Study Comparing Carfilzomib, Lenalidomide, and Dexamethasone with Lenalidomide and Dexamethasone for Newly Diagnosed Multiple Myeloma Patients Ineligible for Transplant

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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 specifically for patients who have been newly diagnosed with multiple myeloma and are not eligible for a procedure known as autologous stem cell transplantation. The trial aims to compare two different treatment combinations. One group of patients will receive a combination of three medications: Carfilzomib, Lenalidomide, and Dexamethasone, referred to as KRd. The other group will receive a combination of two medications: Lenalidomide and Dexamethasone, referred to as Rd. Carfilzomib is a medication that helps to block certain proteins in cancer cells, while Lenalidomide and Dexamethasone are used to help control the growth of cancer cells and reduce inflammation.

The purpose of the study is to determine how effective the addition of Carfilzomib is to the Lenalidomide-Dexamethasone combination in treating newly diagnosed multiple myeloma patients. The study will observe patients over a period of time to see how well the treatments work in reducing the cancer and improving patient outcomes. Patients will be randomly assigned to one of the two treatment groups and will receive their respective treatments. The study will monitor the patients’ health and response to the treatment over the course of the trial.

Throughout the study, patients will have regular check-ups and assessments to track their progress and any changes in their condition. The trial will also look at various factors such as the quality of life of the patients, the side effects of the treatments, and how long the treatments remain effective. The study is expected to provide valuable information on the best treatment options for patients with multiple myeloma who are not eligible for stem cell transplantation.

1 randomization

Upon joining the study, you will be randomly assigned to one of two treatment groups. This process ensures that each participant has an equal chance of receiving either the experimental treatment or the standard treatment.

2 treatment initiation

If assigned to the experimental group, you will receive a combination of carfilzomib, lenalidomide, and dexamethasone. Carfilzomib is administered as a solution for infusion, while lenalidomide and dexamethasone are taken orally in capsule form.

If assigned to the standard group, you will receive lenalidomide and dexamethasone orally.

3 medication schedule

The specific dosage and frequency of each medication will be determined by the study protocol and your healthcare provider. It is important to follow the prescribed schedule to ensure the effectiveness of the treatment.

4 monitoring and assessments

Regular monitoring will be conducted to assess your response to the treatment. This includes blood tests, imaging studies, and other evaluations as needed.

Bone marrow samples will be collected after 1 and 2 years of treatment to evaluate the presence of minimal residual disease (MRD).

5 follow-up

Your progress will be tracked throughout the study, with follow-up visits scheduled to monitor your health and any side effects from the treatment.

The study aims to determine the progression-free survival (PFS) and overall survival (OS) among participants.

6 completion

The study is expected to conclude by May 2025. At the end of the study, a final assessment will be conducted to evaluate the overall outcomes and any long-term effects of the treatment.

Who Can Join the Study?

The patient must have a new diagnosis of Multiple Myeloma (a type of blood cancer).
The patient should be 65 years or older or not suitable for ASCT (a procedure where a patient’s own stem cells are used).
The patient must have symptoms based on CRAB criteria: high calcium levels, kidney problems, low red blood cells, or bone damage.
The patient should have at least 10% of plasma cells in the bone marrow.
The patient must have a left ventricular ejection fraction (LVEF) of 40% or more, which is a measure of heart function.
The patient’s blood pressure should be less than 140/90 mmHg even with treatment.
Females who can have children must follow a Pregnancy Prevention Plan and use effective birth control.
Males must use a barrier method of birth control if sexually active with females who can have children.
The patient must be considered fit or intermediate according to a specific health score.
The patient must provide written informed consent to participate.
The patient must be able to attend hospital visits and follow the study procedures.
The patient must agree to use acceptable methods of birth control.
The patient must have a measurable disease according to specific criteria.
The patient must have an ECOG performance status of less than 3, which measures daily living abilities.
The patient must have certain laboratory values within specific limits, such as platelet count, neutrophil count, calcium levels, liver enzymes, and kidney function.

Who Cannot Join the Study?

