Not recruiting

Study on Carfilzomib, Lenalidomide, and Dexamethasone for Patients Under 70 with High-Risk Smoldering Multiple Myeloma

Verified siteRegistered drugNo placebo

Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

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 smoldering multiple myeloma, which is a type of blood cancer that has a high risk of progressing to a more serious form called symptomatic myeloma. The study aims to evaluate the effectiveness of a combination of treatments in patients under 70 years old who are at high risk of this progression. The treatments being studied include carfilzomib, lenalidomide, and dexamethasone, which are used as initial therapy. This is followed by a high-dose treatment with melphalan and a procedure called autologous peripheral blood stem cell transplantation, where a patient's own blood stem cells are used to help recover from the high-dose treatment.

After the initial treatment and transplantation, patients will receive further treatment with the combination of carfilzomib, lenalidomide, and dexamethasone, known as consolidation therapy, to strengthen the response to the initial treatment. Finally, patients will continue with maintenance therapy using lenalidomide and dexamethasone to help keep the disease under control. The study will also involve the use of pomalidomide in different dosages, which is another medication that can help manage multiple myeloma. Additionally, daratumumab, an injection, is part of the study to explore its potential benefits in this treatment plan.

The purpose of the study is to assess how well these treatments work together in achieving a complete response, which means the disease is not detectable using specific tests. The study will monitor patients over a period of time to see how they respond to the treatments and to ensure their safety throughout the process. The goal is to find the best way to manage smoldering multiple myeloma and prevent it from becoming more serious.

The research process

The trial runs in 4 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Induction therapy
Begin the trial with **induction therapy**. This involves taking a combination of medications to prepare the body for further treatment. The medications include **dexamethasone** and **pomalidomide**. **Dexamethasone** is taken orally, and the dosage will be determined by the healthcare provider. **Pomalidomide** is available in different strengths: 1 mg, 2 mg, 3 mg, and 4 mg capsules, and the specific dosage will be prescribed by the healthcare provider.
The duration and frequency of taking these medications will be specified by the healthcare provider. Regular monitoring and follow-up visits will be scheduled to assess the response to the treatment.
Step 2
High-dose therapy and stem cell transplantation
After completing the induction therapy, proceed to **high-dose therapy** followed by **autologous peripheral blood stem cell transplantation**. This step involves receiving a high dose of chemotherapy to eliminate cancer cells, followed by the transplantation of your own blood stem cells to help restore the bone marrow.
This phase requires hospitalization and close monitoring by the healthcare team to manage any side effects and ensure recovery.
Step 3
Consolidation therapy
Following the transplantation, begin **consolidation therapy**. This phase aims to strengthen the response achieved from the previous treatments. The same combination of medications used in the induction phase, including **dexamethasone** and **pomalidomide**, will be administered.
The healthcare provider will determine the specific dosage and schedule for these medications. Regular follow-up visits will be necessary to monitor progress and adjust treatment as needed.
Step 4
Maintenance therapy
Enter the **maintenance therapy** phase to help maintain the response to treatment and prevent disease progression. This involves taking **lenalidomide** and **dexamethasone** as prescribed by the healthcare provider.
The duration of this phase will be determined by the healthcare provider, and regular monitoring will continue to ensure the effectiveness of the treatment.

Who can join the trial?

7 criteria

The patient must be able to meet all the clinical trial requirements, according to the investigator's opinion.
The patient must voluntarily sign the informed consent document before any study procedures that are not part of standard clinical care are carried out. The patient must be aware that they can withdraw from the study at any time without affecting their future medical care.
The patient must be aged between 18 and 70 years and eligible to receive high-dose therapy and autologous peripheral blood stem cell transplant (a procedure where a patient's own blood-forming stem cells are collected, stored, and then given back to the patient after intensive treatment).
The patient must have been diagnosed with smoldering multiple myeloma (SMM) with a high risk of progression to symptomatic multiple myeloma (MM) or ultra-high risk of progression to symptomatic disease in the five years prior to inclusion in the study. This means having certain levels of abnormal cells or proteins in the blood or bone marrow, without symptoms like bone damage, high calcium levels, kidney failure, or anemia.
The patient must have an ECOG performance status of less than 2, which means they should be fully active or only slightly restricted in physical activities.
The patient must be able to attend scheduled visits.
Women who can become pregnant must have a negative pregnancy test within 14 days before starting treatment with the study drug. Sexually active women must agree to use two methods of contraception while receiving the study drug and have regular pregnancy tests during and after the treatment.

Who cannot join the trial?

