Not recruitingRare disease

Study of Daratumumab, Bortezomib, Cyclophosphamide, and Dexamethasone for Treating Multiple Myeloma Patients with Extramedullary Disease

Verified siteRegistered drugNo placebo

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying a condition known as Multiple Myeloma, which is a type of cancer that affects plasma cells in the bone marrow. In this study, the focus is on patients who have a specific form of this disease called extramedullary disease, where the cancer cells spread outside the bone marrow to other parts of the body like the skin, liver, or lungs. The trial aims to evaluate the effectiveness of a combination of medications in treating this condition. The medications being tested include Daratumumab, Bortezomib, Cyclophosphamide, and Dexamethasone. Daratumumab is given as a solution for injection under the skin, while Bortezomib is a powder that is mixed into a solution for injection. Cyclophosphamide is administered intravenously, and Dexamethasone can be taken orally or through an IV.

The purpose of the study is to assess how well these medications work together in achieving a complete response, which means the disappearance of all signs of cancer in response to treatment. Participants in the study will receive these medications over a period of up to 36 months. The study will monitor the participants' health and response to the treatment, including how long the response lasts, the time until the disease progresses, and overall survival rates. Safety and any side effects experienced by participants will also be closely observed.

Throughout the study, participants will undergo various assessments to track their progress. These may include imaging tests like MRI or PET-CT scans to check the spread of the disease and blood tests to measure the levels of cancer cells. The study aims to provide valuable information on the effectiveness and safety of this treatment combination for patients with Multiple Myeloma presenting with extramedullary disease.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Initial assessment
Upon joining the study, an initial assessment is conducted to confirm eligibility. This includes a review of medical history and a physical examination.
Baseline radiologic assessments are performed to document the extent of the disease.
Step 2
Treatment initiation
The treatment involves a combination of medications: daratumumab, bortezomib, cyclophosphamide, and dexamethasone.
Daratumumab is administered as a subcutaneous injection. The dosage and frequency are determined by the study protocol.
Bortezomib is given as a subcutaneous injection. The dosage and schedule are specified in the study guidelines.
Cyclophosphamide is administered either orally or intravenously, depending on the specific requirements of the study.
Dexamethasone is taken orally, with the dosage and frequency outlined in the study protocol.
Step 3
Ongoing monitoring
Regular monitoring is conducted to assess the response to treatment. This includes blood tests, imaging studies, and other necessary evaluations.
The primary goal is to evaluate the Complete Response (CR) rate, which indicates the absence of detectable disease.
Step 4
Follow-up assessments
Follow-up assessments are scheduled to monitor the Duration of Response (DoR), Progression Free Survival (PFS), and Overall Survival (OS).
Safety is evaluated by monitoring for any adverse events throughout the trial.
Step 5
Completion of trial
The trial is estimated to conclude by June 22, 2027. Final assessments will be conducted to determine the overall outcomes and effectiveness of the treatment.

Who can join the trial?

8 criteria

Must have a confirmed diagnosis of Multiple Myeloma (MM) according to specific guidelines.
Can be newly diagnosed or have had a relapse, but should have received no more than one previous treatment. The disease should be present in areas like the skin, liver, lungs, central nervous system, lymph nodes, or other tissues, but not just in the bones. This should be confirmed by certain medical tests or a biopsy, which is a small sample of tissue taken for examination.
If previously treated, must have shown improvement with at least one treatment and have evidence of the disease worsening after the last treatment.
Must be 18 years of age or older.
Should have a performance status of 2 or less on a specific scale that measures daily living abilities. If the central nervous system is involved, a higher status is acceptable.
Must sign a consent form to show understanding and willingness to participate in the trial.
Must have measurable disease, which means the presence of certain proteins in the blood or urine that can be tracked.
Women who can have children must have a negative pregnancy test before starting. They must agree to use reliable birth control methods during the trial and for a certain period after. Men must also use condoms during sexual contact and follow birth control instructions during and after the trial. Women must not breastfeed, and both men and women must not donate eggs or sperm for a specified time after the trial.

Who cannot join the trial?

5 criteria

Patients who do not have Multiple Myeloma with extramedullary disease. Multiple Myeloma is a type of cancer that affects certain blood cells, and extramedullary disease means the cancer has spread outside the bone marrow.
Patients who are not within the specified age range for the study.
Patients who do not belong to the specific clinical trial group required for the study.
Patients who are not male or female, as the study includes both genders.
Patients who are considered part of a vulnerable population, which means they might need special protection or care.

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Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

Alexandra Hospital
Verified
Athens, Greece
Azienda Ospedaliera Universitaria Citta' Della Salute E Della Scienza Di Torino
Verified
Turin, Italy
Azienda Unita Sanitaria Locale Di Bologna
Verified
Bologna, Italy

Trial locations

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Investigated drugs

Daratumumab
is a medication used in this trial to treat multiple myeloma, a type of blood cancer. It works by targeting a specific protein on the surface of cancer cells, helping the immune system to identify and destroy these cells.
Bortezomib
is another medication used in the trial. It helps to treat multiple myeloma by interfering with the growth of cancer cells, ultimately leading to their death. It is often used in combination with other medications to enhance its effectiveness.
Cyclophosphamide
is a chemotherapy drug included in the trial. It works by slowing or stopping the growth of cancer cells. It is commonly used in combination with other cancer treatments to improve outcomes.
Dexamethasone
is a steroid medication used in the trial to help reduce inflammation and suppress the immune system. It is often used alongside other cancer treatments to help manage side effects and improve the effectiveness of the treatment regimen.

What is already known about the treatment

Daratumumab
This medication is administered intravenously and is currently used in the treatment of multiple myeloma, particularly in patients with extramedullary disease. It is well-documented in medical literature as an effective therapy for this condition. Daratumumab works by targeting a specific protein on the surface of myeloma cells, leading to their destruction by the immune system. It is classified as a monoclonal antibody.
Bortezomib
Administered via injection, Bortezomib is a well-established treatment for multiple myeloma, including cases with extramedullary disease. It is recognized in medical literature for its effectiveness in this area. Bortezomib inhibits proteasomes, which are enzyme complexes that break down proteins in cells, leading to cancer cell death. It belongs to the class of proteasome inhibitors.
Cyclophosphamide
This medication is taken orally or by injection and is used in the treatment of multiple myeloma with extramedullary disease. It is widely referenced in medical literature as a chemotherapy agent. Cyclophosphamide works by interfering with the DNA of cancer cells, preventing their growth and division. It is classified as an alkylating agent.
Dexamethasone
Administered orally or by injection, Dexamethasone is used in the treatment of multiple myeloma, including cases with extramedullary disease. It is well-documented in medical literature for its role in reducing inflammation and suppressing the immune response. Dexamethasone is a corticosteroid that helps enhance the effects of other cancer treatments.

Investigated diseases

Multiple Myeloma – Multiple Myeloma is a type of blood cancer that affects plasma cells, which are a type of white blood cell found in the bone marrow. In this disease, abnormal plasma cells multiply uncontrollably, leading to the production of a large amount of abnormal proteins. These proteins can cause damage to bones and other organs. The disease often progresses with symptoms such as bone pain, frequent infections, and anemia. In some cases, it can present with extramedullary disease, where the cancer cells form tumors outside the bone marrow. As the disease advances, it can lead to complications like kidney damage and increased calcium levels in the blood.