Study on Treating Smoldering and Active Multiple Myeloma with Dexamethasone, Lenalidomide, and Carfilzomib for Patients in Iceland

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What is this study about?

This clinical trial is focused on studying Multiple Myeloma, a type of blood cancer that affects plasma cells in the bone marrow. The study involves patients with both smoldering and active forms of this disease. The treatment being tested includes a combination of medications: Dexamethasone, Lenalidomide, and Carfilzomib (also known by its code name PR-171). These medications are used to see if they can effectively treat patients with different risk levels of smoldering multiple myeloma.

The purpose of the study is to evaluate how well these treatments work in achieving a state called MRD negativity, which means no minimal residual disease is detected, three years after starting the treatment. Patients with intermediate-risk smoldering multiple myeloma will receive a combination of dexamethasone and lenalidomide, while those with high-risk smoldering multiple myeloma will receive all three medications: dexamethasone, lenalidomide, and carfilzomib. The study will also look at the safety of these treatments and their overall effects on the disease.

Participants in the study will follow a treatment plan over a period of time, with regular check-ups to monitor their health and the progress of the disease. The study aims to provide valuable information on the effectiveness of these treatments in managing multiple myeloma and improving patient outcomes. The trial is expected to continue until 2027, with the goal of better understanding how these medications can help patients with this condition.

1 enrollment

Upon joining the study, you will be enrolled in a clinical trial aimed at treating multiple myeloma or smoldering multiple myeloma.

You will be required to provide informed written consent and meet specific eligibility criteria, including being at least 18 years old and having untreated active multiple myeloma or smoldering multiple myeloma.

2 initial assessment

An initial assessment will be conducted to evaluate your health status and confirm eligibility. This may include blood tests, urine tests, and other diagnostic procedures to measure disease markers.

A negative pregnancy test is required for women of childbearing potential, conducted within 7 days prior to entry.

3 treatment plan

Based on your risk level, a treatment plan will be developed. If you have intermediate-risk smoldering multiple myeloma, you will receive a combination of dexamethasone and lenalidomide. If you have high-risk smoldering multiple myeloma, you will receive a combination of dexamethasone, lenalidomide, and carfilzomib.

4 medication administration

You will receive carfilzomib as an infusion. The specific dosage and frequency will be determined by the study protocol.

Lenalidomide will be administered orally in the form of hard capsules. The dosage and frequency will be specified in your treatment plan.

Dexamethasone will also be taken orally in tablet form, with dosage and frequency outlined in your treatment plan.

5 ongoing monitoring

Throughout the trial, regular monitoring will be conducted to assess your response to treatment and any side effects. This may include blood tests, imaging studies, and other evaluations.

You will be required to adhere to the study schedule and report any changes in your health to the study team.

6 evaluation of outcomes

The primary goal is to determine the rate of minimal residual disease (MRD) negativity three years after enrollment. This means assessing whether the disease is undetectable at a molecular level.

Secondary outcomes include clinical response and safety, which will be evaluated according to established guidelines.

7 completion

The trial is expected to continue until September 2027. Upon completion, final assessments will be conducted to evaluate the long-term effects of the treatment.

You will receive information about the results of the study and any further steps if necessary.

Who Can Join the Study?

Have active Multiple Myeloma (MM) or Smoldering Multiple Myeloma (SMM) that has not been treated yet.
Be willing to follow strict birth control measures as outlined in the study plan.
Be willing and able to follow the study schedule and other requirements.
Be at least 18 years old and expected to live for at least 6 more months.
Have measurable disease, which means having certain levels of specific proteins in the blood or urine, or a certain percentage of plasma cells in the bone marrow.
Have had no prior treatment for MM or SMM, except for treatment of a solitary plasmacytoma (a single tumor of plasma cells), and at least 7 days should have passed since the last radiation treatment.
Have an ECOG performance status of 0, 1, or 2, which is a scale used to assess how the disease affects daily living abilities.
Provide informed written consent to participate in the study.
If a woman of childbearing potential, have a negative pregnancy test within 7 days before starting the study.

Who Cannot Join the Study?

Patients with any other active cancer cannot participate.
Patients who have had a heart attack or severe heart problems in the past 6 months are not eligible.
Patients with uncontrolled high blood pressure cannot join the study.
Patients with severe liver disease are excluded.
Patients with severe kidney disease cannot participate.
Patients who are pregnant or breastfeeding are not eligible.
Patients with a history of severe allergic reactions to the study drugs cannot join.
Patients with active infections that require treatment are excluded.
Patients who have received other experimental treatments in the last 4 weeks cannot participate.
Patients with a history of certain blood disorders are not eligible.

Where you can join this trial?

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Other Sites

Site Name	City	Country	Status
Landspitali	Reykjavik	Iceland

Trial status

Country	Status	Recruitment Start
Iceland	Not yet recruiting	17.12.2018

Trial locations

Investigated drugs:

Dexamethasone is a medication that helps reduce inflammation in the body. It is often used to treat conditions that involve an overactive immune system. In this trial, it is used as part of a combination therapy to help manage multiple myeloma, a type of blood cancer. By reducing inflammation, dexamethasone can help control the growth of cancer cells.

Lenalidomide is a medication that affects the immune system and helps slow down or stop the growth of cancer cells. It is used in this trial to treat multiple myeloma by working alongside other medications to enhance the body’s ability to fight the cancer. Lenalidomide can also help improve the function of the bone marrow, where blood cells are produced.

Carfilzomib is a medication that targets and breaks down proteins in cancer cells, which can lead to the death of these cells. It is used in this trial for patients with a higher risk of multiple myeloma. By disrupting the cancer cells’ ability to manage proteins, carfilzomib helps to control the progression of the disease.

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. It begins when a single plasma cell becomes abnormal and starts to multiply uncontrollably, leading to an accumulation of abnormal cells in the bone marrow. These abnormal cells produce a large amount of a single type of antibody, which can cause damage to bones and interfere with the production of normal blood cells. As the disease progresses, it can lead to bone pain, fractures, anemia, kidney dysfunction, and increased susceptibility to infections. The disease often progresses in a series of stages, starting with a condition known as smoldering multiple myeloma, which may not cause symptoms initially. Over time, it can advance to active multiple myeloma, where symptoms become more pronounced and require medical intervention.

Trial ID:

2024-519353-11-00

NCT ID:

NCT03327597

Trial Phase:

Therapeutic exploratory (Phase II)

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Study on Treating Smoldering and Active Multiple Myeloma with Dexamethasone, Lenalidomide, and Carfilzomib for Patients in Iceland

What is this study about?

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