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A Phase 3 Study Comparing Ramantamig Plus Daratumumab With Standard Daratumumab-Based Treatments in People With Newly Diagnosed Multiple Myeloma Who Are Not Planning an Initial Stem Cell Transplant
Multiple myeloma is a type of blood cancer that affects plasma cells in the bone marrow. Although treatments are available, the disease can become harder to control over time, creating a need for new treatment options. This study is investigating whether a new treatment combination containing ramantamig and daratumumab can help people with newly diagnosed multiple myeloma. Participants will receive either the new treatment combination or a currently used standard treatment. Researchers will monitor how well the treatments control the cancer and assess their safety. The information gained from this study may help improve treatment options for future patients with multiple myeloma.
What you need to know
Who can take part?
Key Inclusion Criteria
- Adults aged 18 years or older
- Newly diagnosed multiple myeloma with measurable disease
- Not planning an initial stem cell transplant (ineligible or deferred)
- ECOG performance status 0-2
- Adequate kidney, liver, and blood function
- Able to comply with study requirements and provide consent
Key Exclusion Criteria
- Significant frailty or uncontrolled medical conditions
- Active serious infection (including uncontrolled HIV, hepatitis B/C)
- Recent major heart problems (e.g. heart attack, stroke)
- Another active or high-risk cancer
- Prior treatment for multiple myeloma (except limited steroids)
- Allergy or contraindication to study medications
- Recent investigational treatment or major surgery
What is involved for me?
- Attend study visits and be randomly assigned to receive either the investigational treatment (ramantamig plus daratumumab) or a standard treatment regimen.
- Undergo screening assessments, including physical examinations, blood and urine tests, heart monitoring (ECG), bone marrow testing, and imaging scans.
- Receive study treatment and attend regular follow-up visits to monitor your response and any side effects.
- Have regular blood and urine tests throughout the study to assess disease status and safety.
- Undergo bone marrow samples and imaging scans at scheduled timepoints to evaluate how well the treatment is working.
- Complete questionnaires about your symptoms, quality of life, and treatment experience.
- Be followed long-term so researchers can monitor disease progression, survival, and ongoing safety.