Patients who have a different type of cancer or medical condition that is not related to multiple myeloma. Multiple myeloma is a type of blood cancer.
Patients who are eligible for autologous stem cell transplantation (ASCT). This is a procedure where a patient’s own stem cells are used to replace damaged or destroyed bone marrow.
Patients who are under 65 years old, unless they are not eligible for ASCT.
Patients who are unable to follow the study procedures or take the study medications as required.
Patients who have any other medical condition that the study doctors believe would make it unsafe for them to participate.
Patients who are pregnant or breastfeeding, as the study medications may not be safe for the baby.
Patients who have participated in another clinical trial recently, which might interfere with the results of this study.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country
Azienda Ospedaliero Universitaria Careggi	Florence	Italy
IRCCS Humanitas Research Hospital	Rozzano	Italy
Azienda Ospedaliero Universitaria Consorziale Policlinico di Bari	Bari	Italy

Other Sites

Site Name	City	Country
Istituto Europeo Di Oncologia S.r.l.	Milan	Italy
Casa Sollievo Della Sofferenza	San Giovanni Rotondo	Italy
Azienda Ospedaliera S Maria Di Terni	Terni	Italy
Azienda Sanitaria Universitaria Friuli Centrale	Udine	Italy
Hospital Santa Maria Della Misericordia	Perugia	Italy
Grande Ospedale Metropolitano Bianchi Melacrino Morelli	Reggio Calabria	Italy
Azienda Ospedaliera Papardo	Messina	Italy
ASST Grande Ospedale Metropolitano Niguarda	Milan	Italy
Istituto Di Candiolo Fondazione Del Piemonte Per Loncologia IRCCS	Candiolo	Italy
Universita’ Politecnica Delle Marche	Ancona	Italy
Azienda Ospedaliero-Universitaria Maggiore Della Carita	Novara	Italy
ARNAS G. Brotzu	Cagliari	Italy
Azienda Unita Sanitaria Locale Della Romagna	Faenza	Italy
Azienda Sanitaria Territoriale Di Ascoli Piceno	Ascoli Piceno	Italy
Universita Degli Studi Di Brescia	Brescia	Italy
Fondazione I.R.C.C.S. Istituto Neurologico Besta	Milan	Italy
IRCCS CROB	Rionero In Vulture	Italy
Aqkyplu Okuvaqifepm Ogxjxdwe Rwikoht Vtnin Srebp Ctgqcuma	Palermo	Italy
Iyucdour Rrtzfqwge Pfu Ln Spfmhd Dfj Tqsyqx Dlap Atmwumw Ijpf Sksgjh	Meldola	Italy
Atjtyzh Oqeimiegwhi Uozbdmluuqhaz Czotprvqobvf Dathu Sggrfd E Docja Sgcigqm Dq Txsnck	Turin	Italy
Aninhjg Ubs Iyjnz Dj Rmjbsu Edpark	Reggio Emilia	Italy
Aodjcsp Oomjphgejzd Piil Groakfkr Xkcbq	Bergamo	Italy
Ufpdslclly Dbjzo Sljcj Ds Rpve Li Swnrxldw	Rome	Italy

Trial status

Country	Status	Recruitment Start
Italy	Not recruiting	01.05.2019

Trial locations

Investigated drugs:

Carfilzomib is a medication used in this trial to treat multiple myeloma. It works by blocking certain proteins in cancer cells, which can help to stop their growth and lead to their death. In this study, Carfilzomib is being added to a standard treatment to see if it improves outcomes for patients who are not eligible for a stem cell transplant.

Lenalidomide is a medication that helps the immune system attack cancer cells and also prevents the growth of new blood vessels that tumors need to grow. It is part of the standard treatment for multiple myeloma and is being used in both groups of this trial to compare its effectiveness with and without Carfilzomib.

Dexamethasone is a type of steroid that reduces inflammation and helps to control the immune system. It is used in combination with other medications to treat multiple myeloma by helping to reduce the number of cancer cells in the body. In this trial, it is used alongside Lenalidomide and Carfilzomib to evaluate the best treatment approach.

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. In this disease, cancerous plasma cells multiply and crowd out healthy blood cells, leading to problems like anemia, bone damage, and kidney issues. As the disease progresses, it can cause bone pain, frequent infections, and fatigue due to the overproduction of abnormal proteins. These proteins can also lead to kidney damage and other organ dysfunctions. The disease often progresses slowly, but it can become more aggressive over time. It is typically diagnosed in older adults and is not considered a rare disease.

Trial ID:

2024-513396-41-00

Protocol code:

EMN20

NCT ID:

NCT04096066

Trial Phase:

Therapeutic confirmatory (Phase III)

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Study Comparing Carfilzomib, Lenalidomide, and Dexamethasone with Lenalidomide and Dexamethasone for Newly Diagnosed Multiple Myeloma Patients Ineligible for Transplant

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?