Study on Dara-RVd and Teclistamab-RVd for People with Multiple Myeloma

Inclusion Criteria

• Have a confirmed diagnosis of multiple myeloma with measurable disease.
• Have standard risk multiple myeloma, excluding certain high-risk genetic abnormalities.
• Be newly diagnosed and considered a candidate for high-dose chemotherapy and stem cell transplant.
• Be 18 years or older.
• Have a performance status score of 0 to 2, indicating full activity or some restriction in strenuous activities.
• Have adequate organ and blood function, including:
  • Hemoglobin level of at least 7.5 g/dL.
  • Neutrophil count of at least 1.0 x 10^9/L.
  • Platelet count of at least 75 x 10^9/L.
  • Creatinine clearance of at least 30 ml/min.
  • Liver function within specified limits.
• Be able to tolerate blood clot prevention strategies like aspirin or other anticoagulants.
• Be registered in the mandatory REMS program and comply with its requirements, including contraception methods.

Exclusion Criteria

• Have received more than one cycle of prior treatment for multiple myeloma.
• Have certain other blood disorders or conditions like plasma cell leukemia or amyloidosis.
• Have had another active cancer within the past two years, except for certain skin cancers.
• Have significant uncontrolled health conditions that could interfere with the study.
• Have a history of severe lung disease, asthma, or autoimmune diseases requiring treatment.
• Have a history of severe psychiatric conditions or substance abuse.
• Test positive for HIV, hepatitis B, or hepatitis C, unless under specific conditions.
• Have significant heart disease or recent heart attack.
• Be pregnant or breastfeeding.
• Be unwilling to give informed consent or unable to comply with the study requirements.