Study comparing daratumumab, lenalidomide and dexamethasone followed by linvoseltamab versus continued initial treatment in newly diagnosed multiple myeloma patients
This clinical trial focuses on treating patients with newly diagnosed Multiple Myeloma who are not eligible for transplant. The study compares two treatment approaches. The first approach uses a combination of Daratumumab, Lenalidomide, and Dexamethasone followed by Linvoseltamab. The second approach continues with Daratumumab, Lenalidomide, and Dexamethasone throughout the treatment period.
Multiple Myeloma is a type of blood cancer that affects plasma cells, which are special white blood cells that help fight infections. The study aims to determine which treatment combination is more effective at eliminating cancer cells to a level that cannot be detected by very sensitive testing methods.
The medications used in this study are given in different ways. Lenalidomide is taken by mouth in capsule form, while Daratumumab and Linvoseltamab are given through an infusion into a vein. Dexamethasone can be given either as tablets by mouth or as an injection. The treatment continues for several weeks, and patients will need regular visits to the hospital for monitoring and receiving their medications.
1Initial treatment phase
You will receive a combination of three medications: daratumumab (given by injection), lenalidomide (taken as capsules by mouth), and dexamethasone (taken as tablets by mouth)
This initial treatment will be provided to all study participants
2Treatment assignment
You will be randomly assigned to one of two treatment groups
The assignment process is done by computer and cannot be chosen by you or your doctor
3Continuation phase
Depending on your assigned group, you will either:
Continue with the same three-drug combination (daratumumab, lenalidomide, and dexamethasone)
Or switch to linvoseltamab (given by infusion into a vein)
4Hospital stay requirement
If assigned to the linvoseltamab group, you will need to stay in or near the hospital (within 30 minutes) after receiving the first dose
5Monitoring and testing
Regular blood tests will be performed to monitor your health
Bone marrow samples will be collected at various points during the study
Your disease status will be regularly evaluated through various tests
6Study duration
The study is planned to run from September 2025 to October 2035
Your participation duration will depend on how your condition responds to treatment
Who Can Join the Study?
You must have a confirmed diagnosis of Multiple Myeloma with symptoms
You must be 18 years or older
You must be able to provide written informed consent to participate
You must be able to understand and complete study questionnaires
You must not be eligible for high-dose chemotherapy and stem cell transplant due to:
– Advanced age, or
– Significant health conditions that could affect treatment tolerance
You must have measurable disease levels through at least one of these tests:
– Specific protein levels in blood of 1 g/dL or higher
– Specific protein levels in 24-hour urine collection of 200 mg or higher
– Certain blood protein chain levels of 10 mg/dL or higher
Your physical performance status must be rated as 0, 1, or 2 (able to perform most daily activities)
Your blood tests must show:
– Adequate white blood cell counts
– Hemoglobin levels of 7.5 g/dL or higher
– Adequate platelet counts
– Kidney function of 30 mL/min or better
– Acceptable liver function tests
– Controlled calcium levels
You must be willing to:
– Attend clinic visits
– Undergo bone marrow tests
– Stay near the hospital (within 30 minutes) if assigned to the experimental treatment group
You must agree to follow pregnancy prevention guidelines if taking study medications
Who Cannot Join the Study?
Prior treatment for multiple myeloma (except for emergency use of local radiation therapy or a short course of corticosteroids)
Age under 18 years
Pregnant or breastfeeding women
History of other cancers within 3 years before starting the study (except for adequately treated non-melanoma skin cancer or carcinoma in situ)
Severe heart conditions including heart failure (reduced heart’s ability to pump blood) or uncontrolled angina (chest pain)
Severe kidney problems requiring dialysis
Active, uncontrolled infections
Known HIV infection (human immunodeficiency virus)
Active hepatitis B or C infection (liver infections)
Major surgery within 4 weeks before starting the study
Participation in other clinical trials within 4 weeks before this study
Mental conditions that could interfere with following study procedures
Daratumumab is a medication used to treat multiple myeloma. It works by targeting a specific protein on cancer cells, helping the immune system identify and destroy these cells.
Lenalidomide is a medication that helps fight multiple myeloma by strengthening the immune system and preventing the growth of cancer cells. It also works by blocking the blood supply to cancer cells.
Dexamethasone is a steroid medication that helps reduce inflammation and suppress the immune system. In multiple myeloma treatment, it is often used in combination with other medications to enhance their effectiveness.
Linvoseltamab is an investigational medication being studied for the treatment of multiple myeloma. It is being tested as an alternative treatment option to compare its effectiveness with the standard treatment combination.
Multiple Myeloma – A type of blood cancer that develops in plasma cells, which are white blood cells that help fight infections. In this condition, abnormal plasma cells multiply uncontrollably in the bone marrow, forming tumors in multiple bones throughout the body. These cancerous cells interfere with the production of normal blood cells and can cause bone damage, leading to weakened bones. The disease also causes the overproduction of a single type of antibody, which can damage the kidneys and other organs. Multiple myeloma typically develops gradually and can affect various parts of the body, particularly the bones of the spine, skull, pelvis, rib cage, and hips.
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