This clinical trial focuses on treating patients with Multiple Myeloma, a type of blood cancer affecting plasma cells in the bone marrow. The study evaluates a treatment combination using elranatamab with lenalidomide and compares it to standard treatments. The medications used in the study include bortezomib, dexamethasone, daratumumab, and human normal immunoglobulin.
The purpose of this research is to determine if using elranatamab and lenalidomide together is more effective than current standard treatments for newly diagnosed multiple myeloma patients. The study is divided into two main phases: a consolidation phase, which follows initial treatment, and a maintenance phase, which aims to prevent the disease from returning.
During the study, patients will receive different combinations of medications through various methods, including oral capsules, tablets, and injections under the skin. Some medications will be given through an infusion into a vein. The treatment schedule will vary depending on which study group the patient is assigned to, and the total treatment period may last several months to years.
1Initial treatment phase
Treatment begins with a combination of medications to target multiple myeloma
You will receive lenalidomide capsules taken by mouth
A bortezomib injection will be administered under the skin
Dexamethasone tablets will be taken orally
You will also receive normal immunoglobulin through an intravenous infusion
2Consolidation phase
This phase includes two possible treatment paths:
Path 1: Combination of elranatamab and lenalidomide
Path 2: Standard chemotherapy followed by stem cell transplant
The treatment path will be determined randomly
Elranatamab is administered as an injection under the skin
Lenalidomide is taken as oral capsules
3Maintenance phase
This phase also includes two possible treatment paths:
Path 1: Treatment with elranatamab injections under the skin
Path 2: Standard care treatment
The treatment path will be determined randomly
Regular assessments will monitor your response to treatment
Blood tests and medical examinations will be conducted throughout this phase
4Follow-up period
Regular monitoring will continue to track your health status
Assessment of treatment effectiveness will be performed
Your overall health and quality of life will be evaluated
The study will continue until March 2036
Who Can Join the Study?
Age between 18 and 70 years old, both men and women can participate
Must have newly diagnosed multiple myeloma that qualifies for high-dose chemotherapy and stem cell transplantation
Must have at least 10% abnormal plasma cells in bone marrow OR have a confirmed tumor made up of plasma cells
Must have at least one of these signs:
– High calcium levels in blood
– Reduced kidney function
– Low red blood cell count (anemia)
– Bone damage visible on scans
– High levels of abnormal proteins in blood or urine
Must have a performance status of 2 or better (able to perform most daily activities)
Must meet specific blood test requirements:
– Adequate red blood cell levels
– Adequate white blood cell counts
– Normal liver function
– Kidney function at least 40% of normal
– Acceptable calcium levels
– Adequate platelet counts
Must be willing and able to provide written informed consent
Women who can become pregnant must have a negative pregnancy test during screening and before starting treatment
Who Cannot Join the Study?
History of cancer other than Multiple Myeloma within the past 5 years, except for adequately treated skin cancers
Pregnant or breastfeeding women
Known active or chronic hepatitis B or C infection (inflammation of the liver caused by viruses)
Elranatamab is a medication being studied for treating newly diagnosed multiple myeloma. It belongs to a class of drugs that help the immune system fight cancer cells. It is being tested as part of a combination therapy during the consolidation phase of treatment and as a maintenance therapy.
Lenalidomide is a medication commonly used to treat multiple myeloma. It works by helping to strengthen the immune system and can slow or stop the growth of cancer cells. In this trial, it is being studied in combination with elranatamab during the consolidation phase of treatment.
Autologous Stem Cell Transplant is a standard treatment procedure for multiple myeloma where the patient’s own healthy blood-forming stem cells are collected and later reinfused after receiving high-dose chemotherapy. This trial is evaluating whether the combination of elranatamab and lenalidomide could potentially replace this procedure.
Multiple Myeloma – A type of blood cancer that develops in plasma cells, which are white blood cells that produce antibodies. The condition occurs when abnormal plasma cells multiply rapidly in the bone marrow, crowding out healthy blood cells and producing faulty antibodies called M proteins. These abnormal cells can cause several issues throughout the body, particularly in the bones, which can become weak and prone to problems. Over time, the disease can affect multiple body systems, including the bones, blood, kidneys, and immune system. The disease typically develops gradually, and some people may not experience symptoms in early stages.
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