Study on Daratumumab for Multiple Myeloma Patients with Minimal Residual Disease Reappearance or Biochemical Relapse

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What is this study about?

This clinical trial is focused on studying a condition called Multiple Myeloma, which is a type of blood cancer. The study is particularly interested in patients who have a small amount of cancer cells left after treatment, known as Minimal Residual Disease (MRD), or those who experience a return of cancer signs without symptoms, called a biochemical relapse. The treatment being tested is a medication called Daratumumab, which is given as an injection under the skin. The purpose of the study is to see if using Daratumumab can help prevent the cancer from coming back or getting worse in these patients.

Participants in the study will be divided into two groups. One group will receive the Daratumumab treatment, while the other group will be observed without receiving the medication. The study will compare how long patients in each group remain free from new symptoms or complications related to Multiple Myeloma. This period is referred to as event-free survival (EFS). The study aims to determine if Daratumumab can extend the time patients remain without new cancer symptoms or other serious health issues.

The trial will monitor patients over a period of time to assess the effectiveness of Daratumumab in preventing the progression of Multiple Myeloma. The study will also look at the overall response rate, which measures how many patients experience a reduction in cancer signs. This information will help researchers understand if Daratumumab is a beneficial preventive treatment for patients with minimal residual disease or biochemical relapse of Multiple Myeloma.

1 joining the study

Upon joining the study, you will be asked to provide informed consent. This means you agree to participate after understanding the study’s purpose, procedures, and potential risks and benefits.

You will undergo a series of initial assessments to confirm your eligibility. These assessments include a review of your medical history, physical examination, and laboratory tests.

2 randomization

If eligible, you will be randomly assigned to one of two groups: the daratumumab treatment group or the observation group. Randomization is like flipping a coin to decide which group you will be in.

3 treatment phase

If you are in the daratumumab treatment group, you will receive DARZALEX 1800 mg as a solution for injection. This medication is administered subcutaneously, meaning it is injected under the skin.

The frequency and duration of the treatment will be explained to you by the study team. It is important to attend all scheduled treatment sessions.

4 observation phase

If you are in the observation group, you will not receive the study medication. Instead, your health will be monitored regularly to track any changes in your condition.

5 follow-up assessments

Throughout the study, you will have regular follow-up assessments. These may include physical exams, blood tests, and other evaluations to monitor your health and the effects of the treatment or observation.

The study team will inform you of the schedule for these assessments and any specific instructions you need to follow.

6 end of study

At the end of the study, you will have a final assessment to evaluate your overall health and any effects of the treatment or observation.

The study team will discuss the results with you and provide guidance on any further steps or treatments that may be necessary.

Who Can Join the Study?

Patients must have been diagnosed with symptomatic Multiple Myeloma (MM) and have completed one or two previous treatments. A stem cell transplant is not considered a separate treatment and is not required.
Patients must have shown at least a Partial Response (PR) to their last treatment and are experiencing a type of progression that does not show symptoms.
Women who can have children must have a negative pregnancy test and agree to use two reliable forms of birth control or practice complete abstinence during the study.
Men must agree to use a latex condom during sexual contact with women who can have children while in the study and for at least 28 days after stopping the study, even if they have had a vasectomy.
Patients must provide voluntary written consent to participate in the study.
Participants must be at least 18 years old.
Participants must have a life expectancy of more than 3 months.
Participants must have an ECOG performance status of 0-2, which measures their ability to perform daily activities.
Participants must have adequate liver function, with specific levels of bilirubin and liver enzymes (AST and ALT) within acceptable limits.
Participants must have certain levels of blood cells: ANC (a type of white blood cell) of at least 1.0 x 10⁹/L, hemoglobin of at least 8 g/dL, and platelet count of at least 75 x 10⁹/L.
Participants must have a calculated creatinine clearance of at least 50 mL/min, which measures kidney function, or a serum creatinine level below 2 g/dL.

Who Cannot Join the Study?

Patients who have any other serious medical conditions that could interfere with the study.
Patients who are pregnant or breastfeeding.
Patients who have had another type of cancer within the last 5 years, except for skin cancer that is not melanoma.
Patients who have an active infection that requires treatment with antibiotics or antiviral medications.
Patients who have received any other investigational drug within the last 30 days.
Patients who have a known allergy to the study medication or any of its ingredients.
Patients who have a history of drug or alcohol abuse within the last 2 years.
Patients who have a mental health condition that could interfere with their ability to participate in the study.
Patients who have had a major surgery within the last 4 weeks.
Patients who have received a blood transfusion within the last 2 weeks.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country	Status
Uniwersytecki Szpital Kliniczny Im Jana Mikulicza Radeckiego We Wroclawiu	Wroclaw	Poland

Other Sites

Site Name	City	Country
Instytut Hematologii I Transfuzjologii	Warsaw	Poland
Szpital Uniwersytecki Nr 2 Im Dr Jana Biziela W Bydgoszczy	Bydgoszcz	Poland
Uniwersytecki Szpital Kliniczny W Poznaniu	Poznan	Poland
Nuukwzdj Icnrejnv Oyxmurhhj Ikt Mqxne Sarroxyadeenjadpogovuebwmbyo Ifpzdfjl Bibnnnzi	Cracow	Poland
Ukprqckkhrxizb Csikrqe Kozpnqvdf	Gdansk	Poland
Sfucwrswkrk Phjvsaher Seolqcs Kqzszdafd Ixeddrpwstp Mhthgulwqia Ssl W Khvkzsdnjw	Katowice	Poland

Trial status

Country	Status	Recruitment Start
Poland	Not recruiting	11.10.2018

Trial locations

Investigated drugs:

Daratumumab

Daratumumab is a medication used in the treatment of 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. In this clinical trial, daratumumab is being tested to see if it can help prevent the progression of the disease in patients who show signs of minimal residual disease or have a biochemical relapse. The goal is to see if using daratumumab can extend the time patients remain free from new symptoms or complications related to multiple myeloma.

Multiple Myeloma – Multiple Myeloma is a type of blood cancer that affects plasma cells, which are a kind of white blood cell found in the bone marrow. The disease begins when abnormal plasma cells multiply uncontrollably, leading to the production of a large amount of abnormal proteins. As it progresses, these abnormal cells crowd out healthy blood cells, causing symptoms such as bone pain, anemia, and kidney dysfunction. Over time, the disease can lead to weakened bones, increased risk of infections, and other complications. The progression of Multiple Myeloma is often characterized by periods of remission and relapse.

Minimal Residual Disease – Minimal Residual Disease refers to the small number of cancer cells that may remain in a patient’s body after treatment and are not detectable using standard diagnostic methods. These residual cells can be a source of relapse, as they have the potential to grow and cause the disease to return. The presence of Minimal Residual Disease is an important factor in understanding the progression of certain cancers, including blood cancers like Multiple Myeloma. Monitoring for Minimal Residual Disease helps in assessing the effectiveness of treatment and the likelihood of disease recurrence. The progression of the disease can be influenced by the presence and behavior of these residual cells.

Trial ID:

2024-518400-50-00

Protocol code:

PMC008

Trial Phase:

Therapeutic exploratory (Phase II)

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Study on Daratumumab for Multiple Myeloma Patients with Minimal Residual Disease Reappearance or Biochemical Relapse

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Who Can Join the Study?

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