syndrome.
• Pregnant or breastfeeding women.
• Uncontrolled high blood pressure or diabetes.
• Active hepatitis B or C infection, unless controlled.
• Positive HIV test.
• Severe heart disease or recent heart attack.
• Severe lung disease or asthma.
• Digestive issues preventing absorption of oral medication.
• Uncontrolled illness or psychiatric conditions.
• Severe nerve damage.
• Allergies to study medications.
• Recent major surgery.
• Previous allogeneic stem cell transplant.
• History of myeloma affecting the brain.
• Disease progression on specific drug combinations.
• Previous severe side effects from study drugs.