Study on Teclistamab or Talquetamab with Daratumumab for High-Risk Smoldering Myeloma (REVIVE Study)

Inclusion Criteria

• Must have a confirmed diagnosis of smoldering multiple myeloma (SMM) with specific blood and bone marrow characteristics.
• No anemia, kidney failure, or high calcium levels unless unrelated to multiple myeloma.
• Must have measurable disease within the past 4 weeks, such as specific levels of proteins in blood or urine.
• Must be 18 years or older.
• Must be in good general health with a performance status of 0 or 1.
• Must have adequate organ and bone marrow function based on specific blood tests.
• Must have high-risk SMM based on clinical and genetic factors.
• Women of childbearing potential must have a negative pregnancy test and agree to use effective contraception during the study and for 3 months after.
• Men must agree to use condoms during the study and for 3 months after.
• Must be able to understand and sign a consent form.
• Must be willing to follow study requirements and lifestyle restrictions.

Exclusion Criteria

• Have received prior systemic treatments for SMM or multiple myeloma, except for one cycle of therapy with a 4-week break before starting the study.
• Currently receiving other investigational treatments.
• Have received a live vaccine within 4 weeks before starting the study.
• Have allergies to medications used in the study.
• Have certain infections like HIV, hepatitis B, or hepatitis C.
• Have severe lung conditions like COPD or asthma.
• Have a history of severe allergic reactions to similar drugs.
• Women who are breastfeeding or plan to become pregnant during the study.
• Men who plan to father a child during the study or within 3 months after.
• Have serious heart conditions or uncontrolled illnesses.
• Have had another active cancer requiring treatment in the past 24 months.
• Have any condition that might affect participation in the study.