12 criteria

Patients with any other active cancer or history of cancer within the last 5 years, except for skin cancer that is not melanoma.
Patients with serious heart problems, such as heart failure or recent heart attack.
Patients with uncontrolled high blood pressure.
Patients with severe lung disease that makes breathing difficult.
Patients with active infections that require treatment with antibiotics or antiviral medications.
Patients with liver disease that affects liver function.
Patients with kidney disease that affects kidney function.
Patients who are pregnant or breastfeeding.
Patients who have had a major surgery within the last 4 weeks.
Patients who are currently participating in another clinical trial.
Patients with known allergies to the study medication or its ingredients.
Patients with any condition that, in the opinion of the study doctor, makes participation unsafe or not in the best interest of the patient.

Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

Tell us about your condition – we search every trial in Europe and connect you with the right site.

We usually reply within a few days

Verified sites

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

Hospital Clinic De Barcelona
Verified
Barcelona, Spain
Hospital Clinico San Carlos
Verified
Madrid, Spain
Hospital Universitario 12 De Octubre
Verified
Madrid, Spain

Trial locations

Where you can join this trial

Countries are shaded by recruitment status. Click a recruiting country to ask about joining there.

Not recruiting

Not finding your country?

Not sure what to do next?

Joining a clinical trial can seem overwhelming. We guide you step by step, so you know exactly what to expect and how we support you through the process.

See the full process and FAQ

Investigated drugs

Carfilzomib
is a medication used in this trial to help treat smoldering multiple myeloma, a type of blood cancer. It works by blocking the action of certain proteins in cancer cells, which can slow down or stop their growth. This medication is part of the initial treatment phase to help reduce the number of cancer cells in the body.
Lenalidomide
is another medication used in this trial. It helps the immune system fight cancer by affecting the way the immune cells work. It can also stop the growth of new blood vessels that tumors need to grow. In this study, it is used during different phases of treatment to help control the disease and maintain the response to therapy.
Dexamethasone
is a type of steroid used in this trial. It helps reduce inflammation and can also kill cancer cells. In this study, it is used alongside other medications to enhance their effects and help manage the disease more effectively.
Melphalan
is a chemotherapy drug used in this trial during the high-dose therapy phase. It works by damaging the DNA of cancer cells, which can prevent them from dividing and growing. This medication is used before the stem cell transplant to help eliminate as many cancer cells as possible.

What is already known about the treatment

Carfilzomib
Carfilzomib is administered intravenously, meaning it is given directly into a vein through an injection. It is currently being studied in clinical trials for its effectiveness in treating smoldering multiple myeloma, a condition with a high risk of progressing to symptomatic myeloma. Carfilzomib works by blocking the action of proteasomes, which are structures inside cells that break down proteins. By inhibiting these proteasomes, carfilzomib causes an accumulation of proteins within the cancer cells, leading to their death. It is classified as a proteasome inhibitor in pharmacology.
Lenalidomide
Lenalidomide is taken orally in the form of a capsule. It is being used in clinical trials to treat smoldering multiple myeloma, a precursor to more severe forms of myeloma. Lenalidomide works by modulating the immune system and directly attacking cancer cells, which helps to slow down or stop their growth. It belongs to a class of drugs known as immunomodulatory agents.
Dexamethasone
Dexamethasone is administered orally or intravenously, depending on the specific treatment plan. It is part of clinical trials for treating smoldering multiple myeloma, a condition that can develop into a more aggressive form of myeloma. Dexamethasone is a corticosteroid that reduces inflammation and suppresses the immune system, which can help control the growth of cancer cells. It is classified as a glucocorticoid in pharmacology.
Melphalan
Melphalan is given intravenously, typically as part of a high-dose chemotherapy regimen. It is used in clinical trials for patients with smoldering multiple myeloma at high risk of progression. Melphalan works by damaging the DNA of cancer cells, which prevents them from dividing and growing. It is classified as an alkylating agent in pharmacology.

Investigated diseases

Smoldering Multiple Myeloma – Smoldering multiple myeloma is a condition characterized by the presence of abnormal plasma cells in the bone marrow, which produce a monoclonal protein. It is considered an early or asymptomatic form of multiple myeloma, where the disease is present but not causing symptoms. Over time, the condition can progress to symptomatic multiple myeloma, where symptoms such as bone pain, anemia, and kidney dysfunction may occur. The progression is marked by an increase in the number of abnormal plasma cells and the amount of monoclonal protein. Monitoring is essential to detect any changes that indicate progression to active disease. The condition is typically identified through blood tests and bone marrow examination.