Study Comparing Carfilzomib, Lenalidomide, and Dexamethasone with Lenalidomide and Dexamethasone for Patients with High-Risk Smoldering Multiple Myeloma

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What is this study about?

This clinical trial is focused on studying a condition known as Smoldering Multiple Myeloma, which is a precursor to a type of blood cancer called Multiple Myeloma. The study aims to compare the effectiveness of two treatment combinations for patients with high-risk smoldering multiple myeloma. One group of patients will receive a combination of three medications: Carfilzomib (also known by its code name PR-171), Lenalidomide, and Dexamethasone. The other group will receive only Lenalidomide and Dexamethasone. The purpose of the study is to evaluate how well these treatments work in preventing the progression of the disease.

Participants in the study will be randomly assigned to one of the two treatment groups. The study will involve several cycles of treatment, and the progress of the disease will be monitored throughout. The study will assess the response to treatment after nine cycles, and patients will be followed up to see how long they remain free from disease progression. The study will also look at the overall response rate, which means how many patients show at least a partial improvement in their condition, and the safety of the treatment combinations.

The trial will use a method called next-generation flow cytometry to measure the presence of cancer cells in the bone marrow. This method helps determine if the treatment is effective in reducing the number of cancer cells. The study will also explore the relationship between the reduction of cancer cells and the length of time patients remain free from disease progression. The safety of the treatment will be closely monitored, including any side effects that may occur. The study is expected to continue until early 2029, providing valuable information on the best treatment approach for high-risk smoldering multiple myeloma.

1 joining the study

Upon joining the study, the patient will be randomly assigned to one of two treatment groups. The first group will receive a combination of carfilzomib, lenalidomide, and dexamethasone. The second group will receive lenalidomide and dexamethasone only.

2 treatment cycle 1 to 9

For the group receiving carfilzomib, lenalidomide, and dexamethasone:

The patient will receive carfilzomib intravenously. The specific dosage and frequency will be determined by the study protocol.

The patient will take lenalidomide orally in capsule form. The dosage will vary between 5 mg, 10 mg, 15 mg, and 25 mg, depending on the cycle and the patient’s response.

The patient will take dexamethasone orally in tablet form. The dosage will vary between 2 mg, 4 mg, and 8 mg, depending on the cycle and the patient’s response.

For the group receiving lenalidomide and dexamethasone:

The patient will take lenalidomide orally in capsule form. The dosage will vary between 5 mg, 10 mg, 15 mg, and 25 mg, depending on the cycle and the patient’s response.

The patient will take dexamethasone orally in tablet form. The dosage will vary between 2 mg, 4 mg, and 8 mg, depending on the cycle and the patient’s response.

3 evaluation after cycle 9

After completing 9 cycles, the patient’s response to the treatment will be evaluated. The main goal is to assess the rate of minimal residual disease (MRD) negativity using next-generation flow cytometry. This evaluation helps determine the effectiveness of the treatment.

4 maintenance phase

If the patient achieves a successful response, they may enter a maintenance phase. During this phase, the treatment regimen may be adjusted based on the patient’s condition and response to the initial cycles.

5 ongoing monitoring

Throughout the study, the patient’s health and response to treatment will be closely monitored. This includes regular assessments of disease progression, overall survival, and any side effects experienced.

Who Can Join the Study?

Patients must have a confirmed diagnosis of Smoldering Multiple Myeloma. This means they have a specific type of blood cancer that is not yet causing symptoms.
Patients must provide written informed consent, which means they agree to participate in the study after understanding all the details.
Patients must have a Creatinine Clearance of at least 50 ml/min. This is a test to check how well the kidneys are working.
Patients must be able to give informed consent, meaning they understand the study and agree to participate.
Patients must have high-risk Smoldering Multiple Myeloma according to specific medical criteria.
Patients must have a measurable disease, meaning the disease can be measured or tracked by doctors.
Patients must be over 18 years old.
Patients must have a WHO/ECOG performance status of 2 or less. This is a scale that measures how well a patient can perform daily activities.
Patients must have normal organ and bone marrow function, meaning their organs and bone marrow are working properly.
Patients must be willing and able to use adequate contraception during and after the therapy. This applies to all men and premenopausal women to prevent pregnancy during the study.
Females who can have children must have a negative pregnancy test before starting the treatment and again within 24 hours of starting lenalidomide treatment, which is a medication used in the study.

Who Cannot Join the Study?

Patients with any other serious medical condition that could interfere with the study.
Patients who have had another type of cancer in the past, unless it was treated and cured.
Patients who are currently pregnant or breastfeeding.
Patients who have participated in another clinical trial within the last 30 days.
Patients who have an active infection that requires treatment.
Patients with a history of allergic reactions to the study medications.
Patients who have a mental health condition that could affect their ability to participate in the study.
Patients who are unable to follow the study procedures or attend the required visits.

Where you can join this trial?

Verified and Recommended Sites

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Verified Sites

Site Name	City	Country
Oslo Universitetssykehus HF	Oslo	Norway
Zuyderland Medisch Centrum Stichting	Geleen	The Netherlands
Frisius	Heerenveen	The Netherlands

Other Sites

Site Name	City	Country
Jeroen Bosch Ziekenhuis Stichting	s-Hertogenbosch	The Netherlands
Stichting Radboud University Medical Center	Nijmegen	The Netherlands
Spaarne Gasthuis	Hoofddorp	The Netherlands
Adkjchufb Uau	Amsterdam	The Netherlands
Ejahrnm Usabrpzsnypx Mpihckj Cnajcfc Rbqvnpcdd (zruomgw Mxe	Rotterdam	The Netherlands

Trial status

Country	Status	Recruitment Start
Norway	Not recruiting	02.01.2019
The Netherlands	Not recruiting	02.01.2019

Trial locations

Investigated drugs:

Carfilzomib is a medication used in this trial to treat high-risk smoldering multiple myeloma. It works by blocking certain proteins in cancer cells, which can help stop the growth and spread of the cancer.

Lenalidomide is another medication used in the trial. It helps the immune system attack cancer cells and can also stop the growth of new blood vessels that tumors need to grow.

Dexamethasone is a steroid used in the trial to reduce inflammation and help control the immune system. It can also help enhance the effects of other cancer treatments.

Investigated diseases:

Plasma cell myeloma

Smoldering Multiple Myeloma – This is a condition characterized by the presence of abnormal plasma cells in the bone marrow, which are not yet causing symptoms or organ damage. It is considered an early or asymptomatic form of multiple myeloma. Over time, the condition may progress to active multiple myeloma, but it remains stable in some individuals for many years. Monitoring is essential to detect any signs of progression to symptomatic disease. The progression involves an increase in the number of abnormal plasma cells and potential development of symptoms.

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. It leads to the production of abnormal proteins that can cause damage to bones, kidneys, and the immune system. The disease progresses as these abnormal cells multiply, leading to bone pain, fractures, anemia, and increased risk of infections. Over time, the accumulation of these cells can cause significant health issues, including organ damage. The progression is typically marked by worsening symptoms and increased levels of abnormal proteins in the blood or urine.

Trial ID:

2024-511334-12-00

Protocol code:

HO147

Trial Phase:

Therapeutic exploratory (Phase II)

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Study Comparing Carfilzomib, Lenalidomide, and Dexamethasone with Lenalidomide and Dexamethasone for Patients with High-Risk Smoldering Multiple Myeloma

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?