Study on Melflufen and Dexamethasone for Elderly Patients with Relapsed Multiple Myeloma

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What is this study about?

This clinical trial is focused on studying a condition called Relapsed Multiple Myeloma, which is a type of blood cancer that returns after treatment. The study will explore the effectiveness of a treatment combination involving two medications: Melflufen and Dexamethasone. Melflufen is a type of chemotherapy drug, while Dexamethasone is a steroid that helps reduce inflammation and is often used to treat various conditions, including cancer.

The purpose of the study is to evaluate how well this combination works in elderly patients who have experienced a second or further relapse of their multiple myeloma. Participants in the study will receive either the treatment combination or a placebo. The study will monitor the participants over a period of time to see how their condition responds to the treatment. The treatment will be administered either orally or through an intravenous infusion, depending on the specific medication.

Throughout the study, researchers will track the overall response rate, which means they will look at how many participants show improvement in their condition. They will also observe how long the response lasts, the time it takes for the disease to progress, and the overall survival of the participants. The study aims to provide valuable information on the potential benefits of using Melflufen and Dexamethasone together for treating relapsed multiple myeloma in elderly patients.

1 initial assessment

Upon joining the study, an initial assessment is conducted to confirm eligibility. This includes reviewing medical history and current health status.

Eligibility criteria include age between 70 and 85 years, previous treatment for multiple myeloma, and specific health parameters such as liver and kidney function.

2 treatment initiation

The treatment phase begins with the administration of melphalan flufenamide and dexamethasone.

Melphalan flufenamide is given as an intravenous infusion. The specific dosage and frequency are determined by the study protocol.

Dexamethasone is administered orally in the form of drops. The dosage and frequency are also specified in the study protocol.

3 ongoing monitoring

Regular monitoring is conducted to assess the response to treatment. This includes blood tests and other assessments to evaluate the effectiveness and safety of the treatment.

The primary goal is to measure the overall response rate, which includes any improvement in the condition as defined by specific criteria.

4 response evaluation

The duration of response is evaluated, which is the time from the first documented improvement to any progression of the disease.

Progression-free survival is also assessed, which is the time from the start of treatment to any progression of the disease or death.

5 study completion

The study is estimated to conclude by August 2027. At the end of the study, a final assessment is conducted to evaluate the overall survival and time to response.

Participants’ data will be analyzed to determine the effectiveness of the treatment in managing relapsed multiple myeloma.

Who Can Join the Study?

Patients must have relapsed multiple myeloma, which means the disease has returned after treatment.
The disease must have progressed or relapsed after receiving 2 or more previous treatments.
Patients need to have adequate liver function, which includes:
- Total bilirubin level no more than 1.5 times the upper limit of normal (ULN).
- AST (a liver enzyme) level no more than 2.5 times the ULN.
- ALT (another liver enzyme) level no more than 2.5 times the ULN.
Patients must have an estimated creatinine clearance of at least 30 mL/min. This measures how well the kidneys are working.
Patients need to have adequate bone marrow function, which includes:
- Absolute neutrophil count of at least 1.0 × 10⁹/L. Neutrophils are a type of white blood cell.
- Platelet count of at least 50 × 10⁹/L. Platelets help with blood clotting.
- Hemoglobin level of at least 8 g/dL. Hemoglobin is a protein in red blood cells that carries oxygen.
Non-vasectomized male patients must agree to use appropriate birth control methods.
Patients must be willing and able to attend study visits and follow the study procedures.
Patients must provide written informed consent, which means they agree to participate after understanding the study details.
Patients must have a life expectancy of at least 3 months.
Patients must have been previously treated with at least one drug from each of the following categories:
- Anti-CD38 monoclonal antibodies (MoAbs)
- Immunomodulatory drugs (IMiDs)
- Proteasome inhibitors
Patients must be between 70 and 85 years old.
Patients must have an ECOG performance status of 2 or less. This is a scale that measures how well patients can perform daily activities.
Patients must have certain levels of M-protein in their blood or urine, which are markers of multiple myeloma.
Patients must have a left ventricular ejection fraction (LVEF) of at least 40%, as determined by a heart scan. This measures how well the heart pumps blood.

Who Cannot Join the Study?

Patients who have not experienced a relapse of their condition. A relapse means that the disease has returned after a period of improvement.
Patients who are not in their second or later relapse. This means the study is for those who have had the disease return at least twice.
Patients who are not considered elderly. The study is focused on older adults.
Patients who are part of a vulnerable population. This refers to groups who may need special protection, such as children or those unable to give consent.

Where you can join this trial?

Verified and Recommended Sites

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Verified Sites

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Other Sites

Site Name	City	Country
Casa Sollievo Della Sofferenza	San Giovanni Rotondo	Italy
Azienda Sanitaria Universitaria Friuli Centrale	Udine	Italy
Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone	Palermo	Italy
Azienda Socio Sanitaria Territoriale Ovest Milanese	Legnano	Italy
ASST Grande Ospedale Metropolitano Niguarda	Milan	Italy
Universita’ Di Pisa	Pisa	Italy
Universita’ Politecnica Delle Marche	Ancona	Italy
Azienda Sociosanitaria Territoriale Santi Paolo E Carlo	Milan	Italy
Aurcths Onovrlxhejx Uddtyixbvwdjo Pynqi	Parma	Italy
Aguyqik Oahbudbaexr Uvektwymzhmhx Cmywzgbfuqop Dkhoa Slgbes E Dvgne Sdevzyn Df Tqopyp	Turin	Italy

Trial status

Country	Status	Recruitment Start
Italy	Not yet recruiting	15.02.2025

Trial locations

Investigated drugs:

Melflufen is a medication being studied for its effectiveness in treating elderly patients with multiple myeloma who have experienced a second or subsequent relapse. It is designed to target and destroy cancer cells more effectively by delivering a chemotherapy agent directly to the cancer cells.

Dexamethasone is a type of steroid medication used in this trial to help reduce inflammation and suppress the immune system. It is often used in combination with other cancer treatments to enhance their effectiveness and manage symptoms associated with cancer.

Relapsed Multiple Myeloma – This is a type of blood cancer that affects plasma cells, which are a type of white blood cell found in the bone marrow. In relapsed multiple myeloma, the disease returns after a period of improvement or remission. The condition is characterized by the overproduction of abnormal plasma cells, which can crowd out healthy blood cells and lead to bone damage, kidney problems, and weakened immune function. As the disease progresses, patients may experience symptoms such as bone pain, fatigue, and frequent infections. The progression of relapsed multiple myeloma can vary, with periods of stability followed by periods of active disease.

Trial ID:

2024-514652-33-00

Protocol code:

MELISSA

Trial Phase:

Therapeutic exploratory (Phase II)

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Study on Melflufen and Dexamethasone for Elderly Patients with Relapsed Multiple Myeloma

What is this study about?

Who Can Join the Study?

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