Safety and Efficacy of RN1201 Injection as First-Line Treatment for Newly Diagnosed Multiple Myeloma

Inclusion criteria

• Willingness to participate in the trial and provide written informed consent.

• 2. Diagnosis of multiple myeloma (MM) per the 2017 revised WHO criteria.
• 3. BCMA-positive multiple myeloma documented at screening or in prior medical records.
• 4. Aged 18 - 70 years, any gender.
• 5. Life expectancy of at least 12 weeks.
• 6. Serum total bilirubin < twice the upper limit of normal (ULN); serum creatinine within normal range;
• 7. alanine aminotransferase (ALT) and aspartate aminotransferase (AST) < three times ULN.
• 8. ECOG performance status score of 0 - 2.
• 9. Left ventricular ejection fraction (LVEF) ≥50% with no pericardial effusion.
• 10. Ability to adhere to the study visit schedule and protocol requirements.

Exclusion criteria

• Patients with serious active infections.

• 2. Subjects with acquired or congenital immunodeficiency.
• 3. Subjects with Class III/IV heart failure per NYHA criteria.
• 4. Subjects with epilepsy or other central nervous system diseases.
• 5. Subjects with a history of primary cancer, except:

• Resected non-melanoma (e.g., basal cell carcinoma)
• Cured carcinoma in situ (e.g., cervical, bladder, breast cancer)
• 6. Systemic high-dose steroid use within 2 weeks before treatment.
• 7. Pregnant, breastfeeding women, or those planning pregnancy in 6 months.
• 8. Participation in other clinical trials within one month.
• 9. Major surgery within 14 days before the first study drug dose.
• 10. Any condition the investigator deems may raise subject risks or affect trial results.